Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide
Phase: NA
Conditions: Suicide Prevention
Sponsor: Ohio State University

1 
 
Feasibility Trial of a Single Session of Crisis Response Planning for 
Youth at High Risk for Suicide 
NCT06164106 
9/25/2024 
 
PRINCIPAL INVESTIGATOR: 
STEPHANIE GORKA, PHD 
THE OHIO STATE UNIVERSITY, COLLEGE OF MEDICINE 
DEPARTMENT OF PSYCHIATRY AND BEHAVIORAL HEALTH 
 
CO-INVESTIGATORS: 
LAUREN KHAZEM, PHD 
THE OHIO STATE UNIVERSITY, COLLEGE OF MEDICINE 
DEPARTMENT OF PSYCHIATRY AND BEHAVIORAL HEALTH 
 
HEATHER WASTLER, PHD 
THE OHIO STATE UNIVERSITY, COLLEGE OF MEDICINE 
DEPARTMENT OF PSYCHIATRY AND BEHAVIORAL HEALTH 
 
STUDY LOCATION(S):  
THE OHIO STATE UNIVERSITY 
INSTITUTE FOR BEHAVIORAL MEDICINE RESEARCH 
460 MEDICAL CENTER DRIVE 
COLUMBUS, OH 43210 
 

2 
 
LIST OF ABBREVIATIONS  
 
AE 
 
 
Adverse Event 
ASQ  
 
Ask Suicide Screening Question 
CITI 
 
 
Citi.gov Human subjects training 
CO-I  
 
Co-Investigator 
CRP  
 
Crisis Response Planning 
DIAMOND-KID 
The Diagnostic Interview for Anxiety, Mood, and OCD and Related 
Neuropsychiatric Disorders Child and Adolescent Version 
EMA  
 
Ecological momentary assessment  
HIPAA 
 
Health Insurance Portability and Accountability Act 
IRB 
 
 
Institutional Review Board 
OSU 
Ohio State University 
OSUWMC 
Ohio State University Wexner Medical Center  
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
SAE  
 
Serious Adverse Event 
TAU  
 
Treatment as Usual 
 

3 
 
1.0 Background/Scientific Rationale  
Suicide is a serious public health issue and a common cause of death. In the US, 
the prevalence of suicide has risen in the last two decades, particularly amongst youth1. 
Recent reports reveal that 10% of high school students have made a suicide attempt and 
22% have considered suicide2. There is an urgent need for better access to suicide 
prevention and this need is reflected in the national prioritized agenda for suicide 
research.  
Effective multi-session outpatient therapies exist for suicide prevention; however, 
less than one-third of youth who experience suicidal thoughts engage in regular 
treatment3. Accordingly, there has been a shift in focus towards ultra-brief risk 
management strategies that are highly transportable and easily scalable to reach more 
individuals in need. Along these lines, recent studies led by our group have shown that a 
single session of crisis response planning (CRP) reduces suicidal behavior by up to 76%, 
while also rapidly reducing the severity of suicidal ideation and number of psychiatric 
inpatient days in high-risk populations4.  
During CRP, therapists and individuals collaboratively develop a personalized plan 
for managing acute periods of intense affective arousal to mitigate risk during real-world 
crises. Most prior studies investigating the effectiveness of CRP have been conducted in 
adults, such as military personnel4-6. Prior studies have also largely involved in-person, 
face-to-face administration of CRP. However, youth experience significant barriers to in-
person treatment including financial costs, transportation issues, stigma/shame, concern 
for lack of anonymity, and difficulty navigating the mental health treatment system7. Novel 
virtual care technologies offer accessible and cost-effective intervention delivery options 
that have shown to be effective in promoting health in youth8-11. There is an untapped 
potential for virtual approaches to engage high-risk youth who typically do not receive 
treatment but could significantly benefit. Thus, the primary goal of this study is to adapt 
and pilot test a virtual chat-based CRP protocol for youth at high-risk for suicide. 
CRP will be adapted by utilizing a virtual chat-based platform. Given that CRP has 
never been tested in youth, we will use a 3-arm design to disentangle the effects of CRP 
from the virtual platform. A total of 90 youth, ages 14-18, who screen positive on the Ask 
Suicide-Screening Questions (ASQ) will complete a study screen and 2-weeks of daily 
ecological momentary assessment (EMA) designed to capture baseline mood and 
suicidal thoughts and behaviors. The EMA will also measure real-time use of various 
emotion regulation strategies. Participants will then be randomized to one of three 
treatment arms: 1) in-person CRP; 2) virtual CRP; or 3) virtual crisis risk management 
(control). Changes in mood, suicidality, and behavior will be assessed using an additional 
2 weeks of daily EMA. At the end of the protocol 10 individuals per treatment arm (30 in 
total) will be randomized to complete an in-depth interview to assess feasibility and 
acceptability of the intervention and the research protocol. Questions rooted in a 
theoretically driven implementation science framework will be used to identify 
intervention-related facilitators and barriers to guide adaptation and implementation of the 
intervention. The Specific Aims are as follows:  
 
