Comparing the Effectiveness of Two-Way Caring Contacts Texts vs One-Way Caring Contacts Texts vs Enhanced Usual Care to Reduce Suicidal Behavior in Youth and Adults Screening At-Risk for Suicide in Primary Care or Behavioral Health Clinics
Phase: NA
Conditions: Suicide, Suicide Prevention, Suicide and Self-harm
Sponsor: St. Luke's Health System, Boise, Idaho

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The SPRING Trial: Comparing Suicide Prevention Interventions to Guide Follow-up Care
Comparing the Effectiveness of Two-Way Caring Contacts Texts vs One-Way Caring Contacts Texts vs 
Enhanced Usual Care to Reduce Suicidal Behavior in Youth and Adults Screening At-Risk for Suicide in 
Primary Care or Behavioral Health Clinics: The SPRING Trial
Principal Investigator
Anna Radin, DrPH, MPH, Applied Research Scientist, St. Luke’s Health System; 208-381-8468; 
radina@slhs.org 
Funded by American Foundation for Suicide Prevention (#TBT-0-022-22). Grant Proposal Title: 
Effectiveness of Two-Way Caring Texts vs One-Way Caring Texts vs Usual Care: A Pragmatic Randomized 
Controlled Trial.
Confidentiality Statement
This document is confidential communication.  Acceptance of this document constitutes agreement by the recipient 
that no unpublished information contained herein will be published or disclosed without prior approval of the 
Principal Investigator.

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Table of Contents
Tables & Figures ...........................................................................................................................................4
Tables........................................................................................................................................................4
Figures ......................................................................................................................................................4
List of Acronyms ...........................................................................................................................................7
Statement of Compliance.............................................................................................................................9
Statement of Attribution for Protocol Template..........................................................................................9
Funding for the SPRING Trial ........................................................................................................................9
Investigator’s Signature..............................................................................................................................10
1.
Protocol Summary .............................................................................................................................11
1.1 Synopsis............................................................................................................................................11
1.2 Schema / Study Flow Diagram..........................................................................................................12
2.
Research Questions & Specific Aims .................................................................................................13
2.1
Research Questions ....................................................................................................................13
2.1  Specific Aims....................................................................................................................................13
3. Introduction ...........................................................................................................................................13
3.1 Background.......................................................................................................................................13
3.2 Significance.......................................................................................................................................14
4. Research Methods .................................................................................................................................15
4.1 Study Design .....................................................................................................................................15
4.2 Randomization..................................................................................................................................15
4.3 Masking ............................................................................................................................................15
5. Study Population & Setting ...................................................................................................................16
5.1  Inclusion & Exclusion Criteria ..........................................................................................................16
5.1.1 Inclusion Criteria........................................................................................................................16
5.1.2  Exclusion Criteria ......................................................................................................................16
5.2. Statistical Power and Sample Size ...................................................................................................16
5.3 Recruitment Plan ..............................................................................................................................17

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5.4 Retention..........................................................................................................................................17
5.5 Populations for Analyses ..................................................................................................................18
6. Study Procedures...................................................................................................................................18
6.1 Schedule of Activities........................................................................................................................19
7.     Conceptual Model ..............................................................................................................................21
8.  Study Measures.....................................................................................................................................22
8.1 Primary Outcome..............................................................................................................................22
8.2 Secondary Outcomes........................................................................................................................22
8.3 Exploratory & Safety Outcomes .......................................................................................................22
8.4 Other Measures................................................................................................................................23
9.    Description of Interventions...............................................................................................................23
9.1  Enhanced Usual Care Alone (UC).....................................................................................................23
9.2  Two-way Caring Contacts (CC2).......................................................................................................24
9.3  One-way Caring Contacts (CC1).......................................................................................................24
9.4 Process Evaluation & Fidelity Monitoring.........................................................................................24
10.
Discontinuation and Participant Withdrawal ...............................................................................24
10.1 Discontinuation of Study Intervention ...........................................................................................24
10.2 Participant Discontinuation and Withdrawal from the Study ........................................................25
10.3 Lost to Follow-Up............................................................................................................................25
11.
Data & Safety Monitoring..............................................................................................................26
11.1 Overview of Data & Safety Monitoring Plan...................................................................................26
11.2 Role of the Data & Safety Monitoring Board (DSMB).....................................................................26
11.3 Safety Monitoring...........................................................................................................................26
11.4 Adverse Events and Serious Adverse Events ..................................................................................27
11.5 Role of the Research / Medical Monitor (RM)................................................................................27
12.
Data Collection & Management ....................................................................................................27
12.1 Data Collection ...............................................................................................................................27
12.2 Data Management..........................................................................................................................30
13.
Statistical Analysis..........................................................................................................................30
13.1 Data Analysis...................................................................................................................................30

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13.1.1  Primary Analysis......................................................................................................................30
13.1.2  Secondary Analyses ................................................................................................................31
13.1.3  Subgroup Analyses..................................................................................................................31
13.2 Planned Interim Analyses ...............................................................................................................31
13.3 Assessing Long-Term Survival.........................................................................................................32
13.4 Assessing Agreement between Suicide Outcome Measures..........................................................33
14.
Engaging People with Lived Experience with Suicide ...................................................................33
15.
Risk / Benefit Analysis ...................................................................................................................33
15.1 Potential Risks.................................................................................................................................33
15.2 Potential Benefits ...........................................................................................................................34
16. Oversight for Human Subjects Protection & Regulatory Considerations...........................................35
16.1 Human Subjects Protection ............................................................................................................35
16.2 Risks to Human Subjects.................................................................................................................35
16.2.1 Involvement of Human Subjects..............................................................................................35
16.2.2 Protecting Individuals with Urgent Clinical Needs...................................................................35
16.3 Informed Consent Process..............................................................................................................35
16.4 Documentation of Informed Consent.............................................................................................36
16.5 Inclusion of Women and Minorities ...............................................................................................36
16.6 Inclusion of Minors .........................................................................................................................36
16.7 Cost and Compensation for Participation.......................................................................................36
16.8 Study Discontinuation and Closure.................................................................................................37
16.9 Confidentiality & Privacy ................................................................................................................37
16.10 Study Records Retention ..............................................................................................................38
16.11 Publication & Data Sharing Policy.................................................................................................38
16.11.1 National Institute for Mental Health Data Archive (NDA) .....................................................38
16.12 Dissemination of Results ..............................................................................................................39
16.13 Conflict of Interest Policy..............................................................................................................39
16.14 Protocol Deviations ......................................................................................................................39
16.15 Key Roles for Study Oversight.......................................................................................................39
16.15.1 Data and Safety Monitoring Board........................................................................................40

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16.16 Quality Assurance & Quality Control............................................................................................40
17
Institutional Roles..........................................................................................................................41
17.1 St. Luke’s Health System, Boise, ID – Primary Research Institution ...............................................41
17.2 Idaho Crisis and Suicide Hotline (Hotline), Boise, ID – Intervention Delivery.................................41
17.3 University of Washington (UW), Seattle, WA – Subject Matter Expertise and Biostatistics Support
................................................................................................................................................................41
18. References............................................................................................................................................42
Appendix A: C-SSRS Screening Questions & Scoring Criteria.....................................................................48
Appendix B: SPRING Brief Assessment of Capacity to Consent (S-BACC) ..................................................49

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Tables & Figures
Tables
Table 1: Schedule of SPRING Trial Activities...............................................................................................20
Table 2: SPRING Trial Key Variables & Other Data Elements......................................................................27
Table 3: Upper and Lower Stopping Boundaries for Planned Interim Analyses.........................................31
Table 4: Key Roles for Study Oversight, SPRING Trial.................................................................................38
Figures
Figure 1: SPRING Trial Flow Diagram..........................................................................................................13
Figure 2: SPRING Trial Conceptual Model...................................................................................................21

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List of Acronyms
AE
Adverse Event
AFSP
American Foundation for Suicide Prevention
AIMS
Advancing Integrated Mental Health Solutions
CBPR
Community-Based Participatory Research
CC1
One-Way Caring Contacts Text Messages
CC2
Two-Way Caring Contacts Text Messages
CFR
Code of Federal Regulations
C-SSRS
Columbia Suicide Severity Rating Scale
DSMB
Data & Safety Monitoring Board
ED
Emergency Department
GMS
General Mattering Scale
HASS
Harkavy-Asnis Suicide Scale
HIPAA
Health Insurance Portability and Accountability Act of 1996
Hotline
Idaho Crisis and Suicide Hotline
ICH GCP
International Council on Harmonisation Good Clinical Practice 
INQ-15
Interpersonal Needs Questionnaire - 15
IRB
Institutional Review Board
ITHS
Institute of Translational Health Sciences
NDA
National Institute of Mental Health Data Archive
NIH
National Institutes of Health
NIMH
National Institute of Mental Health
NSSI
Non-Suicidal Self-Injury
OHRP
Office of Human Research Protections

