Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS) - Feasibility Sub-Study
Phase: NA
Conditions: Suicide
Sponsor: Duke University

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page i of 103 
 
Comprehensive Adaptive Multisite Prevention of University student Suicide 
(CAMPUS): A Multisite Trial 
NCT04728815 
 
Protocol Number 
2.7 
Date 
08 April 2023 
National Clinical Trial (NCT) Identified Number 
Pending 
Funding Organization 
National Institutes of Health (NIH)/ 
National Institute of Mental Health (NIMH) 
Principal Investigators/ Participating Sites/ 
Grant numbers 
Jacqueline Pistorello, PhD 
University of Nevada, Reno (R01-MH116052) 
Address: Counseling Services, Pennington Student 
Achievement Center, Suite 420, Mailstop 0080, 
Reno, NV 89557-0080 
Email: pistorel@unr.edu 
Telephone: (775) 682-9620 
 
Scott Compton, PhD 
Duke University Medical Center (R01-MH116062) 
Address: 2608 Erwin Road, Durham NC 27705 
Email: compt004@duke.edu 
Office Telephone: (919) 668-0063 
 
John Seeley, PhD 
University of Oregon (R01-MH116050) 
Address: 340 HEDCO Building, 5261 University of 
Oregon, Eugene, OR 97403 
Email: jseeley@uoregon.edu 
Telephone: 541-346-3005 
 
Shireen Rizvi, PhD  
Rutgers University (R01-MH116061) 
Address: 152 Frelinghuysen Road, Piscataway, NJ 
08854 
Email: slrizvi@gsapp.rutgers.edu 
Telephone: 848-445-3914 
Data Coordinating Center 
Duke Data Center (DDC), Duke University Medical 
Center 
sIRB  
Duke University Medical Center 
 
 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
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Table of Contents 
Table of Contents .................................................................................................................................................... ii 
STATEMENT OF COMPLIANCE ............................................................................................................................. 4 
1 
PROTOCOL SUMMARY ............................................................................................................................... 5 
1.1 
Synopsis ................................................................................................................................................ 5 
1.2 
Schema and Adpative Treatment Strategies ................................................................................... 9 
1.3 
Schedule of Activities ........................................................................................................................ 10 
2 
INTRODUCTION .......................................................................................................................................... 14 
2.1 
Study Rationale .................................................................................................................................. 14 
2.1.1 
campus Trial ................................................................................................................... 14 
2.2 
Background......................................................................................................................................... 15 
2.3 
Risk/Benefit Assessment .................................................................................................................. 20 
2.3.1 
Known Potential Risks ................................................................................................... 20 
2.3.2 
Known Potential Benefits .............................................................................................. 21 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 22 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 26 
4 
STUDY DESIGN ........................................................................................................................................... 29 
4.1 
The Study Teams(s) .......................................................................................................................... 29 
4.2 
Overall Design .................................................................................................................................... 30 
4.3 
Scientific Rationale for Study Design.............................................................................................. 30 
4.4 
Justification for Intervention ............................................................................................................. 31 
4.5 
End-of-Study Definition ..................................................................................................................... 32 
5 
STUDY POPULATION ................................................................................................................................ 33 
5.1 
Inclusion Criteria ................................................................................................................................ 33 
5.2 
Exclusion Criteria ............................................................................................................................... 34 
5.3 
Screen Failures .................................................................................................................................. 34 
5.4 
Strategies for Recruitment and Retention ...................................................................................... 34 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 36 
6.1 
Study Intervention(s) ......................................................................................................................... 36 
6.1.1 
Pre-screening ................................................................................................................. 36 
6.1.2 
Screening ........................................................................................................................ 37 
6.1.3 
Baseline 37 
6.1.4 
randomization ................................................................................................................. 37 
6.1.5 
Study Intervention Description ..................................................................................... 38 
6.1.6 
ADMINISTRATION AND/or dosing ............................................................................. 39 
6.2 
Fidelity ................................................................................................................................................. 40 
6.2.1 
Interventionist Training and Tracking .......................................................................... 40 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 41 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 41 
6.5 
Concomitant Therapy ........................................................................................................................ 41 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 42 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 42 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 42 
7.3 
Lost to Follow-Up ............................................................................................................................... 43 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 44 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 44 
8.2 
Safety Assessments .......................................................................................................................... 48 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 49 
8.3.1 
Definition of Adverse Events ........................................................................................ 49 

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8.3.2 
Definition of Serious Adverse Events .......................................................................... 50 
8.3.3 
Classification of an Adverse Event .............................................................................. 50 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 52 
8.3.5 
Event Reporting .............................................................................................................. 52 
8.4 
Unanticipated Problems .................................................................................................................... 54 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 54 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 55 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 55 
9.1 
campus trial Statistical Hypotheses ................................................................................................ 55 
9.2 
campus trial Sample Size Determination ....................................................................................... 56 
9.3 
campus trial Statistical Analyses ..................................................................................................... 57 
9.3.1 
General Approach .......................................................................................................... 57 
9.3.2 
Analysis of the Primary Endpoint(s) ............................................................................ 57 
9.3.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 59 
9.3.4 
Baseline Descriptive Statistics ..................................................................................... 60 
9.3.5 
Planned Interim Analyses ............................................................................................. 60 
9.3.6 
Sub-Group Analyses ..................................................................................................... 60 
9.3.7 
Exploratory Analyses ..................................................................................................... 60 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 62 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 62 
10.1.1 
Informed Consent Process ........................................................................................... 62 
10.1.2 
Study Discontinuation and Closure ............................................................................. 64 
10.1.3 
Confidentiality and Privacy ........................................................................................... 64 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 64 
10.1.5 
Key Roles and Study Governance .............................................................................. 65 
10.1.6 
Safety Oversight ............................................................................................................. 67 
10.1.7 
Clinical Monitoring .......................................................................................................... 67 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 67 
10.1.9 
Data Handling and Record Keeping ............................................................................ 70 
10.1.10 
Protocol Deviations ........................................................................................................ 71 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 71 
10.1.12 
Conflict of Interest Policy .............................................................................................. 72 
10.2 
Abbreviations and Special Terms ................................................................................................... 73 
10.3 
Protocol Amendment History ........................................................................................................... 76 
11 
REFERENCES ............................................................................................................................................. 94 
 

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Version Date: 08 April 2023 
 
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STATEMENT OF COMPLIANCE 
This trial will be conducted in compliance with the following protocol, International Conference on 
Harmonization Guidance for Industry, Good Clinical Practice: Consolidated Guidance (ICH E6), applicable 
Code of Federal Regulations, and the National Institute of Mental Health (NIMH) Terms of Award. The 
Principal Investigator (PI) will ensure that no deviation from, or changes to, the protocol will take place 
without prior agreement from the sponsor and funding agency and documented approval from the 
Institutional Review Board (IRB), except where necessary to eliminate immediate hazard(s) to trial 
participants. All personnel involved in the conduct of this study have completed Human Subjects 
Protection and Good Clinical Practice (GCP) Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) will 
be obtained before any participant is enrolled. Any amendment to the protocol will require review and 
approval by the IRB before changes are implemented to the study. All changes to the consent form will 
be IRB approved; a determination will be made regarding whether a new consent needs to be obtained 
from participants who provided consent, using a previously approved consent form. 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Comprehensive Adaptive Multisite Prevention of University student 
Suicide (CAMPUS): A Multisite Trial  
Study Description: 
Suicide is the 2nd leading cause of death among college students and 
suicidal ideation and suicide-related behaviors are a frequent 
presenting problem at college counseling centers (CCCs), which are 
overburdened. Studies show that some students respond rapidly to 
treatment, whereas others require considerably more resources. 
Evidence-based adaptive treatment strategies (ATSs) are needed to 
address this heterogeneity in responsivity and complexity. ATSs 
individualize treatment via decision rules specifying how the type and 
intensity of an intervention can be sequenced based on risk factors, 
response, or compliance.  
In the wake of the COVID-19 pandemic, CCCs are now offering 
teletherapy to address the mental health needs of students. This rapid 
transition to teletherapy service delivery within CCCs has clear 
implications for the CAMPUS Trial. The goal of the original 
Collaborative R01 study was to evaluate 4 adaptive treatment 
sequences (ATSs) when delivered entirely in person. Because of the 
need for CCCs to begin offering therapeutic services online and the 
reality that teletherapy will continue beyond the near future, the 
results from the original CAMPUS Trial would be less relevant and 
informative to CCCs of the future.  
Therefore, we conducted a multi-site feasibility study which was a 
small-scale, modified version of the larger trial used to 1) evaluate the 
feasibility and acceptability of the interventions when delivered via a 
hybrid model and (2) to fine-tune online study procedures, including 
recruitment, training, supervision, interventions, assessments, data 
collection, and safety monitoring. Based on data from the feasibility 
study, we are proposing to modify our original design. Like the 
feasibility study, the modified CAMPUS Trial will use a hybrid 
treatment model, which will evaluate the relative effectiveness of 
treatment when delivered either via telehealth, in person, or a 
combination, and transition study procedures to an online format. 
Decisions about what type of sessions to hold will be made by the 
counselor and based on several factors, including university and CCC 
policy, location/preference of the student participant, and 

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location/preference of the counselor participant. In addition, we are 
proposing modifications to the overall length of the trial and the 
treatments to better fit within the CCC setting.  
The multisite CAMPUS Trial will enroll moderately to severely suicidal 
college students in the “emerging adulthood” phase (ages 18-25) 
seeking services at CCCs and evaluate the relative effectiveness of the 
adaptive treatment strategies (ATSs) when delivered via a hybrid 
model. The four ATSs will be developed and refined within the context 
of the current sequential multiple assignment randomized trial 
(SMART). The SMART will have two stages of intervention. In Stage 1, 
480 participants from the participating CCCs will be randomized to 4-6 
weeks of: (1) a suicide-focused treatment – Collaborative Assessment 
and Management of Suicidality (CAMS) or (2) Treatment as Usual 
(TAU).  
Sufficient responders to either intervention will enter the 
maintenance phase. Non-responders will be re-randomized to one of 
two Stage 2 higher intensity/dosage intervention options for an 
additional 1-8 weeks: (1) CAMS (either continued or administered for 
the first time) or (2) Counseling Center Dialectical Behavior Therapy 
Dialectical Behavioral Therapy for College Counseling settings (CC-
DBT), which includes individual therapy and skills training. 
For the CAMPUS Trial, we will also enroll up to 40 CCC counselors who 
will serve as study counselor participants and periodically complete 
measures focused on the experience of counselors working with 
suicidal college students. 
Objectives: 
The overall purpose of the multisite CAMPUS Trial is to evaluate the 
relative effectiveness of four adaptive treatment strategies (ATSs) to 
treat college students who report suicidal ideation when first seeking 
services at their college counseling center.  
The CAMPUS Trial aims to identify which sequence(s) of treatments 
are most effective on average (average treatment effect or ATE), 
which treatment sequence(s) are most cost-effective for college 
counseling centers to provide, and whether outcomes vary based on 
key student characteristics (heterogeneity of treatment effect or HTE). 
Another aim of the CAMPUS Trial is to assess counselor participants’ 
experience of participating in the study and providing treatment to 
suicidal college students, including examining their expectations for 
therapy and beliefs about suicide. These analyses will be qualitative 
and exploratory in nature and will not have specified hypotheses. 

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Endpoints: 
Primary Endpoints/Outcome Measures: The primary endpoint for the 
CAMPUS Trial is reduction in suicidal risk at the end of Stage 1 
treatment, Stage 2 treatment, and at 3-month follow-up. Differences 
in suicidal risk will be operationally defined as changes in suicidal 
ideation, non-suicidal self-injury, and suicide attempts, as well as 
differences in deaths by suicide. 
Secondary Endpoints/Outcome Measures: Secondary outcomes for 
the CAMPUS Trial are changes in overall distress, depression, social 
and generalized anxiety, substance abuse, eating concerns, academic 
functioning, health care utilization, and student participant ratings of 
severity and improvement in suicidal risk. 
Study Population: 
Recruitment of 480 college students (aged 18-25) is the target for 
randomization to Stage 1 treatments. Up to 40 counselors will also be 
recruited to participate as study therapists. The number of counselor 
participants may increase or decrease throughout the project based 
on turnover, but we expect to maintain approximately 24 participating 
counselors at any given time across the participating sites in each of 
the enrollment years. 
Phase or Stage: 
Phase III Clinical Trial 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
This multisite study will include the following four primary sites: 
University of Nevada – Reno, Duke University, University of Oregon, 
and Rutgers University. Research will be conducted at each site 
through each College Counseling Center (CCC). The Single IRB will be 
sponsored and overseen by Duke University. Other CCCs may be 
added as performance sites in the future to increase enrollment 
numbers as needed. 
Description of Study 
Intervention/ 
Experimental 
Manipulation: 
The multisite study will utilize a SMART design. Suicidal college 
students seeking counseling services through the College Counseling 
Centers (CCCs) will be recruited.  
In Stage 1, student participants will be initially randomized into either 
treatment as usual (TAU) or Collaborative Assessment and 
Management of Suicidality (CAMS). Student participants receiving TAU 
will receive the customary treatment they would receive at the CCC. 
Student participants receiving the CAMS intervention will receive 
CAMS through weekly sessions with a counselor that will last for 50-60 
minutes.  
Responders to either CAMS or TAU may stop treatment after 4 
sessions (minimum dose of treatment), based on counselors’ ratings 

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of improvement of students’ symptoms of suicidality. Stage 1 has an 
intended duration of no more than 6 weeks.  
Non-responders to Stage 1 treatments will be re-randomized to one of 
two Stage 2 treatments: CAMS or College Counseling Dialectical 
Behavior Therapy (CC-DBT). Student participants receiving CC-DBT will 
engage in individual therapy and either a skills training group or 
individual skills training. Stage 2 has an intended treatment duration 
of 1-8 weeks.  
All treatment in Stage 1 and Stage 2 (TAU, CAMS, and CC-DBT) will be 
administered via a hybrid intervention model, either online or in 
person. For the purposes of these studies, a hybrid intervention model 
means that a student participant’s course of care may be delivered 
completely via telehealth, completely in person, or via a combination 
of in person and telehealth sessions. Decisions about what type or 
format of sessions to hold will be made by the counselor and based on 
several factors: university policy, CCC policy, location of 
student/counselor participants, and preference of the 
student/counselor participants. Data will be collected on the number 
of sessions conducted via each modality (captured via EHR). Such data 
will be explored to inform more richly tailored ATSs. 
Counselors will provide TAU, CAMS, and CC-DBT to study participants. 
They will also participate in CAMS and CC-DBT trainings and ongoing 
consultation teams for each. In addition, counselors will complete 
questionnaires at regular intervals throughout their participation in 
the study. 
Study Duration: 
The duration of the CAMPUS Trial is approximately 30 months (2.5 
years) total duration from beginning of recruitment until final data 
collection. 
Participant Duration: Total student participant duration is 26 weeks, which includes a 12-
week follow-up assessment. Total student participant duration in 
active treatment can range from 4-14 academic weeks (not including 
campus holiday breaks or periods where students are ineligible for 
CCC services due to being out of state). Counselor participant duration 
will range from 1-2 years. 
 
 

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1.2 
SCHEMA AND ADPATIVE TREATMENT STRATEGIES 
 

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1.3 
SCHEDULE OF ACTIVITIES 
All participants will self-refer to an initial appointment (i.e., intake) at their CCC, and as part of 
standard operating procedures will meet with an intake counselor, either in-person or remotely 
following practices of the CCC, as a first step to access CCC services. As part of the CCC’s 
standard clinic workflow, all students seeking services will complete the Counseling Center 
Assessment of Psychological Symptoms (CCAPS-62). Students who meet inclusion and exclusion 
criteria will be given a brief explanation of the study by the intake counselor. Interested 
students will be scheduled for an appointment conducted either in-person or remotely with a 
member of the research who will review the consent form with each student. Students who 
sign the consent form will then complete a baseline assessment with the Independent 
Evaluator (IE), either online or in-person. 
The schedule of activities for the CAMPUS Trial is presented in Table 1 on the next page.  
 

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Version Date: 08 April 2023 
 
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Table 1. Schedule of Activities for the CAMPUS Trial 
 
 
 
Stage 1 
Stage 2 
 
 
-1 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
26 
Completed by CCC Intake Counselor 
Screening Data Form* 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Completed by Student Participants 
Demographic Information 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sexual Orientation and Gender Identity  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Counseling Center Assessment of Psychological Symptoms (CCAPS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical Global Impression – Severity (CGI-S) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Clinical Global Impression – Improvement (CGI-I) 
 
 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Adverse Events and Serious Adverse Events (AE/SAE) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Difficulties in Emotional Regulation Scale (DERS) 
 
X 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
DBT Ways of Coping Checklist (WCCL) 
 
X 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Acceptance and Action Questionnaire (AAQ) 
 
X 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Suicide Cognitions Scale (SCS) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Self-Efficacy for Managing Emotions  
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Optimism Hope Scale (OHS) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Personality Assessment Inventory-Borderline Features Scale (PAI-BOR) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Life Stressor Checklist-Revised (LSC-R) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Drug Abuse Screening Test (DAST) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Alcohol Use Disorders Identification Test (AUDIT) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Student Treatment Credibility Questionnaire (STCQ) 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Student Treatment Expectations Questionnaire (STEQ) 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Client Satisfaction Questionnaire (CSQ) 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
Academic Functioning 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Completed by Independent Evaluators 
University of Washington Risk Assessment Protocol (UWRAP) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Clinical Global Impression – Severity (CGI-S) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 

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Table 1. Schedule of Activities for the CAMPUS Trial 
 
 
 
Stage 1 
Stage 2 
 
 
-1 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
26 
Clinical Global Impression – Improvement (CGI-I) 
 
 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Scale for Suicidal Ideation (SSI) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Self-Injurious Thoughts and Behaviors Interview (SITBI) 
 
X 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Global Assessment Scale (GAS) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Treatment History Interview (THI) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Completed by Research Staff 
Informed Consent 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Checklist 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CAMS Rating Scale-31 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DBT Adherence Rating Scale1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Completed by Counselor Participants 
Reveal Randomization 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Demographic Information Form (DIF)2 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment Compliance Item* 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
AE/SAE Summary Form 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Clinical Global Impression – Severity (CGI-S) 3 
 
 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
Clinical Global Impression – Improvement (CGI-I) 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Treatment Assignment Reaction Form 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Counselor Treatment Expectations Questionnaire (CTEQ) 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Client Satisfaction Questionnaire-Counselor (CSQ-C) and Counselor Satisfaction Rating3 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
Reasons for Termination Checklist3 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
TAU Questionnaire3 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Counselor Telehealth Questionnaires (CTSQ)3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Zero Suicide Workforce Survey- Abbreviated (ZSWS)4 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Focused Interview5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 

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Table 1. Schedule of Activities for the CAMPUS Trial 
 
 
 
Stage 1 
Stage 2 
 
 
-1 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
26 
Notes (1): 1. Research staff will complete this measure on a random sample of therapy sessions. 2. Counselor participants will complete this measure once when they enter the study. 3. Counselor 
participants will complete this measure following students’ last treatment session which may be earlier than Week 14. 4. Counselor participants will complete this measure at the start of their 
participation in the study and then every six months. 5. Counselor participants will complete this interview at the end of their participation in the study. 
Notes (2): §For all assessments collected as part of an Independent Evaluator (IE) visit (i.e., those assessments not collected specifically at treatment visits), there will be a +/-1 week window around 
the scheduled assessment date for purposes of data collection. IE assessments collected outside of this window will still be collected and values will be imputed based on when the assessment should 
have occurred.  
Notes (3): *These measures are exclusively collected in the Titanium electronic medical record and will be exported at regular intervals throughout the study period. 
 

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2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE 
2.1.1 CAMPUS TRIAL  
Suicidal College Students Represent a Major Public Health Concern 
Among college students, suicide is the second leading cause of death;20 10% of college students 
report having attempted suicide in their lifetime with 2% attempting in the last year alone.38 
Suicidal ideation (SI) is even more frequent: 25% of students report a history of severe SI, 
including 10% in the last year.38 These numbers are climbing among college students—not 
surprising considering that suicide rates among individuals 10-24 years old has been trending 
up since 2007.39,40 Some students, particularly those who self-identify as sexual and gender 
minorities (SGM), such as transgender or non-binary/genderqueer, lesbian, gay, bisexual, and 
queer (or other self-identity) may be at even higher risk.18,19  
 
CCCs are the front line for mental health services for growing numbers of suicidal students.22,41 
Yet CCCs face limited resources42 and higher demand for services with increasingly complex 
cases,21,43 with more than half reporting that waitlists develop within a few weeks and last 
throughout the term.25 Despite aspiring to provide only brief therapy,22 data show that in 
practice CCCs are providing 20 sessions or more to a segment of their student population,44 20% 
of students have been shown to use 50% of counseling resources,45 and highly distressed 
students appear to need a higher number of sessions.46 Suicidal risk (SR) is likely a key culprit of 
this crisis: one third of treatment seeking students report SI—20% of those at clinical levels in 
the last year,21 SI has become a primary presentation at CCCs,43 CCC resources devoted to 
“rapid access” services have increased by 28%,21 and threat-to-life students use 20-30% more 
services than other students.21 Chronically suicidal students greatly strain CCC resources.21,47 
The stakes are also high when suicide occurs on a campus.26 CCCs are commonly held directly 
accountable in malpractice litigation and administrators are realizing that untreated suicidality 
puts the entire institution at risk. Many severely suicidal students remain in school,21 which, in 
fact, has suicide-protective benefits at a population level.48,4 Having a validated, cost-effective, 
evidence-based approach to treating suicidal students would be very helpful to CCCs.26 
Importantly, suicidal college students are not a homogeneous group. They vary in risk and 
response to treatment and thus a “one size fits all” approach to treatment is not effective for 
this heterogeneous population.50 While many students experience an isolated suicidal episode, 
40-50% of severely suicidal students report multiple episodes of SI.51 In a sample of CCC 
treatment-seeking suicidal students, 52% quickly resolved suicidality in 6-7 sessions, while 
others remained suicidal (17%), dropped out of care (22%), or were hospitalized (7%).27 Thus, 
some suicidal students require more intensive forms of treatment while most respond to 
briefer forms of care.46 It has become imperative to identify an appropriate sequence of 
evidence-based interventions to address SR in CCCs, matched to different levels of severity 
and/or responses to treatment, to optimize clinical care and resource efficiency. 
 
 

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Addressing suicidal risk in college students today will help society in the future 
There are additional reasons to address SR in college students: 1) evidence-based approaches 
for this population apply to a large and diverse population given that 49% of 18-to-24-year-olds 
are enrolled in college and rates of non-white students are rapidly increasing;52 2) the emerging 
adulthood period (18-25 years of age) is developmentally significant53,54–with poor adjustment 
and mental health problems having lifelong consequences,55,56 thus successful treatment may 
impact years of downstream public health costs; and 3) today’s college students are 
tomorrow’s likely leaders–society at large has a stake in their mental health. Although college 
students have often been studied as a convenience sample, that’s not the case in this study. 
Something critical is happening with college students right now, that includes increased suicidal 
thinking and behavior as well as other mental health problems and reduced resilience/skillful 
behavior, which are thankfully combined with less stigma towards mental health treatment.57 
There are many pathways to suicide,58 and large-scale studies like this can give us the 
opportunity not only to prevent suicidal behaviors but also to understand how best to help 
students. 
2.2 
BACKGROUND  
This Project Will Test Adaptive Treatment Strategies for Suicidal College Students 
There is no empirical guidance on how to treat the heterogeneity of suicidal students seeking 
services at CCCs.26 CCCs would benefit significantly from understanding how to sequence 
individualized care—which treatments work best and how intensive do they need to be? In 
recent years, adaptive treatment strategies (ATSs)28 have been investigated using 
methodological innovations such as sequential multiple assignment randomized trials 
(SMARTs).17,59 We are proposing to investigate sequences of suicide-focused treatments that 
could be utilized in CCCs to treat and/or triage a wide range of college students presenting with 
SR. Moreover, the study will significantly add to the current literature by evaluating treatments 
when delivered in a hybrid online/in-person format and will better reflect the actual practice 
within CCCs. Although there are other empirically supported suicide-focused approaches,60 the 
two approaches described below were specifically selected for inclusion because they 1) have 
already been tested at a CCC, 2) have moderate to considerable empirical validation, and 3) 
complement each other well when implemented in a stepped care fashion. 
 
1) Collaborative Assessment and Management of Suicidality (CAMS)7 is an evidence-based, 
suicide-focused approach61 that was first developed and studied in a CCC specifically for college 
students.62 CAMS is a problem-focused treatment that targets client-defined suicidal “drivers” 
or issues that lead to SI.7 Central to CAMS is the use of the Suicide Status Form (SSF), a 
multipurpose clinical assessment, treatment planning, tracking, and outcome tool.7 The SSF 
serves as a clinical roadmap to guide collaboration as counselor and client sit next to each other 
exploring SR through quantitative/qualitative assessments and suicide-specific treatment 
planning. All CAMS sessions begin with a consideration of the “SSF Core Assessment.” Sessions 
then focus on the CAMS Stabilization Plan (CSP) and the client’s suicidal drivers. All sessions end 
by updating the CSP and problem-focused care targeting suicidal drivers. CAMS is theoretically 
agnostic; counselors use their own approach to treating patient-identified suicidal drivers. Eight 

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open clinical trials of CAMS have shown significant reductions in SR and overall distress,63 two 
of these with college students.27,64 Furthermore, four RCTs have found that CAMS reduced SI 
compared to control care-as-usual,65 led to reductions in overall distress while increasing hope 
and patient satisfaction in comparison to control care,66 performed similarly to DBT in terms of 
reductions in NSSI and suicide attempts (SAs),67 and reduced SI and depression more than 
TAU4—the latter specifically with college students. 
 