2.0 
Objectives/Aims 

4 
 
 Aim 1. Assess the feasibility and acceptability of traditional and virtual CRP in 
adolescents. Hypothesis 1: Virtual CRP will be rated as more feasible and acceptable 
compared with traditional CRP and the control intervention.  
Aim 2. Examine whether a single session of CRP changes suicide risk in 
adolescents. Hypothesis 2: Both versions of CRP will be associated with changes in 
frequency and severity of suicidal ideation and behavior compared with the control. 
Virtual CRP will be equally as effective as traditional CRP at reducing suicide risk 
suggesting virtual CRP is a promising scalable intervention adaptation.  
Exploratory. Identify mechanisms of CRP treatment success. Explore common 
mechanisms related to CRP treatment success, including treatment-related increases in 
emotion regulation capacity, by capturing complementary constructs at the screen and 
via EMA. This exploratory aim will shed light on the developmental specificity of identified 
processes to guide future mechanistic adaptations.  
 
Study duration. Participants will remain enrolled in the study for 5-6 weeks which 
includes the virtual screening session, two weeks of pre-intervention EMA, the single-
treatment intervention, two weeks of post-intervention EMA, and online follow-up session.  
 
 
3.0 
Eligibility 
 
3.1 Inclusion Criteria 
 
Participants will be required to be: (a) 14-18 years old at the time of 
assent/consent; (b) their legal guardian is willing and able to give parental 
permission (if under 18 years old), (c) able to give informed assent/consent 
(as applicable); and (d) endorse current desires to make a suicide attempt 
as defined as answering “yes” to item #3 on the Ask Suicide Screening 
Question (ASQ) tool. 
 
3.2 Exclusion Criteria 
 
Exclusion criteria will include: (a) factors that would interfere with data 
interpretation including serious medical or neurologic conditions; (b) current 
severe substance use disorder; (c) lack of access to a personal smartphone 
and; (d) lack of fluency in English. 
 
3.3 Excluded or Vulnerable Populations 
 
No individuals will be allowed to participate in the study if they are less than 
14 years of age or older than 18 years of age. This age range was chosen 
to focus on high-risk high-school aged-youth.  
 
 
4.0 
Subject Enrollment 

5 
 
• 
We propose to recruit 90 youth who are acutely suicidal from Nationwide 
Children’s Hospital (NCH), the Ohio State University Wexner Medical 
Center (OSUWMC) system, local high schools, and the surrounding 
community through word-of-mouth referrals, posted flyers, and PeachJar. 
PeachJar is a service through Columbus City Schools that sends out flyers 
via email to parents of kids in the school system. No information about 
parents of children will be provided to research staff; the flyer will be shared 
through PeachJar administrators. For those who are recruited through 
OSUWMC and NCH, no medical records will be reviewed.  
• 
Participants will be recruited through advertisements and social media. We 
will also use print ads and word-of-mouth referrals.  
• 
Advertisements will include a QR code that when scanned will direct 
interested individuals to the study’s online Recruitment Survey on REDCap. 
If the individual chooses, they will complete the online survey that assesses 
for initial eligibility criteria. 
• 
Study staff will determine potential participants’ eligibility for the research. 
• 
If an individual meets this initial eligibility criteria on the survey, trained 
clinical research staff or investigators will call the individual and complete a 
phone screen to further assess eligibility for the research study. 
• 
Following the completion of the phone screen, potentially eligible individuals 
will be scheduled for a virtual screening session and have a copy of the 
parental permission and assent forms or consent form (dependent upon 
age) emailed to the interested individual and legal guardian (if under 18 
years old). 
• 
If the individual is under 18 years old, at the beginning of the virtual 
screening session, participants and their legal guardian will provide 
informed assent and parental permission. If the individual is 18, a legal 
guardian will not be present and consent will be obtained. Specifically, once 
the procedures are explained to them in detail, participants will be given 
ample time to read the parental permission and assent forms or consent 
form, formulate questions, and ponder the responses. Participants will have 
time between initial contact and the scheduled screening session to discuss 
participation with people of their choice. We will emphasize to participants 
and their legal guardian (if under 18) the voluntary nature of their 
participation in the study. Participants will also be told that they are free to 
drop out of the study at any time for any reason.  
Online Screening Sessions: For individuals under 18 years old, 
parental permission and assent will be collected via REDCap 
software. The authenticity requirements involve Remote Signing, 
Username & Password. During the phone screen, if participants 
are found to be eligible, they will establish a password with study 
staff. The study staff will enter the passcode in the participant’s 
REDCap record.  Participants and their legal guardian are 
provided a link to sign the assent and parental permission forms 
in REDCap. Participants and their legal guardians are then asked 
for the password, which is cross referenced with the password 

6 
 
already on file in the REDCap project. The completed parental 
permission and assent forms will be downloaded and stored in 
the PI’s laboratory in a locked cabinet and locked office. A copy 
of the signed parental permission and assent forms are provided 
by REDCap. 
 
If the individual is 18, the procedures above will be followed 
except that a legal guardian will not be present and only consent 
will be obtained. 
 