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PHI
Protected Health Information
PHQ-2 
Patient Health Questionnaire-2 
PHQ-9
Patient Health Questionnaire-9 
PHQ-A
Patient Health Questionnaire for Adolescents
PI
Principal Investigator
PLES
People with Lived Experience with Suicide
REDCap
Research Electronic Data Capture
RM
Research/Medical Monitor
SAE
Serious Adverse Event
S-BACC
Spring Brief Assessment of Capability to Consent
SITBI-R
Self-Injurious Thoughts and Behaviors Interview - Revised
SLHS
St. Luke’s Health System
SPRING
Comparing the Effectiveness of Suicide Prevention Interventions to Guide 
Follow-up Care
UAP
Unanticipated Problem
UC
Usual Care
US
United States
USPS Task Force 
United States Preventive Services Task Force
VA
Veterans Administration
UW
University of Washington

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Statement of Compliance
The trial will be conducted in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP), and American Foundation for Suicide Prevention. The Principal Investigator will 
assure that no deviation from, or changes to the protocol will take place without prior agreement from 
the funding agency and documented approval from the St. Luke’s Institutional Review Board (IRB), 
except where necessary to eliminate an immediate hazard to the trial participants.  All personnel 
involved in the conduct of this study have completed Human Subjects Protection and ICH GCP Training.
The protocol, informed consent form, recruitment materials, and all participant-facing materials will be 
submitted to the St. Luke’s IRB for review and approval.  Approval of the protocol and all relevant 
documents must be obtained before any participant is consented and enrolled in the study.  In addition 
to SLHS IRB approval, St. Luke’s Research Final Authorization will be in place before study activities 
begin. Any amendment to the protocol or supporting documents will require review and approval by the 
IRB before the changes are implemented to the study.  All changes to the consent forms will be IRB 
approved.  Depending on the extent of changes, the research team and/or the IRB will determine 
whether participants who provided consent using a previously approved consent form need to be 
reconsented using the revised consent form.
Statement of Attribution for Protocol Template
Significant portions of the outline and content for this protocol were adapted based on or directly 
copied from sample text provided in the National Institutes of Health Behavioral and Social Intervention 
Clinical Trial Protocol Template (v3.0 – 20180827).  Because this publicly available resource was used 
extensively in developing this protocol, we are including this statement of attribution in lieu of individual 
citations for this reference.  Other references used are cited accordingly and listed in the 

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18. References section of this protocol.
Funding for the SPRING Trial
The research described in this protocol is funded through a 20% by 2025 Research Focus Grant from the 
American Foundation for Suicide Prevention, award # TBT-0-022-22. The title of the awarded proposal 
is: “Effectiveness of Two-Way Caring Texts vs One-Way Caring Texts vs Usual Care: A Pragmatic 
Randomized Controlled Trial.”

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Investigator’s Signature
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines.
Principal Investigator:
Signed: _____________________________________________  Date: ___________________________
Name: Anna K. Radin, DrPH, MPH
Title: Research Scientist, St. Luke’s Applied Research Division
Principal Investigator contact information
Affiliation: St. Luke’s Health System, Research Department, Applied Research Division
Address: St. Luke’s Plaza, Plaza II
  701 E Morrison Knudsen Dr., Research Department
  Boise, ID 83712
Phone: 208-381-8468
Email: Radina@slhs.org

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1. Protocol Summary
1.1 Synopsis
Title
The SPRING Trial: Comparing the Effectiveness of Suicide Prevention Interventions to 
Guide Follow-up Care Models
Contract 
Number:
AFSP TBT-0-022-22
Study 
Description
Pragmatic randomized controlled trial to compare the effectiveness of two-way Caring 
Contacts text messages (CC2) versus one-way Caring Contacts text messages (CC1) 
versus best available usual care alone (UC) for suicide prevention.  
Specific Aims
1.
Measure the effectiveness of augmenting best available usual care with two-way 
Caring Contacts text messages (CC2) and one-way Caring Contacts texts (CC1) 
compared to best available usual care alone (UC) for preventing suicidal behavior. 
Hypothesis: CC2 and CC1 are more effective than usual care. 
2.
Determine whether CC1 are noninferior to CC2 for preventing suicidal behavior. 
Hypothesis: CC1 are inferior to CC2. 
3.
Describe the feasibility of implementing CC2 and CC1 in partnership with a state 
crisis and suicide prevention hotline. 
Hypothesis: CC2 will require more resources than CC1 but both will be 
acceptable and feasible to deliver through a state crisis and suicide hotline. 
Outcomes
The primary outcome is suicidal behavior, measured by the difference between study 
arms in the average area under the curve of the Active Suicidal Behavior Sub-Scale of 
the Harkavy-Asnis Suicide Scale (HASS).1 Secondary outcomes include suicidal ideation, 
(HASS), 1 suicide attempts (Columbia Suicide Severity Rating Scale (C-SSRS)),2use of 
crisis care for suicidality (electronic health records), and use of outpatient mental 
health services (self-report).  All outcome measures will be assessed at baseline, 3, 6, 
and 12 months.
Study 
Population
Adolescents (aged 12-17) and adults (18+) who screen positive for suicidal ideation or 
behavior using the Columbia Suicide Severity Rating Scale (C-SSRS) at one of the study 
sites will be eligible to participate.  
Description 
of Study Sites
Participants will be recruited from primary care clinics and outpatient behavioral 
health clinics at St. Luke’s Health System in Idaho.  
Study 
Duration
This study will last for 3 years, with survival assessed for up to 10 years.
Participant 
Duration
Participants will be followed for 12 months.  Participants will complete assessments at 
baseline, 3 months, 6 months, and 12 months.

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1.2 Schema / Study Flow Diagram
Figure 1: SPRING Trial Flow Diagram

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2. Research Questions & Specific Aims
2.1 Research Questions: Do Caring Contacts text messages improve outcomes for patients at risk for 
suicide? Are one-way Caring Contacts texts inferior to two-way Caring Contacts texts?
2.1  Specific Aims
1.
Measure the effectiveness of augmenting best available usual care with two-way Caring 
Contacts text messages (CC2) and one-way Caring Contacts texts (CC1) compared to best 
available usual care alone (UC) for preventing suicidal behavior.  

Hypothesis: CC2 and CC1 are more effective than usual care.
2.
Determine whether CC1 are noninferior to CC2 for preventing suicidal behavior.

Hypothesis: CC1 are inferior to CC2.
3.
Describe the feasibility of implementing CC2 and CC1 in partnership with a state crisis and 
suicide prevention hotline.

Hypothesis: CC2 will require more resources than CC1 but both will be acceptable 
and feasible to deliver through a state crisis and suicide hotline.
3. Introduction
3.1 Background
Suicide is a leading cause of death in the United States (US); 4 nearly 840,000 lives were lost to suicide 
from 1999-2020. 5  Idaho’s suicide rate is consistently among the top ten nationally, and in 2020 was the 
fifth highest in the US, 72% higher than the national average.5  The American Foundation for Suicide 
Prevention (AFSP) has called for research to identify effective interventions that, if implemented at 
scale, could reduce suicide deaths by 20% by 2025.6  Caring Contacts is one of the few evidence-based 
interventions shown to reduce suicide deaths, 7,8 and it is feasible to implement at scale, including in 
rural and low-resource settings.9-11 
The Caring Contacts model involves sending brief, non-demanding expressions of care to suicidal 
individuals, to let them know that they are being thought of and as a gentle reminder that help is 
available if needed.  The first Caring Contacts efficacy trial randomized patients with recent suicide 
attempts who refused ongoing care to receive either typed caring letters or no further contact.  The 
mean probability of suicide-free survival after two years was significantly higher in the contact arm 
(0.983, 95% CI: [0.977, 0.989]) than in the no contact arm (0.964, 95% CI: [0.957, 0.971]).7 In other 
randomized controlled trials, Caring Contacts have proven effective when delivered by post cards,12,13 
and more recently, two-way text messages. 14  A recent trial of text message-based Caring Contacts 
found that compared to usual care, Caring Contacts were associated with lower odds of experiencing 
any suicidal ideation since baseline (OR: 0.56, 95% CI: [0.33, 0.95]) and lower odds of suicide attempt 