CCCs need an efficient and effective stepped-care approach to treating suicidal students, 
delivering more intensive treatments only to those who need it. CAMS is flexible and easy to 
train and thus may be an ideal first-line intervention; moreover, a large proportion of CCCs 
report already using CAMS.43 While there are other empirically-based suicide-focused 
approaches,68,69 they have either not been tested within a CCC and/or require more extensive 
training than CAMS. The adaptive approach we are proposing fits with the recommendations70 
supporting the Zero Suicide policy initiative:71 (a) target suicidal ideation and behaviors instead 
of mental disorders, (b) train counselors to deal directly with SR, and (c) base clinical care on SR 
stratification and evidence-based suicide-specific interventions. We hypothesize that starting 
with CAMS, then ending treatment/entering maintenance if student participants resolve their 
SR or switching to a more intensive treatment if there is an insufficient early response would be 
ideal ATSs for suicidal students. 
 
2) Dialectical Behavior Therapy 8,29 adapted for the college counseling center environment (CC-
DBT). DBT is an empirically validated treatment for complex clinical presentations, including 
borderline personality disorder (BPD), SI, and NSSI. Comprehensive DBT (which includes 
individual therapy, skills group, between-session skills coaching, and peer consultation for 
counselors) produces gains for suicidal BPD patients across a variety of domains, including SI, 
BPD, SAs, NSSI, hospitalizations, and social functioning.15,72 DBT is based on a skills deficit model 
that suggests that BPD is a disorder of emotion dysregulation stemming from important deficits 
in interpersonal, emotion regulation, and distress tolerance skills. Suicidal behavior is viewed as 
maladaptive problem-solving behavior reinforced by either an immediate reduction in 
emotional arousal and/or by the environment’s response.29 Thus, DBT focuses on teaching 
skills, particularly emotion regulation, and facilitating the replacement of maladaptive 
behaviors with skillful behavior.  
 
The team has conducted the only RCT to date using comprehensive DBT for suicidal college 
students.10 Compared to an optimized control condition, 7-12 months of DBT led to significantly 
greater decreases in SI, depression, NSSI events, and BPD criteria, and greater improvements in 
social adjustment. DBT was particularly effective for suicidal students who were lower 
functioning at pretreatment. However, some students dropped out before the end of 
treatment due to improvement, suggesting that a less intensive and shorter approach might be 
adequate for a few students (see Preliminary Studies). Although there has only been one RCT 
with DBT at CCCs, open trials have also been conducted with DBT at CCCs,11,73 and more than a 
dozen studies have investigated the use of DBT skills groups in CCCs.9 A recent survey 
concluded that approximately one third of CCCs already use DBT,9 and a significant body of 

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research indicates that DBT is effective for the types of problems treated at CCCs.74 Our study 
will evaluate an adaptation of comprehensive DBT for college counseling centers (CC-DBT) as a 
second stage treatment for students who are insufficient responders to CAMS or TAU.  
 
The Proposed Methodology Is Innovative for Suicidal Risk (SR) Interventions 
As treatments for other mental health problems move to a remote format, there is also a 
critical need to develop best practices and treatments about how to clinically manage students 
online who are at risk for suicide.  
 
Adaptive Sequences of Care for Suicidal Students Have a High Potential for Subsequent 
Dissemination 
Both CAMS and DBT have been shown to reduce SR in college students10,75 and are already 
being implemented in CCCs.9,43 What remains to be seen is whether a sequence of care can be 
identified with clearly articulated decision points for optimal outcomes.25 The adaptive strategy 
proposed squarely fits within the brief therapy model on which most CCCs operate. Based on 
our feasibility pilot, we estimate that half of the student participants will resolve their SR in 
Stage 1 (within 4-6 sessions) comporting with the 6-session average in CCCs.21 Although 
providing an additional 1-8 sessions in Stage 2 for insufficient responders might appear to tax 
CCCs’ resources, longer-term care for a segment of the students (20+ sessions) is already 
happening,44 students presenting with threat-to-self are already using a third more services,44 
and removing suicidal students from campus incurs litigation risk76 as well as eliminates a 
potentially potent protective factor.26 Our adapted form of DBT (CC-DBT) is designed to 
disseminate within CCCs. This study will be informative about the most effective sequences of 
care for suicidal students and may inform which students to refer out to more intensive, longer-
term community approaches, such as comprehensive DBT. 
 
Importantly, this study might also identify student characteristics that would help predict who 
will be responsive to first-line approaches in general, or to specific first- and second-line 
approaches. Recent research has suggested that first-line suicide-focused approaches, such as 
CAMS, may be best suited for acute suicidal presentations, with individuals with lower 
complexity, such as less initial distress,33 fewer BPD criteria, and fewer than 2 suicide attempts. 
Other characteristics that might be indicative of greater risk, such as sexual and gender 
minorities (SGM), can also be explored. Although not many studies have been conducted with 
SGM and suicidality at CCCs, research has shown that transgender and nonbinary individuals 
are at higher risk for SI, suicide attempts (SAs), and death than the general population.18 
 
The economic cost-benefit ratio of identifying different sequences of care at CCCs to treat 
different suicidal states or profiles could be significant. It is possible that the implementation of 
a CAMS+DBT sequence of care may prove cost-effective to CCCs in several different ways. 
Identifying rapid responders to CAMS, for example, may reduce costs because some of these 
students may currently be receiving more treatment than needed. The provision of intensive 
services through DBT may reduce other costs, such as preventing school withdrawals77 or 
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To address the generalizability of the current study, we will examine the ATSs across sites that 
differ in terms of student diversity (ethnic, racial, national origin, sexual and gender identity), 
type of school (public vs. private), and geographic location (West, Pacific NW, South, and East 
Coast regions). The multisite trial will employ an effectiveness-implementation Hybrid Type 1 
design to examine both clinical effectiveness and implementation outcomes.37 The hybrid 
design will also allow the investigation of potential facilitators and barriers to implementing 
each of the adaptive strategies across the participating CCCs. 
 
This Multisite Study Will Elucidate Mechanisms of Change in Suicide-Focused Approaches 
While the identification of transdiagnostic mechanisms of change has become a high priority in 
suicide research, there is a paucity of research on mechanisms of change within suicide-focused 
treatments.79 Bryan80 has hypothesized that evidence-based treatments for suicidal risk (SR) 
share three common mechanisms of change: cognitive flexibility, emotion regulation, and 
cognitive reappraisal. This aligns with the CAMS and DBT literature.7,81 CAMS purports to create 
therapeutic change through an intentional collaborative approach to treatment: assessment of 
SR; suicide-specific treatment planning; deconstruction of, and problem-solving for, patient-
defined suicidal “drivers;” and an explicit focus on reasons for living.7 Thus, CAMS is entirely 
suicide-focused and known/predicted mediators of change include reductions in suicidal 
cognitions82 and suicide-focused attentional bias.82,83 The putative mechanisms unique to DBT 
are quite different: hierarchical targeting of problems, mindfulness, dialectical focus, emotion 
regulation, distress tolerance, counselor self-disclosure, chain analysis, commitment strategies, 
validation, and telephone consultation.81 Among these, the research-supported mediators for 
DBT include skills use,84 self-efficacy for managing emotions,188 and emotion 
regulation/experiential avoidance.84-86 
 
The CAMPUS Trial is adequately powered (moderate effect size estimates) to examine known 
and putative mechanisms of change in CAMS and CC-DBT and whether each works through 
different or overlapping mechanisms. In addition to known mediators, we will investigate 
promising exploratory ones identified through RDoC79 and SR-based87 reviews. 
 
The Proposed Methodology Is Innovative for Suicidal Risk (SR) Interventions 
Although there are a few adaptive strategy studies in the treatment of depression,88,89 none 
have examined SR specifically and none have undertaken an evaluation of relative treatment 
effectiveness via a hybrid online/in-person format that allows for maximal clinical flexibility 
with respect to the provision of care. Despite the strong relationship between depression and 
SR,90 meta-analyses failed to show that depression treatments impact SR specifically.91 Data 
suggest that SR should be the focus of care independent of diagnosis.68,69 This is consistent with 
NIMH’s RDoC framework.92 There is a clear need for evidence-based guidelines regarding 
suicide-specific, least-restrictive, and cost-effective clinical care for suicidal individuals.7,93 
Uniform treatment of something as complex and heterogeneous as suicidal thoughts, feelings, 
and behaviors may not be adequate.50,7 A recent meta-analysis of 50 years of research shows 
that our traditional risk factor approach for SR has not yielded desired gains,94 with authors 

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suggesting that the field needs to move from a “one size fits all” approach to tailoring clinical 
work to different suicidal states. 
 
SMART designs provide a rigorous and principled approach to constructing decision rules that 
guide adaptive interventions, including type, dosage, sequence, and response to treatment.17 
ATSs are recommended when patients vary in response to treatment, the effectiveness of an 
intervention changes over time due to waxing and waning of symptoms, comorbidity renders 
treatment more complex, there is a high probability of relapse, and adherence to interventions 
is difficult to achieve.17 All of these conditions apply when treating SR at CCCs. Also, ATSs may 
help bridge the critical gap between research and practice,17 as ATSs mirror more closely what 
happens in the real world (e.g., if one treatment does not work, try another). 
 
This study will address critical questions about SR interventions (in CCCs and elsewhere), 
including, for example: 1) Do we need a suicide-specific approach (CAMS) to address SR or is 
TAU sufficient as a first stage intervention? 2) Do we need an intensive, suicide-focused 
approach (CC-DBT) for individuals who do not respond to first-stage interventions? 3) Are the 
costs incurred by a more comprehensive approach (CC-DBT) worth it relative to the gains? We 
will also be able to determine differential effects of a particular sequence. We may find, for 
example, that clients are satisfied with CC-DBT after CAMS, but not after TAU (or vice-versa) or 
that only CC-DBT reduces SR among insufficient responders to stage 1. Few other designs allow 
this level of contextual understanding. Thus, this methodological approach (ATSs and a SMART), 
independent of the context of CCCs, is particularly innovative in terms of its application to SR. 
 
Utilizing CAMS and CC-DBT, Distinct Suicide-Focused Treatments, in a Sequenced Format is 
Innovative 
Examining what theoretically distinct approaches have to offer and then bringing them 
together in a sequence of care is innovative. CC-DBT might not be needed for all suicidal college 
students;10 conversely CAMS, a flexible first-line approach of low intensity and cost, might be all 
that is needed for many, but not all, suicidal college students.27 As far as we know, this is the 
first attempt to bring these two distinct suicide-focused approaches, one that is flexible and 
theoretically agnostic and one that is multimodal and comprehensive, together in an adaptive, 
pragmatic, and rigorous scientific manner. 
 
Attempting to Improve the Quality of Mental Health Services in CCCs is Innovative 
The NIMH Strategic Plan (Objective 4) acknowledges the need to generate research findings 
that “will inform the real-world community practice setting.” CCCs in the US are becoming a 
formidable force in mental health treatment delivery.95 No longer developmentally focused, 
CCCs now treat a wide gamut of psychological issues. More than 23 million individuals may 
come into contact with psychotherapy for the first time in a CCC, given that the 18-25 age range 
targeted in this study is often implicated in the onset/maintenance of psychological disorders.96 
Approximately 10% of college students are served by CCCs.42 Yet CCCs are continually being 
tasked to “do more with less.”97 As a result, many CCCs are now using procedures commonly 
found in community mental health agencies, such as waitlists, session limits, and psychiatric 

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consultation and referral.95 Thus, the provision of timely and effective treatments in this 
context would be of high public health value. We are not aware of any controlled study that 
focuses specifically on improving the quality of service delivery in this context, despite the dire 
need and the high number of individuals affected. The bulk of the studies pertaining to CCC 
services, although useful, are often descriptive,42 do not use randomization,21 and the solutions 
(e.g., session limits) are often guided more by “word-of-mouth” than by evidence-based 
research. Research at CCCs has been deemed “a necessity” given that “understanding the 
unique qualities of [CCCs’] environment is fundamental to the development of best practices 
necessary to serve the mental health needs of college students.”98 This hybrid effectiveness-
implementation multisite study proposes to blend components of clinical effectiveness and 
implementation research for more rapid translational gains for the potential dissemination and 
scalability of empirically-validated treatments at CCCs. 
2.3 
RISK/BENEFIT ASSESSMENT  
2.3.1 KNOWN POTENTIAL RISKS  
Risk 1. Worsening of symptoms because of the interventions. With any intervention, there is 
always the risk that the intervention will affect the individual negatively. There is a slight risk 
that discussing suicidality specifically or feeling dejected by lack of improvement may increase 
psychological distress, including suicidal thoughts and behaviors, during and possibly following 
the completion of the intervention. As there is not an extensive literature on the impact of 
suicide-focused care via teletherapy, it is unknown whether the remote arrangement of 
teletherapy in the CAMPUS trial will lead to a greater risk of worsening symptoms because of 
interventions. 
 
Risk 2. Breach of confidentiality. There is a slight risk that participants will have their privacy 
violated if information about them is not kept confidential or if participants’ online data is 
accessed by unauthorized users. Participants’ discussions of imminent suicidality/homicidality, 
child abuse/neglect, or elder abuse/neglect may result in a breach of confidentiality (including 
within the campus) due to counselors’ duty to report. In addition, as some clinical care and 
assessments will be provided through online platforms, there is a risk that private clinical 
communications could be “hacked” by third parties which might compromise confidentiality. 
Further, if participants are not alone in private spaces during assessments or therapy sessions, 
other people may hear personal information about the participant.  
 
Risk 3. Emotional distress associated with assessments. There is a slight risk that assessments 
with questions about sensitive topics like suicidal ideation and behaviors, substance abuse, 
gender identity, and sexual orientation may result in increased distress and potentially 
increased suicidality.  
 
Risk 4. Being involuntarily hospitalized. There is a slight risk that participants in this study, 
given that they are moderately to severely suicidal, may be civilly committed to a psychiatric 
setting involuntarily. 

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Risk 5. Feeling coerced to participate in the study. Because participation in the study will start 
within a clinical setting (the CCCs), there is a slight possibility that participants will feel 
pressured to be part of the study. 
2.3.2 KNOWN POTENTIAL BENEFITS  
There are several potential direct (and indirect) benefits of the CAMPUS trial to the participants 
and to the greater public. In the wake of the COVID-19 pandemic, there is little empirical 
knowledge about the effectiveness of online training for clinicians and delivery of suicide-
focused care via teletherapy. As pandemically-driven public health requirements include 
physical distancing and the use of masks, and generally reduce interpersonal contact, there are 
many compelling arguments for carefully studying the effectiveness of online training and 
delivery of care.  
 
A hybrid teletherapy/in-person model of treatment delivery would also provide CCCs with the 
flexibility to move treatment online seamlessly in the event of campus shutdowns in the future 
or even as part of regular campus operations, given that residential students leave their 
campuses during academic breaks. As noted previously, considering the level of severity of 
students presenting to counseling and the relative lower percentage of students (versus those 
not in counseling) who actually die by suicide, it is thought that campus counseling is associated 
with a six-fold reduction in suicides among college students — something that can not only save 
lives and much heartache to parents/family, but also avoid enormous repercussions to the 
whole campus (e.g., campus being shut down in some instances, classes cancelled, residence 
hall floors being shut down, friends being distraught and unable to attend classes, copy-cat 
acts). There are some data from TAU, CAMS, and DBT research to suggest that these treatments 
are likely to be helpful to a significant number of the participants in this project. Study 
participation will include careful assessments of suicidal risk at least three times during the 
study—a level of monitoring far beyond that which CCC clients usually receive, helping raise 
student participants’ awareness of their own suicidal risk. Regardless of treatment assignment, 
participants may derive a sense of accomplishment from participation in research and 
contributing to the knowledge of treatment for other students struggling with suicidal ideation. 
Given the demands and constraints of the pandemic, it is vital for the field to know whether a 
hybrid teletherapy/in-person format to provide care to suicidal college students can be done 
safely and effectively.  
 
There are benefits to counselor participants as well, who will receive training in how to help 
students presenting with suicidal risk. Treating this population can be very distressing to 
counselors and receiving specialized training and ongoing case consultation was reported as a 
great benefit of participation by counselors in the pilot and feasibility study. Similarly, the CCCs 
may benefit from having guidelines on how to treat suicidal students participating in these 
studies via a hybrid teletherapy/in-person format. As noted in other sections of the proposal, 
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without much guidance. Participating in these studies gives them more knowledge and more 
guidance on how to proceed. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Minimizing Risk 1.  
Several strategies are being proposed to help minimize the risk of worsening of symptoms, or 
to increase the potential to avert emergent crises or quickly detect an adverse event if one 
should occur: 
• 
Recruitment and consent procedures are expected to help minimize this potential 
impact. For example, from the outset of each study, prospective participants will be 
informed by the intake counselor (or member of the research team) about the study 
and the likely possibility that the treatment will focus on suicidal risk, so they will be less 
likely to be surprised later by the content of the treatment. This aspect will be 
reinforced again during the informed consent process. 
• 
Counselor participants will be self-selected based on their experience and interest in 
working with suicidality in a hybrid teletherapy/in-person format. Not all counselors are 
skilled and comfortable dealing with suicidal risk, so having counselors who are willing 
to work with this population and who are not afraid of discussing suicidal thoughts and 
behaviors, or dealing with potential crisis situations, will greatly increase the quality of 
care and the likelihood of counselors responding appropriately to imminent suicidal 
ideation (should it occur), including discerning the waxing and waning typical of 
suicidality from actual worsening of symptoms.  
• 
Counselor participants will be extensively trained to conduct CAMS and CC-DBT via 
online/in-person training and consultation. Online and in-person training will be 
conducted by experts in CAMS and CC-DBT and ongoing expert consultation will address 
any concerns regarding worsening or lack of improvement in symptoms in a particular 
participant. Additionally, each CCC has a weekly staff or case management meeting to 
discuss any cases giving rise to safety concerns—thus this will be available for discussion 
of TAU treatments. 
• 
All treatments provided as part of the study will allow for the possibility of increasing 
the frequency of sessions should a particular client need more support for a period of 
time. It is quite common in clinical care to add an extra session when the client is 
struggling. [Note: All CCC contacts with a student client are documented in the student’s 
CCC treatment file. Therefore, dosage of treatment will be monitored.] 
• 
Several procedures at the participating CCCs, although called by different names, are 
geared toward addressing crises and detecting adverse events early in the process 
(although study participants will receive unique treatments and complete research 
assessments, they will also be treated as regular clinic clients—one of the 
“effectiveness-based elements” of this study): 1) Students in crisis, regardless of who 
the counselor is, can contact the CCC at any time during business hours and receive 
crisis management as needed. 2) All clients are given the number to a 24-hour Crisis Call 
hotline and the Crisis Text Line. 3) The CCCs are part of University-wide teams that seek, 
with students’ permission, to help students who are involved with multiple departments 

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campus-wide (e.g., financial aid, judicial affairs, counseling, campus police, disability 
resource services) and this allows counselors to more effectively help manage certain 
crisis situations (e.g., students often become suicidal because of loss of financial aid and 
access to information through the financial aid officer on the team may help prevent a 
suicidal crisis). 
• 
Because of the remote nature of teletherapy care, student’s current location as well as 
emergency contact numbers for third party involvement (e.g., parents or roommates 
approved by the client) will be obtained for each client should there be a worsening of 
symptoms.  
• 
There will also be an understanding of secondary, even tertiary, backup methods for 
reconnecting with clients should there be technological issues or an unstable internet 
connection.  
• 
As is routinely done in conventional clinical trials, student participants who worsen 
significantly may be removed from the study if this is deemed to be in the clinical 
interests of the student participant (e.g., a student participant may need to withdraw 
from school to pursue a higher level of care). This is often done in collaborative 
discussions between student participant and counselor. 
• 
Project Coordinators (PCs), PIs, Co-Is, and consultants will be available for consultation 
with the participating counselors on a regular basis. Additionally, the PIs or Co-Is in 
charge of clinical supervision will be available as needed for consultation regarding 
safety concerns, regardless of current condition assignment, to all participating 
counselors. 
• 
The NIMH Data Safety and Monitoring Board (DSMB) will monitor all adverse events on 
a regular basis. 
 
Minimizing Risk 2. 
Breach of confidentiality, including unauthorized access to digital data. Several precautions will 
be taken to protect the confidentiality and privacy of participants from being violated, including 
unauthorized access to digital data. Risk will be minimized as follows: 
• 
All online clinical care across the four research sites will be provided via 
videoconferencing on platforms that are fully HIPAA compliant, such as HIPAA-
compliant Zoom.  
• 
At the beginning of each session, counselors will make sure that the client is in a secure 
location where other family members or friends may not be able to listen in on 
teletherapy sessions. Clients may need to use headphones as part of the effort to 
minimize what others might hear of any teletherapy session.  
• 
Confidentiality and the limits to confidentiality will be discussed with participants and 
stated in the informed consent.  
• 
A concern of college student participants might be the release of information about 
mental health to their academic departments or their families. We will assure 
participants in the informed consent that we will be unable to disclose this type of 
information to anyone outside the CCC, unless the student participant has signed a 
release of information or one of the limits of confidentiality applies. However, we will 

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explain that even if one of the limits applies (e.g., imminent suicidality), we will make 
every attempt to discuss this with the client first and only those who absolutely need to 
know will be informed (e.g., their parents or a roommate if they live in an off-campus 
apartment). As part of the assessment process, we will collect emergency contact 
information (parent or other trusted family member/emergency contact adult’s name 
and phone number) and we will also discuss conditions under which a parent or 
guardian, or this emergency contact person, may be notified for assistance in case of an 
emergency. Such conditions may include situations such as: the student participant is 
imminently suicidal and/or is perceived as a danger to themselves or others but does 
not agree to a safety plan or has missed/cancelled appointments and their commitment 
to safety cannot be confirmed. Counselors will review these crisis management 
strategies with student participants during their first therapy session. This aspect is 
particularly important given the remote nature of teletherapy.  
• 
Unique ID: Participants will be assigned a unique study ID and a GUID (Global Unique 
Identifier) to be used in the completion of all online questionnaires. The individual’s 
name and identifying personal information will not be maintained in computer files that 
can be accessed via the same system. The GUID is a universal subject ID allowing 
researchers to share data specific to a study participant without exposing personally 
identifiable information (PII) and match participants across studies. 
• 
Security of computers and networking hardware: The Duke University Medical Center 
(DUMC) servers hosting the REDCap data repositories are connected to the Duke 
internal network and protected by the Duke Health Enterprise firewall; access to the 
repositories is permitted only through properly authenticated web application 
programming interfaces. REDCap data are encrypted both at rest and in transit. The 
DUMC database-hosting infrastructure has been audited by the Duke Information 
Security Office for compliance with HIPAA and Duke Health data security policies. 
Procedures are in place for rapid recovery from hardware or database failure. All 
telehealth delivery will be conducted on fully HIPAA-compliant teleconferencing 
platforms.  
• 
User authentication/roles: User access to the REDCap web portal relies on a centrally 
managed list of users within the Duke Data Center (DDC), their authentication 
credentials, and their roles and access privileges. The REDCap platform used in the 
current study will leverage the Duke Health Enterprise authentication system. The DDC 
will manage user access groups and will provide granular control over specific access 
permissions, depending on study role (e.g., PC, RA), to specific aspects of the portal, 
such as eCRFs or study management functions. Password complexity and expiration 
rules are managed by the Duke ISO to ensure compliance. Usernames will be set for 
periodic review to make sure that changes to staff roles are audited jointly with the PIs. 
• 
Security of transmitted data: All self-report measures will be collected using a secure 
online survey program relying on SSL (Secure Sockets Layer) encryption such as REDCap 
or Qualtrics. This technology guarantees the privacy of all data transferred between the 
participant and data center and assures visitors that the site they are accessing is 
authentic. To initiate this secure connection, the IEs will register each participant into 

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the REDCap system, entering their unique study ID, and then ask him/her to complete 
the self-report measures. For subsequent assessments conducted remotely, the IE will 
email a unique link to the participant for completing the self-report measures. 
• 
The only individuals who will have access to any information linking participant names 
to participant codes will be the Principal Investigators (PIs), Project Coordinators (PCs), 
Independent Evaluators (IEs), Research Assistants (RAs) and, if needed, an overseeing 
ethical body (IRB or DSMB). Others will only have access to first names (e.g., the PIs 
while doing case consultations) or the GUID. Moreover, all data published in reports or 
articles will be described in aggregate form. 
 
Minimizing Risk 3.  
Emotional distress associated with assessments. Although studies show that asking about 
suicidal ideation does not increase the risk of suicidal behavior,152,30 it is possible that 
assessments may increase emotional distress. Therefore, the following precautions will be 
taken: 
• 
The assessments across timepoints will be conducted by well-trained IEs with 
experience treating suicidal individuals. Assessments of suicidal risk will primarily occur 
in interview formats (e.g., SSI, SITBI), so the IE conducting the assessments can respond 
appropriately if the participant becomes emotionally dysregulated. The interview-based 
assessments will also use validation strategies to ensure that participants feel 
supported. 
• 
Standard policies (e.g., obtaining current address and an emergency contact) will be 
developed to manage suicide risk when evaluated remotely.  
• 
Assessments will be limited to those domains essential to conducting the evaluation of 
treatment response and acceptability.  
• 
The total time spent completing interviews/questionnaires for the CAMPUS Trial for 
student participants will be 2-3 minutes a week and between 60-180 minutes at 
baseline and between 45-120 minutes at the middle of Stage 1, the end of Stage 1, the 
middle of Stage 2, the end of Stage 2, and 3-month follow-up, depending on the 
assessment timepoint and the student participants’ responses to the interview 
questions (an affirmative answer to a question on suicidality/self-injury/ suicide 
attempt(s) results in follow-up questions). 
• 
Finally, and importantly, to ascertain the safety of participants during/after scheduled 
assessments, the IEs will rely on the commonly utilized University of Washington Risk 
Assessment Protocol (UWRAP).110 This protocol will guide the IEs through a series of 
questions and strategies to help ensure that participants are safe prior to ending the 
assessment session. 
 
Minimizing Risk 4.  
Being involuntarily hospitalized. The following precautions will be taken to avoid involuntary 
hospitalizations: 

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• 
When student participants indicate that they are imminently suicidal and are not 
able/willing to take steps to guarantee they will not hurt themselves, the potential 
scenarios for voluntary vs. involuntary hospitalization will be discussed in detail. 
• 
Every option for voluntary hospitalization will be explored. In the case of an online 
assessment or therapy session, these options will also be coordinated with the help of a 
third party. Often, students will agree to go to the hospital on a voluntary basis. 
Sometimes, suggesting that they call a friend or a family member who will go with them 
to the emergency room helps them decide to go voluntarily. 
• 
Consultation with a parent/other trusted family member/emergency contact adult will 
be explored with the student participant as well. 
 