• 
After obtaining informed consent or parental permission and assent, a 
trained staff member will perform a clinical assessment of suicidal thoughts 
and safety, treatment history, and administer a small battery of self-report 
questionnaires. Initial eligibility for the research will be documented in the 
research record. Screening visit data from participants who consented to 
participate in the study, but are not eligible, will be saved. Final 
determination of participant eligibility will be made by the PI or the PI in 
consultation with research staff. 
• 
Eligible participants will download the Metricwire app at the end of the 
screening session. The next day, participant will complete clinical 
assessments four times a day for 14 days via smartphone technology. 
• 
Participants will then be randomized to either in-person CRP, virtual CRP, 
or standard crisis risk management (the control intervention). All treatments 
take approximately 30-minutes to 1-hour.  
• 
Immediately after the intervention, participants will continue to compete 
clinical assessments four times a day for 14 days via the same smartphone 
technology. 
• 
At the end of the 14-day post-intervention window, participants will complete 
a short battery of questionnaires and a brief clinical assessment of suicidal 
thoughts and safety, conducted by clinically trained research staff. 10 
participants from each study arm (a total of 30 participants) will also be 
randomized to complete a brief qualitative interview that assess the 
feasibility and accessibility of the corresponding treatment interventions.  
• 
Participants not engaged in mental health treatment services will be 
provided our mental health services referral list. 
• 
Participants who turn 18 while enrolled in the study will be required to sign 
the most up-to-date consent form in order to continue participating in the 
study. If the participant does not sign the consent form after turning 18, they 
will be withdrawn from the study. 
• 
Termination Criteria:  Participants may be terminated for any of the 
following: (a) completion of study; (b) participant request to exit or withdraw 
consent; (c) development of a systemic, medical, neurologic, or psychiatric 
illness requiring treatment that would exclude participation; and (d) non-
compliance with study protocol requirements. 
 
5.0 
Study Design and Procedures 

7 
 
Participants. A total of 90 individuals with active suicidal thoughts and/or urges will be 
recruited. In order to capture individuals at high risk for suicide, participants will be 
required to endorse current suicidal ideation and intent, defined as answer “yes” to 
question 3 on the Ask Suicide-Screening Questions Survey (ASQ)12. Exclusion criteria 
are listed above. 
 
Recruitment. Participants will be recruited from the community and the OSUWMC and 
NCH. We will use a wide variety of recruitment methods including online and in-person 
advertisements and word-of-mouth referrals. More specifically, collaborators at NCH 
clinics will distribute approved flyers. For those who are recruited through OSUWMC and 
NCH, no medical records will be reviewed. 
 
Entry Assessments. Inclusion/exclusion criteria. Potential participants will be 
screened using a battery of questionnaires and a brief clinical interview that assesses for 
treatment history, suicidal thoughts, and safety. Exclusionary criteria will be those that 
would interfere with data interpretation (e.g., serious medical or neurologic conditions, 
current severe substance use disorder, lack of access to a personal smartphone, and 
lack of fluency in English). If interested participants meet eligibility criteria and provide 
parental permission and assent, they will be enrolled in the study. 
 
Study Overview. This study is a mixed methods randomized control trial combining 
clinical interviewing, EMA data collection, brief one session intervention, and qualitative 
interviews (Fig. 1). Participants will first complete a virtual screening visit that includes 
collecting informed consent or parental permission and assent, assessment of study 
eligibility, clinical interviews, and questionnaires. For individuals under 18 years old, after 
a legal guardian provides parental permission, they will not be present during study 
activities and not have access to the participant’s data (unless limits to confidentiality 
apply). 
The following day after the screening visit, the 2-week pre-treatment ecological 
momentary assessment (EMA) data burst will begin. EMA prompts will be delivered four 
times per day during non-school hours and capture mood, suicidal thoughts and urges, 
behavior, and volitional emotion regulation strategies. The timing of these surveys will be 
set based on the participant’s schedule. However, the total range of time that EMA 
prompts will be sent is between 7am to 10pm. Each prompt will include an option to 
request to speak to study staff. Information regarding if a wellness check was completed, 
changes in suicide risk, and adverse events will be documented by study staff as 
applicable. 
At the end of the 2 weeks of pre-intervention EMA, participants will be randomized to 
one of three treatment arms: 1) traditional, in-person, Crisis Response Planning (CRP); 
2) virtual CRP; or 3) virtual crisis risk management (treatment as usual [TAU]/control). All 
interventions will be a single, 30 minute-1-hour, session. The following day after the 
intervention, the post-treatment EMA data burst will begin. The prompt structure and 
items will be identical to the pre-treatment protocol, though new items capturing real-world 
use of the intervention plan (all 3 arms) will be included. At the end of the post-intervention 
EMA protocol, participants will complete follow-up questionnaires, a clinical assessment 
of suicidal thoughts and safety, and a qualitative interview (if randomized). 