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(OR: 0.52, 95% CI: [0.29, 0.92]). 14  A systematic review and meta-analysis concluded that Caring 
Contacts is protective against attempts at 12 months (RR: 0.57, 95% CI: [0.40, 0.80]), but the effect on 
suicide deaths was inconclusive. 8 The authors recommend additional efficacy and effectiveness 
research.
As the evidence base for Caring Contacts has expanded, interest in scaling up the intervention has too.  
Several key implementation questions remain.  Efficacy trials published to date have involved two-way 
Caring Contacts in which participants had met the sender – either in person, or by phone - and were 
invited to reply to them if they chose to do so. 7,12-14  A recently completed randomized controlled trial 
by our team found no significant difference in loneliness (adjusted mean difference: -1.0, 95% CI: [-3.0, 
1.0]) or suicidal ideation and behavior (adjusted mean difference: 0.2, 95% CI: [0.0, 0.5]) between 
participants receiving two-way caring texts from someone they had spoken with and gotten to know 
over the phone versus someone they never met.11 It may not be necessary to introduce the Caring 
Contacts recipient and sender for the intervention to be effective.  
However, in practice, Caring Contacts programs delivered at scale often only offer one-way contacts, 15-
17 which are simpler and less resource intensive to manage.  Sending one-way text messages to which 
recipients cannot reply or interact with the sender is meaningfully different than two-way caring 
texts.  The hypothesized causal mechanism of Caring Contacts is to make people feel valued and cared; 
one-way texts may not achieve that goal and could potentially even have the opposite effect, as many 
technology-literate Americans are likely to understand that one-way messages may be pre-scheduled 
and sent in bulk.  In other fields of biomedical research, two-way texting interventions have been shown 
to be more effective than otherwise similar one-way texting interventions.  For example, a meta-analysis 
(8 randomized clinical trials, pooled n=1,994 patients) comparing two-way texting interventions to one-
way texting interventions for improving medication adherence found that two-way texting significantly 
improved adherence (23% improvement, 95% CI: [13%-35%]), while one-way texting had no significant 
effect.18  Despite their wide adoption, it remains unknown whether one-way caring text messages are 
effective as they have never been compared to two-way texts nor to usual care.  
3.2 Significance
The proposed research would provide high quality evidence to determine whether one-way Caring 
Contacts is better than best available usual care alone and at least as effective as two-way Caring 
Contacts.  Delivering two-way Caring Contacts via text is more operationally complex and resource 
intensive than sending one-way messages that don’t require monitoring or responses.  Research is 
needed to justify the additional expense and effort required to scale-up the evidence-based two-way 
Caring Contacts.  
In the proposed study, Caring Contacts would be delivered by a trusted community resource – the Idaho 
Crisis and Suicide Hotline (Hotline) – in partnership with an established research team at St. Luke’s 

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Health System (SLHS).  Our previous research has shown this model is feasible, including in rural areas 
and states with limited resources such as ours. Nationally, the Suicide Lifeline fielded over 3.3 million 
contacts in 2020.  The introduction of 988, a three-digit dialing code that callers across the United States 
can use to access mental health and crisis support is expected to result in 6-12 million contacts in year 
one and 13-40 million annual contacts by year five. 19  Part of the vision of the transition to 988 is 
equipping state crisis and suicide prevention hotlines to “reduce the deadly gaps in the existing 
fragmented behavioral health crisis care system by enabling Lifeline/988 centers to stay in contact and 
follow up with those in crisis.”19 There is promise in scaling up Caring Contacts to deliver 988 follow-up 
support, but it is critical that the version being delivered at scale be evidence-based. 
Insurance companies and electronic health records companies have also expressed a growing interest in 
Caring Contacts.  SLHS has been collaborating with Epic Systems Corporation, which provides electronic 
health records software to hospitals serving 78% of patients in the US,20 on suicide prevention clinical 
workflows and Caring Contacts.  Epic is actively designing Caring Contacts modules that health systems 
could adopt for use with MyChart, their mobile electronic health record and patient-provider messaging 
system.  The results of this study could also inform that work as Epic is currently developing one-way 
Caring Contacts.  This research is urgently needed to inform decisions about which model of Caring 
Contacts to implement at 988 Lifeline centers, and for follow-up support from health systems, crisis 
centers, and other settings across the United States and beyond. 
4. Research Methods
4.1 Study Design
The proposed study is a pragmatic randomized controlled trial with participants assigned to one of three 
intervention arms: two-way caring text messages (CC2), one-way caring text messages (CC1), and best 
available usual care alone (UC).
4.2 Randomization
Randomization will occur at the individual level.  Participants will be randomized in a 1:1:1 ratio to one 
of the three intervention arms.  The study statistician will generate a random list of treatment 
assignments with varying block sizes. Research Electronic Data Capture (REDCap) 21,22 will pull the next 
treatment assignment from the list at the time of randomization. The list will be concealed from the 
study staff conducting enrollment.  Randomization will occur prior to enrollment during the informed 
consent process so that participants can see the intervention arm to which they were randomized 
before they decide whether to enroll in the study, but remain masked to the other treatment 
conditions.
4.3 Masking
This trial will be single masked, with most members of the study team including the senior statistician

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masked to aggregate data by treatment arm. Participants will be aware of their own treatment but 
unaware of alternative treatment arms.  Masking interventionists or participants to the assigned 
intervention is not feasible due to the nature of the intervention. 
5. Study Population & Setting
The primary study population for this research is adolescent and adult patients identified as at risk for 
suicide during a primary care or behavioral health clinic encounter at St. Luke’s Health System in Idaho.  
Study sites will include up to 60 SLHS primary care clinics and up to 25 ambulatory behavioral health 
clinics. 
5.1  Inclusion & Exclusion Criteria
5.1.1 Inclusion Criteria

Adolescents (12-17 years old) and adults (18+)

Response of “yes” to at least one item on the Columbia Suicide Severity Rating Scale (C-SSRS) 
six-item screener at a SLHS primary care or behavioral health clinic, or electronic health record 
or provider note from an eligible encounter indicates suicide risk 
o
Eligible encounters may include in-person clinic encounters, virtual encounters, or 
telephone encounters including suicide risk triage telephone encounters

Ability to send and receive text messages

Ability to receive phone calls

Ability to receive emails

Participant and legal guardian (if applicable) speak, read, and understand English
o
Accommodations may be made for individuals with impaired hearing
5.1.2  Exclusion Criteria

Individuals who participated in a previous SLHS randomized controlled trial related to Caring 
Contacts (SPARC Trial or MHAPPS Trial)

Patients who are unable or unwilling to provide informed consent*, for example, due to acute or 
chronic cognitive impairment (i.e.: acute psychosis, intoxication, or intellectual disability).  

Primary Care Provider, Behavioral Health Provider, or Principal Investigator determines that 
participation in the research is not in the best interest of the patient or the study team.
*The SPRING Brief Assessment of Capability to Consent is included as an appendix and will be used by 
trained Research Coordinators as needed to assess ability to provide informed consent for the study.
5.2. Statistical Power and Sample Size 
Because the study is designed to assess both the effectiveness of Caring Contacts as compared to usual 
care as well as the noninferiority of CC1 as compared to CC2, there are two components to the sample 
size and power calculations. Both assume a standard deviation of 5 in the area under the curve (AUC) of 

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HASS Active Suicidal Behavior Subscale scores over 12 months based on previously published studies 
23and data from an ongoing trial with suicidal patients at SLHS.9 With a sample size of 759, we will have 
80% power to detect a true difference between the CC arms and the UC arm of 1.26 units in the AUC of 
HASS scores over 12 months accounting for one formal interim analysis for efficacy. Similarly, a sample 
size of 759 will allow 89% power to determine noninferiority of CC1 to CC2 if the two interventions are 
truly equivalent, when using a noninferiority margin of 1.0. We plan to enroll 849 participants to 
account for up to 30% potential lost to follow-up.
Power for superiority
Improvement in CC arm compared to UC arm
Power
Sample Size per Arm
Total Sample Size
1.26
80%
253
759
Power for noninferiority
Noninferiority Margin
True difference 
between CC1 and CC2
Power
Sample Size 
per Arm
Total Sample Size
-1.0
0
89%
253
759
5.3 Recruitment Plan
SLHS routinely screens primary care and behavioral health patients aged 12 and older for suicidality 
using the C-SSRS. 24-30  Patients generally self-complete the C-SSRS screener on an iPad or on paper; 
screeners are sometimes completed together with clinic staff or provider.  Patients who respond “yes” 
to any of the six items on the C-SSRS screener may be notified by a message on the screening 
iPad/tablet or paper screener that they may be eligible for a research study and will be given the 
opportunity to opt into contact from the research team to learn more or defer until they can discuss 
with their provider.  Additionally, providers or social workers may refer patients to the study. Research 
coordinators will contact patients who opt in by text message, phone, or email to schedule a time for a 
study enrollment call. Informed consent and study enrollment will be completed over the phone using 
the REDCap informed consent framework.  Texting to schedule phone-based consent and enrollment 
has been successful and well-received by our participants in other studies. Accommodations may be 
made for patients with hearing impairment.
5.4 Retention
A variety of methods will be used to improve retention of research participants. A contact sheet will be 
provided at enrollment allowing patients to share additional contact information (including alternative 
phone numbers, or email addresses) that may be used to contact participants for retention purposes.  A 
primary phone number, a secondary phone number/emergency contact, and an email address are 
required; providing additional sources of contact on the contact sheet is optional.  Email, text messages, 
phone calls, or other forms of contact may be used for retention purposes or to assist with scheduling 
and completing surveys, including retention texts, which may be sent in between survey periods. 