Minimizing Risk 5.  
Feeling coerced to participate in the study. Although this is unlikely to occur based on our 
experience (plenty of students decline research participation!), the following precautions will 
be taken: 
• 
Intake counselors and/or members of the research team will describe the study to 
students who seem interested in hearing about it. They may say something like, “We are 
currently conducting a study here to help students who may be struggling with 
suicidality. Would you like to hear more about it?” If a student says no directly or 
indirectly, the intake counselor will end this discussion and move on to other treatment 
options. 
• 
The intake counselor will clarify that, “There are other options for treatment. The study 
is just one of them.” 
• 
During the consent process, the member of the research team will ensure that there is 
enough time for questions and discussion before a student signs the consent form. 
• 
The PI or the PC will make themselves available throughout the study to consult with 
the participant and/or his/her counselor if there are any concerns about the student 
participant continuing to participate. 
• 
It will be made very clear both by the intake counselor and by the research staff that 
participation is voluntary and that declining to participate will have absolutely no impact 
on the student’s ability to receive services at the CCC, now or in the future. 
3 
OBJECTIVES AND ENDPOINTS  
Table 2 provides a summary of the objectives, endpoints, and justification for the endpoints for 
the CAMPUS Trial that will be conducted immediately following the feasibility study. A more 
detailed description of the measures can be found in Section 8.1. 
 
Table 2. CAMPUS Trial Objectives, Endpoints, and Justification 
Objectives 
Endpoints 
Justification for Endpoints 
Primary Aims of the CAMPUS Trial 
Suicide-Related Behaviors  
Aim 1: To compare four pre-specified 
ATSs in terms of primary and secondary 
Scale for Suicidal Ideation 
(SSI)  
 
The primary outcomes will be reduction 
in suicidal risk (SR; suicidal ideation 
primarily but also non-suicidal self-

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Table 2. CAMPUS Trial Objectives, Endpoints, and Justification 
Objectives 
Endpoints 
Justification for Endpoints 
outcomes. Hypothesis 1: The ATS that 
begins with CAMS and then augments 
with DBT for insufficient responders will 
be more effective in reducing SR than 
the other ATSs. 
 
Aim 2: To determine whether a suicide-
focused first-line intervention (e.g., 
CAMS) produces greater reductions in 
SR than a non-suicide focused one (e.g., 
TAU). Hypothesis 2: ATSs that begin 
with CAMS will be more effective in 
reducing SR than those beginning with 
TAU. 
 
Aim 3: To determine whether providing 
a comprehensive suicide-focused 
approach (e.g., CC-DBT) among 
insufficient responders to Stage 1 
treatments will be more effective in 
reducing SR than a less intensive 
suicide-focused approach (e.g., CAMS). 
Hypothesis 3: Adding CC-DBT at Stage 2 
with insufficient responders to Stage 1 
will be more effective in reducing SR 
compared to adding or continuing 
CAMS at Stage 2. 
Self-Injurious Thoughts 
and Behaviors Interview 
(SITBI) 
injury, suicide attempts, and suicides) at 
the end of Stage 1, Stage 2, and at 3-
month follow-up. 
 
Recognizing that measurement of 
suicide-related behaviors is fraught with 
challenges,112 we are defining 
SR as “suicidal ideation, attitudes, 
behaviors and plans which take into 
account severity, intent, and ability to 
cope with ideation without engaging in 
suicidal behaviors, such as 
planning/rehearsal, non-suicidal self-
injury (NSSI), suicide attempts (SAs), and 
suicide.” Our primary assessment 
measures for SR are two interviews to 
measure suicidal ideation (SI; defined as 
self-reported thoughts of suicide-related 
behavior) and suicidal behaviors, 
including suicide attempts and NSSI. 
Suicides will also be tallied. 
Secondary Aims of the CAMPUS Trial: Functioning 
Functioning – Relevant to Aims 1-3 
described above and Aims 4-5 described 
below. 
Counseling Center 
Assessment of 
Psychological Symptoms 
(CCAPS-62 or CCAPS-34). 
 
Clinical Global Impression 
for Severity (CGI-S) and 
Improvement (CGI-I).  
Secondary outcome measures will be 
overall distress, depression, social and 
generalized anxiety, substance abuse, 
eating concerns, academic functioning, 
clinical global impressions by 
participants and assessors of severity 
and improvement in suicidal risk. 
Secondary Aims of the CAMPUS Trial: Mediation 
Aim 4: To evaluate treatment-specific 
mediators of change. Hypothesis 4a: 
Treatment effects in CAMS, relative to 
TAU, will be mediated by improvement 
in suicide-focused processes, including 
suicidal cognitions, suicide-focused 
attentional bias, and hopelessness. 
Hypothesis 4b: Treatment effects in 
DBT, relative to Stage 2 CAMS, will be 
mediated by increased emotion 
regulation, self-efficacy for managing 
emotions, and improved skills. 
The Difficulties in 
Emotion Regulation Scale 
(DERS)  
 
The DBT-Ways of Coping 
Check List (DBT-WCCL)  
 
The Acceptance and 
Action Questionnaire II 
(AAQ-II)  
 
The measures listed include those found 
in previous studies to mediate outcome 
in CC-DBT and CAMS.  

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Table 2. CAMPUS Trial Objectives, Endpoints, and Justification 
Objectives 
Endpoints 
Justification for Endpoints 
The Suicide Cognitions 
Scale (SCS)  
 
The Optimism Hope Scale 
(OHS)  
PROMIS Self-Efficacy for 
Managing Emotions 
Secondary Aims of the CAMPUS Trial: Moderation 
Aim 5: To evaluate whether (1) number 
of lifetime suicide attempts (SAs),31 (2) 
Borderline Personality Disorder (BPD) 
features,32 (3) baseline distress,33 (4) 
sexual and gender minority (SGM) self-
identification,18,19 and (5) comorbid 
substance and alcohol abuse affect, 
predict or moderate treatment 
response. 
 
Hypothesis 5a: Student participants 
with >2 prior SAs,31 more BPD 
features,32 and SGM (self-identified)34 
will be less responsive to Stage 1 
treatments. Hypothesis 5b: Student 
participants with >2 prior SAs, high 
baseline distress, more BPD features, 
and SGM (self-identified) 18,19 will be 
more likely to respond to CC-DBT than 
to CAMS in Stage 2.  
History of previous 
suicide attempts (SITBI) 
 
The Personality 
Assessment Inventory – 
Borderline Features Scale 
(PAI-BOR)  
 
The Optimism Hope Scale 
(OHS)  
 
The Global Assessment 
Scale (GAS)  
 
Sexual orientation and 
gender identity  
 
Alcohol Use Disorders 
Identification Test 
(AUDIT) and Drug Abuse 
Screening Test (DAST)  
Aim 5 pertains to the identification of 
predictors and moderators of treatment 
response, which could be incorporated 
as secondary tailoring variables in later 
studies or during dissemination. 
Potential predictors and moderators 
were gleaned from the suicidology 
literature and/or from CC-DBT and 
CAMS. 
Tertiary/Exploratory Aims of the CAMPUS Trial: Implementation and Process  
Aim 6: To evaluate the ATSs in CCC 
settings, we will assess implementation 
outcomes outlined by Proctor35 
employing the Quality Implementation 
Framework (QIF).36 A mixed-methods 
process evaluation will be conducted 
with CCC stakeholders to identify 
facilitators/barriers to implementation 
and sustainability. 
 
The Client Satisfaction 
Questionnaire (CSQ-8)  
 
CSQ-8 (Therapist Version) 
and Reasons for 
Termination Checklist  
 
Treatment Credibility 
Questionnaire  
 
Treatment Expectations 
Questionnaire 
 
The Treatment History 
Interview (THI)  
The implementation monitoring plan will 
be guided by 1) critical steps of the 
Quality Implementation Framework 
(QIF)36; 2) process evaluation and 
implementation monitoring outlined by 
Saunders135; and 3) implementation 
outcomes specified by Proctor.35 The 
process evaluation will include both 
quantitative and qualitative assessments 
to monitor the implementation activities 
and address barriers that may arise 
during the study. The mixed methods 
will include feedback from the student 
participants, counseling staff, and 
directors. 
Aim 7. To explore counselor 
experiences working with suicidal 
college students. All analyses for this 
aim will be exploratory. Counselors will 
CSQ-8 (Therapist Version) 
and Reasons for 
Termination Checklist 
 
Aspects of counselor participants’ 
experiences to be explored include their 
beliefs about suicide, self-identified 
theoretical orientation and training 

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Table 2. CAMPUS Trial Objectives, Endpoints, and Justification 
Objectives 
Endpoints 
Justification for Endpoints 
be separated into clinically relevant 
groups based on cut-points on key 
demographic variables. Between-group 
differences on counselor measures will 
be explored. 
Counselor Treatment 
Expectations  
 
Zero Suicide Workforce 
Survey (abbreviated) 
 
Focused Interview 
 
Demographic Information 
Form 
 
TAU Questionnaire 
experiences, expectations for and 
satisfaction with providing different 
types of therapy during the study, and 
general experiences of participating in 
the study. 
Aim 8: Within each treatment stage, 
determine whether CAMS produces 
greater reductions in SR than TAU 
(Stage 1) and whether CC-DBT produces 
greater reductions in SR than 
Continued CAMS (Stage 2). 
Scale for Suicidal Ideation 
(SSI)  
 
Self-Injurious Thoughts 
and Behaviors Interview 
(SITBI) 
The primary outcomes will be reduction 
in suicidal risk (SR; suicidal ideation 
primarily but also non-suicidal self-
injury, suicide attempts, and suicides) at 
the end of Stage 1, Stage 2, and at 3-
month follow-up. 
 
Recognizing that measurement of 
suicide-related behaviors is fraught with 
challenges,112 we are defining SR as 
“suicidal ideation, attitudes, behaviors 
and plans which take into account 
severity, intent, and ability to cope with 
ideation without engaging in suicidal 
behaviors, such as planning/rehearsal, 
non-suicidal self-injury (NSSI), suicide 
attempts (SAs), and suicide.” Our 
primary assessment measures for SR are 
two interviews to measure suicidal 
ideation (SI; defined as self-reported 
thoughts of suicide-related behavior) 
and suicidal behaviors, including suicide 
attempts and NSSI. Suicides will also be 
tallied. 
 
4 
STUDY DESIGN 
4.1 
THE STUDY TEAMS(S) 
Student participants: Students who meet all inclusion and no exclusion criteria and provide 
consent. 
Counselor participants: CCC counselors who meet all inclusion and no exclusion criteria and 
provide consent. 
Intake counselor: CCC counselor who meets all new students seeking mental health services. 

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Study liaison: Research staff, employed by the CCC, who are responsible for acting as a liaison 
between the CCC and study. Duties may include exporting study data form the 
electronic medical record, conducting consent visits, facilitating participant recruitment 
and treatment, and meeting with potential student participants and counselor 
participants.  
Independent Evaluator (IE): Research staff responsible for conducting all baseline and 
longitudinal assessments. 
Project Coordinator (PC): Site research staff responsible for day-to-day operations of the study. 
4.2 
OVERALL DESIGN 
As shown in Figure 1 (on page 9), the proposed multisite SMART will involve randomization at 
two stages. At Stage 1, all student participants (N = 480) will be randomized to 4-6 weeks of 
CAMS or TAU. Beginning at session 4, the counselor will rate the student participant in terms of 
clinical response. Insufficient responders (e.g., non-responders) to Stage 1 will be re-
randomized to one of two Stage 2 treatments for an additional 1-8 weeks: 1) CAMS (either 
continued or for the first time) or 2) CC-DBT.  
 
Thus, four ATSs are possible:  
• 
ATS-1: Start with CAMS, if responding, enter maintenance treatment; if not, continue 
with CAMS;  
• 
ATS-2: Start with CAMS, if responding, enter maintenance treatment; if not, switch to 
CC-DBT;  
• 
ATS-3: Start with TAU, if responding, enter maintenance treatment; if not, switch to 
CAMS;  
• 
ATS-4: Start with TAU, if responding, enter maintenance treatment; if not, switch to CC-
DBT. 
 
Our pilot showed at Stage 1, 48% and 44% treatment response rates across CAMS and TAU, 
with 27% and 17% attrition rates, respectively—differences not statistically significant. Based 
on these findings, we assume an equal response rate of 50% across both Stage 1 treatments 
(CAMS and TAU), leaving N=240 participants eligible for Stage 2 treatments. Treatment 
responders at the end of Stage 1 will end study treatment and enter maintenance, which 
includes monthly monitoring and continued assessments with the IEs. All student participants 
will complete weekly measures as part of treatment. Research assessments by independent 
evaluators (IEs) will be conducted at baseline, mid-Stage 1 (Week 3), end of Stage 1 (Week 6), 
mid-Stage 2 (Week 10), end of Stage 2 (Week 14), and at 3-month follow-up (Week 26). 
 
4.3 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
SMART designs provide a rigorous and principled approach to constructing decision rules that 
guide adaptive interventions, including type, dosage, sequence, and response to treatment.17 
ATSs are recommended when patients vary in response to treatment, the effectiveness of an 
intervention changes over time due to waxing and waning of symptoms, comorbidity renders 

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treatment more complex, there is a high probability of relapse, and adherence to interventions 
is difficult to achieve.17 All of these conditions apply when treating SR at CCCs. Also, ATSs may 
help bridge the critical gap between research and practice,17 as ATSs mirror more closely what 
happens in the real world (e.g., if one treatment does not work, try another). In addition, the 
lengths of treatment for our stages (4-6 weeks for Stage 1 and up to 8 weeks for Stage 2) were 
chosen in order to best match practices of CCCs (where average number of sessions is 5-6) and 
therefore are most likely to be implemented. 
 
4.4 
JUSTIFICATION FOR INTERVENTION 
First Stage (Stage 1) of SMART Study (N=480): Randomization to TAU or CAMS (4-6 Weeks). 
After baseline, student participants will be randomly assigned to TAU (n= 240) or CAMS 
(n=240). Stage 1 treatment will last 4-6 weeks. We chose this treatment length because the 
average number of sessions at CCCs is 5.22 (with a median of 4 sessions),21 6-8 CAMS sessions 
were enough to resolve SR in college students in an earlier trial,27 and in our CAMPUS feasibility 
study, average number of Stage 1 sessions was 6. Student participants who appear to be 
deteriorating (worsening SI on the Counselor CGI-I scale) or who maintain high levels of SI 
without improvement may be re-randomized to Stage 2 early after session 4.  
 
Student participants randomly assigned to TAU will receive the customary treatment they 
would receive at that CCC—on average, weekly individual therapy, but it may also occasionally 
include group participation and/or medication referral. Counselors conducting TAU treatment 
will be informed to do counseling as usual for a period of 4-6 weeks, except that counselors will 
be asked not to utilize CAMS or DBT strategies. The book entitled “Collaborative Assessment 
and Management of Suicidality: Managing Suicidal Risk: A Collaborative Approach (2nd 
edition)”7 will serve as the manual for CAMS treatment in Stage 1/Stage 2. CAMS individual 
sessions will be provided weekly for 50-60 minutes and will follow the Suicide Status Form.  
 
Second Stage (Stage 2) of SMART Study (n≈240): Re-randomization to CC-DBT or CAMS (1-8 
Weeks). The treatment length for Stage 2 was chosen based on previous studies with CAMS and 
DBT, ease of dissemination to CCCs later, and informed by data from the CAMPUS feasibility 
study. Based on previous CAMS studies,27 our pilot study and CAMPUS feasibility study, we 
estimate that n≈240 of student participants will resolve their SR during Stage 1 and that n≈240 
will be re-randomized to Stage 2.  
 
DBT Individual Therapy. Participants will receive weekly individual teletherapy/in-person 
sessions with a CC-DBT-trained counselor for up to 8 weeks total. The DBT manual29 guidelines 
such as orienting clients to the treatment model, using a diary card to monitor problematic 
behaviors, relying on a hierarchy of targets to guide treatment at each session, and conducting 
chain and solution analyses to determine and address controlling variables of problematic 
behavior will be followed.145  
 

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DBT Skills Training. The skills training sessions will follow the DBT Skills Training manual,8,29,144 
but adapted to fit within a standard academic term (6 weeks). The skills training sessions will be 
provided via teletherapy/in person and will include skills from all four modules of skills 
acquisition (mindfulness, emotion regulation, interpersonal effectiveness, and distress 
tolerance), but with the following modifications: greater focus on emotion regulation given past 
research with college students,12,146 and fewer skills taught within each module. Depending on 
participant flow and time of the semester/quarter, skills training may be conducted individually 
or in group format. 
 
Peer consultation team is an inherent part of DBT. Counselors will participate in weekly DBT 
consultation team meetings conducted remotely or in person.29,147 Phone/text skills coaching is 
viewed as essential for the generalization of DBT skills to the environment.29 Counselors will 
coach their own student participants but, adapting to this setting, they will be encouraged to 
observe their own limits and comply with local CCC policies/legal requirements, as warranted. 
 
Hybrid Intervention Model 
For the purposes of these studies, hybrid intervention model means that a student participant’s 
course of treatment may be delivered completely via telehealth, completely in person, or via a 
combination of in-person and telehealth sessions. Decisions about what type of sessions to hold 
will be made by the counselor and based on several factors, including university and CCC policy, 
location/preference of the student participant, and location/preference of the counselor 
participant. We will be collecting data on the number of sessions conducted via each modality 
(captured via Titanium, the electronic medical record [EMR] utilized by all sites) as well as the 
number of participants who receive just teletherapy, just in-person sessions, and a 
combination. We recognize that allowing the modality of treatment delivery to vary between- 
and within-subjects may contribute to greater variability. We considered alternative treatment 
designs (e.g., constraining the treatment delivery to telehealth only) to reduce this variability. 
However, we decided to allow for flexibility in treatment delivery for several reasons. First, 
because this variability in delivery mode will occur across all arms, irrespective of treatment 
type, we do not expect it to bias the outcome analyses. Second, we do not believe constraining 
modality is reflective of the reality of practice in CCCs going forward (i.e., beyond the 
immediate response to Covid-19). Thus, we believe constraining the treatment modality in the 
study design would limit the external validity of the trial results. Third, relatedly, we believe a 
hybrid model has the greatest dissemination and implementation potential in the future across 
CCCs, where the expectation is that delivery of treatment will continue to vary within and 
across settings and will likely be some combination of in person and remote sessions. Thus, the 
resulting sequencing of care allows for this flexibility by design. 
4.5 
END-OF-STUDY DEFINITION 
The end of the study for the CAMPUS Trial, is defined as completion of the Week 26 follow-up 
assessment shown in Table 1 Schedule of Activities (beginning on Page 16). Student participants 

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who terminate early will receive an end of study assessment identical to that required of 
participants who complete the entire protocol. 
5 
STUDY POPULATION 
There are two study populations for these research projects (a) college students and (b) CCC 
counselors. The inclusion and exclusion criteria for each are described below.  
5.1 
INCLUSION CRITERIA 
College Students. We will recruit N=480 male, female, and transgender/nonbinary college 
students across the participating sites for the CAMPUS trial. Inclusion criteria to participate in 
the study consists of:  
(1) Enrolled at the university. 
(2) Eligible to receive counseling services either in person or remotely at the campus CCC. 
(3) 18 to 25 years of age. 
(4) Moderate to severe SI over the last two weeks indicated by one or more of the 
following: 
• A score of ≥2 on the Counseling Center Assessment of Psychological Symptoms 
(CCAPS) question, “I have thoughts of ending my life.” 
• Self-report during clinical interview at intake 
• Other intake questionnaires given as standard clinical practice at CCCs (e.g., C-SSRS) 
(5) Suicidality is a focus of treatment 
(6) Agree to video recording of all therapy and assessment sessions. 
 
CCC Counselors  
We will recruit approximately N≈24 counselor participants across all participating sites. The 
number of counselor participants may increase or decrease throughout the project based on 
turnover, but we expect to maintain approximately 24 participating counselors at a time in each 
of the enrollment years.  
 
Inclusion criteria to participate in the study consists of:  
1. Currently or soon to be employed as a counselor or trainee at the CCC for at least the 
next year; 
2. Willingness to work with suicidal college students; 
3. Interested in learning to implement Collaborative Assessment and Management of 
Suicidality (CAMS) and Dialectical Behavioral Therapy for College Counseling settings 
(CC-DBT); 
4. Willing to attend trainings in CAMS and CC-DBT; 
5. Willing to have therapy sessions video-recorded and rated for adherence to the 
treatment model;  
6. Interested in attending weekly consultation meetings to improve the quality and 
adherence of study treatments; and 
7. Willing to complete measures about themselves and their student participants. 

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5.2 
EXCLUSION CRITERIA 
Exclusion Criteria for Student Participants and Rationale:  
1. Students who are deemed clinically inappropriate to receive services at the CCC by an 
intake counselor because of imminent risk, severe psychosis, or inability to remain 
enrolled in school (e.g., academic failure);  
2. Students being unable to remain enrolled in their university long enough to go through 
the minimum number of sessions for Stage 1 (4 sessions); 
3. Students who have received services at the CCC within the last three months (i.e., ATSs 
must be based on a new treatment episode). 
 
Exclusion Criteria for Counselor Participants:  
Counselors will be excluded if they don’t meet inclusion criteria or do not consent to study 
participation after recruitment.  
5.3 
SCREEN FAILURES 
Due to the focus of the study, potential participants will have access to the CCC no matter if 
they are receiving treatment through participation in the study or not. Screen failures, and/or 
student participants who decide that they would no longer be able to participate in the study, 
will continue to have access to the CCC for services.  
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Recruitment and Retention Strategies for Student Participants 
Across participating sites, we will recruit a total of 480 student participants for the CAMPUS 
Trial. Recruitment will take place over 2 years.  
 
Gender. In terms of gender, female students are more likely to seek treatment than male 
students. This is the case based on data collected at each of the participating sites and in terms 
of national data for treatment-seeking students.2 Therefore, based on site and national data, 
we are predicting across sites that 60% of participants will be female, 38% will be male, and 2% 
will be transgender/non-binary. Two important caveats apply here: 1) Although, in general 
populations, females are more likely to report suicidal ideation than males, that discrepancy 
appears to not exist among treatment-seeking college students.21 Therefore, the estimated 
gender breakdown will stay the same even among suicidal treatment-seeking college students 
and this matches our experience in other suicide-focused intervention studies. 2) Currently, 
approximately 1.6% of treatment-seeking college students nationwide self-identify as 
transgender or non-binary.21 The NIH planned inclusion table does not allow these categories to 
be entered until the demographic data are in hand. So, it’s not going to be reflected in the 
inclusion table, but it is an important demographic category given the known higher suicide 
rates for this segment of the population.18 These data will be collected as part of this study, 
reflected in recruitment reports later, and gender identity (cisgender vs. transgender/non-
binary) will be explored as a moderator of treatment response in this study. 
 

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Ethnicity/Race. Across all sites, Non-Hispanic White/Caucasian students are the most common 
category. One site, Rutgers Newark has a higher percentage of African American/Black students 
(25%). One site, Duke, has a higher percentage of Asian/Asian American students (28%), and 
two sites (UNR and Rutgers Newark) have a higher percentage of Latinos (18% and 25%, 
respectively). We have averaged these percentages, and across all sites, we are predicting the 
following: 12% African American/Black, 1% or less American Indian/Alaska Native, 15% Asian 
American/Asian, 15% Hispanic/Latino/a, 1% or less Native Hawaiian or Pacific Islander, 10% 
Multi-racial, and 47% White/Caucasian. For the study, data will be collected on both ethnicity 
(Latino vs. not) and race to facilitate recruitment reports. 
 
Inclusion of Children. No children will be included in the study. This is justified based on the 
setting and scientifically. The target sample for this study is college students who are between 
18 and 25 years old. We set 18 as an age minimum because a) 18 is suggested as the start of 
“emerging adulthood”;53 b) most college students are 18 and older, thus rendering our findings 
more generalizable; c) the proportion of college students under 18 is minimal (<5%); and d) 
students under 18 would need parental consent in most of the sites to participate which would 
impact recruitment procedures considerably as the study is currently designed. 
 
Procedures to Monitor Enrollment and Track/Retain Participants. Recruitment and enrollment 
will be carefully monitored. The site PC will track participant flow through a REDCap database, 
from referral into the study (or not), date initial consent is scheduled, whether participant 
consented or not (if not, the reason(s) for refusing to participate will be documented), and 
dates of planned assessments, which will be shared with the IE locally, as well as the Duke Data 
Center (DDC). This database will be able to notify users via text or email of upcoming and over-
due assessments to help facilitate participant retention.  
 
To expedite referrals into the study for this high-risk population and minimize loss of 
participants, the intake counselor or study liaison will schedule an appointment with an IE 
directly within 24-48 hours. Participant tracking logs will be reviewed weekly locally by each site 
and by the cross-site SC to monitor recruitment and diversity of the sample. Files will be 
maintained by the DDC, with access granted to relevant individuals across sites. 
 
Strategies to Ensure a Diverse, Representative Sample. As noted above, demographics will be 
tallied and tracked weekly with an eye towards ensuring that the study sample includes a 
representative sample of women and minorities (see Inclusion of Women and Minorities for 
more detail). Only students who are 18-25 years of age will participate (see Inclusion of 
Children). Inclusion of women (and men) and minorities was not a problem during the pilot and 
other studies conducted at the other sites. However, recruitment reports comparing the study 
sample to the population of other treatment-seeking students at that site will be discussed 
weekly during the cross-site SC call and reviewed every six months by the DSMB. If a significant 
discrepancy emerges, this will be discussed, investigated further, and corrective measures 
implemented, as advised. 
 