8 
 
 
 
Figure1. 
Initial Clinical Interview Assessments. At the screening session, trained study staff will 
conduct the following clinical interviews: Columbia Suicide Severity Rating Scale (C-
SSRS)13, Antidepressant Treatment History Form (ATHF), Psychiatric Treatment History 
Form, and Lethality Rating Scale (LRS; this form will only be completed if participants 
report history of past suicide attempt)14. If alcohol and substance use is reported on self-
report forms, the Diagnostic Interview for Anxiety, Mood, and OCD and Related 
Neuropsychiatric Disorders (DIAMOND)15 alcohol use and substance use disorder 
modules will be completed to assess for exclusionary criteria. 
 
 
Initial Self-Report Assessments. At the screening visit, participants will complete the 
following self-report measures (see Table 1):  
 
Baseline Demographic and Health Measures: Contact Information Form, NIH 
GUID 
Information 
Form, 
Demographic 
Questionnaire, 
General 
Health 
Questionnaire, Pubertal Development Scale (PDS)16, and Treatment Preference 
Questionnaire. 
 
Baseline Measures of Psychiatric Symptoms and Personality: Regulation of 
Emotion Systems Survey17, Beck Depression Inventory (BDI-II)18, PHQ-9 modified 
for adolescents19, Beck Anxiety Inventory (BAI)20, Anxiety Sensitivity Index (ASI)-
321, Beck Hopelessness Scale for Children (BHS-C)22, Pediatric Loneliness Scale, 
Short UPPS-P Impulsive Behavior Scale (SUPPS-P)23, Timeline Follow-Back 
(TLFB; past 30 days)24, Alcohol Use Disorders Identification Test (AUDIT)25, Drug 
Abuse Screening Test – Adolescent Version (DAST-A)26, Cannabis Use Disorder 
Identification Test (CUDIT)27, Snaith-Hamilton Pleasure Scale (SHAPS)28, the 
Personality Inventory for DSM-5 Faceted Brief Form (PID-5)29, Intolerance of 
Uncertainty for Children (IUS-C)30, The Child PTSD Symptom Scale (CPSS-5) 
self-report31, Insomnia Severity Index (ISI)32, Peer Relationships Questionnaire33, 
and Family Relationships Questionnaire34. 
 
Baseline Measures of Suicidality: ASQ12, Self-Injurious Thoughts and Behaviors 
Interview–Revised Self- Report (SITBI-R)35, Beck’s Scale for Suicidal Ideation (SSI 
– past week)36, and Suicide Cognitions Scale –Revised (SCS)37. 
 
Follow-up 
forms and 
interviews 

9 
 
Randomization Procedures. At the end of the pre-treatment EMA, we will use stratified 
block randomization to assign youth to one of the three treatment interventions. Biological 
sex and history of suicide attempts will be our strata to ensure balance across the groups, 
consistent with adult CRP studies. Suicide attempt history has three levels: no prior 
attempts, one prior attempt, and 2+ prior attempts as data indicate that individuals with 
multiple suicide attempts have higher levels of pathology compared to individuals with 
single attempts and no attempts38. A computerized randomization scheme will be used to 
minimize the potential for bias in condition assignment. The same randomization 
procedure will be utilized to assigned 10 participants from each treatment arm to complete 
the qualitative interview at the end of the study. 
 
Treatment Conditions. Descriptions of CRP (in-person and virtual) and the control 
condition are described and summarized in Table 2 below. We will obtain parental 
permission and assent at the screen to record intervention sessions. All interventions will 
be reviewed, scored, and discussed during clinical supervision. 
 
 
Table 2. 
 
CRP Intervention. Participants can be assigned to either in-person (traditional) CRP or 
virtual (chat-based) CRP. The protocols will be nearly identical with appropriate 
technology-related adaptions (see below). The CRP session will last 30 minutes-1-hour. 
Consistent with the published protocol39,40 the session will include the following standard 
suicide intervention strategies: supportive listening, provision of crisis resources, and 
referral to a mental health professional (if not already established). The CRP active 
component involves a collaborative process in which the therapist invites the individual to 
share the events, symptoms, and contextual factors leading up to and surrounding the 
participant’s recent suicidal crisis. Next, the individual and therapist identify the 
participant’s personal warning signs for an emotional crisis, self-management coping 
skills, reasons for living, and sources of social support. These components are written, by 
the participant on an index card (in-person) or virtual whiteboard (virtual). The CRP 
document serves as a concrete reference for individuals in the real-world. 
 
Virtual CRP Adaptations. The virtual CRP protocol will include all elements of the 
evidence-based, traditional CRP. Dialog between the therapist and participant will 
transpire via the Doxy.me chat window (without video). The dialog will be semi-structured 

10 
 
and include pre-developed text/prompts and an overarching framework for chat-based 
interaction. The therapist will lead the participant through the CRP development using the 
Doxy.me whiteboard feature that allows for participants to simultaneously view an 
editable document. At the end of the session, this document can be saved to the 
participant’s computer and/or phone for future reference. 
 