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5.5 Populations for Analyses
Analyses will be completed using the following populations:
1.
Intention to Treat (ITT) Analytic Population: Data for all participants that complete study 
enrollment and the baseline survey will be included in this dataset.
2.
Safety Analysis Dataset: The safety analysis will include data for all participants who 
completed study enrollment and the baseline survey (e.g., the ITT Analytic Population 
Dataset).
3.
Per-Protocol Analysis Dataset: Data for a subset of participants who were retained for the 
duration of the study and received the assigned intervention.
4.
Additional Datasets: Additional datasets may be developed to complete sensitivity analyses, 
for example, where missing data have been imputed using different techniques.
6. Study Procedures 
Pre-Consent – Best available usual care according to SLHS policy. Generally available to all patients 
but adherence to standard workflows may vary and actual delivery of each of the below is based on 
individual patient needs, staff/provider availability, and provider clinical judgment. 

C-SSRS screening for suicide risk at primary care or behavioral health clinic encounter 
(Generally during clinic encounter; screening may be completed in advance via myChart, on 
iPads or paper during the encounter, virtually, or in-person).

Clinical risk assessment

Development of safety plan or a connection and support plan or other appropriate clinical 
intervention

Referrals to other care

Medication management
     Pre-Screening – Review of eligibility prior to contacting patient

Study staff may review medical records of patients referred to the study or who indicate 
interest in learning more about the study after being identified as potentially eligible.
o
The medical record review allows study staff to carefully review eligibility criteria, 
and to identify patients with evidence of cognitive impairment or intellectual 
disability so that they can plan to utilize the S-BACC form to assess capability to 
provide informed consent.
    Baseline / Enrollment Call – All participants (virtual/by phone, following clinical encounter)

Informed consent (including randomization) and study enrollment 

Baseline survey

Sharing of tailored resource list

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
Optional warm hand-off to 988
     
 Follow-Up Intervention – CC1 & CC2 participants only (Baseline – 12 months) 

CC1: one-way text messages; participants may not reply

CC2: two-way text messages to which participants may reply if they choose  
      3-Month Outcome Assessment – All participants (+ 4 weeks variance window) (REDCap survey  
      link sent via email, text, or phone call) 

3-Month Outcome Survey
      6-Month Outcome Assessment – All participants (+ 4 weeks variance window) (REDCap survey 
      link sent via email or text, or phone call)

6-Month Outcome Survey
      12 Month Outcome Assessment – All participants (+ 4 weeks variance window) (REDCap survey 
      link sent via email or text, or phone call)

12-Month Outcome Survey
6.1 Schedule of Activities
Table 1: Schedule of SPRING Trial Activities
Pre-Consent 
(Usual Care) 
Study Enrollment 
& Baseline
Baseline – 12 
months
3 months
6 months
12 months
Columbia Suicide Severity Rating Scale (C-SSRS) 
screening/clinic encounter to establish eligibility
X
Receipt of best available usual care (e.g. 
screening, assessment, clinical intervention, 
referrals, medication management, crisis care, 
etc.)
X
X
Informed consent/assent
X
Baseline survey
X
Tailored resource list shared with participant & 
warm handoff to 988 offered (all participants)
X

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Caring text messages (CC1 & CC2 intervention 
arms only)
X
3-Month outcome survey
X
6-Month outcome survey
X
12-Month outcome survey
X

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7.     Conceptual Model
Figure 2: SPRING Trial Conceptual Model

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8.  Study Measures
Key variables to be collected for this study are summarized in Table 2.
8.1 Primary Outcome
Suicidal behavior is the primary outcome and will be measured using the Harkavy-Asnis Suicide Scale 
(HASS) Active Suicidal Behavior Subscale.  The HASS includes three sub-scales, each of which have been 
validated for self-report, with strong psychometric properties in adolescents and adults. 23 1  The Active 
Suicidal Behavior Subscale of the HASS asks about the frequency of each of five active suicidal behaviors, 
including suicide attempt planning, and actual and aborted/interrupted suicide attempts.  Participants 
respond using the Likert scale response options used by Asarnow et al. in their validation study, 23 which 
will be modified to fit the time period based on each survey (past six months will be used for baseline 
and 12-month outcome surveys, and past 3 months will be used for 3- and 6-month outcome surveys).  
Each of the sub-scales of the HASS are scored separately. Scoring is completed by summing the number 
of the associated response category for all the items in the sub-scale. 23  
The primary outcome will be the cumulative risk of suicidal behavior assessed using area under the 
curve of the HASS scores over the 12-month study period. The area under the curve summary measure 
will be calculated for each participant.
8.2 Secondary Outcomes
Secondary outcomes include suicide attempts, suicide ideation, suicide-related ED utilization and 
hospitalization, and outpatient mental health treatment.  Suicide attempts will be measured using the 
Columbia Suicide Severity Rating Scale (C-SSRS).2,30-323,33 Suicidal ideation will be measured using the 
Passive Suicidal Ideation Subscale of the HASS, which includes 12 items. 23  Suicide-related ED utilization 
and hospitalization will be assessed by self-report and using electronic medical records. Outpatient 
mental health treatment will be self-reported and assessed using electronic medical records. Reason for 
visit/diagnoses may be reviewed in electronic medical records for any inpatient or outpatient 
encounters that occur during the study period. All outcomes will be measured at baseline, 3 months, 6 
months, and 12 months. 
8.3 Exploratory & Safety Outcomes
Exploratory and safety outcomes include thwarted belongingness, perceived burdensomeness, a 
combined measure of suicidal ideation and behavior, suicide attempts (including actual, aborted, or 
interrupted attempts), perceived mattering to others, non-suicidal self-injury, all-cause ED utilization 
and hospitalizations, suicide deaths, and all-cause mortality.  Thwarted belongingness and perceived 
burdensomeness will be measured using the 15-item version of the Interpersonal Needs Questionnaire. 
34-37 Suicide attempts, including a count, will be measured using the Self-Injurious Thoughts and Behavior 
Interview - Revised (SITBI-R) which is valid for self-report in adolescents and adults. 3,33 A combined 
indicator of suicidal ideation and behavior will be assessed using the Columbia Suicide Severity Rating 

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Scale self-report 6-item screener for primary care (C-SSRS).24-30 The C-SSRS self-report screener is widely 
used in clinical practice, including at SLHS, and will be used to determine eligibility for the study. 
Participants will also self-complete the C-SSRS at baseline following enrollment, and at 3, 6, and 12 
months.  The C-SSRS self-report 6-item screener has strong psychometric properties for use with both 
adolescent and adult and populations, including excellent sensitivity and specificity,38 convergent 
validity, 2 and incremental validity.2 The C-SSRS self-report screener is widely used in clinical practice, 
including at SLHS, and will be used to determine eligibility for the study. Participants will also self-
complete the C-SSRS at baseline following enrollment, and at 3, 6, and 12 months.  The C-SSRS self-
report 6-item screener has strong psychometric properties for use with both adolescent and adult and 
populations, including excellent sensitivity and specificity,38 convergent validity, 2 and incremental 
validity.2  Non-suicidal self-injury will be measured with items from the SITBI-R.  The General Mattering 
Scale (GMS) 39-41 will be used to assess the extent to which participants believe they matter to other 
people. The frequency of suicide attempts (including actual attempts, interrupted attempts, and self-
aborted attempts) will be measured using the two-item Suicide Attempts Sub-Scale of the HASS.23 All-
cause ED utilization and hospitalizations are positively associated with mental health diagnoses. 42  The 
number of and reason for visit/diagnoses for ED encounters and hospitalizations will be assessed using 
electronic medical records.  The manner and cause/lethal means of suicide deaths and all  deaths will be 
assessed based on electronic medical records and vital records. 
8.4 Other Measures
We will collect data on age and sex at birth, as well as gender identity and sexual orientation, all of 
which are strongly associated with risk of suicidal ideation and behavior.5,43,44  Gender identity and 
sexual orientation will be assed using questions from CDC’s Youth Risk Behavior Surveillance System 
Questionnaire.45  Suicide rates differ by race and ethnicity, 5 which will be self-reported using US Census 
categories.46  Religious affiliation and practice is associated with suicidality, but the magnitude and 
direction of that association differs depending on the religion, and its intersection with socio-cultural 
factors (e.g.: sexuality). 47  We will include items from a recent Pew Research Religious Landscape Study 
to assess religiosity. 48 Compared to other adults, active-duty military or veterans face a 57.3% higher 
adjusted suicide rate. 49  The Health Resources & Services Administration’s Office of Rural Health Policy 
urban-rural designation for census tracts50 will be used to classify participants as urban or rural 
residents. Compared to large urban areas, residence in the most rural and remote parts of the US is 
associated with a 96% higher rate of suicide,5 lower socioeconomic status,51 and worse overall health 
outcomes. 51  Thirty-five of Idaho’s 44 counties are classified as rural. 50Financial crises and low socio-
economic status (SES) are associated with increased suicidality.52  We will collect data related to SES 
including income, education, and employment using questions from the US Census Bureau’s American 
Community Survey.46  Lethal means for planned and actual suicide attempts will be self-reported.26 
Utilization of 988 will be self-reported by participants to determine how different sub-groups & 
treatment arms used this resource before and during the study. 