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Table 4. Assessment Reimbursement Amount by Visit for CAMPUS Trial 
 
Assessment Point 
Type 
Baseline  
Mid 
Stage 1 
End of 
Stage 1  
Mid 
Stage 2 
End of 
Stage 2 
3-Month 
Follow Up 
Visit Reimbursement 
$40 
$20 
$40 
$20 
$50 
$50 
 
Participant Incentives. Participants will be reimbursed for completing study assessments at 
baseline ($40), mid-Stage 1 ($20), Stage 1 post ($40), mid-Stage 2 ($20), Stage 2 post ($50), and 
3-month F/U ($50). Unless noted otherwise, the timeframe for assessments will fit the study 
design: “last month” for all assessment points, also “lifetime” and “last 6 months” at baseline, 
and “last 3 months” at F/U. The maximum total reimbursement for any student participant who 
completes all assessments as scheduled is $220 (see Table 4 above).  
 
Recruitment and Retention Strategies for Counselor Participants 
This study will recruit approximately 24 counselor participants across the participating sites. 
Additional counselors will be recruited during the second year of the study to replace 
counselors who left during the first year, if needed. Recruitment will take place at the beginning 
of the study, prior to student participant enrollment.  
 
Gender/Race/Ethnicity. Counselor participants will be initially identified by the CCC Director and 
referred to the site investigators for possible study participation. The racial, ethnic, and gender 
breakdown of the counselor participants are expected to reflect the diversity of the overall CCC 
staff.  
 
Procedures to Monitor Enrollment and Track/Retain Participants. We will conduct an annual 
check-in with all counselor participants to review their experiences with the study and to 
determine whether they will continue participating as a study counselor for an additional year. 
To ensure that we maintain an adequate number of counselor participants, we will ask all 
counselor participants to notify the study team at least four months in advance if they are 
considering ending their participation. This will allow adequate time to identify and train 
replacement counselors.  
 
Strategies to Ensure a Diverse, Representative Sample. N/A 
 
Participant Incentives. Counselor participants will receive ongoing consultation and as-needed 
individual supervision.  
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 
STUDY INTERVENTION(S)  
6.1.1 PRE-SCREENING 

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Potential student participants will contact the college counseling center (CCC) to set up an 
initial appointment to access services (remote or in person dependent on local CCC policies). 
The student will be scheduled for an initial session with a counselor (for this first contact, the 
counselor will be referred to as “intake” and “intake counselor,” respectively, henceforth).  
6.1.2 SCREENING 
Assessment of suicide risk (SR) and other safety issues are addressed by the intake counselor 
during the intake session across all participating sites. When the student meets for the intake 
session, as part of routine intake procedures, they will complete the Counseling Center 
Assessment of Psychological Symptoms (CCAPS-62). If the student selects a 2 or above on the 
question, “I have thoughts of ending my life,” (range is 0 “not at all like me” to 4 “extremely like 
me”) or endorses suicidality on other intake questionnaires or via self-report to the counselor 
the intake counselor will give the student a brief explanation of the study. Intake counselors will 
complete the Screening Data Form to assess basic inclusion and exclusion criteria. If a student 
meets all inclusion and no exclusion criteria and is interested in participating in the study, the 
PC will be notified, and an appointment will be scheduled with the research team for 
consenting (an e-consent process will be used) and a baseline assessment, which may be 
remote or in-person. If conducted remotely, the IE will reach out to the student ahead of the 
appointment with a link to a secure telehealth videoconferencing meeting. For students who 
decline to participate, the intake counselor will document reasons for declining participation.  
6.1.3 BASELINE 
The baseline assessment is conducted by the IE, either online or in person. The IE will first 
review the e-consent in detail with the student and answer any questions. The IE will confirm 
that the student agrees with: (1) being randomized to one of two treatments; (2) the possibility 
of proceeding in an “adaptive” manner—ending treatment/going into maintenance or being 
randomized to one of two treatments for up to 8 additional weeks; (3) possibly participating in 
a group (if assigned to DBT); (4) completing assessments even if no longer in treatment; (5) 
providing information to create a unique identifier; and (6) having their therapy sessions video-
recorded. After consent is obtained, questionnaire/interview baseline assessments will be 
conducted by the IE (see Table 1). At the end of this assessment or within 1 business day, 
student participants will receive confirmation of who their counselor will be and the date of 
their first teletherapy/in-person appointment (typically within 7 days after the baseline visit, 
but clinical concerns will take precedence). Students who decline participation prior to giving 
consent, or who enroll but later choose to withdraw from the study, will have access to the 
usual care at the CCC (Note: all randomized student participants will be included in the ITT 
analyses). 
6.1.4 RANDOMIZATION 

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Following the completion of the baseline assessment, the site PC will review the consent, 
document the randomization block variables (gender, medication, past suicide attempt), obtain 
randomization assignment from the Data Center at Duke University, and reveal randomization 
results to an already assigned counselor. Note that student participants will learn of their 
treatment assignment by the counselor at their first treatment visit (this procedure was used in 
the pilot project and received very favorably by students and counselors).  
6.1.5 STUDY INTERVENTION DESCRIPTION 
Study interventions include Treatment as Usual (TAU), the Collaborative Assessment and 
Management of Suicidality (CAMS), or CC-DBT. 
 
TAU: Treatment as Usual consists of normal College Counseling Center (CCC) therapeutic 
procedures. TAU will allow counselors to determine level of care and therapeutic modality 
depending on the needs of the participant.  
 
CAMS: CAMS is an evidence-based, suicide focused approach61 that was first developed and 
studied in a CCC specifically for college students.62 CAMS is a problem-focused treatment that 
targets client-defined suicidal “drivers” or issues that lead to SI.7 Central to CAMS is the use of 
the Suicide Status Form (SSF), a multipurpose clinical assessment, treatment planning, tracking, 
and outcome tool.7 The SSF serves as a clinical roadmap to guide collaboration as counselor and 
client sit next to each other exploring SR through quantitative/qualitative assessments and 
suicide-specific treatment planning. All CAMS sessions begin with a consideration of the “SSF 
Core Assessment.” Sessions then focus on the CAMS Stabilization Plan (CSP) and the client’s 
suicidal drivers. All sessions end by updating the CSP and problem-focused care targeting 
suicidal drivers. CAMS is theoretically agnostic; counselors use their own approach to treating 
client-identified suicidal drivers.  
 
CC-DBT: DBT 8,29 is an empirically validated treatment for complex clinical presentations, 
including BPD, SI, and NSSI. DBT (which includes individual therapy, skills group, and peer 
consultation for counselors) produces gains for suicidal BPD clients across a variety of domains, 
including SI, BPD, SAs, NSSI, hospitalizations, and social functioning.15,72 DBT is based on a skills 
deficit model that suggests that BPD is a disorder of emotion dysregulation stemming from 
important deficits in interpersonal, emotion regulation, and distress tolerance skills. Suicidal 
behavior is viewed as maladaptive problem-solving behavior reinforced by either an immediate 
reduction in emotional arousal and/or by the environment’s response.29 Thus, DBT focuses on 
teaching skills, particularly emotion regulation, and facilitating the replacement of maladaptive 
behaviors with skillful behavior. We will use an adaptation of DBT, CC-DBT, that is designed to 
disseminate within CCCs. Participants will receive up to 8 weeks of individual CC-DBT sessions 
as well as 6 weeks of DBT skills training. Counselor participants will attend weekly consultation 
team meetings. CC-DBT includes key DBT elements such as orienting clients to the treatment 
model, using a diary card to monitor problematic behaviors, relying on a hierarchy of targets to 
guide treatment at each session, and conducting chain and solution analyses to determine and 
address controlling variables of problematic behavior will be followed.145  

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Stage 1: Student participants will initially be randomized to TAU or CAMS. The duration of Stage 
1 treatment will range from 4-6 weeks.  
 
Stage 2: Non-responders to Stage 1 Treatments will be randomized into either CAMS or CC-
DBT. The duration of Stage 2 treatment will range from 1-8 weeks.  
 
6.1.6 ADMINISTRATION AND/OR DOSING 
Treatment dosage for Stage 1 will consist of prescribed weekly sessions for up to 6 weeks for 
TAU or CAMS, followed by up to 8 weeks of CAMS or CC-DBT. It is assumed that weekly sessions 
align with typical CCCs. The counselor (interventionist) will be trained on CAMS and CC-DBT and 
will be evaluated for fidelity of implementation throughout the study. Length of time (e.g., 
student participant weeks in treatment) will be determined based on student participant 
responsiveness to their assigned treatment condition.  
 
Except for the CC-DBT skills group and possibly other CCC therapy groups in the TAU condition, 
student participants will have no contact with other student participants, as this is an 
individualized treatment per each student participant.  
 
Management of Student Participants in the Maintenance Phase. Student participants who are 
classified as responders during either stage 1 or stage 2 will end active study treatment and 
enter maintenance. Students may continue to receive CCC services during study maintenance. 
Students will continue to complete regularly scheduled IE assessments and remain in 
maintenance until the end of their study participation at 26 weeks. During the maintenance 
phase, the study team will contact students every four weeks. The four-week contact schedule 
will continue until their final assessment point. It is possible that students may experience a 
relapse in suicidality during the maintenance phase, which may be reported during the 
scheduled IE assessments, in response to a 4-week contact, or by the student spontaneously 
contacting a member of the CAMPUS trial clinical or research team. In these instances, students 
will be referred to their CCC for standard care. As noted elsewhere in this protocol (see section 
6.5), treatments received outside of the study will be documented via the treatment history 
interview (THI).  
 
Management of College Session Breaks. CAMS and CC-DBT individual sessions will be 
conducted either in-person or remotely via a HIPAA-compliant telehealth platform. Thus, 
management of treatment during short breaks will not be difficult. The end of an academic 
term often serves as a natural and longer-term break in treatment in CCCs. Given the nature of 
the academic calendar, participants may take a “break” from the study treatment while they 
are on academic breaks if they are unable or ineligible to receive CCC services (e.g., residing out 
of state for the summer), and then continue where they left off upon return. This is an essential 
adaptation to the setting, and it has been considered in terms of recruitment rates and will also 

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be considered in the analyses (e.g., dosage defined as number of sessions and not time since 
randomization per stage; number of additional treatment sessions received). 
 
6.2 
FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
Initial Suicide-Focused Treatments Training. During the training phase, the counselor 
participants will be asked to read manuals for CAMS7 and DBT,8,29 participate in a 3-hour online 
orientation to the study, and then 12-hours of CAMS remote training and 25-30-hours of DBT 
remote or in-person training, spread over multiple days. Each site will also have weekly DBT 
peer consultation team meetings. Remote consultation from DBT and CAMS experts will occur 
more frequently (e.g., weekly) when the trial begins and will occur less frequently as 
consultation teams grow in skill. 
 
Counselor participants joining the study after the first study year will receive the same type and 
intensity of training (3-hour orientation to the study, 12-hours of remote CAMS training, and 
25-30 hours of DBT training) as other counselor participants but the timing and delivery of the 
trainings will be dictated each year, based on the number of new counselor participants and 
their availability. 
Certification Requirements. Participant counselors’ first randomized case will be supervised 
more closely as a certification case. If a counselor does not receive satisfactory ratings on their 
certification case, an individualized adherence plan will be created with the therapist and 
DBT/CAMS experts. Any concerns about ongoing problems with counselors meeting adherence 
standards will be discussed with the QA committee. Under rare circumstances, counselors who 
consistently do not meet adherence standards may be asked to not provide a specific 
treatment or to leave the study. 
Treatment Adherence to CAMS and DBT. All treatment sessions will be digitally recorded. 
During the counselor training phase, counselors will participate in weekly remote group 
consultation/supervision (CAMS or DBT), which will be supplemented with individual site-level 
remote supervision as needed. A Standardized Operating Procedure (SOP) will be developed for 
certifying that counselors are adherent to CAMS and DBT treatment protocols. Following the 
training phase, two sessions will be randomly selected to be rated for adherence per DBT 
student, one from the first two sessions and one from the remaining sessions. A random 
sample of 10% of DBT skills group sessions will be selected for rating. For CAMS sessions in 
Stage 1, the first session will be rated for adherence and one other session will be randomly 
selected from the other sessions for adherence rating. For CAMS sessions in Stage 2, the first 
session after re-randomization into CAMS will be selected for rating and then one other session 
will be randomly selected. Feedback will be provided to counselor participants (but not in real 
time) and tallied in terms of percent of time counselor participants met minimal (DBT) or 
satisfactory (CAMS) adherence. 

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6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
Randomization 
We will rely on an adaptive-biased coin design109 to attempt to balance conditions at each stage 
based on gender, previous suicide attempt(s), and current psychotropic medications. At Stage 
2, the PC will obtain information on the blocking variables, along with the tailoring variable, 
from counselors and the electronic medical record (EMR; Titanium for all sites) prior to 
randomization. The PC at each site will randomize subjects via the centralized database using a 
customized system tailored for the SMART design housed at the Duke Data Center. 
 
All assessments of the main endpoints will be performed by the independent evaluators (IEs), 
who will remain blind to treatment status. It is always possible that student participants could 
tell the IE during their assessments about the type of therapy they have been receiving. To 
mitigate this risk, all student participants will be reminded about the importance of not telling 
the IEs which treatment they received. It is also possible that counselor participants could tell 
the IE which treatment condition a particular student participant is in; counselor participants 
will be frequently reminded not to do so. To evaluate how well blinding was maintained, the IEs 
will be asked to indicate what treatment group(s) they thought the student participant 
belonged to at the end of stage 1 and, if applicable, at the end of stage 2.  
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
Student participant adherence will be tracked through EMR systems at each site including 
weekly therapeutic sessions.  
6.5 
CONCOMITANT THERAPY 
If it is discovered during or after the study that a participant received a “crossover-treatment” 
on his/her own or received any other form of therapy, we will document these treatments in 
the clinical record and on the treatment history form that is completed by the student 
participant and the IE and develop procedures to minimize this threat as much as possible for 
use in the large-scale trial.  
 
While clinical and research staff are expected to strongly discourage treatment outside the 
study, these student participants will continue to be treated within their assigned treatment 
arm. Stated differently, student participants receiving non-protocol treatments on their own 
accord are not automatically considered premature terminators. On the other hand, student 
participant-initiated crossover treatments should prompt consideration of a review of the 
student participant’s clinical status. An example of this would be the case of a student 
participant-initiated psychiatric hospitalization for worsening depression, which would 
automatically lead to premature termination. 
 
Handling of Medications. Student participants will neither be asked to discontinue medications 
or to start medications as part of the study. Following regular CCC practice, student participants 
may be referred for a psychiatric consultation if needed. We will stratify on current use of 
psychotropic medication at both randomization points to equate medication use across 

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conditions. We will also assess for any mid-treatment use of medications via data collected on 
the treatment history interview. Approximately a quarter of students presenting to a CCC are 
already on a psychiatric medication.42 This approach to medication reaches a good balance of 
allowing for medications while not including an active protocol on psychotropic management 
and it seems appropriate, given the limited evidence of pharmacotherapy-only treatment for 
SR.148 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
Involvement in this study will be completely voluntary, and participants may withdraw from the 
study at any time. Withdrawal from the study will not prohibit student participants from 
continuing to receive counseling services from their college counseling center or counselor 
participants from continuing with their normal job duties at the CCC. If the potential student 
participant shows a lack of interest during intake and consent procedures, the intake counselor 
will drop the subject. Consent is an ongoing process, so as the study progresses, counselors will 
be instructed to contact the PC or the PI if the student participant expresses any concerns 
about continued participation and the PC or PI will be available to meet with the student 
participant and/or his/her counselor to discuss any concerns regarding continued student 
participation throughout the study. 
 
Missing four consecutive “scheduled” treatment sessions without any contact with the research 
team or study counselor will constitute treatment dropout. (Note: attempts will be made to 
continue collecting outcome data on all student participants who are considered treatment 
dropouts.) Student participants who are contacted and inform the study team that they no 
longer wish to provide assessment data will be considered to have withdrawn consent and 
therefore meet the definition of a study dropout. For more detailed operational definitions, see 
section 7.2 below. 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from the study at any time upon request. An investigator may 
discontinue or withdraw a participant from the study for the following reasons: 
• Death of participant. 
• Participant withdraws from the school. 
• Acute, chronic, or long-term physical or psychiatric illness in the participant leading to 
inpatient hospitalization during the study. 
• Any clinical AE, onset of new medical condition or other situation that occurs such that 
continued participation in the study would not be in the best interest of the participant. 
 
As with many other long-term studies, we will experience multiple scenarios of participant 
attrition. To develop procedures to appropriately manage these scenarios consistently across 
the sites, the various types of attrition have been defined below.  

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A. Study Dropout (aka Withdrawal of Consent). Study dropout refers to a student 
participant who withdraws from the assessment portion of the study. A student 
participant who drops out of the assessment component is not eligible to receive study 
treatment.  
 
B. Treatment Non-Compliance. Treatment non-compliance pertains to a student 
participant who continues to participate in the treatment and assessment components 
of the study, but often fails to follow the study treatment procedures (e.g., refuses to 
appropriately engage in therapy or tends to miss treatment sessions, etc.). Such student 
participants have not withdrawn consent (those that do withdraw consent are classified 
as Study Dropouts) for either the treatment or assessment components, but simply have 
failed to fully participate in the assigned treatment arm. 
 
C. Treatment Dropout. Treatment dropout pertains to a student participant who has 
withdrawn consent for the treatment component only. By definition, a treatment 
dropout is a student participant who is no longer willing to participate at all in his/her 
assigned treatment but is willing to participate in the assessment component.  
 
D. Premature Termination. Premature termination refers to a student participant for 
whom the clinical team recommends additional treatment above what can be provided 
in the assigned treatment arm as randomized. The student participant, however, 
continues to participate in the assessment component and, insofar as possible, in the 
treatment component of the study.  
 
Premature termination occurs when the student participant deteriorates or develops an 
urgent clinical crisis that leads the clinical team to recommend the termination from the 
assigned study treatment as randomized. Such cases are equivalent to “investigator-
initiated protocol violators.” Premature termination from the assigned treatment arm 
simply means that the assigned treatment is no longer adequate to meet the clinical 
needs of the student participant. It does not necessarily mean that the intervention 
within the assigned treatment has been discontinued. 
 
The reason for student participant study dropout, treatment dropout, and premature 
termination will be recorded. Consistent with intention-to-treat principles, student participants 
who sign informed consent and to whom randomization is revealed but do not receive the 
study intervention (e.g., choose to study drop before starting treatment) will not be replaced. 
Likewise, student participants who sign informed consent and are randomized and receive the 
study intervention but subsequently drop out of the study, or are prematurely terminated from 
the study, will not be replaced. 
7.3 
LOST TO FOLLOW-UP 

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A student participant will be considered lost to follow-up if he or she fails to complete 
scheduled assessments and study staff are unable to contact the participant after at least 3 
attempts.  
 
The following actions will be taken if a student participant fails to complete a scheduled 
assessment: 
• The site IE will attempt to contact the student participant by telephone and email, 
reschedule the missed visit as soon as feasible, counsel the student participant on the 
importance of maintaining the assigned visit schedule and ascertain if the student 
participant wishes to and/or should continue in the study. 
• The IE will ask the counselor if the student participant has changed phone 
number/email, is attending therapy, and/or has been in contact and may ask the 
counselor to prompt the student participant to contact study staff.  
• Before a student participant is deemed lost to follow-up, the investigator or designee 
will make every effort to regain contact with the student participant (where possible, 3 
telephone calls and, if necessary, a certified letter to the student participant’s last 
known mailing address or local equivalent methods). These contact attempts will be 
documented in the student participant’s medical record or study file.  
• Should the student participant continue to be unreachable, he or she will be considered 
to have withdrawn from the study with a primary reason of lost to follow-up. 
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
We have divided measures into demographics, primary and secondary dependent variables 
(DVs), mediators, moderators, and implementation/process variables. Measures were selected 
if they: 1) fit the study aims, 2) have adequate psychometrics, 3) are listed as Common Data 
Elements in NIH or have been used in previous SR studies, 4) have shown sensitivity to change, 
5) have been used with college students, 6) map onto the RDoC categories (Negative Valence 
Systems, Positive Valence Systems, Cognitive Systems, Social Processes, and Arousal and 
Regulatory Systems),79 7) are directly relevant to the application of CAMS or DBT, and 8) allow 
for reduced burden to student participants—the latter in response to reviewers’ concerns. 
 
Demographic Variables.  
With student participants’ consent, age, marital status, family income, residence, GPA, race, 
year in school, major, ethnicity, sexual orientation, cultural identity, and gender identity will be 
obtained via EMR/the registrar or by completing the Demographic Information Form at 
baseline. 
 
SMART Primary Tailoring Variable: Sufficient vs. Insufficient Response to Stage 1 Treatments.  
Unique to SMARTs are tailoring variables or variables upon which subsequent randomizations 
are based.59 For this trial, sufficient treatment response will be the primary tailoring variable 
and assessed by the Clinical Global Impressions (CGI),103 adapted to SR. As noted in Preliminary 

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Studies, the CGI, adapted to SR, showed high inter-rater reliability and construct validity; this 
fits with other studies demonstrating that non-blinded trained counselors typically can offer 
CGI ratings commensurate to blinded IEs.111  
 
In SMARTs, a tailoring variable is a tool for clinical decision-making, in this case deciding on 
response to treatment, and therefore it will be based on clinical assessments by providers (and 
not the IE).59 Beginning at session 4 and following each subsequent session, the counselor will 
complete the 7-point Likert-style CGI developed in the CAMPUS feasibility study to rate overall 
improvement in SR since baseline from (1) “Very much improved” to (7) “Very much worse.” 
Sufficient response will be defined as an Improvement score of ≤ 2 (“Much improved” or “Very 
much improved”). 
 
A student participant in Stage 1 showing significant worsening may be re-randomized to Stage 2 
conditions earlier. Similarly, students who begin the study with significant suicidality and show 
no improvement after 4 sessions may also be considered for early randomization to Stage 2.  
 
Primary DV: Suicide-Related Behaviors – Relevant to Aims 1, 2, and 3.  
Recognizing that measurement of suicide-related behaviors is fraught with challenges,112 we 
are defining SR as “suicidal ideation, attitudes, behaviors and plans which take into account 
severity, intent, and ability to cope with ideation without engaging in suicidal behaviors, such as 
planning/rehearsal, NSSI, suicide attempts (SAs), and suicide.” Our primary assessment 
measures for SR are two interviews to measure suicidal ideation (SI; defined as self-reported 
thoughts of suicide-related behavior) and suicidal behaviors, including suicide attempts and 
non-suicidal self-injury (NSSI). Suicides will also be tallied. 
1) The Scale for Suicide Ideation—Current (SSI)99,113 is a 19-question interview that assesses 
the student participant’s highest SI in the past 2 weeks, including attitudes, behaviors, and 
plans. Each item is rated as 0,1, or 2 with a total scale of 0-38. The IEs will be trained and 
certified on the SSI. 
2) The Self-Injurious Thoughts and Behaviors Interview (SITBI)114 is a 3-15-minute interview 
containing modules that assess SI, suicide plans, suicide gestures, suicide attempts, and 
NSSI. The SITBI has been used with college students.115,116 The IEs will be trained and 
certified on the SITBI. 
 
Secondary DVs/Covariates: Functioning – Relevant to All Aims 
1) The CCAPS-34107 assesses key domains of college student mental health (Depression, 
Generalized Anxiety, Social Anxiety, Academic Distress, Eating Concerns, Substance Use, 
and Hostility/Anger) and an overall Distress Index score. Students respond to questions 
using a 5-point rating scale (“not at all like me” to “extremely like me”). The CCAPS-34 takes 
only 2-3 minutes to complete107 and is widely used in CCCs.221 The CCAPS will be assessed 
at all assessment points and at every session. The question on SI will screen prospective 
participants and the weekly administration can track SI fluctuations more frequently. 

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2) The CGI-I and CGI-S103 are secondary DVs when completed by IEs, counselors, and student 
participants—allowing for differences among reporters to be evaluated. The pilot data 
provided support for the inter-rater reliability and construct validity of this measure. 
3) Academic Functioning will be obtained via self-report by student participants. Academic 
functioning will include cumulative grade point average, enrollment status, and number of 
credits attempted vs. completed.  
 
Mechanisms of Change/Mediators of Treatment – Relevant to Aim 4 
1) The measures listed below include those found in prior studies (some by our team) to 
mediate outcome in DBT (#1-3) and CAMS (#4-5). The Difficulties in Emotion Regulation 
Scale (DERS)117 includes 36 items rated on a 6-point scale to assess awareness and 
understanding of emotional experience, acceptance of emotions, ability to modulate 
emotional arousal, and effective action in the presence of intense emotions. See 
Preliminary Studies section. 
2) The DBT-Ways of Coping Check List (DBT-WCCL)104 is a 59-item self-report questionnaire 
measuring the use of DBT skills and dysfunctional, non-DBT coping strategies over the 
previous month. All items are rated from 0 to 3 (“never use” to “always use”). The DBT-
WCCL includes two subscales, one assessing coping via DBT skills and one assessing coping 
via dysfunctional means. See Preliminary Studies section. 
3) The Acceptance and Action Questionnaire II (AAQ-II)118 is a 7-item self-report measure of 
experiential avoidance rated on a 7-point scale (“never true” to “always true”). See 
Preliminary Studies. 
4) The Suicide Cognitions Scale (SCS)119 is an 18-item self-report measure based on the 
residual risk model with Unlovability, Unbearability, and Unsolvability subscales. It 
predicted SI after controlling for depression severity and hopelessness120 and uniquely 
discriminated SR between control and CAMS care.106 
5) The Optimism and Hope Scale (OHS)102 is a 14-item self-report measure used to assess a 
combination of dispositional optimism and trait hopefulness.  
6) PROMIS Self-Efficacy for Managing Emotions-Short Form 4a is a 4-item self-report measure 
which asks participants to rate, at that moment using a 1 (I am not at all confident) to 5 (I 
am very confident) scale, the following four items: (1) I can bounce back from 
disappointment, (2) I can avoid feeling discouraged, (3) I can find ways to manage stress, 
(4) I can handle negative feelings. 
 