Virtual Crisis Risk Management (Control). Standard crisis risk management will serve 
as the control condition, similar to PI Gorka’s R01 (2021H0039). The virtual intervention 
will also take place via Doxy.me. The session will last 30-minutes - 1-hour and include 
several of the basic risk management components listed above (Table 2). Following a 
semi-structured suicide risk assessment (i.e., C-SSRS13), participants will be asked to 
complete a self-guided safety plan worksheet independently (The Stanley-Brown Safety 
Plan41). The Stanley-Brown Safety Plan was previously identified as a “best practice” by 
the Suicide Prevention Resource Center/American Foundation for Suicide Prevention 
Best Practices Registry for Suicide Prevention42 and has been utilized across clinical 
suicide studies43. 
The worksheet will be shared via Doxy.me and briefly reviewed by the therapist. 
The control intervention meets the expectations for standard risk management, though 
by design it lacks the engaging and collaborative aspects of CRP.  
Doxy.me is a widely used telemedicine platform that has been used across the 
medical field and in research studies. The platform is HIPAA, General Data Protection 
Regulation (GDPR), The Personal Information Protection and Electronic Documents Act 
(PIPEDA), and Health Information Technology for Economic and Clinical Health 
(HITECH) compliant44. 
 
Post-Treatment EMA. The day following the intervention, the 14-day post-treatment 
EMA data burst will begin. The EMA items and structure will be almost identical to the 
pre-treatment protocol outlined above. However, several additional items will be included 
assessing how frequently the CRP (and control plan) is being used and its perceived 
effectiveness. Participants will rate on a 10-point scale to what extent they engaged in 
specific parts of their safety plan and how effective the plan was at changing their 
emotional experience. Similar to the pre-treatment EMA, each prompt will include an 
option to request to speak to study staff. Information regarding if a wellness check was 
completed, changes in suicide risk, and adverse events will be documented by study staff 
as applicable. 
 
Post-Treatment Follow-up Session. At the end of the EMA period, participants will  
complete a clinical assessment of suicidal thoughts and safety (C-SSRS). If randomized, 
participants will also complete a virtual qualitative interview that will be recorded. Topics 
to be assessed during the qualitative interview will include comfort of use, clarity of the 
protocol, likelihood of use, and perceived usefulness. In addition, participants will 
complete a battery of questionnaires to measure the acceptability and feasibility of the 
interventions as well as change in behavior and psychiatric symptoms:  
 
Follow-up Self-Report Questionnaires: Beck SSI-past week, BDI, BHS-
C, ASQ, SCS, Pediatric Loneliness Scale, PHQ-A, BAI, ASI-3, IUS-C, 

11 
 
Regulation of Emotion Systems Survey, ISI, TFLB, AUDIT, DAST-A, 
CUDIT, System Usability Scale (SUS; for those who complete virtual 
treatments only)45, CRP Form (for those who complete CRP only), Client 
Satisfaction Questionnaire (CSQ-8)46, and Acceptability of Intervention 
Measure (AIM), Intervention Appropriateness Measure (IAM), and 
Feasibility of Intervention Measure (FIM) Combined Form47. 
 
 
SAFETY PLAN. If a participant reports severe suicide ideation during a survey, an 
automated email alert will be sent to the research team via email and text message. 
Severe suicide ideation is defined as a score of 7 or higher on item 26 (“How strong is 
your intention to kill yourself right now?”) where the possible range is 0-10. A score of 8 
or higher represents a value that is approximately two standard deviations above the 
mean suicide ideation score reported in a community sample of suicidal individuals and 
approximately half of a standard deviation above the mean suicide ideation score 
reported in a psychiatric inpatient sample. These procedures have been used in prior 
studies by PI Gorka. When an automated alert is received by the research team, a 
member of the research team will contact the participant to conduct a risk assessment to 
clarify the nature of risk using the same procedures outlined above, review the 
participant’s safety plan, and determine if the participant is at imminent risk to harm 
himself/herself, thereby warranting further evaluation for possible hospitalization and/or 
activation of emergency services (e.g., wellness check by law enforcement).   
 
 
Self-report Data Processing. All measures will be self-entered, checked for 
discrepancies, and cleaned. Analyses will assume that ‘missingness’ occurred at random, 
with data imputed when necessary.  
 
6.0 
Expected Risks/Benefits 
 
Based on prior studies by PI Gorka, a majority of actively suicidal participants are 
anticipated to benefit from the crisis response planning and crisis risk management 
interventions provided as part of the study. 
 
6.1 Diagnostic/Assessment/Therapy Audio Recordings Procedures and 
Breach of Confidentiality: The diagnostic interviews (and questionnaires) may 
be time consuming and boring to some individuals. However, these are necessary 
to determine eligibility for the study and test hypotheses. In addition, questions 
about suicidal behavior, substance use, and audio recordings of therapy sessions 
may be considered sensitive by some participants. The collection of such data 
poses a potential risk of loss of confidentiality around sensitive information such 
as psychiatric status, history of substance use, etc. Information pertaining to 
psychiatric treatment or medical care will be protected in accordance with 42 CFR 
Part 2 and HIPAA regulations as applicable. Participants will be informed in the 
parental permission and assent documents that confidentiality will be limited in 
cases where the participant reveals intentions to harm themselves or others, and 

12 
 
the investigator feels that the proper authorities may need to be notified to prevent 
the occurrence of harm to the participant, or others (see additional details below). 
Confidentiality may also be broken in instances of reported ongoing child or elder 
abuse, as per mandated reporting guidelines. Interviews will be conducted by 
trained study staff who will maintain confidentiality and all data from interviews and 
questionnaires will be assigned an ID number to conceal the identity of the 
participant. Loss of confidentiality is also possible during the online assessments, 
particularly if participants complete these tasks at home, near family members 
and/or roommates. Participants will be informed of this risk during the informed 
assent document and prior to all online assessments.  
 