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9.    Description of Interventions
9.1  Enhanced Usual Care Alone (UC)
Participants randomized to the UC arm will receive best available usual care from the health system, 
such as standardized clinical assessments, the safety planning intervention or other intervention(s), 
appropriate referrals and/or medication management through a system wide electronic health record 
system-assisted suicide care clinical workflow.  Usual care will vary based on patient clinical needs, 
availability of providers/staff, and provider clinical judgment.  Following study enrollment, all 
participants will be given a list of resources, offered a warm hand-off to 988, and encouragement to call 
or text 988 as needed.  
9.2  Two-way Caring Contacts (CC2)
In addition to receiving enhanced usual care as described above, a series of 25 standardized outgoing 
Caring Contacts text messages will be sent to participants randomized to the CC2 intervention arm 
through our online texting platform.  To remind participants that they can respond, the outgoing texts 
will periodically invite replies in a non-demanding way, e.g., “Hope you’re doing well this week, Anna. 
Feel free to text me back if you feel like it, I’m here for you.”  Responses to CC2 participant replies will 
be unscripted and individually tailored.  
9.3  One-way Caring Contacts (CC1)
In addition to receiving enhanced usual care as described above, CC1 participants will be sent 25 caring 
texts, such as “Even though know we do not personally know each other, we truly value your wellbeing 
and are thinking of you. If you’d like to connect with someone, feel free to call or text 988 anytime – 
their team would be happy to hear from you.”  CC1 participants will not be able to reply to the texts and 
the online texting platform will block incoming messages.  This will be clearly communicated to CC1 
participants during the informed consent process and they will be asked to sign off on understanding 
this and other key points before enrolling in the study.
9.4 Process Evaluation & Fidelity Monitoring
The study will include regular monitoring of study enrollment and other key study processes as well as 
fidelity of delivery of the active follow-up interventions. The timing and content of all contacts from the 
Hotline to participants will be tracked and recorded by the Hotline for each study participant. Study staff 
will review a selection of incoming and outgoing text messages to ensure adherence to the schedule and 
content outlined in study documents (scheduled/standard texts) and Jerome Motto’s principles of 
Caring Contacts 53 (unscripted text replies to participants). 

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10. Discontinuation and Participant Withdrawal
10.1 Discontinuation of Study Intervention 
Participants may voluntarily discontinue the study intervention at any timepoint by contacting study 
staff.  When a participant discontinues the intervention but remains in the study, remaining study 
procedures will be completed as indicated in the study protocol.  
Data to be collected at the time of study intervention discontinuation will include the following: 

The date of discontinuation of the intervention

The reason(s) for discontinuing the intervention (if available)
The participant will be eligible to complete future assessments (3-, 6-, and 12-month outcome surveys), 
even if they decide to withdraw from the intervention.
10.2 Participant Discontinuation and Withdrawal from the Study
Participants are free to withdraw from participation in the study at any time upon written request to the 
SPRING Trial email account (spring@slhs.org).  Additionally, study investigators may discontinue a 
participant from the study for the following reasons:
1.
Lost to follow-up; unable to contact subject (see section 10.3 Lost to Follow-Up)
2.
Any event or medical condition or situation occurs such that continued collection of follow-up 
study data would not be feasible or in the best interest of the participant 
3.
Any event or situation occurs in which the safety or wellbeing of study staff is compromised by 
allowing a participant to continue to participate in the research
4.
The participant meets an exclusion criterion or fails to meet an inclusion criterion (either newly 
developed or not previously recognized) that precludes further study participation
5.
The PI determines keeping the participant in the study is not in the best interest of the 
participant, study staff, St. Luke’s and study partners, and/or the study itself. 
The date of discontinuation and reason for discontinuation or withdrawal from the study will be 
recorded in the SPRING Trial study records.  
10.3 Lost to Follow-Up
A study participant will be considered lost to follow-up if s/he fails to complete all remaining study 
follow-up assessments and study staff are unable to contact the participant after at least 3 attempts.  
The following actions must be taken before a participant will be declared lost to follow-up.

Study staff will attempt to contact the participant, re-send the REDCap survey or reschedule the 
missed phone-based assessment, and ascertain whether the participant wishes to and/or should 
continue in the study.

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
The study staff will make every effort to regain contact with the participant (using text, email, 
phone call, and/or alternative means of contact that the participant may have included during 
the study enrollment process).

Should the participant continue to be unreachable, s/he will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up.
11.Data & Safety Monitoring
11.1 Overview of Data & Safety Monitoring Plan
This research will include a designated Research/Medical Monitor (RM), a clinician with appropriate 
psychiatric and medical training and experience reviewing safety outcomes for suicide prevention 
clinical trials.  This research will also include a Data and Safety Monitoring Board (DSMB).  The RM will 
also chair the DSMB.  The DSMB will be convened and managed in partnership with the University of 
Washington’s Institute of Translational Health Sciences (UW ITHS).  The study team will monitor survey 
responses and follow a standard procedure approved by the DSMB to assess safety for those 
participants reporting acute risk for suicide on a survey.
11.2 Role of the Data & Safety Monitoring Board (DSMB)
The DSMB will review and oversee the following elements:
1.
Study enrollment by study site and population (adults, adolescents)
2.
Retention of study participants at 3, 6, and 12 months
3.
Data completeness and quality
4.
Intervention fidelity data
5.
Safety outcomes by intervention and age category (adults, adolescents)
6.
Sample size assumptions vs observed data and whether to recalculate sample size
7.
Interim analyses to assess whether one intervention is significantly more effective than the 
other(s)
8.
Decisions related to stopping the trial early due to one or several of the elements above
11.3 Safety Monitoring 
This protocol considers completed suicide, suicide attempts, and inpatient admission in the context of 
suicidal study participants as expected events.  These will be routinely tracked as key safety outcomes.  
The following safety outcomes will be assessed for each participant at 3, 6, and 12 months and reviewed 
by the Data and Safety Monitoring Board according to the DSMB charter to determine whether the rate 
of safety outcomes differs by intervention arm:

Death by suicide

Attempted suicide

Interrupted or aborted suicide attempt

Psychiatric hospitalization

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
Medical hospitalization related to self-harm or attempted suicide
Participants’ electronic medical records may be accessed to assess and monitor safety outcomes, 
including following death.
11.4 Adverse Events and Serious Adverse Events
This protocol does not include tracking of adverse events (AEs).  This protocol does not include real-time 
tracking of serious adverse events (SAEs) for several reasons.  First, as stated above, the most important 
events that would be defined as SAEs are expected safety outcomes in the context of study participants 
experiencing suicidality.  All deaths of study participants will be reviewed and assessed to determine 
whether the cause of death is suicide.  We do not anticipate any SAEs beyond those listed as safety 
outcomes above, but unanticipated SAEs that occur will be reviewed by the DSMB and the IRB.  Second, 
the most important safety question to ascertain in the context of this trial is whether rates of safety 
outcomes or SAEs are differential across the two intervention groups.  Given that the CC2 intervention 
includes frequent contact with study participants (and the CC1 and UC conditions do not), if the study 
were to monitor AEs and/or SAEs in real-time, differential rates of ascertainment would be expected.  
Any attempt to compare rates of AEs or SAEs across intervention groups could be substantially biased 
due to differential ascertainment.  Instead, this protocol will monitor safety outcomes collected at 3, 6, 
and 12 months as part of routine study outcome assessments through regular DSMB meetings to ensure 
equal ascertainment of outcomes across intervention groups.  This is the most valid and reliable way to 
review safety data in the context of this pragmatic clinical trial.
11.5 Role of the Research / Medical Monitor (RM)
The RM for this protocol will participate as a subject matter expert on the DSMB and will also conduct 
an independent review of study personnel’s responses to study participants who experience suicidal 
crisis or one of the safety outcomes in the context of study-related activities.  If study personnel (such as 
research coordinators, or clinic/ED staff or providers) become aware of a clinically complex situation 
during the study, that participant’s needs should be placed above any responsibilities related to the 
study protocol.  The goal of the RM review is to assess participant safety and determine what is in the 
participant’s best interest this when potential issues are flagged by the PI.
12.Data Collection & Management
12.1 Data Collection
All data will be self-reported by participants using online surveys 21,22 sent by text or email, based on 
participant preference, or extracted from the electronic health record (Epic).  Caring Contacts data will 
be captured from our online texting platform.54 