Moderators of Treatment—Relevant to Aim 5 
Aim 5 pertains to the identification of predictors and moderators of treatment response, which 
could be incorporated as secondary tailoring variables in later studies or during dissemination. 
Potential predictors and moderators were gleaned from the suicidology literature and/or from 
DBT and CAMS specifically: 
1) History of previous suicide attempts has been predictive of SR and moderated treatment 
response.31 
2) Personality Assessment Inventory – Borderline Features Scale (PAI-BOR)123 is commonly 
used to assess BPD features in college students.124,125 The scale consists of 24 items, rated 

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on a 4-point scale, with a 0-72 range (38 is the cutoff for significant BPD features). BPD 
features has served as a proxy for chronicity.32 
3) Optimism and Hope Scale (OHS)102 See above. The OHS has been able to predict 
subsequent death by suicide.126  
4) Global Assessment Scale (GAS)127 is a measure of an individual’s social, psychological, and 
work- related functioning ranging from 1 to 100 (higher is better) and will be completed by 
the IE. 
5) Sexual orientation, gender identity, and cultural identity will be assessed as sexual and 
gender minorities (SGM)/LGBTQ+ individuals are at an increased risk for suicide, suicide 
attempts, NSSI, and SI.18,19 Importantly, there are still large research gaps within this 
population (see128). Given the growing number of college students who identify as non-
binary or transgender or with another culture, our large multisite study will add to the 
literature regarding this population.129 
6) Alcohol Use Disorders Identification Test (AUDIT)185 is a 10-item self-report measure of the 
severity of problematic alcohol use. 
7) Drug Abuse Screening Test (DAST)186 is a 10-item self-report measure of the severity of 
problematic substance use. 
 
Implementation and Process Measures – Relevant to Aim 6 
The implementation monitoring plan will be guided by 1) critical steps of the Quality 
Implementation Framework (QIF)36; 2) process evaluation and implementation monitoring 
outlined by Saunders135; and 3) implementation outcomes specified by Proctor.35 The process 
evaluation will include both quantitative and qualitative assessments to monitor the 
implementation activities and address barriers that may arise during the study. The mixed 
methods will include feedback from the student participants, counseling staff, and directors. 
1) Client Satisfaction Questionnaire (CSQ-8)136 is an 8-item questionnaire that assesses clients’ 
satisfaction with treatment and has been used in other CAMS studies.66 See Preliminary 
Studies. 
2) CSQ-8 (Therapist Version) and Reasons for Termination Checklist. Counselor participants’ 
acceptability of and satisfaction with the interventions will be assessed at the end of Stage 
1 and Stage 2 via the therapist version of the CSQ and Reasons for Termination Checklist. 
These measures were used in other CAMS66 studies and our pilot. 
3) Treatment Credibility Questionnaire. After session 1 of each stage, student participants will 
rate the therapy they are receiving on seven items adapted from Borkovec and Nau137 that 
ask how logical, scientific, or potentially helpful the treatment appears to be. 
4) Therapist Expectations. Two Likert-style questions regarding expectations about treatment 
utilized in prior studies66 will be completed by counselor participants at the end of the first 
session in Stage 1 and Stage 2. 
5) Treatment History Interview (THI)138 is an interview to gather information about a client’s 
psychiatric and medical treatment over a period of time, including psychotherapy, 
comprehensive treatment programs, case management, self-help groups, inpatient units, 
emergency treatment (e.g., emergency room visits, police wellness checks), medical 
treatment, as well as the use of psychotropic and other medications. The THI will be 

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collected at baseline, end of Stage 2, and follow-up. Data will be utilized descriptively and 
for cost analyses. 
6) Telehealth Usability Questionnaire (TUQ)187 is a 15-item questionnaire that assesses 
student participants’ acceptability with using telehealth platforms for therapy. 
7) TUQ-C (Counselor Version) is an adapted version of the TUQ questionnaire that assesses 
counselor participants’ acceptability with using telehealth platforms for therapy. 
Counselors who provide DBT skills training via telehealth will also complete an adapted 
TUQ for DBT skills training.  
8) Focused Interview. Counselor participants will each complete a focused interview at the 
end of their participation in the study. An independent party will conduct the focused 
interviews, which will center on each participant’s experience of the study. 
9) Counselor Session Telehealth Questionnaire (CSTQ). The CSTQ will be used to assess 
counselor perceptions of the technical adequacy of the virtual modality used during 
telehealth with their clients as part of the CAMPUS study. The CSTQ will also be used to 
evaluate counselor perceptions of comfort conducting therapy and risk assessment for 
heightened risk clients over a virtual format. The CSTQ is a 5-item measure and will be 
completed after every telehealth session. 
 
Counselor Measures – Relevant to Aim 7 
Aim 7 will explore aspects of counselor participants’ experiences, including their beliefs about 
suicide, self-identified theoretical orientation and training experiences, expectations for and 
satisfaction with providing different types of therapy during the study, and general experiences 
of participating in the study. 
1) CSQ-8 (Therapist Version) and Reasons for Termination Checklist. See above. 
2) Therapist Expectations. See above. 
3) Focused Interview. See above. 
4) Zero Suicide Workforce Survey (Abbreviated). The Zero Suicide Workforce Survey 
(Abbreviated) assesses counselor participants’ beliefs about suicide, techniques that 
counselor participants implement with suicidal clients, and confidence in their ability to 
treat suicidal clients. 
5) Demographic Information Form. The Demographic Information Form will assess counselor 
participants’ self-reported gender, race, ethnicity, sexual orientation, education level, years 
of clinical experience, years of experience working with suicidal clients, theoretical 
orientation, and experience with suicide, CAMS, and DBT. 
6) TAU Questionnaire. The TAU Questionnaire will assess the interventions that counselor 
participants implemented during TAU. Counselor participants will complete this measure at 
the end of Stage 1 for each student participant they treat who was randomized to TAU. 
8.2 
SAFETY ASSESSMENTS 
To monitor the safety of student participants, AEs and SAEs will be monitored at each 
treatment and assessment visit. For treatment visits, study counselors will document any new 
AEs/SAEs spontaneously reported during therapy sessions. Unsolicited events that meet the 
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research team to ascertain onset, severity, relatedness to treatment, outcome, and measures 
taken to address AE or SAE, if any.  
 
During each assessment visits, AEs and SAEs will also be assessed and monitored through 
general inquiry by the IEs. During remote assessments, IEs will first inquire as to where the 
participant is physically located. IEs will also implement the University of Washington Risk 
Assessment Protocol (UWRAP)110 at each assessment to monitor suicide risk more closely.  
 
The following specific steps will be taken: 
1) The first step in managing risk during and following assessments with suicidal and other 
highly distressed or volatile student participants is to assess the participant’s mood before 
the assessment starts. To this end, the IE administers the UWRAP pre-assessment 
questions at the beginning of each assessment session which assesses the student 
participant’s level of stress and urges to suicide, self-harm, or use substances at the 
beginning of the assessment. The IE uses this information in structuring and pacing the 
assessment to the subject participant’s tolerance. 
2) At the first assessment meeting (and reviewed thereafter as needed), the IE begins the 
UWRAP Mood Improvement Protocol. Two items are used to determine strategies the 
student participant can use to manage any distress caused by the assessments.  
3) At the end of each assessment session, the IE administers the UWRAP Debriefing Form, 
which asks about the student participant’s mood, stress, and urges at that point. Thus, the 
IE can tell how the student participant’s mood has changed during the session.  
4) An Imminent Suicide Risk and Serious Self-Injury Form must be completed if the student 
participant rates suicidality higher than 4 on a 7-point scale or states that he/she is 
uncertain about being able to control suicidal impulses. 
5) If suicide risk is moderate to high, the IE implements the necessary Suicide/Distress 
Intervention Protocol for Assessors. In these instances, IEs must also call the site PI (or 
his/her designee) to review the suicide risk assessment and intervention. 
6) The Debriefing Form lists the strategies for responding to suicidal risk and those used 
should be checked off and described, if necessary. 
7) At the end of the assessments, IEs offer and engage student participants in mood 
improvement activities according to the Mood Improvement Protocol. If there is not high 
risk, the IE then closes the assessment, works with the student participant to improve 
his/her mood, and sends the student participant home (if in person) or ends the videocall 
(if remote). The IE then makes a mood improvement rating for the student participant. 
8) At the end of each assessment, IEs provide student participants with crisis resources and 
emergency phone numbers. 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
An Adverse Event (AE) is any untoward medical occurrence in a study subject that does not 
necessarily have a causal relationship with this treatment. 

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An AE therefore can be any unfavorable and unintended sign (including laboratory finding), 
symptom or disease temporally associated with participation in an investigational study, 
whether or not considered intervention-related. In addition to new events, any increase in the 
severity or frequency of a pre-existing condition that occurs after the subject signs a consent 
form for participation is considered an AE. This includes any side effect, injury, toxicity, or 
sensitivity reaction. 
 
Any condition, laboratory abnormality, or physical finding with an onset date prior to the 
subject signing consent for study participation is considered pre-existing in nature and part of 
the subject’s medical history and will not be recorded as an AE. 
 
In this study, we will classify the following as Adverse Events (AEs): 
• Breach of confidentiality. 
• Evidence of coercion to participate. 
• Evidence of distress during assessments (as indicated by a score of >5 on item 2 of the 
UWRAP Debriefing Form and an increase of at least one point on this same item when 
compared to the UWRAP Pre-Assessment). 
• Significant increase in suicidal ideation (as measured by a CGI-I score of 6 or 7, which is 
completed weekly by counselors following session 4 and at each assessment point by 
the IEs). 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
A Serious Adverse Event (SAE) is any adverse event occurring during the study or within 30 days 
of termination of the subject from the study that results in one or more of the following 
outcomes: 
• Suicide death 
• Non-suicide death 
• Suicide attempt (not death) with non-zero intent to die  
• Inpatient Hospitalization (specify below) 
o Suicidal ideation 
o Non-suicidal self-injury (NSSI) 
o Other mental health event (e.g., depression, homicidal ideation, anxiety) 
o Other non-mental health event (excludes scheduled hospitalizations for non-
acute, unrelated cause such as an elective surgery) 
• Emergency Department (ED) visit, not resulting in inpatient hospitalization (specify 
below) 
o Suicidal ideation 
o Non-suicidal self-injury (NSSI) 
o Other mental health event (e.g., depression, homicidal ideation, anxiety) 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 

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8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) the following guidelines will be used to describe severity.  
• Mild – Events require minimal or no treatment and do not interfere in participant’s daily 
activities or functioning.  
• Moderate – Events result in a low level of inconvenience and may result in some 
interference in participant’s daily activities or functioning. 
• Severe – Events interrupt a participant’s usual daily activity or functioning and may 
require systemic drug therapy or other treatment. Severe events are usually potentially 
life-threatening or incapacitating. Of note, the term “severe” does not necessarily 
equate to “serious.” 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All adverse events (AEs) will have their relationship to study procedures, including the 
intervention, assessed by the student participant’s treating counselor and/or IE based on the 
temporal relationship and his/her clinical judgment. The degree of certainty about causality will 
be graded using the categories below.  
• Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event, including an abnormal 
laboratory test result, occurs in a plausible time relationship to study procedures 
administration and cannot be explained by concurrent disease or other drugs or 
chemicals. The response to withdrawal of the study procedures should be clinically 
plausible. The event must be pharmacologically or phenomenologically definitive. 
• Possibly Related – There is some evidence to suggest a causal relationship, and the 
influence of other factors is unlikely. The clinical event, including an abnormal 
laboratory test result, occurs within a reasonable time after administration of the study 
procedures, is unlikely to be attributed to concurrent disease or other drugs or 
chemicals, and follows a clinically reasonable response on withdrawal.  
• Not related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship 
improbable (e.g., the event did not occur within a reasonable time after administration 
of the study procedures) and in which other drugs or chemicals or underlying disease 
provides plausible explanations (e.g., the participant’s clinical condition, other 
concomitant treatments). 
8.3.3.3 EXPECTEDNESS  
The study team will be responsible for determining whether an adverse event (AE) is expected 
or unexpected. An AE will be considered unexpected if the nature, severity, or frequency of the 
event is not consistent with the risk information previously described for the study procedures. 
• Expected Adverse Event – an adverse event that may be reasonably anticipated to occur 
because of the study procedure(s) or the natural progression of the subject’s underlying 
disease, disorder, or condition. 

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• Unexpected Adverse Event – an adverse event that is not anticipated to occur because 
of the study procedure(s) or one that is not part of the natural progression of the 
subject’s underlying disease, disorder, or condition.  
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the 
attention of study personnel during study visits and interviews of a participant presenting for 
care, or upon review by a study monitor. 
 
As indicated in 8.4.1, AEs will be captured on the appropriate case report form (CRF). 
Information to be collected includes date and time the study team became aware of the event, 
event description, time of onset, study team’s assessment of severity, relationship to study 
procedures, expectedness, time of resolution/stabilization of the event. AEs, as indicated in 
8.4.1, occurring while on study will be documented appropriately regardless of relationship and 
will be followed until resolved or 7 days post-last intervention for all AEs or 30 days post-last 
intervention for all SAEs. 
 
Any medical or psychiatric condition that is present at the time that the participant is screened 
will be considered as baseline and not reported as an AE. However, if the participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed. Documentation of onset and duration of 
each episode will be maintained for AEs characterized as intermittent. 
 
The study team will record events with start dates occurring any time after informed consent is 
obtained until 7 days (for AEs) or 30 days (for SAEs) post-last treatment visit. At each treatment 
visit, study counselors will document unsolicited AE/SAEs since the last therapy session 
discussed during that therapy session. At each study assessment visit, IEs will inquire about and 
document the occurrence of AE/SAEs since the last assessment. Events will be followed for 
outcome information until resolution or stabilization. 
8.3.5 EVENT REPORTING  
Adverse events and serious adverse events that will be tracked for this study are described in 
8.4.1. Considering the nature of the study, we expect most of these events will be considered 
unrelated to the study procedures, including serious adverse events, like suicide attempts. If 
AEs/SAEs occur, the following procedure will be activated: 
 
The research staff member who observes or is notified of an adverse event (e.g., significant 
distress during the baseline assessment) will notify the Principal Investigator (or his/her 
designee) on the same business day. The PI (or his/her designee) will complete an Adverse 
Event Form for each event and will determine if the event is an SAE. If the AE is determined to 
be an SAE, the Serious Adverse Event Form will be completed.  

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All reports will be made in writing to the NIMH DSMB representative, NIMH Program Official 
(PO), and sIRB. These reports should indicate that the monitoring entities (i.e., the PI and IRB, 
and/or DSMB) and appropriate regulatory entities (e.g., OHRP, FDA) have been notified in 
accordance with the approved monitoring plan and federal regulations. Reports will be 
submitted to the monitoring entity (e.g., NIH-DSMB) at least annually or on a schedule 
determined by the monitoring entity’s policy. Monitoring entities may require more frequent 
reporting. 
 
To local IRB and Sponsor  
Any AE is reportable to the sIRB and local IRB within 5 business days when it meets the 
following definition: 
 
Any harm experienced by a subject or other individual that, in the opinion of the 
investigator, is unexpected AND at least probably related to the research. (Note: A harm 
is at least probably related to the research if in the opinion of the investigator the 
research procedures more likely than not caused the harm.) 
 
All AE/SAEs with an onset date after the subject signs consent for study participation will also 
be reported to the IRB at the time of annual renewal. Details of the event will include severity, 
relationship to study intervention, duration, action taken, and outcome. All AE/SAEs that are 
considered related to the study intervention will be followed to resolution, or stabilization if 
improvement is not expected. AE/SAEs that completely resolve and then recur will be recorded 
as a new AE/SAE. AE/SAEs that are considered related to the study intervention and continue at 
30 days post-last intervention will have a comment in the source documents by the site PI that 
the event has stabilized or is not expected to improve. 
 
To NIMH DSMB 
All AEs and SAEs will be reported to the NIMH DSMB in data reports prepared three times 
annually. Details of the event will include the AE, severity, expectedness, relationship to study 
intervention, duration (start/stop date), action taken, and outcome.  
 
In addition, SAEs will be reported to the NIH DSMB within 72 business hours of the site PI’s 
awareness of the event.  
 
All AE/SAEs that are considered related to study intervention must be followed to resolution or 
stabilization if improvement is not expected. AE/SAEs that completely resolve and then recur 
should be recorded as a new AE/SAE. AE/SAEs that are considered related to study intervention 
and continuing at 30 days post-last intervention should have a comment in the source 
documents by the PI that the event has stabilized or is not expected to improve. Other 
supporting documentation of the event may be requested by the DSMB/NIMH and should be 
provided as soon as possible.  
 

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DSMB/Regulatory reporting criteria for the PI are presented in Table 6. 
 
Table 6. DSMB/Regulatory Reporting Criteria for Study PIs 
 
Related to Intervention 
NOT Related to Intervention 
Expected Event 
DSMB Tri-Annually 
DSMB Tri-Annually 
Unexpected Event 
DSMB Immediately 
DSMB Tri-Annually 
Death 
DSMB Immediately 
DSMB Immediately 
Note: DSMB Immediately = The AE/SAE should be reported as soon as possible to the NIMH 
DSMB, within 3 business days. The SAE will also be included in the SAE section of the next 
DSMB Report. 
 
Table 7 defines the reporting requirements for a variety of study related events. 
 
Table 7. Study Reporting Requirements. 
Reportable Event 
When is Event Reported to the NIMH 
Reported By 
IRB or DSMB 
Suspensions or 
Terminations 
Any suspension or termination of approval must 
include a statement of the reason(s) for the action 
and must be reported promptly to the NIMH PO 
within 3 business days of receipt. 
Regulatory or 
Monitoring Entity and 
Investigator 
Deaths related to 
study participation 
Deaths must be reported immediately (no later 
than within 3 business days) of the principal 
investigator first learning of the death. 
Investigator 
Expected and 
Unexpected Serious 
Adverse Events 
related to study 
participation 
Reported to the NIMH PO within 3 business days of 
the study team becoming aware of the SAE. 
Investigator 
Unanticipated 
Problems Involving 
Risks to Participants 
or Others 
Reported to the NIMH PO and NIMH-DSMB 
representative within 3 business days of the 
investigator learning of the event. 
Investigator 
Serious or Continuing 
Noncompliance  
Reported to the NIMH PO and NIMH-DSMB 
representative within 3 business days of IRB 
determination. 
Institution 
Adverse Event  
For all AEs that are deemed expected and/or 
unrelated to the study, a summary should be 
submitted to the NIMH PO with the annual 
progress report. 
Investigator 
Protocol Violations 
With the annual progress report. 
Investigator 
 
8.4 
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human 
Research Protections (OHRP). OHRP considers unanticipated problems involving risks to 

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participants or others to include, in general, any incident, experience, or outcome that meets 
all of the following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the Institutional Review 
Board (IRB)-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; 
• Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
• Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known 
or recognized. 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review 
Board (IRB), the NIMH DSMB, and to the Duke Data Center (DDC)/lead principal investigator 
(PI). The UP report will include the following information: 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB 
project number 
• A detailed description of the event, incident, experience, or outcome  
• An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP 
• A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:  
• UPs that are serious adverse events (SAEs) will be reported to the IRB, the NIMH DSMB, 
and to the DDC/study sponsor/funding agency within 3 business days of the investigator 
becoming aware of the event  
• Any other UP will be reported to the IRB, the NIMH DSMB, and to the DDC/study 
sponsor/funding agency within 5 business days of the investigator becoming aware of 
the problem  
• All UPs should be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), the supporting agency head (or designee), 
and the Office for Human Research Protections (OHRP) within 10 working days of the 
IRB’s receipt of the report of the problem from the investigator 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
CAMPUS TRIAL STATISTICAL HYPOTHESES 
The statistical hypotheses and endpoints have been previously summarized in Section 3 above. 

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9.2 
CAMPUS TRIAL SAMPLE SIZE DETERMINATION 
Power for Aim 1:  
Sample size for the study is based primarily on Aim 1, although we also provide effect size (ES) 
estimates for the other aims given the proposed sample size. With respect to Aim 1, with a total 
sample of 480, the approach provided by Crivello and colleagues178,179,180 guarantees that the 
adaptive intervention with the lowest estimated mean suicide risk (ideation + behaviors) at 
post-treatment is, in fact, the best adaptive intervention with 90% probability. This calculation 
assumes that the best two ATSs differ by d = 0.25 (or ≥2 points on the SSI), which corresponds 
to a small ES estimate.181 
 
Power for Aim 2:  
Aim 2 is a two-sample comparison (cells A+B+C vs. D+E+F). Using a two-side, two-sample t-test 
based on Type-I error rate of 2.5%, a sample of 240 randomized to each Stage 1 treatment arm 
(N=480 total), we will have 85% power to detect a small, standardized ES of d = 0.30 in the 
between groups difference in change on the primary outcomes. Based on prior studies and our 
pilot data with SD=7 for SSI,113 this ES corresponds to a clinically meaningful difference of 2 in 
the SSI. Note that this is a conservative estimate of power: in the repeated measures LMM, 
power increases in proportion to the within person correlation in baseline to 26-week SSI which 
can be as high as 0.40 (p<.01, based on pilot data). At 3-month follow-up (assuming a baseline 
to 48-week within correlation of 0.3) we will have 94% power to detect the same moderate ES. 
 
Power for Aim 3:  
Assuming about 50% response (N=240) and about 50% insufficient response rate [N=240, which 
is chosen to be slightly higher for a value divisible by the four possible treatment paths from 
Stage 1 to Stage 2 (CAMS-CAMS, CAMS-DBT, TAU-CAMS, and TAU-DBT) (based on pilot data)] to 
Stage 1 treatments corresponding to N=60 potential student participants to be randomized to 
each of the 4 Stage 2 arms among the non-responders as illustrated in the Schema Figure in 
section 1.2. We anticipate an at most Stage 1 attrition rate of about 25% among those with an 
insufficient response leaving N=180 total student participants to be randomized in Stage 2 
(approximately 45 student participants per ATS). Estimates of attrition are chosen as equal 
across each treatment path but are in essence worst case scenarios, where we may see less 
attrition for specific treatment paths compared to others; therefore, all power estimates are 
conservative, with more power achievable with more available student participants for 
different treatment combinations. Based on the method outlined by Oetting and colleagues182 
and a within-person correlation of 0.60, 2.5% Type-I error, we will have over 80% power to 
detect a difference of ≥3.4 (d = 0.34) in change in SSI between DBT vs. CAMS. 
 
Power for Aims 4 and 5:  
Best practices for power calculations for mediation and moderation models within SMART 
designs are still debated. For mediation, we will use the work of Fritz and MacKinnon,183 who 
document sample size requirements to guarantee 80% power under the sequential regression 
framework166 and the formulas of Vittinghoff et al.184 Under the assumption of a medium effect 
for intervention on the mediator and a medium effect for intervention on outcome covarying 

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the mediator, and an alpha=0.025, the total sample size is calculated as N=166. Therefore, our 
design consisting of a sample size of 480 within Stage 1 and at least 90 subjects per two Stage 2 
arms (CAMS vs CC-DBT) (N=180 total), is sufficiently powered to detect mediation within Stage 
2. For moderation, we use Cohen’s181 power tables, our sample size of 480 at the start of Stage 
1 and at least 90 subjects per arm at Stage 2 is more than sufficient to detect a medium-to-
large ES for a moderator. 
 
Table 8. The 4 Adaptive treatment strategies embedded in the proposed SMART 
Adaptive 
Treatment 
Strategy 
Stage 1 
Treatment 
Status at End of Stage 1 
Stage 2 Treatment 
Cells Involved in 
Comparisons 
1 
CAMS 
Responder 
Maintenance/ Monitoring 
A 
A + B 
Insufficient Responder 
Continue CAMS 
B 
2 
CAMS 
Responder 
Maintenance/ Monitoring 
A 
A + C 
Insufficient Responder 
Switch to CC-DBT 
C 
3 
TAU 
Responder 
Maintenance/ Monitoring 
D 
D + E 
Insufficient Responder 
Switch to CAMS 
E 
4 
TAU 
Responder 
Maintenance/ Monitoring 
D 
D + F 
Insufficient Responder 
Switch to CC-DBT 
F 
 
9.3 
CAMPUS TRIAL STATISTICAL ANALYSES 
9.3.1 GENERAL APPROACH 
Overview and Intent-to-Treat. The proposed trial design of adaptive treatment strategies 
(ATSs) is like a factorial design;156,157,158,159 different analytic subgroups (see Table 8) are 
combined to answer different questions. Aim 1 is the trial’s primary aim; Aims 2-5 are 
secondary aims and Aim 6 as an implementation aim. All student participants, once 
randomized, will be included in the intent-to-treat sample, and every effort will be made to 
collect all primary and secondary outcomes even if a student participant does not engage in 
randomly assigned treatments. The primary outcome of interest is suicidal risk, which includes 
suicidal ideation as well as suicide-related behaviors, such as non-suicidal self-injury (NSSI) and 
suicide attempts (SAs); however suicidal ideation is the primary DV due to relatively low rates 
of suicidal behaviors post-baseline with college students. Suicides will be tallied as well. All 
analyses allow for the inclusion of covariates listed as demographics and covariates in Section 
8.1. Covariates will enter the model based in clinical importance (gender, age, current alcohol 
use, current substance use, etc.) and retained on a case-by-case basis based on statistical 
significance. 
9.3.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
Aim 1 analyses (Primary Aim) will compare and contrast the 4 pre-specified ATSs embedded in 
the SMART design to determine whether one is clearly better or worse than the others with 
respect to mean suicidal ideation (SI) and suicide-related behaviors (NSSI and suicide attempts), 
which are the primary outcomes, at the end of 14 weeks of treatment. The data analysis 
method of Robins and colleagues160,161 will be used to contrast the 4 ATSs based on reducing 

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suicide-related risk behaviors (SI, NSSI, and suicide attempts) to determine whether any of the 
interventions appear to be clearly better or worse than others. As part of the design, a student 
participant will contribute differentially to one or more of the 4 strategies (depending on the 
treatments to which he or she is randomized and whether he or she is a treatment responder), 
requiring a weighted comparison. Specifically, this analysis involves a weighted comparison of 
the cells A+B vs. A+C vs. D+E vs. D+F (see Table 8); the method by Robins and colleagues160,161 
weights each student participant using the known randomization probabilities. Linear contrasts 
among the components of the ATSs will be performed to further understand impact on efficacy. 
Similar analyses will compare the 4 strategies on the follow-up and secondary outcomes 
outlined above. Additionally, in response to reviewers’ input, a composite outcome including 
suicidal ideation, suicide attempts, and NSSI will be derived. Death by suicide will be tallied but 
not included in the composite score. Song and colleagues162 provide a thorough discussion of 
the best ways to create composite scores, especially when dealing with a mixture of continuous 
and count outcomes. The analysis team will determine the best approach in the 
formation/derivation of the composite using the steps discussed by Song et al162. Similar 
analyses will compare the 4 strategies on the derived composite as outlined above. 
 