6.2 High-Risk Management Procedures: The PI and Co-Is have independently 
conducted multiple studies with acutely suicidal individuals and have 
considerable experience managing suicide risk. If a research staff member 
becomes aware that the participant is at imminent risk to harm themselves, the 
following questions will be asked to clarify the nature of risk (and to identify those 
at imminent risk requiring consideration for hospitalization): (1) Do you have a 
plan for killing yourself and do you intend to act on the plan?; (2) Do you have a 
desire to kill yourself that you believe you might act on?; (3) Have you already 
taken steps to act on your plan?  If so, what steps have you taken? Once a 
participant is identified as potentially imminent risk, the researcher will conduct a 
more thorough assessment to include possible evaluation by an investigator, all 
of whom are clinical psychologists and psychiatrists, for possible hospitalization. 
In the instance where a participant is determined to be in imminent risk to harm 
themselves, the participant’s legal guardian will be immediately notified and 
referred to their nearest emergency department. Our research lab is located one 
block away from OSU psychiatry inpatient and outpatient mental health facilities. 
If a participant is determined to be in imminent risk during an in-person visit, their 
legal guardian will be immediately notified, and research staff will escort the 
participant to one of these facilities for further evaluation.  
 
7.0  
Data Collection and Management Procedures 
 
• 
Sources of material from human participants include: (a) informed parental 
permission and assent or consent, (b) screen form, (c) diagnostic interviews, (d) 
self-report questionnaires, (e) therapy session recordings. 
• 
Each participant is given a unique number and there is a password-protected 
master key database separate from study data linking the participant with the code 
only accessible to OSU research team members. This file is a password-protected 
master key database, which links the participant with unique participant codes; it 
is stored on the password-protected server, described above, and kept separate 
from study data. The information in this file could be used to indirectly identify 
participants. The record linking participants to the research codes will be destroyed 
6 years after completion of the study, thereby anonymizing the data. 

13 
 
• 
Therapy session recordings will be stored onto the audio recorder’s internal 
memory. At the start of each interview, research staff will inform participants that 
the recorder is being turned on. After turning the recorder on, research staff will 
verbally notify the participant and ask him or her to verbally confirm that they are 
aware of the recorder being turned on. At the end of each workday, staff members 
will upload audio recordings to the encrypted, secured server within the PIs 
laboratory. Once the audio files have been successfully uploaded, staff members 
will delete the audio files from the audio recorder’s internal memory. Staff members 
will confirm the successful deletion of audio files from the recorder’s internal 
memory via visual inspection of the digital file list, which is displayed on a screen 
located on the front of the recorder. Audio recordings can then be accessed for 
review by the investigators via the same security procedures that are in place for 
accessing research data. Audio recorders will be locked when not in use using the 
same procedures required for security and storage of PHI. 
• 
All research materials from participants will be labeled with the unique participant 
code (not participant name).  
• 
Paper forms with the participant code will be kept in a locked cabinet where only 
official study staff has access.  
• 
Only official OSU study staff have access to the data. If any member of the 
research study leaves, his or her access to the network and all files will be removed 
immediately, thereby terminating access to this file and other files associated with 
the study.  
 
8.0 
Data and Safety Monitoring 
• 
We have developed a formal data safety and monitoring plan to ensure the 
ongoing safety of participants (as well as the integrity of the study). The plan 
involves weekly meetings that will be used to communicate any concerns or issues 
with safety, confidentiality, or progress. 
• 
Weekly meetings of the research staff of this study will be conducted that will 
include review of accrual, consenting procedures, protocol adherence, adverse 
events, and quality control of all data obtained from the study in the previous week. 
All changes in protocol design will be reviewed by the OSU IRB before such 
changes in protocol design take place.  
• 
All adverse events (AE) occurring during the study will be reported and reviewed 
by the PI. All AEs will be reviewed and as necessary, medically treated or referred 
to medical treatment as determined by the PI. If deemed necessary by the PI, a 
participant may be withdrawn from the study. AEs will be evaluated for serious 
adverse event (SAE) criteria. If an SAE should occur, it will be reported to the IRB. 
The initial report will be followed by a complete SAE report, sent to the IRB. If a 
participant withdraws from the study or the PI discontinues a participant’s 
participation due to a SAE, the participant will receive follow-up medical care as 
necessary. Follow-up care will continue until the participant no longer requires 
hospitalization, the condition is stabilized with no future change expected, or the 
problem is determined to be unrelated to the study. The outcome of SAEs will be 
reported to the IRB. 
 