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Table 2: SPRING Trial Key Variables & Other Data Elements
Variable
Tool/Source
Routinely 
collected as 
usual care
Mode of contact
Who will collect
Primary, Secondary, Safety & Exploratory Outcomes (Baseline + 3, 6, 12 months)
Primary Outcome
Suicidal behavior
HASS Active Suicidal 
Behavior Sub-Scale (all 
surveys)
No
REDCap survey
SLHS
Secondary Outcomes
Suicidal ideation
HASS Passive Suicidal 
Ideation Sub-Scale (all 
surveys)
No
REDCap survey
SLHS
Suicide attempts
C-SSRS (all surveys)
No
REDCap survey
SLHS
Outpatient mental health treatment
Self-report, Epic, Claims 
data (all surveys)
Yes
REDCap survey
SLHS
Use of crisis care (ED visits, 
hospitalizations) for suicidality
Self-report, Epic, Claims 
data (all surveys)
Yes
REDCap survey
SLHS
Safety & Exploratory Outcomes
Perceived burdensomeness & 
thwarted belongingness 
INQ-15 (all surveys)
No
REDCap survey
SLHS
Perceived mattering to others
GMS (all surveys)
No
REDCap survey
SLHS
Non-suicidal self-injury (NSSI)
SITBI-R (all surveys)
No
REDCap survey
SLHS
Suicidal ideation
SITBI-R (all surveys)
No
REDCap survey
SLHS
Suicidal ideation & behavior
C-SSRS (all surveys)
No
REDCap survey
SLHS
Suicide Plans & Preparatory Acts
SITBI-R (all surveys)
No
REDCap survey
SLHS
Suicide attempts
HASS Suicide Attempts 
Sub-Scale (all surveys) 
and SITBI-R (all surveys)
No
REDCap survey 
SLHS
Suicide deaths including cause of 
death
Vital records, Epic 
Yes
N/A 
Idaho Dept of 
Health & Welfare, 
SLHS
All-cause mortality including manner 
& cause of death
Vital records, Epic 
Yes
N/A 
Idaho Dept of 
Health & Welfare, 
SLHS
ED utilization or hospitalization (all-
cause), including number and 
diagnoses/reason for visit
All surveys, Epic
Yes
REDCap survey
SLHS
Current Suicidal Crisis
All surveys
No
REDCap survey
SLHS
Use of 988 or suicide hotline
All surveys
No
REDCap survey
SLHS
Sociodemographic & Other Exposure Variables
Age in years at enrollment
Epic, Informed Consent 
Form
Yes
REDCap survey
SLHS
Sex assigned on birth certificate
Epic
Yes
n/a
SLHS

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Race and ethnicity
Epic
Yes
n/a
SLHS
Address including Zip code of 
residence (urban/rural)
Epic
Yes
n/a
SLHS
County of residence (urban/rural)
Epic
Yes
n/a
SLHS
Gender identity, pronouns, 
transgender status, & sexual 
orientation
Baseline survey
No
REDCap survey 
SLHS
Marijuana and illicit drug use
Baseline survey, 3, 6, 
and 12-month outcome 
surveys
No
REDCap survey 
SLHS
Alcohol use
Baseline survey, 3, 6, 
and 12-month outcome 
surveys
No
REDCap survey 
SLHS
Religion & religious practice
Baseline survey
No
REDCap survey 
SLHS
Military / veteran status
Baseline survey
No
REDCap survey
SLHS
Socioeconomic status (employment, 
education / maternal education, 
housing stability, income, 
food/income security)
Baseline survey
No
REDCap survey 
SLHS
Depression 
Baseline survey 
(PHQ-A / PHQ-9)
No
REDCap survey
SLHS
History of suicide attempts & self-
harm; lethal means
Baseline survey
No
REDCap survey 
SLHS
Insurance Provider
Epic
Yes
n/a
SLHS
Suicidal ideation & behavior at 
referring encounter (usual care)
C-SSRS (in Epic)
Yes
n/a
SLHS
Quality of life at baseline
Baseline survey
Euro-Qol
No
REDCap survey 
SLHS
Overall health (presence of co-
morbidities) at baseline
Epic
Yes
n/a
SLHS
Treatment history and medication use
Epic, REDCap surveys
Yes
REDCap survey
SLHS
Referring clinic name & referring 
provider
Epic
Yes
n/a
SLHS
Intervention assignment (CC2, CC1, 
UC)
REDCap
No
n/a
SLHS
Patient Satisfaction
Patient satisfaction with study 
intervention
Outcome surveys
No
REDCap survey
SLHS
Process Variables 
Screening rates & results by clinic and 
provider; referral rates by clinic & 
provider
Epic / D&A dashboard
Yes
n/a
SLHS
Safety Planning/Connection & Support 
Planning completion
Epic / D&A dashboard / 
REDCap / Mosio
No
n/a
SLHS
Individual  who completed safety plan
Epic / REDCap / Mosio
No
n/a
SLHS

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“Dose” of follow-up contact: timing, 
type (phone vs text), and number of 
attempted and successful contacts 
from the Hotline; # outgoing & 
incoming texts + content of texts
Mosio
No
n/a
Hotline
Other Variables
Medical record number (MRN) & 
encounter number (CSN)
Epic
Yes
n/a
SLHS
Encounter date(s) and time(s)
Epic
Yes
n/a
SLHS
Clinic specialty/type
Epic
Yes
n/a
SLHS
Provider(s)
Epic
Yes
n/a
SLHS
Referral(s)
Epic
Yes
n/a
SLHS
Insurance type
Epic
Yes
n/a
SLHS
Does cell phone on record belong 
exclusively to study participant or is it 
shared?
Baseline survey
No
REDCap survey
SLHS
Alternative modes of contact
Baseline survey
No
REDCap survey
SLHS
Death (manner and cause), including 
suicide deaths and all-cause mortality
Epic and vital records
Yes
n/a
SLHS & Idaho 
Department of 
Health & Welfare
12.2 Data Management
Data management will occur using the Research Electronic Data Capture (REDCap) 21,22 tool, a HIPAA-
compliant web-based research application used for building and managing online surveys and providing 
a secure electronic database. Our instance of REDCap is owned and managed by the University of 
Washington’s Institute of Translational Health Sciences. REDCap will be used as the central location for 
online study data storage and participant management. The database is safeguarded against 
unauthorized access by established security procedures; appropriate backup copies of the database and 
related software files will be maintained. The statistics team will compile data from REDCap on a weekly 
basis for reports and to build and maintain a complete dataset.  Baseline data from participants’ 
electronic health records will be entered via REDCap data extraction forms. Twilio, a HIPAA-compliant 
texting platform integrated into REDCap, will be used to send survey links and survey reminders to 
participants.  Mosio, 54 our HIPAA-compliant online texting platform, will be used to deliver Caring 
Contacts, to schedule enrollment calls, to send retention texts and survey reminders, and to make 
phone calls. Mosio records any attempt at contact and successful contact made. To protect the 
confidentiality of participants, data and associated documentation will be available to approved study 
personnel only, under a data-sharing agreement that includes a commitment to: (1) use the data only 
for research purposes; (2) secure the data using appropriate technology; and (3) destroy or return the 
data after analyses are completed. 

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13.Statistical Analysis
13.1 Data Analysis 
13.1.1  Primary Analysis
The primary analysis population is the intention to treat population: all randomized participants who 
complete a baseline survey, grouped with the treatment arm to which they were randomized regardless 
of treatment delivered. An area under the curve analysis will be used to assess HASS score as a measure 
of cumulative risk across the 12-month study period.  A linear model with indicator variables for the 
treatment arms and an indicator of age at enrollment, using heteroskedasticity robust variances will be 
used in the primary model. Multiple imputation will be used to account for missing outcome data and 
Rubin’s rule will be used to combine results across imputations. The primary analysis will use a 
gatekeeping procedure: first, the Caring Contact arms will be compared to usual care; if both CC arms 
are statistically significantly superior to usual care, then a noninferiority comparison will be done for the 
two Caring Contact study arms using a noninferiority margin of 1.0.
13.1.2  Secondary Analyses
The analyses of secondary outcomes will use linear models similar to the primary analysis; for binary 
outcomes, a generalized linear model will be fit with the identity link to allow for the estimation of the 
risk difference. Analyses will be performed using standard statistical software such as R or SAS. A two-
sided type-I error of 0.05 will be used as the threshold to determine statistical significance. Confidence 
intervals will be reported in addition to p-values.
13.1.3  Subgroup Analyses
Subgroup analyses will be completed based on age at enrollment (12-17; 18-24; 25-49; 50+), sex at birth 
(female vs. male), gender identity (cisgender vs. transgender or gender nonconforming), sexual 
orientation (heterosexual vs. homosexual, bisexual, or other) and area of residence (urban vs. rural), and 
place of recruitment (primary care vs behavioral health clinic). To allow for formal testing of 
heterogeneity of the treatment effect across subgroups, a linear model of the AUC summary measures 
will be fit with indicator variables for the CC treatment arms and adolescent age, the subgroups of 
interest and the interaction between subgroup and treatment. The effect of each CC treatment, 
compared to usual care, will be reported along with the 95% confidence interval for the difference in 
means and the p-value testing for the interaction of group with treatment.
13.2 Planned Interim Analyses
An interim analysis is planned for when 50% of 6-month outcome data are available (or as determined 
by the Data Safety and Monitoring Board) to assess grounds for early stopping if one of the arms is 