Aim 2 analyses will contrast ATSs beginning with CAMS vs. interventions beginning with TAU 
(i.e., to evaluate the main effect of initial treatment) on change (decrease) in suicide-related 
risk behaviors (SI, NSSI, and suicide attempts—the primary outcomes) from baseline to the end 
of Stage 2 (the primary contrast). This is a comparison of cells A+B+C vs. D+E+F (see Figure 2 
and Table 8). Note that the primary continuous longitudinal outcome is assessed at baseline, 
mid-Stage 1 (3 weeks), post Stage 1 (6 weeks), mid-Stage 2 (10 weeks), post-Stage 2 (14 weeks) 
(end of acute treatment) and then again at 3-month follow-up (26 weeks), for a total of 6 
measurement occasions. Linear mixed models163 (LMM, also known as random effects or 
growth curve models), fit with SAS PROC MIXED will be used to analyze the longitudinal data. 
LMMs use all available measurements, allowing student participants to have an unequal 
number of observations and producing unbiased parameter estimates as long as unobserved 
values are missing at random. The analysis will fit a LMM with fixed effects for the intercept, 
time, group, and a group-by-time interaction term, where group is an indicator of phase-one 
treatment (CAMS vs. TAU as referent). The LMM will also include random effects for the 
intercept and time and an unstructured within-person correlation structure for the residual 
errors and will adjust for the following measures collected at baseline (pre-randomization): site, 
age, race, and clinical severity. Model diagnostics will be used to determine suitability of more 
parsimonious (e.g., autoregressive) correlation structures, and nonlinear (e.g., quadratic) 
effects for time. We do not expect the intervention effects to be attenuated due to counselor 
participants who are cross classified between the interventions. Nonetheless, we will assess the 
potential attenuation by assessing the counselor x intervention interaction. If significant, we 
will examine if the attenuation effect is limited to a select few counselors and eliminate as 
needed to remove potential counselor contamination of intervention effects. Counselor will be 
treated as a random effect which models potential correlation between student participants 
within a common counselor. If there is not sufficient variance, indicated by the reliability 
estimate of the random effect falling below 0.02 (a slighter lower threshold compared to 

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Raudenbush and Bryk164 (p.125), we will treat counselor as a fixed effect. The primary contrast 
is between groups’ difference in change from baseline to month 6 (end of acute treatment 
through Stage 1 and Stage 2 active treatment). The follow-up contrast at week 26 (12 weeks 
post-acute treatment) will also be examined in this and in all subsequent analyses. LMMs like 
the above for the primary outcome will be run for the secondary longitudinal outcomes: CAMS 
vs. TAU on CCAPS subscales (Depression, Anxiety, Academic Distress, Overall Distress), CGI-I 
and CGI-S (measured by IE), and cumulative GPA. 
 
AIM 3 analyses will examine the relative effectiveness of switching to a more comprehensive 
suicide-focused treatment approach (e.g., CC-DBT) among those who do not respond 
sufficiently to Stage 1 treatments vs. a less intensive suicide-focused approach (e.g., CAMS). 
This analysis is a comparison of cells C+F (switch to CC-DBT) vs. B+E (switch or continue with 
CAMS) in Table 8. Both primary and secondary longitudinal outcomes outlined above will be 
examined using an LMM like that described above, but (a) including only the subset of 
responders to Phase 1 treatment, (b) defining group as switching to CC-DBT (cells C+F) vs. 
continuing or switching to CAMS (cells B+E), and (c) using monthly longitudinal outcomes from 
week 4 to week 24 (7 measurement occasions). 
9.3.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
AIMS 1-3 analyses are the same as the preceding subsection 9.4.2. 
 
AIM 4 analyses focus on treatment-specific mediation in both CAMS and CC-DBT. The potential 
mediators (for CC-DBT: DERS, DBT-WCCL, and AAQ; for CAMS: SCS, OHS; Self-Efficacy,) are 
assessed at baseline, midpoints, and endpoints. To maintain the temporal sequence order of 
the mediator per Kraemer and colleagues,165 mediation occurs when, after partialling out the 
change in the mediator (baseline through midpoints), the relationship between intervention 
condition and the change in outcome from midpoint(s) through endpoint, when controlling for 
early change in the outcome (baseline to midpoint), is significantly reduced (in full mediation 
the relationship is zero). Standard mediation analyses166 assume sequential ignorability. We will 
implement causal mediation approaches,167,168 as described by MacKinnon and 
colleagues,169 which provide an adjustment due to potential unmeasured confounding and the 
violation of the assumption of sequential ignorability. The analysis team has experience 
implementing these models.170,171 VanderWeele’s research team172 recently described the 
above mediation technique specifically suited for LMM framed under a generalized mixed 
effects structure, which we will incorporate. We will fit separate causal mediation models for 
Stage 1 and Stage 2. Exploratory analyses will focus on multiple mediation and moderated 
mediation within the causal mediation framework. 
 
AIM 5 analyses focus on moderation within Stage 1 and Stage 2 (gender identity, sexual 
orientation, minority culture, number of prior suicide attempts, AUDIT, DAST, PAI-BOR, OHS, 
GAS). A moderator is a baseline characteristic that has a differential effect on outcome across 
intervention condition165 and, in the context of a SMART, could be used to further individualize 
treatment to a particular student participant. Note that a predictor is a non-specific 

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moderator—namely, it does not vary by treatment condition. Assessment of moderation will be 
made by augmenting our outcome analyses described above to include the interaction of the 
effect of intervention with the potential moderator. Predictor analyses will be conducted in the 
absence of moderation by removing the interaction term. Additionally, analyses will focus on 
developing a personalized advantage index (PAI). The PAI was discussed by DeRubeis et al.173 as 
a set of algorithms that can be used to select the optimal treatment for a given patient. Kessler 
et al.174 used machine learning methods to develop his selection algorithm. We will do the 
same with the SAS software procedure PROC QLEARN,175 which uses the Q-Learning technique 
described in Nahum-Shani et al.159 
9.3.4 BASELINE DESCRIPTIVE STATISTICS 
We will compare Stage 1 treatment conditions on baseline measures to evaluate group 
equivalency using inferential statistics. 
9.3.5 PLANNED INTERIM ANALYSES  
N/A 
9.3.6 SUB-GROUP ANALYSES 
We plan to conduct sub-group analyses for the moderation analyses in Aim 5 described 
previously in Section 3. 
9.3.7 EXPLORATORY ANALYSES 
Aim 6 analyses focus on the implementation of ATSs within CCC settings. Descriptive statistics 
with confidence intervals will be derived for the implementation outcomes within Stage 1 and 
Stage 2 separately. For student participant level measures nested within counselor, we will 
implement HLM to account for the clustering attributable to student participants within 
counselor. A benchmarking procedure will be used to compare various treatment 
combinations.176 Stakeholder interviews and the quarterly CCIAB meetings will be audio-
recorded for subsequent transcription. Thematic content analysis techniques will be used to 
analyze the transcript text. Data management and data reduction will be accomplished using 
the ATLAS-ti text-analysis software. To examine the efficiency of alternative intervention 
strategies, we will estimate the service costs for each of the four ATSs. Our cost analyses 
consider both the payer perspective, focusing on service costs, as well as the patient 
perspective, focusing on cost-effectiveness, which considers health outcomes in addition to 
service costs. Psychological service utilization will be measured primarily through EMRs from 
the CCCs and through health care visits at the student health centers. To capture services 
outside of the universities, the Treatment History Interview (THI) will be administered at follow-
up. Service utilization will be converted to monetary costs using average reimbursement rates 
for the corresponding category of services in the national Medical Expenditure Panel Survey 
(MEPS). We will also query each site about any local reimbursement rates, to examine 
comparability with the MEPS data and to gain a sense of potential variability across regions. In 
addition to service costs, implementation costs such as participation in trainings and 

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supervision corresponding to the intervention will be tracked using logs of personnel time (and 
multiplied by corresponding wage and facility overhead rates). To make cost-effectiveness 
comparisons, incremental cost-effective ratios (ICERs) will be calculated as the incremental cost 
divided by the incremental clinical benefits (e.g., remission rate of suicide risk) for each pairwise 
comparison of intervention strategies. Uncertainty surrounding these estimates will be 
calculated as cost-effectiveness acceptability curves and confidence intervals, using 
bootstrapping with Monte Carlo simulations. In addition, we will conduct an exploratory 
analysis of the “hidden costs” to college campuses associated with not providing adequate 
treatment for students experiencing suicidal ideation and behaviors (e.g., crises on campus, 
NSSI in residence halls). 
 
Aim 7 analyses focus on the experience of counselors in the study. Given the relatively small 
sample size, the fact that the same counselors will be administering all treatments, and no a 
priori hypotheses, we regard these analyses as exploratory. Counselors will be divided into 
clinically relevant groups based on cut-points on key demographic variables (e.g., age, gender, 
years of overall experience, years of experience treating suicidal students, etc.). Analyses of 
variance will be used to examine differences in continuous outcomes; logistic regression 
analyses and contingency table analyses will be used to analyze differences in dichotomous 
outcomes. We will also use effect size benchmarks and descriptive statistics to gauge potentially 
meaningful effects (e.g., eta-square > .06; odd ratios > 2.0). 
 
Aim 8 analyses focus on statistical contrast of the two randomized arms within Stage 1 and the 
two randomized arms within Stage 2. For Stage 1 comparisons, linear mixed models163 (LMM, 
also known as random effects or growth curve models), fit with SAS PROC MIXED will be used to 
analyze the longitudinal data. LMMs use all available measurements, allowing student 
participants to have an unequal number of observations and producing unbiased parameter 
estimates if unobserved values are missing at random. The analysis will fit a LMM with fixed 
effects for the intercept, time, group, and a group-by-time interaction term, where group is an 
indicator of stage-one treatment (CAMS vs. TAU as referent). The LMM will also include random 
effects for the intercept and time and an unstructured within-person correlation structure for 
the residual errors and will adjust for the following measures collected at baseline (pre-
randomization): site, age, race, and clinical severity. Model diagnostics will be used to 
determine suitability of more parsimonious (e.g., autoregressive) correlation structures, and 
nonlinear (e.g., quadratic) effects for time. Complexity of the model may be constrained by the 
available repeated measures. Counselor will be treated as a random effect which models 
potential correlation between student participants within a common counselor. If there is not 
sufficient variance, indicated by the reliability estimate of the random effect falling below 0.02 
(a slighter lower threshold compared to Raudenbush and Bryk164 (p.125), we will treat 
counselor as a fixed effect. The primary contrast is between groups’ difference in change from 
baseline to end of Stage 1. Comparison of these findings will be to the results from the linear 
contrasts of the components of the ATS as described in Aim 1. 
 

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Stage 2 analyses within Aim 8 focus on statistical contrast of the two randomized arms within 
Stage 2. Patients are the non-responders from Stage 1. Linear mixed models163 (LMM, also 
known as random effects or growth curve models), fit with SAS PROC MIXED will be used to 
analyze the longitudinal data. LMMs use all available measurements, allowing student 
participants to have an unequal number of observations and producing unbiased parameter 
estimates if unobserved values are missing at random. The analysis will fit a LMM with fixed 
effects for the intercept, time, group, and a group-by-time interaction term, where group is an 
indicator of stage-one treatment (CC-DBT vs. CAMS as referent). The LMM will also include 
random effects for the intercept and time and an unstructured within-person correlation 
structure for the residual errors and will adjust for the following measures collected at baseline 
(pre-randomization): site, age, race, and clinical severity. Model diagnostics will be used to 
determine suitability of more parsimonious (e.g., autoregressive) correlation structures, and 
nonlinear (e.g., quadratic) effects for time. Complexity of the model and variance/covariance 
structures may be constrained by the available repeated measures. Counselor will be treated as 
a random effect which models potential correlation between student participants within a 
common counselor. If there is not sufficient variance, indicated by the reliability estimate of the 
random effect falling below 0.02 (a slighter lower threshold compared to Raudenbush and 
Bryk164 (p.125), we will treat counselor as a fixed effect. The primary contrast is between 
groups’ difference in change from Stage 2 randomization to end of Stage 2. Comparison of 
these findings will be to the results from the linear contrasts of the components of the ATS as 
described in Aim 1. 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
Prior to starting any study procedures all participants (both student participants and counselor 
participants) will complete their respective informed consent document and be provided with the 
opportunity to ask any questions or concerns they might have about the project.  
10.1.1.1 
CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Consents describing in detail the study intervention, study procedures, and risks will be given to 
the participant and documentation of informed consent will be completed prior to starting the 
study intervention. Given the remote nature of the study, all consents, even those completed in 
person, will be read and signed using an eConsent process. eConsent is available via REDCap 
(managed and stored on Duke Secure Servers). This functionality provides the ability to consent 
remote participants or participants in clinic via laptop, tablet or other touchscreen device. 
Participants will have the capability to sign electronically with a stylus, mouse, or finger. Once 
the consent form is submitted, participants will receive an email that includes a PDF attachment 
with a copy of the signed consent form. Written versions of the e-consents for both student 
participants and counselor participants are submitted with this protocol. 

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10.1.1.2 
CONSENT PROCEDURES AND DOCUMENTATION 
Each site IRB and the sIRB will have approved the consent forms and protocol prior to study 
initiation. Students presenting for treatment at one of the CCCs who meet inclusion criteria will 
be informed about the study by the clinic intake counselor (including features such as 
randomization(s) to treatment, variable length and approach to treatment, hybrid delivery of 
treatments, potential participation in a group, and study elements such as completion of 
assessments). Intake counselors, who will have just met the prospective student participant for 
the first time, either via teletherapy or in-person, will be trained on how to present the study in 
a way that is clinically sensitive, gives enough crucial information to the student to be able to 
indicate an interest or not, and allows students to decline easily. Intake counselors routinely 
follow up on suicidality to ascertain level of risk and this will allow them to gauge if this is an 
area the student would need/want to address in treatment. Intake counselors will be trained to 
only approach students who seem open to the idea of participating in a study; if the student 
seems quite distressed and unable to focus, this discussion may be delayed until a future time; 
or if the student shows lack of interest, the intake counselor will drop the subject. If the student 
shows interest in participating after learning about the study in some detail, he/she will be 
scheduled with a member of the local research team.  
 
Research staff will then meet, either online or in-person, depending on campus operations and 
research staff/participant preferences, with the student to go over the consent form in detail, 
prompt for and answer any questions, and obtain consent. The consent form will be detailed 
and will include information such as procedures and randomization(s), the collection of GUID, 
potential type/length of intervention, potential risks and benefits, limits to confidentiality, 
video-recording of sessions and assessments, compensation for assessments, and the ability to 
withdraw from the study without penalty. Both the intake counselor and the research staff will 
inform prospective student participants that declining to participate in the study will not affect 
their usual care at the CCC in any way. Students who decline participation at this stage (or who 
enroll but later choose to withdraw from the study) will have access to the usual care at the 
CCC. Consent is an ongoing process, so as the study progresses, counselors will be instructed to 
contact the Project Coordinator (PC) or the PI if the student participant expresses any concerns 
about continued participation and the PC or PI will be available to meet with the student 
participant and/or his/her counselor to discuss any concerns regarding continued student 
participation throughout the study 
 
Counselor participants will also be consented for participation in the study by research staff 
who do not oversee the counselor participants’ work at the CCC. They will be given the 
opportunity to read the consent, ask questions, and talk with counselors who participated in 
the pilot and/or feasibility studies. The consent form will be detailed and will include 
information such as overall study goals and procedures, randomization processes, the 
collection of GUID, type/length of interventions, potential risks and benefits, limits to 
confidentiality, video-recording of sessions, and the ability to withdraw from the study without 
penalty. 
 

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For both groups, potential participants will be informed that participation is voluntary and that 
they may withdraw from the study at any time, without prejudice. A pdf copy of the signed 
informed consent document will be sent via email to all participants for their records. The 
informed consent process will be conducted and documented in the source document 
(including the date), and the form signed, before the participants undergo any study 
procedures. The rights and welfare of the potential participants will be protected by 
emphasizing to them that the quality of their medical care/employment will not be adversely 
affected if they decline to participate in this study. 
 
Note: The main study consent forms also include opt-in/opt-out sections pertaining to inclusion 
of data in the NDA database, use of recorded video for training purposes, and willingness to be 
contacted in the future about additional research uses of their data. Subject responses to these 
opt-in/opt-out provisions will be tracked and stored within the REDCap database associated 
with each individual consent. These responses will be consulted and followed, prior to any of 
these optional data uses occurring. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to study participants, 
investigator, funding agency, and regulatory authorities. If the study is prematurely terminated 
or suspended, the PI will promptly inform study participants, the IRB, and sponsor/funding 
agency and will provide the reason(s) for the termination or suspension. Participants will be 
contacted, as applicable, and be informed of changes to the study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Demonstration of efficacy that would warrant stopping  
• Insufficient compliance to protocol requirements 
• Data that are not sufficiently complete and/or evaluable 
• Determination that the primary endpoint has been met 
• Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or 
oversight bodies (OHRP, DSMB). 
10.1.3 CONFIDENTIALITY AND PRIVACY  
Please see 2.3.2, minimizing risk due to a breach of confidentiality.  
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  

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All data collected via completion of questionnaires or participation in clinical interviews will be 
kept in each participant’s research record for at least seven (7) years after the study is completed. 
At that time, either the research information not already in the participant’s medical record will 
be destroyed or information identifying the participants will be removed from the database. Any 
research information entered into the participant’s medical record will be kept indefinitely.  
 
All research data will be kept in the REDCap database that is managed by the Duke Data Center 
(DDC) at Duke University Medical Center (DUMC). The servers hosting the REDCap data 
repositories are connected to the Duke internal network and protected by the Duke Health 
Enterprise firewall. Access to the repositories is permitted only through properly authenticated 
web application programming interfaces. REDCap data are encrypted both at rest and in transit. 
The DUMC database-hosting infrastructure has been audited by the Duke Information Security 
Office for compliance with HIPAA and Duke Health data security policies. 
 
The digital recordings of session data will also be kept at locally at sites or at DUMC with QA 
reviewers being granted view-only access to conduct ratings for adherence to the treatment 
model. Digital recordings will also be preserved for seven years, as this is mandated by some of 
the sites. Once these ratings have been completed and at least seven years have passed, the 
video data will be immediately erased. Those student and counselor participants who provide 
consent allowing the use of edited segments of digital recordings for educational/training 
purposes will be kept indefinitely.  
 
With the participant’s approval, de-identified data from this study will also be submitted to the 
National Institute of Mental Health Database (NDA) at the National Institutes of Health (NIH) and 
stored indefinitely. Digital-based data will not be submitted to the NDA at NIH. During the 
conduct of the study, an individual participant can choose to withdraw consent to have his or her 
data stored at NIH.  
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Organizational and administrative structure of the multisite study team 
To ensure scientific integration of research procedures, overall managerial and administrative 
responsibilities will rest with the Steering Committee (SC), which will be comprised of the PIs 
and Co-Is from each site, the Principal Statistician, the NIMH PO, and NIMH DSMB Liaison. As 
relevant, additional team members, including PCs, will participate in SC meetings. The SC will be 
responsible for all decisions concerning the overall research program, including plans for data 
analysis and publications. The SC will hold weekly video conference calls to monitor the overall 
course of the study including recruitment, retention, and any out-of-protocol deviations. In case 
of disagreements, each site will have one vote and the statistician will break a tie. Various 
subcommittees (e.g., Quality Assurance, Treatment, Assessment) will be formed across 
investigators and consultants and these subcommittees will present potential 
challenges/solutions to the SC. 
 

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To facilitate the efficiency of the SC, an Executive Committee (EC) will be constructed which will 
hold weekly calls to manage and facilitate study operations and set the agenda for the SC 
conference calls. The EC will be comprised of the Coordinating Center PI (Dr. Compton), one 
other site PI (which will rotate among the remaining PIs annually), and a Co-I at the Duke site 
(currently Dr. Blalock). The EC will be responsible for suggesting that various subcommittees 
(See Table 9 below) convene to address relevant issues, as needed. These subcommittees will 
problem-solve issues and present potential solutions to the SC for approval (these actions will 
be documented via minutes). 
 
There will also be two boards: (1) a Scientific Advisory Board (SAB) composed of a suicidologist 
with expertise in multisite trials, a psychiatrist, and a college student expert (for names, see 
Table 9) and (2) a College Counseling Implementation Advisory Board (CCIAB), composed of the 
site CCC Directors (for names, see Table 7), four counselors across sites (TBD), and other key 
stakeholders (TBD). 
 
Scott Compton, the PI at Duke University, will serve as the primary liaison with NIMH. The 
PIs/Co-Is/PCs will attend an annual study meeting and also meet at professional conferences 
throughout the year. 
 
Table 9. Administrative and Advisory Organization 
Site 1 
University of Nevada-Reno 
Site 2 
Duke University 
Site 3 
University of Oregon 
Site 4 
Rutgers University 
Jacqueline Pistorello, Lead PI, 
Director of Counseling Services, 
Research Faculty; Francesca 
Kassing, Co-I  
Research Faculty 
David Jobes, Co-I, Professor, 
Catholic University; Robert 
Gallop, Consultant, Professor, 
West Chester University 
Scott Compton, PI, 
Associate Professor 
Kyla Blalock, Co-I, 
Assistant Professor 
John Seeley, PI, Professor; 
Alisia Caban, Co-I, Clinical 
Director; Daniel 
Eisenberg, Co-I, Associate 
Professor, University of 
California, Los Angeles 
Shireen Rizvi, PI, 
Professor 
Linda Oshin, Co-I, 
Assistant Professor 
Steering Committee: Scott Compton (Co-chair), John Seeley (Co-chair), Jacqueline Pistorello, Shireen Rizvi, David 
Jobes, and Robert Gallop, Mary Rooney (NIMH PO), and Lorie Shora (NIMH DSMB Liaison) 
 
Executive Committee: Scott Compton, Kyla Blalock, rotating site PI 
 
Statistical Committee: Robert Gallop, Scott Compton, John Seeley 
 
Assessment Committee: John Seeley, Kyla Blalock, & Scott Compton  
 
Treatment Committee: David Jobes, Shireen Rizvi, Jacqueline Pistorello 
 
CAMS Training Committee: David Jobes, Jacqueline Pistorello 
 
DBT Training Committee: Shireen Rizvi, Jacqueline Pistorello, Kathryn Korslund 
 
Implementation Science Committee: John Seeley, Daniel Eisenberg, Jacqueline Pistorello 
 

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Quality Assurance Committee: Scott Compton, John Seeley, Robert Gallop  
 
Scientific Advisory Board (SAB): Dr. King (Chair and multisite/suicidology expert; U of Michigan), Dr. Walkup 
(Member and psychiatric expert; Northwestern U), Dr. Almirall (statistical and methods expert; U of Michigan), 
and Dr. Meilman (Member and CCC expert; Georgetown U). Goal: To provide scientific guidance to the SC.  
 
College Counseling Implementation Advisory Board (CCIAB): Directors of the participating CCCs and Dr. 
Pistorello (Lead PI). Additional members to be named later. Goal: To provide guidance on study procedures and 
subsequent CCC implementation to the SC. 
 
10.1.6 SAFETY OVERSIGHT 
10.1.7 CLINICAL MONITORING 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects 
are protected, that the reported trial data are accurate, complete, and verifiable, and that the 
conduct of the trial is compliant with currently approved protocol/amendment(s), with GCP, 
and with applicable regulatory requirement(s). The main features are below. 
 
• Monitoring for this study will be performed by NIMH Clinical Trials Operations and 
Biostatistics Branch (CTOBB) monitors.  
• Monitoring will be conducted on-site, throughout the study, and involve targeted data 
verification of key data variables 
• The site PI will be provided copies of monitoring reports within 10 days of each visit and 
will be provided to the NIMH DSMB liaison within 30 days of the visit. 
• Details of clinical site monitoring are documented in the CMP. The CMP describes who 
will conduct the monitoring, at what frequency monitoring will be done, at what level of 
detail monitoring will be performed, and the distribution of monitoring reports. 
• The site will perform internal quality management of study conduct, data collection, 
documentation and completion. An individualized quality management plan will be 
developed to describe the site’s quality management.  
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
We will closely monitor participant recruitment to the study, retention status, withdrawal, and 
adverse events. These data will be entered into REDCap at each site. The DDC will then generate 
reports to be reviewed by relevant entities. The frequency of planned data review for this study 
differs according to the type of data and can be summarized in the following in Table 10: 
 
Table 10. Frequency of Data Review 
Data Type 
Frequency of Review 
Who Will Review It 
Subject recruitment (adherence to 
protocol regarding demographics, 
inclusion/exclusion)  
 
Weekly at the beginning of the 
study and after each recruitment 
cycle thereafter (semester/ 
quarter) 
At each site, local team for local 
recruitment; PCs and PIs across all 
sites; all Boards (DSMB, CCIAB, and 
SAB) 

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Adverse event rates 
As they occur 
At each site, local team for internal 
events; PIs across all sites; 
DSMB/Single IRB. In certain 
instances, NIMH and Local IRBs 
 
Out of range assessment data 
Quarterly 
PIs across all sites. Sub-Committee 
on Quality Assurance composed of 
Dr. Compton (PI at Data 
Management Site), Dr. Gallop 
(Statistician), and Dr. Pistorello (PI 
at Coordinating Site). See Overall 
Structure of Study Team 
 
Stopping rules report regarding 
statistical power implications of 
drop-outs and missing data 
Yearly 
PIs across all sites. Sub-Committee 
on Quality Assurance (see above) 
 
Quality Assurance (QA) Measures 
QA processes will be overseen by the site PIs, in collaboration with PCs and RAs, and will 
include creating and training on study-wide Standard Operating Procedures (SOPs), approving 
and tracking SOP deviations, and ensuring Good Clinical Practice (GCP) and human subjects 
research training. The Duke Data Center (DDC) will provide the PIs with information regarding 
timeliness of data submission from the projects, protocol deviations and missing data. This 
information will help identify areas of deficiency, aspects of GCP that need reinforcement, or 
additional training that may be required. If these steps do not correct deficits or GCP concerns, 
steps may be taken to discipline, relocate, or replace staff members or modify study 
procedures. The DDC will generate the data for NIH data submissions, under the auspices of the 
Quality Assurance Sub-Committee (see above). 
 