14 
 
9.0 
Statistical Considerations and Sample 
 
Aim 1. Assess the feasibility and acceptability of CRP in adolescents. We 
hypothesize that virtual CRP will be rated as more feasible and acceptable than 
traditional CRP and virtual TAU. To examine this hypothesis, we will address each of 
the questions listed in Table 3 (above). We will compare the 3 interventions on our 
measures of acceptability and feasibility including SUS, CSQ-8, IAM, and AIM scores; 
intervention usefulness ratings; enrollment and completion reports; and qualitative 
interview themes. We will further examine whether virtual CRP achieves well-defined 
benchmarks such as SUS scores ≥8064, CSQ-8 scores ≥2765, and IAM scores ≥1660. 
These data will be used to update and modify the virtual chat-based CRP protocol for 
future testing.  
Aim 2. Examine whether CRP reduces suicide risk in adolescents. We 
hypothesize that both versions of CRP will be associated with greater change in 
frequency and severity of suicidal ideation compared with the control intervention. 
Virtual CRP will be equally as effective as traditional CRP at reducing suicide risk 
suggesting virtual CRP is a promising scalable intervention adaptation. To test our 
hypotheses, we will use flexible multilevel mixed models with treatment arm, time (pre 
vs. post), and the arm by time interaction. Suicidal ideation defined as Beck SSI total 
score and EMA suicidal ideation severity scores will be separate dependent variables. 
We anticipate an arm x time interaction that will be followed up using planned 
comparisons.  
Exploratory. Identify potential mechanisms of CRP treatment success. We 
hypothesize that CRP increases capacity for volitional emotion regulation. We will 
measure pre- and post-treatment emotion regulation via: 1) self-report questionnaire; 2) 
dynamic shifts in affect (EMA); and 3) engagement in emotion regulation strategies 
(EMA). We will use a series of multilevel mixed models specifying treatment arm, time, 
and time by treatment arm factors on our emotion regulation outcomes.  
 
Power Analysis and Sample Size Determination. Our sample size was selected 
pragmatically to identify issues related to study acceptability and feasibility. There is 
ample evidence to suggest that a sample size of 90 will achieve saturation on qualitative 
interviews and feasibility and acceptability outcomes (i.e., meaningful new themes are 
unlikely to emerge beyond this size). Our prelim data in adults (R01 sample) suggests 
that CRP is associated with a large reduction in severity of suicidal ideation (ηG2=.455), 
which would suggest sufficient power (>75%) for the present aims though the effects of 
this CRP protocol have never been examined in adolescents. 
 
10.0 Regulatory Requirements 
10.1 Informed Parental Permission, Assent, and Consent 
 
Individuals 14-17 years old: 
• During the initial meeting with study staff, the nature of the research project 
will be described to all potential participants and their legal guardian. A 
written summary, in lay terms, of the research project will be provided to the 
participants in the written informed parental permission and assent 
documents that the participants and legal guardians will review. The 

15 
 
documents will inform the participants of the voluntary nature of the study 
procedures, the purpose of the study, the procedures to be followed, the 
duration of the study, the risks associated with data collection, as well as 
the potential benefits to the community at large.   
• We will specifically request that the legal guardian attend the first virtual lab 
visit, or prior to study participation if the legal guardian’s schedule does not 
allow, to discuss with study staff the procedures with the opportunity to ask 
questions. After providing informed parental permission and assent, 
guardians will not be present during any study activities. Legal guardians 
will be informed that they will not have access to any of the participant’s 
data. 
 
Individuals 18 years old: 
• During the initial meeting with study staff, the nature of the research project 
will be described to all potential participants. A written summary, in lay 
terms, of the research project will be provided to the participants in the 
written informed consent documents that the participant will review. The 
documents will inform the participants of the voluntary nature of the study 
procedures, the purpose of the study, the procedures to be followed, the 
duration of the study, the risks associated with data collection, as well as 
the potential benefits to the community at large.   
 
All participants: 
• Participants will also be informed of limits of confidentiality and mandated 
reporting guidelines. Of note, only individuals who are medically and 
psychiatrically stable will be referred and consented to participate in the 
study. Inability to provide informed consent or parental permission and 
assent is exclusionary. Informed consent, parental permission, and assent 
will be obtained by the PI or designated research staff and the participant 
will receive a copy of the signed consent, parental permission, and assent 
forms. Participants will be informed that they can discontinue participation 
at any time without penalty.   
• Each member of the research team will complete the HIPAA and CITI 
human subjects trainings and will be trained in the research protocol and 
will have reviewed the informed consent document themselves.   
• The informed consent, parental permission, and assent documents will be 
stored in a separate locked file cabinet from any other research files in a 
locked office.  Only research staff on this specific research study will have 
access to the informed consent/assent documents.   
10.2 Subject Confidentiality  
• All data from participants will be marked with a research identifier number 
only and kept in locked cabinets. No data will have participant names on 
them, except for consent forms and payment forms, which will be stored 
separately from other questionnaires in a locked file cabinet. Paper records 
will be kept in locked file drawers in a locked room, to which only authorized 