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overwhelmingly more effective than the other, and/or to re-calculate sample size if the observed data 
depart from the assumptions used for the initial sample size calculations.  
With input from the DSMB, prior to initiation of the trial, we will finalize a monitoring plan to guide 
dropping an arm or early termination of the study. Factors influencing stopping decision may include (a) 
formal stopping rules based upon the primary analysis, (b) information on safety outcomes by treatment 
group, (c) consistency between results for primary and secondary outcomes, and (d) consistency of 
treatment effects across subgroups. The proposed formal stopping boundaries will be symmetric, two-
sided designs which are included in the unified family of group sequential stopping rules. 55,56 Point 
estimates from interim analyses will be based on the bias adjusted point estimate. 57 Confidence 
intervals and p-values will be calculated from the ordering of the outcome space based upon the 
maximum likelihood estimate. 58
Table 3: Upper and Lower Stopping Boundaries for Planned Interim Analyses
Lower Stopping Boundary
Analysis
Sample 
Size
Prop. Max 
Stat Info
Absolute
Difference
Adjusted
Difference
95%
Confidence
Interval
P-value
Interim
380
0.50
-1.56
-1.44
(-2.54, -0.20)
0.013
Final
759-849
1.00
-0.90
-0.83
(-1.76, 0.00)
0.043
Upper Stopping Boundary
Analysis
Sample 
Size
Prop. Max 
Stat Info
Absolute 
Difference
Adjusted
Difference
95% 
Confidence 
Interval
P-value
Interim
380
0.50
1.56
1.44
(0.20, 2.54)
0.013
Final
759-849
1.00
0.90
0.83
(0.00, 1.76)
0.043
Note: sample sizes given are the cumulative number of study participants with the six-month outcome 
available at the time of analysis; we expect about 2/3 of that number will be available for the 
comparison of each two study arms. These calculations assume a standard deviation of 5; at the time of 

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the analysis, the estimated standard deviation from the study data will be used. The boundaries used 
will be adjusted accordingly. The schedule of the interim analyses may be tweaked slightly based on the 
DSMB schedule. The information fraction will be updated to account for these differences as well as 
participants with partial outcomes available. The p-value boundaries are nominal two-sided p-values.
13.3 Assessing Long-Term Survival 
One important outcome of interest in any suicide prevention research is death by suicide.  Given the 
rare nature of this event, we most likely will not see a significant difference in this outcome between the 
two intervention groups over the duration of this three-year study.  However, the study team plans to 
follow participants over time in order to assess the effect of these interventions on death by suicide 
over a 5-10 year period.  Vital records data will be obtained for the purpose of assessing death and 
cause of study death of participants.  These data will be accessed only for those participants who are 
defined in the Modified ITT and the Per-protocol populations for up to ten years following study 
enrollment. 
13.4 Assessing Agreement between Suicide Outcome Measures
A sub-analysis is planned to review the extent to which agreement exists in self-reported outcomes from 
three validated survey instruments included in baseline and outcome surveys for this trial: the Harkavy-
Asnis Suicide Scale (HASS), the Columbia Suicide Severity Rating Scale (C-SSRS), and the Self-Injurious 
Thoughts and Behaviors Interview – Revised (SITBI-R).  There is not agreement in the suicide prevention 
research community on the best instrument to assess suicidal behavior. Comparing the distribution of 
self-reported outcomes across these three tools may contribute valuable information such as any 
differences in consistency by socio-demographic factors. 
14.Engaging People with Lived Experience with Suicide
This research will be informed at all phases by an advisory board of people with lived experience with 
suicide (PLES). SLHS will convene an existing PLES advisory board which currently supports two other 
suicide prevention and mental health clinic trials. First convening in 2020, the PLES Advisory Board 
consists of 15 members and is supported by behavioral health clinicians to ensure the safety of 
members of the group. PLES Advisory Board meetings are structured to facilitate continuous co-learning 
between the research team and advisory board members. Board members share feedback on topics 
such as the title of the study to recruitment materials, the verbiage of Caring Contacts, retention 
strategies, dissemination of results, and ensuring the research reflects the perspective of local 
community members.  
15.Risk / Benefit Analysis
15.1 Potential Risks
There are several potential risks to participation in this study.  Loss of confidentiality due to the 
unintended release of sensitive information is one risk. This risk will be mitigated by storing all electronic 

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data on password protected servers. Data will be shared among research partners through REDCap. 
REDCap is a secure, HIPAA-compliant web-based research data management application, used for 
building and managing online surveys, and providing a secure electronic database.  REDCap is owned 
and managed by the University of Washington’s Institute of Translational Health Sciences (ITHS). 
REDCap will be used as a central location for online study data storage and participant management. 
Use of REDCap will protect against unintended release of sensitive information. Potential loss of privacy 
is a known risk to this research. If a participant shares a phone or email with someone else, there is a 
chance for access to messages intended for the participant. Minor’s texts or emails may be accessible by 
their parents or legal guardian. Potential participants are informed of privacy risks during the informed 
consent process.
Other potential risks include psychological distress from completing study questionnaires related to 
suicidal ideation and behavior.  Research participants will be reminded at enrollment that they may 
discontinue the intervention or leave the study at any point with no consequences to the care they 
receive at SLHS and will be reminded of resources (such as the Hotline) that they can access as needed 
in the event of psychological distress. Participants will be under no duress or pressure to participate in 
or complete this study. Participating in this study will not impact the care they receive, and this will be 
clearly communicated to participants as part of the informed consent process.
Study staff (including anyone involved in enrollment and informed consent or delivery of the follow-up 
intervention or outcome measurements, and/or having access to patient-level data) will be trained on 
the protection of human subjects and HIPAA, with a focus on topics relevant to confidentiality. SLHS 
staff will assist participants in completing informed consent and baseline surveys, and survey links will 
be sent out via text or email, or study staff will assist participants in completing 3-, 6-, and 12-month 
outcome surveys over the phone. Study staff at SLHS, University of Washington and the Hotline will have 
access to protected health information (PHI).
The study is designed to be low burden in terms of participants’ time.  Participants will be reimbursed 
for their time with electronic gift cards.
15.2 Potential Benefits
While this study is designed to improve follow-up support for individuals at risk for suicide, there is no 
guarantee that participants will benefit directly from taking part in this study. Both active follow-up 
conditions (CC1 and CC2) being tested through this trial are in widespread clinical use as standard of 
care at reputable health systems and are expected to improve patient outcomes.  All individuals who 
consent to participate in the study will be offered a tailored list of resources and appropriate 
compensation for their time (see Cost/Compensation for Participation section in this protocol).  

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This research is expected to advance the science of suicide follow-up support and the Caring Contacts 
model, allowing SLHS and other health systems to make an evidence-informed choice about how best to 
deliver follow-up support to patients with suicide risk.
16. Oversight for Human Subjects Protection & Regulatory 
Considerations
16.1 Human Subjects Protection
This study will be conducted with appropriate oversight from the St. Luke’s Health System (SLHS) 
Institutional Review Board (IRB).  The IRB will review and approve all aspects of the study, including the 
protocol, informed consent process, and all relevant study-related documents.  This includes an initial 
review and approval process and continuing review as determined by the IRB, as well as review of any 
modifications made prior to and after initiation of the study.  All changes will be approved by the IRB 
prior to implementation. The Principal Investigator (PI) will be responsible for ensuring compliance with 
IRB regulations and procedures.  All key study personnel will be trained in human subjects’ protection. 
16.2 Risks to Human Subjects
16.2.1 Involvement of Human Subjects
Suicide constitutes a significant public health concern and is a leading causes of death in the United 
States. 59  This study will fill key gaps in the scientific literature outlined in the Background and 
Significance sections of this protocol. The two Caring Contacts models being compared in this study are 
both in widespread clinical practice at reputable health systems in the US. However, they have never 
been compared to see which is most effective, and have not been rigorously evaluated in adolescents.
16.2.2 Protecting Individuals with Urgent Clinical Needs
This protocol prioritizes individual participants’ urgent clinical needs (for example, imminent risk of 
suicide or self-harm) above research related needs or responsibilities.  Study staff will be trained that 
their first responsibility is to protect the safety and wellbeing of study participants (especially those 
experiencing suicidal crisis or another safety outcome), with duty to the research protocol taking second 
priority.  The independent Research/Medical Monitor (RM) will assist with monitoring this by reviewing 
situations where individual study participants’ needs may conflict with the study protocol.  If the RM 
determines that the participant’s needs were not appropriately prioritized, remediation strategies will 
be developed to modify processes and ensure that participants are better protected in the future.  The 
role and qualifications of the RM are further described in the Data and Safety Monitoring section of this 
protocol.