In coordination with the other trial sites, the Duke site in its coordinating capacity, will oversee 
monitoring of all study sites for quality assurance (QA) purposes. Some components of 
monitoring may be delegated to on-site managers, but will still be reviewed on the following 
basis by the central Duke team QA reviewer. For each site, at least every 6 months, 3 subject 
charts will be selected by the QA reviewer. The QA reviewer will randomly select charts to 
review across the entire enrollment period (old and newly enrolled), prioritizing those that have 
not been previously reviewed. Additionally, any site-specific regulatory documentation will be 
reviewed at the same time. The QA reviewer will also have access to the study REDCap 
database to allow comparison between original documents and REDCap entry.  
 
Components of QA review will include the following: 
1. Regulatory documentation verification  
a. 
Protocol – all approved versions.  
b. 
Research summary – all Institutional Review Board (IRB)-approved versions.  
c. 
Informed consents – all IRB-approved versions.  

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d. 
IRB submissions and approvals (initial, amendments, changes to study status, SAEs, 
correspondence, review/approval notices).  
e. 
Delegation of authority/signature log for all key personnel, maintained by site. 
f. 
Documentation of training required to perform assigned study activities  
g. 
FDA 1571/1572; Curriculum vitae (CV), medical license and financial disclosure 
forms for personnel listed on 1572.  
h. 
Data collected and stored as described in the Research Data Security Plan (RDSP) 
(e.g., in REDCap versus in a spreadsheet).  
i. 
Required agreements that have been executed and available (e.g., DTA, MTA).  
 
2. Participant study record  
a. 
Participant consented per policy.  
b. 
Screening/treatment/intervention conducted per protocol.  
c. 
Serious adverse events / adverse events (SAEs/AE) reported per Human Research 
Participants Protections (HRPP) policy. 
d. 
Participant compensation documented (if applicable).  
 
Reporting and Corrective Action  
1. The reviewer records findings and required corrective actions in the QA Review Report 
Form in REDCap. The reviewer routes findings to the designated recipient (e.g., PI, lead CRC) 
via a survey link e-mailed from REDCap. Reviewer findings that can be clarified during the 
review or that do not require additional corrective action are not included in the form.  
2. The PI/Study team resolves deficiencies in a timely manner and provides corrective action 
plans via the Study Team Response Form linked in the REDCap e-mail. PI/Study team 
notifies the reviewer when the form has been completed and submitted.  
3. HIPAA deficiencies including, but not limited to, lost or misplaced PHI must be promptly 
reported by the reviewer to the Privacy Officer in the Duke Office of Audit, Risk and 
Compliance (OARC). There is a 60-day time frame for federal reporting if the missing item is 
a disclosure that is determined to be a reportable breach under HIPAA/HITECH. A formal 
breach analysis must be completed by OARC to make this determination. The 60-day clock 
begins at the time of first discovery of the breach, not at the time of reporting to OARC.  
4. If the reviewer has additional concerns after the initial review of participant and study 
records, the designated reviewer may select additional participants for a follow-up review.  
5. Deficiencies that may warrant escalation include but are not limited to:  
a. 
Expired IRB approvals or delayed submissions  
b. 
Reportable SAEs that were not reported within the required time frame  
c. 
Participants enrolled on non-IRB approved protocols  
d. 
Protocol-specific procedures or treatment occurring prior to consent  
e. 
Missing original consent in study files  
f. 
Ineligible participants enrolled in the study  
g. 
Protocol deviations putting a participant at increased risk of harm  
h. 
Treatment dosing and/or administration deviations determined to be UPIRTSO  
i. 
Confidentiality or privacy violations  

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j. 
Forged documents or signatures  
k. 
Large number of deficiencies or other findings 
 
Reviews and findings from monitoring conducted by the NIMH monitoring team may count 
towards these requirements and also be used to inform future areas of focused monitoring by 
the Duke QA reviewer(s). 
 
Quality Control (QC) Measures 
The Duke Data Center (DDC) will work closely with the PIs and will oversee consistent 
application of scientific standards and methodological rigor for data collection, processing, 
entry, cleaning, and analytics. The DDC will be responsible for QC for all questionnaire data 
collected online and interview data to be entered locally into REDCap at each site by IEs/RAs. 
This will be accomplished by intensive training of all study staff, the development of well-
defined study specific procedures (SSPs), and Manuals of Procedures (MOPs) with detailed 
instructions for procedures involved in data acquisition, processing, and upload to the REDCap 
platform. Fidelity to research procedures will be accomplished by the development of well-
defined protocols and internal audits. Protocol-specific training will be based on the delegated 
roles of investigators and staff as defined in delegation of responsibility logs. IEs will be trained 
in the administration of interviews by experts in those particular interviews by 
reading/observing an administration and then being observed and finally certified by members 
of the assessment committee. Intensive reliability training, continuing interrater reliability 
ratings being performed by IEs across sites and regular cross-site conference calls to avoid drift 
will be QC measures for interview assessments. 
10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Accountability in Data Management 
The project will have internal QC procedures for generation of high-quality data, including 
project-specific MOPs, standardized controls and site data review prior to upload. Any data 
collected on paper forms will be double entered by site study staff and then directly uploaded 
into the REDCap database using specific electronic case report forms (eCRFs) developed by the 
DDC for the study. The data management and statistical team will then download data for 
analysis. Many data validation rules (e.g., blank but required entries, out-of-range values, skip 
patterns) will be enforced by the electronic data capture (EDC) system during data entry. Other, 
more complex error conditions will be checked using custom error-check programs. 
Inconsistencies in data patterns across forms will be used to identify complex errors or confirm 
the validity of data. The DDC will continually monitor data quality as data are entered using 
built-in range-checking values, which we have successfully deployed in other studies. Any 
inconsistencies or possible errors must be resolved by site study staff and approved and 
documented by the DDC. Using the REDCap auditing system, each error will be annotated and 
marked as either resolved by a data update, approved as an extreme value, or unrecoverable. 
Such error checking will be run daily, providing the trial the opportunity to address data issues 

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early when the probability of resolution is highest. We will resolve individual and recurring 
problems with the data entry system during DDC weekly staff meetings. These meetings will be 
used to discuss and resolve issues and answer operational concerns, such as data entry 
questions, use of technologies, and EDC. Dr. Compton will manage the data resolution process 
and host training sessions as needed. Procedures regarding QC will be performed to address 
inconsistencies that emerge following data validation processes. The DDC will also work with 
study staff to address data quality issues and to refine data collection and reporting processes. 
In addition, the DDC will prepare monthly reports for all site PIs and PCs and oversee data QC, 
providing timely reports on quality and submission of data and protocol deviations to the PIs. 
10.1.9.2 
STUDY RECORDS RETENTION  
Study documents will be retained for 7 years after the close of the study. Video-recordings of 
therapy sessions will be maintained for seven years.  
10.1.10 
PROTOCOL DEVIATIONS  
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonization Good Clinical Practice (ICH GCP), or Manual of 
Procedures (MOP) requirements. The noncompliance may be either on the part of the 
participant, the investigator, or the study site staff. As a result of deviations, corrective actions 
will be developed by the site and implemented promptly.  
 
It will be the responsibility of the PIs to use continuous vigilance to identify and report 
deviations within 10 working days of identification of the protocol deviation, or within 10 
working days of the scheduled protocol-required activity. All deviations will be addressed in 
study source documents, reported to the NIMH Program Official and the DDC. Protocol 
deviations will be sent to the reviewing sIRB per their policies. The PIs will be responsible for 
knowing and adhering to the reviewing sIRB requirements. Further details about the handling 
of protocol deviations will be included in the MOP. 
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
This study will be conducted in accordance with the following publication and data sharing 
policies and regulations: 
 
NIH Public Access Policy, which ensures that the public has access to the published results of 
NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts 
that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial 
Information and FDA Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will 
be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in 

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peer-reviewed journals. Data from this study may be requested from other researchers 3 years 
after the completion of the primary endpoint by contacting the PIs.  
 
In addition, this study will comply with the NIH Data Sharing Policy and Implementation 
Guidance, and any other relevant policies.  
10.1.12 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who 
have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will be 
required to have such conflicts managed in a way that is appropriate to their participation in 
the design and conduct of this trial. The study leadership in conjunction with the NIMH has 
established policies and procedures for all study group members to disclose all conflicts of 
interest and will establish a mechanism for the management of all reported dualities of 
interest. 
 
 

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10.2 ABBREVIATIONS AND SPECIAL TERMS 
 
AAQ 
Acceptance and Action Questionnaire 
AE 
Adverse Event 
ATE 
Average Treatment Effect 
ATS 
Adaptive Treatment Strategies 
BPD 
Borderline Personality Disorder 
DBT 
Dialectical Behavior Therapy  
CAMS 
Collaborative Assessment and Management of Suicidality 
CCAPS 
Counseling Center Assessment of Psychological Symptoms 
CCC 
College Counseling Center 
CCIAB 
College Counseling Implementation Advisory Board 
CFR 
Code of Federal Regulations 
CGI-I 
Clinical Global Impression – Improvement  
CGI-S 
Clinical Global Impression – Severity  
CMP 
Clinical Monitoring Plan 
Co-I 
Co-Investigator 
CRF 
Case Report Form 
CRC 
Clinical Research Coordinator 
CSP 
CAMS Stabilization Plan  
CSQ 
Client Satisfaction Questionnaire  
CTEQ 
Counselor Treatment Expectations Questionnaire 
CTOBB 
Clinical Trials Operations and Biostatistics Branch 
CTSQ 
Counselor Session Telehealth Questionnaire 
CV 
Curriculum Vitae 
DBT 
Dialectical Behavior Therapy 
DDC 
Duke Data Center 
DERS 
Difficulties in Emotion Regulation Scale 
DHHS 
Department of Health and Human Services 
DIF 
Demographic Information Form  
DSMB 
Data Safety Monitoring Board 
DTA 
Data Transfer Agreement 
DUMC 
Duke University Medical Center 
DV 
Dependent Variable 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
eCRF 
Electronic Case Report Forms 
EMR 
Electronic Medical Record  
ES 
Effect Size 
FDA 
Food and Drug Administration 
F/U 
Follow-Up 
GAS 
Global Assessment Scale  
GCP 
Good Clinical Practice 
GPA 
Grade Point Average  
GUID 
Global Unique Identifier 
HIPAA 
Health Insurance Portability and Accountability Act  
HITECH 
Health Information Technology for Economic and Clinical Health 
HRPP 
Human Research Participants Protections 
THE 
Heterogeneity of Treatment Effect  

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IB 
Investigator’s Brochure 
ICERs 
Incremental Cost-Effective Ratios 
ICH 
International Council on Harmonization  
ICMJE 
International Committee of Medical Journal Editors 
IE 
Independent Evaluator 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
Information Security Office 
ITT 
Intention-To-Treat 
LMM 
Linear Mixed Model  
LSC-R 
Life Stressor Checklist-Revised 
MEPS 
Medical Expenditure Panel Survey 
MOP 
Manual of Procedures 
MTA 
Material Transfer Agreement 
NCT 
National Clinical Trial 
NDA 
National Institute of Mental Health Database 
NIH  
National Institutes of Health 
NIMH 
National Institute of Mental Health  
NSSI 
Non-Suicidal Self-Injury  
OARC 
Office of Audit, Risk and Compliance 
OHRP 
Office for Human Research Protections 
PAI-BOR 
Personality Assessment Inventory – Borderline Features Scale  
PC 
Project Coordinator 
PI 
Principal Investigator 
PII 
Personally Identifiable Information 
PO 
Program Officer 
QA 
Quality Assurance 
QC 
Quality Control 
QIF 
Quality Implementation Framework 
RA 
Research Assistant 
RDoC 
Research Domain Criteria  
RDSP 
Research Data Security Plan 
REDCap 
Research Electronic Data Capture 
RCT 
Randomized Controlled Trial  
SA 
Suicide Attempt  
SAB 
Scientific Advisory Board 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SC 
Steering Committee  
SCS 
Suicide Cognitions Scale  
SD 
Standard Deviation 
SGM 
Sexual and Gender Minorities 
SI 
Suicidal Ideation 
SITBI 
Self-Injurious Thoughts and Behaviors Interview 
SMART 
Sequential Multiple-Assignment Randomized Trial 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
SR 
Suicidal Risk 
SSF 
Suicide Status Form  

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SSI 
Scale for Suicidal Ideation 
SSL 
Secure Sockets Layer 
STCQ 
Student Treatment Credibility Questionnaire 
STEQ 
Student Treatment Expectations Questionnaire 
TAU 
Treatment as Usual 
THI 
Treatment History Interview 
UP 
Unanticipated Problem 
UPIRTSO 
Unanticipated Problems Involving Risk to Subjects or Others 
US 
United States 
UWRAP 
University of Washington Risk Assessment Protocol  
WCCL 
Ways of Coping Checklist 
ZSWS 
Zero Suicide Workforce Survey - Abbreviated 
 
 
 

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10.3 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
1.0 
4/21/20 
Protocol 
Added two questionnaires to assess 
comorbid substance and alcohol abuse; 
Changes to the protocol made in Table 1 
(on page 8), Table 2 (on page 24), Section 
8.1 (on page 43) and Section 9.3.3 (on 
page 55-56). References were also added.  
Recommendation made by 
the NIMH DSMB. 
1.0 
4/21/20 
Protocol 
Added a questionnaire that assesses 
cultural identity; Changes to the protocol 
made in Section 8.1 (on page 43) and 
Section 9.3.3 (on page 55). Reference was 
also added. 
Recommendation made by 
the NIMH DSMB. 
1.0 
4/21/20 
Protocol 
Modified statistical analysis plan (SAP) in 
Section 9.3.2 on page 54 to include the 
following statement: “Linear contrasts 
among the components of the ATSs will be 
performed to further understand impact 
on efficacy.” 
Recommendation made by 
the NIMH DSMB. 
1.0 
4/21/20 
Protocol 
Added the following wording to Section 
8.4.2 on page 51 to the first and second 
paragraph: “the NIMH DSMB.” 
Recommendation made by 
the NIMH DSMB. 
1.1 
7/13/20 
Protocol 
Added Aim 8 and Aim 9 within Tables of 
Aims (Table 4) under Exploratory Analyses 
consisting of the contrast within Stages of 
the randomized treatments (pages 38-39).  
Recommendation made by 
the NIMH DSMB. 
1.1 
7/13/20 
Protocol 
In Section 9.6.7 (Exploratory Analyses), 
added description of Aim 8 (Comparison of 
CAMS vs. TAU within Stage 1) (pages 77-
78).  
Recommendation made by 
the NIMH DSMB. 
1.1 
7/13/20 
Protocol 
In Section 9.6.7 (Exploratory Analyses), 
added description of Aim 9 (Comparison of 
DBT vs Continued CAMS within Stage 2) 
(page 79). 
Recommendation made by 
the NIMH DSMB. 
2.0 
9/14/20 
Protocol 
Changed title to reflect what we are now 
calling the project in all protocols, 
communications, and correspondence 
(Page i).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
Updated protocol number to ver 2.0 (page 
i) and updated date of submission to 14 
September 2020 (page i). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
Updated Table of Contents (pages ii-iii).  
Necessary change due to 
COVID-19 pandemic. 

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Ver 
Date 
Source 
Description of Change  
Brief Rationale 
2.0 
9/14/20 
Protocol 
In Section 1 (Protocol Summary), updated 
study synopsis to reflect new title, rational 
for revising study protocol, the addition of 
the Feasibility Study to the protocol 
(Overall Feasibility Study description, 
objectives, endpoints, population, and 
experimental manipulation), and a 
statement indicating changes to a hybrid 
delivery format to original larger trial 
design (pages 5-11).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 1.2 (Schema), added a figure 
providing a graphical overview of the 
study design for the feasibility study (page 
12). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 1.3 (Schedule of Activities), 
added a schedule of activities table for the 
Feasibility Study (Table 1) (pages 14-15). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.1 (Study Rationales), provided 
a rationale for why the Feasibility Study is 
needed (pages 19-20).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.2 (Background), added a 
statement that the current design, which 
evaluates treatments delivered remotely 
or in person, will better reflect current and 
future practices within CCCs (page 21). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.2 (Background), added a more 
general statement that the current design 
also better reflects current and future 
mental health practices more broadly 
(page 23).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.2 (Background), added a 
statement about the proposed 
methodology being novel as no studies 
have undertaken an evaluation of a hybrid 
online/in-person format (pages 24-25).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.3.1 (Known Potential Risks), 
added a statement about the unknown 
risks associated with teletherapy (page 
26).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.3.1 (Known Potential Risks), 
added a statement about the potential risk 
that private communications are 
vulnerable to hacking which, if done, may 
compromise confidentiality (page 26).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.3.2 (Known Potential 
Benefits), added a statement about the 
potential benefit of current design to 
address gaps in the current literature. 
Specifically, the need to gather data about 
the potential benefits/effectiveness of 
Necessary change due to 
COVID-19 pandemic. 

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Ver 
Date 
Source 
Description of Change  
Brief Rationale 
online training for clinicians and online 
treatment of college students (pages 27-
28).  
2.0 
9/14/20 
Protocol 
In Section 2.3.3 (Assessment of Potential 
Risks and Benefits), included information 
about the change from in person to hybrid 
format, for training as well, when 
discussing strategies to minimize risk of 
worsening symptoms. Added the 
requirement of knowing the student’s 
current location and emergency contact 
numbers for third party involvement. 
Finally, highlighted our plan of developing 
robust plans for reconnecting with 
students during the provision of care if 
there are technical issues (pages 28-29). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.3.3 (Assessment of Potential 
Risks and Benefits), added information 
relevant to minimizing Risk 2: minimizing 
confidentiality and privacy of participants. 
Noted the use of fully HIPPA compliant 
platform, steps that clinicians will be taken 
to ensure that therapy is provided in a 
secure and private location, and the use of 
unique links for completing all 
assessments (pages 29-31).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.3.3 (Assessment of Potential 
Risks and Benefits), added the following 
statements in the section on steps taken 
to minimize Risk 3 (emotional distress 
resulting from assessments): collecting 
additional contact information to manage 
suicide risk when evaluated remotely, 
indicating the time required to complete 
all Feasibility Study assessments (Page 31).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 2.3.3 (Assessment of Potential 
Risks and Benefits), given the remote 
nature of the therapy, added a statement 
in Minimizing Risk 4 strategies that a third 
party (family member, relative, or friend) 
may be used to help coordinate voluntary 
and/or involuntary hospitalizations, if 
needed. Procedures will be developed to 
identify potential people willing to help as 
a third party during the first treatment 
session (page 32).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 3 (Objectives and Endpoints), 
added summary of the objectives, 
endpoints, and justification for the 
Necessary change due to 
COVID-19 pandemic. 

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Ver 
Date 
Source 
Description of Change  
Brief Rationale 
endpoints for the Feasibility Study in Table 
3 (pages 33-35).  
2.0 
9/14/20 
Protocol 
In Section 4.2 (Overall Designs), added an 
overall summary of the Feasibility Study 
design (page 39). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 4.3 (Scientific Rational for Study 
Designs), added scientific rationale for 
Feasibility Study design (pages 40-41). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 4.4 (Justification for 
Intervention), added justification for 
Feasibility Study interventions (pages 41-
42). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 4.4 (Justification for 
Intervention), added a description of the 
hybrid model and the reasons why we 
decided to allow for flexibility in the 
modality of treatment delivery (page 43). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 4.5 (End-of-Study Definition), 
added end-of-study definition for 
Feasibility Study (pages 43-44).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 5.1 (Inclusion Criteria), added 
the sample size needed for the Feasibility 
Study and updated eligibility criteria to 
include both in person or remote 
treatment (page 44). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 5.4 (Strategies for Recruitment 
and Retention), updated recruitment and 
retention strategies section (5.4) to reflect 
recruitment needed for Feasibility Study 
(page 45). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In Section 5.4 (Strategies for Recruitment 
and Retention), added Table 4 and related 
paragraph that summarizes/reviews 
assessment schedule and participant 
reimbursement amounts (page 47). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
Updated Section 6.1.1 (Pre-screening) to 
include option for intake session to be 
remote or in person (page 48). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
Updated Section 6.1.2 (Screening) to 
include the online e-consenting process 
(page 48). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
Updated Section 6.1.3 (Baseline) to include 
baseline assessment details for the 
Feasibility Study (pages 48-49).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
Updated section 6.1.4 (Randomization) to 
include details specific to the Feasibility 
Study (page 49). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
Updated section 6.1.6 (Administration 
and/or Dosing) to include treatment dose 
in weeks allowed during the Feasibility 
Necessary change due to 
COVID-19 pandemic. 

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Ver 
Date 
Source 
Description of Change  
Brief Rationale 
Study and the use of a HIPAA-complaint 
platform for telehealth sessions (pages 50-
51).  
2.0 
9/14/20 
Protocol 
Updated section 6.2.1 (Interventionist 
Training and Tracking) to include online 
training, certification, and details about 
treatment adherence, including the 
number, frequency, duration of trainings, 
and QA processes for both CAMS and DBT 
(pages 51-52).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 6.3 (Measures to minimize bias: 
randomization and blinding), 
randomization details specific to the 
Feasibility Study are included (page 52).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 8.1 (Endpoint and other non-
safety assessments), outcomes specific to 
the Feasibility Study are listed (pages 55-
56, 60). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 8.2 (Safety Assessments), details 
about how safety assessments will be 
conducted during remote assessments are 
included (pages 61-62). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 9.1 (Statistical Hypotheses), 
details about the aims and hypotheses for 
the Feasibility Study are added. There are 
six (6) Feasibility Study hypotheses (pages 
68-69).  
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 9.2 (Feasibility Study Sample 
Size Determination), a paragraph about 
the rationale for the sample size of the 
Feasibility Study is added (page 69). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 9.3 (Feasibility Study Statistical 
Analysis), details about the Feasibility 
Study statistical analyses are provided, this 
includes cut points for a benchmark 
analysis associated with each hypothesis 
and a description of mitigation strategies 
(pages 69-73). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 10.1.1.1 (Consents and Other 
Informational Documents Provided To 
Participants), included statement about 
our use of an e-consent during both 
feasibility and main study (pages 79-80). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 10.1.1.2, modified description of 
consent process to include e-consenting 
procedures as implemented in REDCap 
(page 80). 
Necessary change due to 
COVID-19 pandemic. 
2.0 
9/14/20 
Protocol 
In section 10.1.5 (Key Roles and Study 
Governance), updated membership of the 
Steering Committee and Executive 
Necessary change due to 
COVID-19 pandemic. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 81 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
Committee to reflect staff changes and 
Duke as Coordinating Center for the study, 
rather than UNR (pages 83-84). 
1.0 
9/14/20 
Feasibility 
Subject 
Consent 
(Multi-site 
Template) 
New Document – Feasibility Subject 
Consent was drafted based on same 
general language used in Main Consents, 
updating study purpose and visit structure, 
etc., accordingly. 
Necessary due to addition 
of Feasibility study portion.  
1.0 
9/14/20 
Feasibility 
Counselor 
Consent 
(Multi-site 
Template) 
New Document – Feasibility Counselor 
Consent was drafted based on same 
general language used in Main Consents, 
updating study purpose and visit structure, 
etc., accordingly. 
Necessary due to addition 
of Feasibility study portion.  
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 1: Inserted  
The therapy sessions may be online, in 
person, or a combination of both. 
Added reference to 
possibility of remote 
treatment sessions. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 2: Moved 
This study is paid for by a grant from the 
National Institute of Mental Health 
(NIMH). This grant 
will help pay for part of Dr. <Last name of 
PI> and <His/her> research team’s 
salaries. 
Moved from bottom of 
previous section to better 
match consent structure. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 2: Deleted  
individual 
Clarifying language as some 
consultation supervision 
may be via group as well as 
individual. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 3: Inserted  
(online, in person, or both) 
Added reference to 
possibility of remote 
treatment sessions. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 3: Deleted  
2 
Specific number deleted to 
allow more leeway as 
regards number of 
questions asked. Likely 
number will be 3, but it also 
could vary slightly from 
session to session. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 3: Inserted  
Treatment visits may be conducted in 
person at <Name of CCC (abbreviation)> 
or online via a HIPAA compliant telehealth 
platform. Decisions about whether 
treatment will occur in person or 
online will depend on the current policies 
at <Name of CCC (abbreviation)>, your 
preferences, and your client’s preferences. 
Study staff can answer any questions you 
have about this process. 
Added reference to 
possibility of remote 
treatment sessions, 
including that relevant 
Counseling Center policies 
will be followed in 
determining 
location/manner of 
treatment. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 82 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 5: Inserted  
It may also feel more challenging to 
provide treatment to suicidal clients via 
telehealth. 
Added reference to 
possibility of remote 
treatment sessions. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 5: Deleted  
individual 
Added reference to 
possibility of remote 
treatment sessions. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 6: Inserted 
The Department of Health and Human 
Services (HHS) has issued a Certificate of 
Confidentiality 
to further protect your privacy. With this 
certificate, unless you have given your 
permission, the researchers may not 
disclose research information that may 
identify you in any Federal, State, or local 
civil, criminal, administrative, legislative, or 
other proceedings. Research information 
protected by this Certificate cannot be 
disclosed to anyone else who is not 
connected with the research unless:  
• 
There is a law that requires 
disclosure (such as to report child 
abuse or communicable diseases 
but not for legal proceedings); 
• 
You have consented to the 
disclosure, including for your 
medical treatment; or 
• 
The research information is used 
for other scientific research, as 
allowed by federal regulations 
protecting research subjects. 
You should understand that a 
Confidentiality Certificate does not 
prevent you from voluntarily releasing 
information about yourself or your 
involvement in this research. If you want 
your research information released to an 
insurer, medical care provider, or any 
other person not connected with the 
research, you must provide consent to 
allow the researchers to release it. This 
means that you must also actively protect 
your own privacy. 
Finally, you should understand that the 
researcher is not prevented from taking 
steps, including reporting to authorities, to 
prevent serious harm to yourself or others. 
Added language pertaining 
to Certificate of 
Confidentiality based upon 
CAMPUS team discussions 
that this should be included 
in the Counselor consents. 
 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 83 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 7: Inserted  
(or alternate remote, secure means) 
 