16 
 
research personnel have access. Confidentiality of participant records is 
assured by assigning each participant with a research identifier 
number/code, and such data are stored in computer files (except for a single 
tracking file) without reference to name, or any other type of personally 
identifiable information (e.g., birth date, etc.). Data that may be reported in 
scientific journals will not include any information that identifies any person 
as a participant in this study. 
• Location and storage of computer files: These files will be stored on a user-
name and password protected local workstation. 
• Single tracking file: This file is a password-protected master key database, 
which links the participant with unique participant codes; it is stored on the 
password-protected server, described above, and kept separate from study 
data. The information in this file could be used to indirectly identify 
participants. Only research study personnel directly involved with the 
project will have access to this file. If any member of the research study 
leaves, his or her access to the network will be removed immediately, 
thereby terminating access to this file and other files associated with the 
study. The record linking participants to the research codes will be 
destroyed 6 years after study completion, thereby anonymizing the data. 
• Limits of Confidentiality on Clinical Information. Confidentiality is 
limited, however, when there is danger to oneself or others, or reports of 
child and elder abuse. If the participant is discovered to be acutely homicidal 
or actively suicidal during the evaluation period PI Gorka will be notified and 
an appropriate clinical decision for emergency psychiatric evaluation will be 
made, including an evaluation of the need for referral to the nearest 
emergency room for potential psychiatric hospitalization. Detailed 
information on the handling of suicide ideation is described above. If the 
participant discloses that a child is the subject of physical or sexual abuse, 
appropriate steps will be taken to ensure safety of the child, including 
contacting Department of Children and Family Services (DCFS). 
Participants will be made explicitly aware of mandated reporting guidelines 
prior to signing the assent or consent form. If it is determined that filing a 
DCFS report is necessary, the PI will be immediately notified. The PI (a 
clinical psychologist) will inform the participant of the report and assess 
expectations and reactions. The PI will provide acute clinical counseling, if 
warranted, and make appropriate clinical referrals. 
• No PHI will be collected in this study. Identifying information includes the 
participants name and contact information (phone number, email address, 
home address). The reasons that we are collecting this information include: 
the participants name for the informed assent document, phone number and 
email address to contact them during the study period. No information from 
the participants’ medical records will be recorded for research purposes.  
10.3 Unanticipated Problems 
• Any unanticipated problems (its occurrence, frequency or severity is new or 
greater than previously known or as expected based on participant 

17 
 
characteristics, including natural progression of disease). They are always 
unanticipated by definition and will be reported to the IRB within 5 business 
days of the PIs (or her team’s) knowledge of the event.     

18 
 
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21 
 
Table 1.  
 
 
 
Questionnaires 
Online 
Screen 
Pre-Treatment 
EMA (14 days) 
Post-
Treatment 
EMA (14 days) 
Post-
Treatment 
Follow-up 
Clinician 
Administered 
Antidepressant Tx History Form (ATHF) 
X 
 
 
 
Psychiatric Treatment History 
X 
 
 
 
C-SSRS 
X 
 
 
X 
LRS (as applicable) 
X 
 
 
 
DIAMOND/DIAMOND-KID AUD/SUD 
Modules (as applicable based on self-report forms) 
X 
 
 
 
Qualitative Interview (if randomized) 
 
 
 
X 
Self-Report 
Forms 
Contact Info Form 
X 
 
 
 
GUID Info Form 
X 
 
 
 
Demographics Form 
X 
 
 
 
Health Questionnaire 
X 
 
 
 
PDS 
X 
 
 
 
PID-5 
X 
 
 
 
BDI  
X 
 
 
X 
BHS-C 
X 
 
 
X 
SSI – past week 
X 
 
 
X 
SCS 
X 
 
 
X 
SITBI 
X 
 
 
 
Pediatric Loneliness Scale 
X 
 
 
X 
ASQ 
X 
 
 
 
ASQ Follow-up 
 
 
 
X 
PHQ-A 
X 
 
 
X 
BAI 
X 
 
 
X 
ASI-3 
X 
 
 
X 
AUDIT  
X 
 
 
 
AUDIT (past month) 
 
 
 
X 
DAST-A 
X 
 
 
 
DAST-A (past month) 
 
 
 
X 
CUDIT 
X 
 
 
 
CUDIT (past month) 
 
 
 
X 
SUPPS-P 
X 
 
 
 
CPSS-5  
X 
 
 
 
IUS-C 
X 
 
 
X 
Regulation of Emotion Systems Survey 
X 
 
 
X 
SHAPS 
X 
 
 
 
Insomnia Severity Index 
X 
 
 
X 
Peer Relationships 
X 
 
 
 
Family Relationships 
X 
 
 
 

22 
 
Treatment Preference Questionnaire 
X 
 
 
X 
TLFB (past 30 days) 
X 
 
 
 
TLFB (since baseline) 
 
 
 
X 
EMA Survey (Pre-Treatment) 
 
X 
(4 times/day) 
 
 
EMA Survey (Post-Treatment) 
 
 
X 
(4 times/day) 
 
CRP form (CRP groups only) 
 
 
 
X 
SUS (virtual interventions only) 
 
 
 
X 
CSQ-8 
 
 
 
X 
AIM, IAM, FIM Combined Form 
 
 
 
X