Added reference to 
possibility of remote 
treatment sessions. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 8: Deleted  
individual 
 
Clarifying language as some 
consultation supervision 
may be via group as well as 
individual. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 8: Deleted 
a free CAMS webinar and 
Unnecessary language 
given the mention of free 
comprehensive CAMS 
training above. 
2.0 
9/14/20 
Main 
Counselor 
Consent 
Page 10: Deleted  
XXX 
Page 10: Inserted  
XXXX 
Minor typographical fix. 
2.0 
9/14/20 
Main Student 
Consent 
Page 1: Inserted  
Your therapy sessions may be 
 
Added note to Concise 
Summary that therapy may 
be online and/or in person. 
2.0 
9/14/20 
Main Student 
Consent 
Page 1: Inserted  
online, in person, or both. 
Added reference to 
possibility of telehealth. 
2.0 
9/14/20 
Main Student 
Consent 
Page 2: Inserted  
and how to adapt these treatments to 
work well via telehealth, when needed. 
Added reference to 
possibility of telehealth. 
2.0 
9/14/20 
Main Student 
Consent 
Page 2: Inserted  
that will occur online via a HIPAA-
compliant telehealth platform such as 
Zoom, or in person. 
Added reference to 
possibility of telehealth. 
2.0 
9/14/20 
Main Student 
Consent 
Page 3: Inserted  
Treatment visits may be conducted in 
person at <Name of CCC (abbreviation)>, 
or online via a HIPAA-compliant telehealth 
platform such as Zoom. Decisions about 
whether treatment will occur in person or 
online will depend on the current policies 
at <Name of CCC (abbreviation)>, your 
preferences, and your counselor's 
preferences. Study staff can answer any 
questions you have about this process.  
Added language about 
possibility of treatment 
involving a mix of in person 
and telehealth, and that 
the decision about format 
will be based on relevant 
Counseling Center policy. 
2.0 
9/14/20 
Main Student 
Consent 
Page 4: Inserted  
You will be interviewed, fill out online 
questionnaires (via a secure internet 
website), and complete an activity online 
during these visits.  
Added language about 
potential online completion 
of some questionnaires. 
2.0 
9/14/20 
Main Student 
Consent 
Page 4: Deleted  
via a secure webcam 
Page 4: Inserted  
via HIPAA compliant telehealth platform, 
such as Zoom. If you are completing 
assessment visits online, study staff will 
work with you to ensure that you have 
Added reference to 
possibility of telehealth. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 84 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
access to a private, confidential setting to 
complete the visit. 
2.0 
9/14/20 
Main Student 
Consent 
Page 4: Inserted  
Access to Records 
In order to gauge the impact of treatment, 
if any, on your campus life, we will ask 
your approval to obtain access to your 
<Name of University> school records 
(GPA, enrollment status, demographics, 
etc.) as well as your usage of services 
elsewhere on campus (e.g., Health Center, 
other Student Services offices, such as 
Accessible Education Center) for a period 
of 12 months after the consent signing 
date. 
No specific information about the type of 
research you are participating in will be 
provided to the university personnel, 
except for the fact that you are a study 
participant who has given us permission to 
collect their institutional data. Once we 
receive the academic and health care use 
information, we will merge the 
information into a file with only a Global 
Universal Identifier (GUID) number and no 
names (GUID is further explained below, in 
the Confidentiality section).  
 
{Please initial your selection below, then 
sign} 
 
I agree to grant researchers access to my 
<Name of University> school records, as 
noted above, for the purposes of this 
study, for a period of 12 months from the 
date of signature below: 
_____ Yes _____ No 
___________________________________
___ _____________________ 
Student Signature Date signed 
Added a section to address 
FERPA permission for 
student educational 
records. 
2.0 
9/14/20 
Main Student 
Consent 
Page 6: Inserted  
Privacy and internet connection issues can 
also be problematic when receiving 
treatment online. 
Noted additional study risk 
of privacy and internet 
connection issues, if 
telehealth is used. 
2.0 
9/14/20 
Main Student 
Consent 
Page 6: Inserted  
, including how to provide this treatment 
online. 
Noted that telehealth 
effectiveness findings are 
an added potential benefit 
to research body of 
knowledge. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 85 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
2.0 
9/14/20 
Main Student 
Consent 
Page 8: Inserted  
(or alternate remote secure means) 
Added mention of possible 
remote GUID generation 
method. 
2.0 
9/14/20 
Main Student 
Consent 
Page 8: Inserted  
Risks Associated with Telehealth 
Generally speaking, the risks and benefits 
of telehealth are similar to those of in-
person sessions. 
There are additional risks, however. First, 
although we will use secure platforms 
(e.g., Zoom for Healthcare) with industry-
standard encryption and security, there is 
no way to guarantee that this software is 
completely failure-proof. As with any 
technology, there is a chance of a security 
breach that would affect the privacy of 
personal and/or medical information. 
Second, since you will be completing 
sessions in your own home, we cannot 
guarantee the same level of privacy that 
you have when you are in our clinic. This 
means that you are responsible for making 
sure that you are in a private area where 
disruptions (e.g., others coming into the 
room or hearing what you say in another 
room) are minimized as much as possible. 
Third, in the event of group sessions 
conducted via video, it is possible that 
your confidentiality could be breached if 
others in the group are not in a 
confidential setting. 
In order to reduce risks to confidentiality, 
we suggest that all video or telephone 
sessions occur in a private room with no 
one else present and that you wear 
headphones to limit the possibility of 
other people overhearing confidential 
information. 
Added a section addressing 
possible risks associated 
with Telehealth. 
2.0 
9/14/20 
Main Student 
Consent 
Page 10: Inserted  
Any additional treatment required, outside 
of that provided by the counseling center, 
will need to be covered by your insurance, 
you, and/or your family, as with your 
regular medical care. 
Added language noting that 
any additional non-
Counseling Center 
treatment that subjects 
may require is not covered 
by the study. 
2.0 
9/14/20 
Main Student 
Consent 
Page 11: Inserted  
your insurance, 
 
Added language noting that 
insurance may also aid with 
payment, if any non-
covered costs were 
incurred. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 86 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
2.0 
9/14/20 
Main Student 
Consent 
Page 12: Deleted  
XXX 
Page 12: Inserted  
XXXX 
Minor typographical fix. 
2.0 
9/14/20 
Main Student 
Consent 
Page 12: Inserted  
{Intentionally Left Blank} 
 
Due to new page 
formatting, note that there 
is some blank page here, 
prior to Statement of 
Consent and signature 
section of ICF. 
2.1 
10/27/20 
Protocol 
Added a question to the Feasibility Study 
rationale section (2.1.1) about the need to 
assess the feasibility of IEs collecting 
outcome assessments remotely (page 20).  
Recommendation made by 
the NIMH DSMB. 
2.1 
10/27/20 
Protocol 
Added hypothesis about feasibility of 
collecting outcome assessments to Table 3 
(page 34). 
Recommendation made by 
the NIMH DSMB. 
2.1 
10/27/20 
Protocol 
In Table 4, combined Aims 8 and 9 into 
one aim, now Aim 8 (page 39). 
Recommendation made by 
the NIMH DSMB. 
2.1 
10/27/20 
Protocol 
In section 8.1, Feasibility Study Outcomes, 
added evaluating feasibility of collecting 
study outcomes as one of the study 
outcomes (page 57). 
Recommendation made by 
the NIMH DSMB. 
2.1 
10/27/20 
Protocol 
In section 9.1, added Aim 4 to the 
Feasibility Study hypotheses list 
(Hypothesis 4) (page 69). 
Recommendation made by 
the NIMH DSMB. 
2.1 
10/27/20 
Protocol 
In section 9.3 (Statistical Analyses), 
described general approach to evaluating 
the feasibility of collecting outcomes 
remotely (page 71). 
Recommendation made by 
the NIMH DSMB. 
2.1 
10/27/20 
Protocol 
In the Statistical Analysis Section, 
Exploratory Analysis subsection (9.6.7), 
combined statistical methods for old Aims 
8 and 9 into one new aim, now Aim 8 
(pages 79-80). 
Recommendation made by 
the NIMH DSMB. 
2.1 
3/12/2021 
Feasibility 
Student ICF 
In Concise Summary, removed 
“,depending on your response to 
treatment” 
Phrase is incorrect if 
randomized to DBT. 
2.1 
3/12/2021 
Feasibility 
Student ICF 
Starting on page 3, updated language to:  
“All of these treatments have helped 
students feel less distressed. For all of 
these treatments, you will be asked to 
complete several brief questionnaires, 
throughout treatment.  
If you were assigned TAU or CAMS in Stage 
1, your counselor will be assessing how 
you are doing at each treatment visit and 
treatment will proceed or end depending 
on sufficient progress. If you show 
Improved clarity for 
subjects regarding how 
Stage 1 and Stage 2 work if 
assigned to DBT.  

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 87 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
sufficient progress in Stage 1, your study 
treatment could end after 4-8 sessions. If 
not, you will move into Stage 2 of the 
study. 
If you were initially assigned to DBT you 
will complete 8 weeks in Stage 1, then you 
will continue DBT in Stage 2 for an 
additional 8 weeks. 
Stage 2 
If you were assigned TAU or CAMS in Stage 
1 and do not show enough improvement 
after Stage 1, you will be randomly 
assigned (like flipping a coin) to either 
CAMS or DBT for Stage 2 for an additional 
8 weeks.” 
2.1 
3/12/2021 
Feasibility 
Student ICF 
Starting on page 4, in Access to Records 
section, updated language to: 
“In order to gauge the impact of 
treatment, if any, on your campus life, we 
will ask your approval to obtain access to 
your <Name of University> school records 
(GPA, enrollment status, demographics, 
semester and cumulative grade point 
average or GPA, credits attempted, credits 
completed, and enrollment status) as well 
as your usage of health services on 
campus (<list Student Health Center and 
Counseling Center>) for a period of 12 
months after the consent signing date. 
This information will help us to assess how 
your treatment has impacted your 
educational and general functioning on 
campus, over a period of a year. 
No specific information about the type of 
research you are participating in will be 
provided to the university personnel, 
except for the fact that you are a study 
participant who has given us permission to 
collect their institutional data. This may 
involve asking you to sign separate 
document(s), specifically requesting that 
the {Campus Registrar’s Office and 
Campus health entities} grant us access to 
only data and information noted above, 
and only over the 12 month timeframe. 
Once we receive the academic and health 
care use information, as part of 
maintaining your confidentiality, we will 
Wording changes to better 
characterize the 
educational and health 
data being sought, partly in 
consult with University 
Counsel for their preferred 
FERPA-related language. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 88 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
merge the information into a file with only 
a Global Universal Identifier (GUID) 
number and no names (GUID is further 
explained below, in the Confidentiality 
section).” 
2.1 
3/12/2021 
Feasibility 
Student ICF 
On page 5, updated language to: 
“clinical and research team (and clinical 
supervisors of your therapist(s), if 
applicable) with the following exceptions: 
(1) transcripts, suitably modified to protect 
your identity, may be used in writings by 
Dr. <Last Name of PI> as illustrations to 
enhance the understanding of persons 
with psychological difficulties similar to 
your own and their treatment and (2) 
edited sections of the recordings may be 
listened to or viewed by those providing 
training to the therapist(s) who provide 
these treatments.” 
Improved clarity for 
subjects regarding how 
clinical supervisors/trainers 
of therapists may have 
access to securely review 
session videos for 
training/supervisory 
purposes. 
2.1 
3/12/2021 
Feasibility 
Student ICF 
At top of page 6, changed “group therapy” 
to “DBT skills training”. 
Non-DBT subjects will not 
get group treatment, so 
providing clearer and more 
correct language for 
subjects. 
2.1 
3/12/2021 
Feasibility 
Student ICF 
At bottom of page 10, updated 
compensation plan to $30 at Baseline, 
Week 8, and Week 16 from $10/$20/$40 
respectively (with possible $20 bonus). 
Total compensation remains $90. 
Study team decision that 
simpler plan was better for 
subject understanding as 
well as disbursement 
management. 
2.2 
9/9/21 
Protocol 
Changed protocol number from 2.1 to 2.2  
Update protocol version. 
2.2 
9/9/21 
Protocol 
Updated Feasibility study sample sizes for 
counselor participants and student 
participants through document. New 
sample size is ~24 for counselor 
participants, ~6 per site. And new sample 
size for student participants is N=62, with 
CAMS n=21, TAU n=20, and DBT n=21. This 
change has been made on the following 
pages: 6, 7, 19, 33, 40, 42, 45, 51, 70, 71 
Change needed to address 
efficacy of updated training 
protocols.  
2.2 
9/9/21 
Protocol 
Corrected a found inconsistency in prior 
version of the protocol regarding the 
number of Stage 2 sessions. Several places 
said between 4-16, correct number is 
between 1-16 and varies by treatment 
condition. This change has been made on 
the following pages: 7, 8, 10, 13, 23, 42 
Corrected inconsistency 
within prior protocol. 
2.2 
9/9/21 
Protocol 
Added a statement about total duration of 
student participation not including 
Corrected oversight in prior 
protocol. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 89 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
holidays or extended breaks. (pages 11, 
52) 
2.2 
9/9/21 
Protocol 
Updated Figure 1 to reflect new sample 
sizes. (page 12) 
Change needed to address 
efficacy of updated training 
protocols.  
2.2 
9/9/21 
Protocol 
Deleted line in Assessment Table 1 that 
indicated students would complete an AE 
form at each treatment visit. (page 14) 
Corrected inconsistency 
within prior protocol. 
2.2 
9/9/21 
Protocol 
Replaced Beck Hopelessness Scale with 
Optimism Hope Scale. (pages 14, 16, 37, 
38, 60) 
OHS measures similar 
construct, is open source 
and shown to be sensitive 
to change. 
2.2 
9/9/21 
Protocol 
Removed the completion of the Treatment 
History Interview (THI) at the week 8 
assessment point. (pages 15, 17, 59) 
Corrected oversight in prior 
protocol. 
2.2 
9/9/21 
Protocol 
Expanded the academic years in which the 
feasibility study will take place to include 
the 2021-2022 academic year.  
Change needed to address 
efficacy of updated training 
protocols and to complete 
enrollment targets for 
feasibility study.  
2.2 
9/9/21 
Protocol 
Added Study Liaison as a study team 
member. (page 39) 
Corrected oversight in prior 
protocol. 
2.2 
9/9/21 
Protocol 
Added a statement in the protocol 
allowing for students who maintain high 
levels of SI without improvement to be 
eligible for re-randomization to Stage 2 
earlier than week 8. (pages 43, 58) 
Corrected oversight in prior 
protocol. 
2.2 
9/9/21 
Protocol 
Expanding study inclusion criteria to 
include those students who endorse SI (1) 
on the CCAPS, (2) during the intake clinical 
interview, or (3) on other measures given 
as part of standard practice at the CCC. 
Specifically, the inclusion criteria for SI will 
now state the following (which changes in 
bold font):  
 
Moderate to severe suicide ideation over 
last two weeks as indicated by one or 
more of the following:  
(1) a score of >=2 on CCAPS question “I 
have thoughts of ending my life”;  
(2) self-report during clinical interview; or  
(3) other intake questionnaires given as 
standard practice at CCCs (e.g., C-SSRS). 
(page 45) 
Correcting potential 
problem with inclusion 
criteria to ensure that all 
appropriate students are 
given opportunity to 
participate in the trial.  
2.2 
9/9/21 
Protocol 
Changed reimbursement schedule to be 
$30 per assessment completed rather than 
an escalating payment schedule. Please 
note that the total reimbursement amount 
does not change. (page 47) 
To enhance data collection. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 90 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
2.2 
9/9/21 
Protocol 
Removal of Stage 1 randomization for 
CAMS and TAU. This is necessary to 
implement the revised training protocols. 
(pages 50, 53) 
Change needed to address 
efficacy of updated training 
protocols for CAMS and 
DBT.  
2.2 
9/9/21 
Protocol 
During the feasibility study, we identified 
the need to accommodate potential gaps 
in treatment due to the academic calendar 
(scheduled breaks such as summer 
vacation). Given our goal to create an 
intervention approach that fits with the 
CCC environment, our intervention and 
assessment schedule must be able to 
handle gaps in care. Therefore, for 
students whose treatment will be 
disrupted due to a scheduled break in the 
academic calendar, we are seeking 
approval to add additional assessment 
points before/after scheduled breaks 
lasting longer than 6 weeks to capture 
their clinical status prior to leaving campus 
and upon their return. These additional 
assessments will only be completed by 
those students who experience a gap in 
treatment and will only include the 
primary outcomes. (Page 52) 
Corrected oversight in prior 
protocol. 
2.2 
9/9/21 
Student ICF 
Changed total sample size from N=44 to 
N=62 and each site sample size to 
approximately n=17. 
Replaced updated Figure 1. Feasibility 
Study Design. Changes were made to the 
sample size in each group in Stage 1: 
CAMS (old n=16, new n=21), TAU (old 
n=16, new n=20), DBT (old n=12, new 
n=21). Sample size for Stage 2 treatments 
were also updated: CAMS (old n=8, new 
n=10) and DBT (old n=8, new n=10). 
Finally, the number of weeks listed for 
Stage 2 CAMS treatment was changed to 
reflect the options more accurately. For 
CAMS, old number of weeks = 8, new = 
“up to 8”. 
To make consistent with 
protocol.  
2.2 
9/9/21 
Student ICF 
Removed references to accessing 
student’s usage of campus health services 
in Section “Access to Records” starting on 
Page 4. This was entered in error as this 
information will be collected during the 
Treatment History Interview (THI). 
To make consistent with 
protocol.  
2.2 
9/9/21 
Student ICF 
Changed reimbursement amount to match 
protocol, namely $30 for each assessment. 
To make consistent with 
protocol.  

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 91 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
Note that the total amount reimbursed 
remains the same. 
2.2 
9/9/21 
Student ICF 
Clarified language about length of study 
participation being dependent upon which 
treatment they are randomly assigned. 
Section “HOW LONG WILL I BE IN THIS 
STUDY” starting on Page 6. 
To make consistent with 
protocol.  
2.2 
9/9/21 
Student ICF 
In Section “HOW LONG WILL I BE IN THIS 
STUDY” starting on Page 6, we clarified 
how study participation will be managed 
during academic breaks (e.g., winter break 
and summer break).  
To make consistent with 
protocol.  
2.2 
9/9/21 
Student ICF 
In Section “WILL MY INFORMATION BE 
KEPT CONFIDENTIAL?” starting on Page 7, 
we added a sentence about sharing 
information gathered during study 
assessments to their treating counselor to 
prevent harm to self or others and to 
coordinate care.  
To correct an oversight in 
last version of ICF 
2.2 
9/9/21 
Counselor ICF 
Clarified that counselor’s weekly time 
commitment for study will depend on 
study caseload and changed overall time 
commitment for study participation from 
12 months to one ‘academic year’.  
To make consistent with 
request protocol changes 
2.2 
9/9/21 
Counselor ICF 
Clarified language regarding study 
expectations for caseload and duration of 
each treatment group. 
To make consistent with 
request protocol changes 
2.2 
9/9/21 
Counselor ICF 
Made minor wording changes with the 
goal of improving readability and clarity. 
For all of these changes, the intended 
content remained the same. Please see 
“tracked changes” version of the ICF for 
examples.  
For clarification.  
2.2 
9/9/21 
Counselor ICF 
Removed language about randomization 
treatments.  
To make consistent with 
request protocol changes 
2.2 
9/9/21 
Counselor ICF 
Updated Figure 1 to reflect new sample 
sizes 
To make consistent with 
request protocol changes 
2.2 
9/9/21 
Counselor ICF 
In section “WHAT ABOUT MY RIGHTS TO 
DECLINE PARTICIPATION OR WITHDRAW 
FROM THE STUDY” starting on page 9, 
added additional details about the process 
for counselors who wish to leave the 
study. 
Improve processes around 
counselors who decide to 
withdraw consent for 
participation.  
2.3 
1/6/22 
Protocol 
Changed total sample size for the 
feasibility study from N=62 to N=85 and 
site sample size from n»12 to n»21. This 
change was made on pages 6, 8, 19, 40, 
42, 45, 46 
To ensure that each 
counselor treats one 
student in CAMS and DBT 
post-certification in the 
respective treatment 
protocol. 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 92 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
2.3 
1/6/22 
Protocol 
Removed tracking of non-mental health 
ED visits as a SAE. Will continue to track 
and report as a standard AE. This was 
removed from the list of SAEs on page 64. 
Clarify what needs to be 
tracked as SAE.  
2.3 
1/6/22 
Protocol 
Updated sample size estimates in “Figure 
1. Feasibility Study Design” on page 12. 
To ensure that each 
counselor treats one 
student in CAMS and DBT 
post-certification in the 
respective treatment 
protocol. 
2.3 
1/6/22 
Protocol 
Added Counselor Session Telehealth 
Questionnaire (CTSQ) as a measure to be 
completed after each telehealth therapy 
session by counselors and by QA raters for 
an assessment of reliability. This change 
was made on pages 17, 61, 91 
To document telehealth 
best practices 
2.3 
1/6/22 
Protocol 
In Table 3 (starting on page 32), we note 
that to achieve the aims of the feasibility 
study, only N=76 students are needed. The 
sample size requested of N=85 is included 
in case therapists need to treat additional 
certification cases because they did not 
pass on the first case or their first case 
withdrew prior to completing treatment. 
This point is also noted in the “Statistical 
Considerations” section on page 70. 
To ensure that each 
counselor can treat an 
additional training case if 
they fail to pass on the first 
one. 
2.3 
1/6/22 
Student ICF 
Changed sample size of study from N=62 
to N=85 and updated Figure 1 
To make consistent with 
protocol. 
2.4 
4/29/22 
Protocol 
Changed protocol to allow for training of 
counselor participants to be either online 
or in-person. Decisions about which 
format to use will be based upon 
counselor preferences, research team 
preferences, and CDC and institutional 
guidelines surrounding large in-person 
meetings at the time. Changes to the 
protocol that reflect this modification are 
on page 28. 
To allow flexibility due to 
changing guidelines 
surrounding COVID-19. 
2.4 
4/29/22 
Protocol 
Clarified AE reporting. Non-suicidal Self-
Injuring (NSSI) will now be tracked and 
reported as an SAE rather than an AE. In 
prior version of the protocol, NSSI was 
listed as an AE and SAE. Changes to the 
protocol that reflect this modification are 
on page 64. 
For clarification. 
2.5 
7/14/22 
Protocol 
Removed all references to CAMPUS 
Feasibility protocol. 
No longer needed as 
feasibility study has been 
completed.  
2.5 
7/14/22 
Protocol 
Changed Total sample size to 480 
Updated sample size to 
match new protocol design 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 93 of 103 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
2.5 
7/14/22 
Protocol 
Changed treatment length to 14 weeks 
and total treatment duration to 26 weeks. 
Updated treatment 
duration to match new 
protocol design. 
2.5 
7/14/22 
Protocol 
Changed follow-up period to 12 weeks 
Updated follow-up period 
to match new protocol 
design. 
2.5 
7/14/22 
Protocol 
Updated Figure 1 and added Figure 2 
Updated to match new 
protocol design and added 
Figure 2 for clarification. 
2.5 
7/14/22 
Protocol 
Updated Table 1 (Assessment Schedule) 
Updated to match new 
protocol.  
2.5 
7/14/22 
Protocol 
Updated description of DBT. 
Updated to match new 
protocol. 
2.5 
7/14/22 
Protocol 
Updated participant reimbursement 
schedule. 
Updated to match new 
protocol.  
2.5 
7/14/22 
Protocol 
Added monthly monitoring of students 
who enter the maintenance phase of the 
ATS and during follow-up period. 
Updated to improve risk 
management of students. 
2.5 
7/14/22 
Protocol 
Changed requirement of 3 consecutive 
sessions of “response” before deciding on 
next treatment phase. 
Old rule was too rigid. New 
rule improves clinical 
flexibility and enhances 
participant retention. 
2.5 
7/14/22 
Protocol 
Changed academic outcomes to self-report 
Necessary as follow-up 
period is now too short. 
2.5 
7/14/22 
Protocol 
Removed Life-Death Implicit Association 
Test 
Too difficult to administer 
in remote environment; too 
burdensome for 
participants. 
2.5 
7/14/22 
Protocol 
Removed Copenhagen Burnout Instrument 
To reduce burden on 
counselors 
2.5 
7/14/22 
Protocol 
Updated power section to reflect new 
sample size. 
Updated to match new 
protocol.  
2.6 
12/30/22 
Protocol 
Minor change to how DBT sessions are 
randomly selected for adherence rating. 
Change is reflected in protocol on page 40 
of this protocol. 
Help to ensure that every 
student's adherence to DBT 
is accurately evaluated, 
regardless of the number of 
sessions they receive 
2.7 
04/08/2023 
Protocol 
In order to enhance clarity, a few minor 
wording changes were made to Inclusion 
Criteria 4 for student participants. The goal 
was to include the phrase "one or more of 
the following:" to improve clarity and 
reduce ambiguity. It's worth noting that this 
change was approved in Version 2.2 of the 
Protocol, but the updated wording was not 
implemented at that time. 
To ensure consistency with 
the approved Protocol 
version 2.2, and for the 
purpose of clarification. 
 
 

CAMPUS Multisite Trial 
 
Protocol No.: 2.7 
Origination Date: 24 August 2020 
 
Version Date: 08 April 2023 
 
Page 94 of 103 
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