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16.3 Informed Consent Process
Before participants enroll in the study, study staff will complete informed consent.  If the patient is 
younger than 18 years of age, his or her parent, guardian, or legally authorized representative will 
provide written consent for the minor to participate in the study and the minor will provide written 
assent to participate. Those participants that assent to study participation prior to age 18 will reconsent 
as adults once they turn 18 before any additional outcome surveys are completed. Participants who turn 
18 during the study may be invited to consent as adults using a text message with a link to the informed 
consent form in REDCap. A phone call for consenting participants who were consented as minors and 
turn 18 years old during the study will be optional, not required. Recruitment materials will be written at 
an age-appropriate reading level to facilitate comprehension.  Furthermore, the People with Lived 
Experience with Suicide (PLES) Advisory Board will review and contribute to the informed consent 
documents for readability and clarity.  
16.4 Documentation of Informed Consent
Informed consent (and assent for minors) will be obtained and documented for all study participants.  
Study staff will document each participants’ eligibility to participate in the study prior to enrollment.  
When the participant signs the informed consent (or assent for participants aged 12-17) documents, the 
study staff will also sign a form attesting that they have screened for eligibility, reviewed the consent 
information, and responded to all questions from the participant.  The informed consent process will be 
completed in REDCap, and the consent/assent form will be combined electronically with attestation 
form in a single patient record.  All primary data collection for this study will be done electronically, 
except in the event of technology failure, when paper-based back-up forms may be used.
16.5 Inclusion of Women and Minorities
Efforts will be made to recruit females and minorities according to their representation in the research 
population. There are no exclusion criteria based on sex/gender or minority status. 
16.6 Inclusion of Minors
Adolescents face a disproportionate burden of suicidal ideation compared to adults, 4,60 and additional 
evidence is needed to determine the most effective form of follow-up care for minors.  Adolescents who 
screen positive for suicide will be included in this study in order to address this critical gap in the 
literature and contribute to the evidence base for Caring Contacts among adolescents with suicidal 
ideation.
16.7 Cost and Compensation for Participation
Costs of participating in this study include the time participants spend enrolling in the study and 
completing questionnaires, and the cost of receiving text messages, emails, and phone calls as part of 

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the intervention and/or outcome assessments.
Study participants will receive financial compensation for their time (up to $130 total over 12 months) in 
the form of online gift cards.  Participants who complete a tax form will receive a compensation email 
including a link to the online gift card following completion of each survey. These funds are intended to 
compensate participants’ time spent discussing sensitive topics and are in no way meant to influence 
participation in the study. The compensation will be distributed as follows:

Baseline/Enrollment: $30

Three-month outcome survey: $30

Six-month outcome survey: $30

Twelve-month outcome survey/study completion: $40
16.8 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 the PIs. If the study is prematurely terminated or 
suspended, the PI will promptly inform all study investigators, study participants, AFSP, and the SLHS 
IRB, and will provide the reason for termination or suspension. Study participants will be informed, as 
applicable, of any changes to the study schedule. 
The following circumstances may warrant termination or suspension:

Determination of unexpected significant or unacceptable risk to participants

Demonstration of differential efficacy that would warrant stopping

Data that are not sufficiently complete and/or evaluable

Determination that the primary endpoint has been met

Determination of futility

Other reasonable causes not listed here
The study may resume once concerns about safety, protocol compliance, and data quality are addressed 
to the satisfaction of AFSP, the SLHS IRB, the Data and Safety Monitoring Board (DSMB), and other 
regulatory or oversight bodies.
16.9 Confidentiality & Privacy
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, the DSMB, the SLHS IRB, and AFSP. This confidentiality is extended to the data being collected as 
part of this study.  Data that could be used to identify a specific study participant will be held in strict 
confidence within the research team.  No personally identifiable information from the study will be 
released to any unauthorized third party without prior written approval of AFSP and the SLHS IRB.
All research activities will be conducted in as private a setting as possible. 

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Authorized representatives of AFSP, the DSMB, or SLHS, including the SLHS IRB, may inspect all 
documents and records required to be maintained by the investigators, including but not limited to 
medical records for the participants of this study.  The clinical study site will permit access to such 
records for authorized review.
Study participants’ contact information will be securely stored for internal use during the study.  At the 
end of the study, all records will be kept in a secure location for 10 years, in accordance with SLHS data 
retention policy.
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted via and stored on REDCap, a HIPAA compliant web-based research database.  At the end 
of the study, all study data will be de-identified prior to publication; research data will be archived at 
SLHS for storage for 10 years.  
16.10 Study Records Retention
Study records will be retained for 10 years, in accordance with SLHS institutional policy.  No records will 
be destroyed before that time without the written consent of AFSP and/or the SLHS Compliance 
department.
16.11 Publication & Data Sharing Policy
The PI will be responsible for developing publication procedures and resolving authorship issues.  This 
study will be conducted in accordance with all AFSP and SLHS data sharing policies and regulations.  This 
trial will be registered at ClinicalTrials.gov, and the results of this trial will be submitted to 
ClinicalTrials.gov, which ensures that the public has access to the published results of this AFSP-funded 
research.  In addition, results will be submitted for publication in peer reviewed journals.  Data from this 
trial may be requested from other researchers 5 years after the completion of the primary endpoint by 
contacting the PI.  Considerations for ensuring confidentiality of these shared data are described in the 
16.9 Confidentiality & Privacy section of this protocol. 
16.11.1 National Institute for Mental Health Data Archive (NDA)
It is American Foundation for Suicide Prevention (AFSP) policy that results and data collected through 
the research that it funds should be made available to the public.  Data from this research will be 
submitted to the National Institute of Mental Health Data Archive (NDA) per AFSP grant requirements. 
The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the 
protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., adherence to 
NDA requirements).  
NDA is a large database where de-identified study data from many NIH studies are stored and managed, 
allowing researchers to learn new and important things about brain science at a more rapid pace.
Data will be de-identified using the GUID Tool, which is loaded on to a SLHS computer.  Participants’ First 
Name, Middle Name, Last Name, Sex, Date of Birth, and City/Municipality of Birth may be entered into 
the SLHS GUID tool to create a unique identifier. The SLHS GUID tool generates a series of one-way hash 

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codes based on the information entered, without the PHI ever leaving the SLHS computer. The hash 
codes are encrypted and securely sent to the GUID system at NDA.
If the hash codes match an existing hash code, the GUID associated with that hash code is sent back to 
the study staff. The GUID is an alphanumeric code that is randomly and persistently linked to the hash 
codes within the secure NDA GUID system and cannot be traced back to the information entered by 
study staff. If the hash codes do not match an existing hash code in the NDA GUID system, a new GUID is 
created and sent back to the SLHS GUID Tool. 
With the NDA GUID Tool, the same participant information will return the same GUID whenever or 
wherever it is entered. This allows NDA to anonymously link participant data records across time and 
locations, without ever receiving identifying information. The ability to link participant records and the 
protection of participant confidentiality are both critical components of NDA data sharing. 
16.12 Dissemination of Results
Any publication or presentation of the results of this study will be presented in aggregate form and will 
not include any patient identifying information.  Results of the study may be shared with study 
participants using contact information provided during study enrollment, such as email. 
16.13 Conflict of Interest Policy
The independence of this study from any actual or perceived influence 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. 
16.14 Protocol Deviations
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or SLHS IRB requirements.  The 
noncompliance may be either on the part of the participant, investigator, study staff, or study site staff.  
Corrective actions will be developed by the site and implemented promptly in the event of protocol 
deviations, consistent with ICH GCP:

Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3

Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1

Section 5.20 Noncompliance, subsections 5.20.1 and 5.20.2
Study staff will conduct quality assurance monitoring and internal audits on a regular basis.  Study staff 
and study site staff will be responsible for being vigilant to identify and report deviations in accordance 
with the SLHS IRB Procedures Manual.  All deviations will be addressed in study source documents and 
reported to the PIs; deviations deemed reportable based on criteria in the SLHS IRB Procedures Manual 
will be reported to the SLHS IRB.  Study staff including study site champions will be responsible for 
knowing and adhering to the IRB requirements.  

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16.15 Key Roles for Study Oversight
Table 4: Key Roles for Study Oversight, SPRING Trial
Principal Investigators & Data & Safety Monitoring Board Chair
Principal Investigator
Data & Safety Monitoring 
Board Chair, Research & Medical Monitor
Anna Radin, DrPH, MPH, 
Applied Research Scientist
Greg Simon, MD, MPH, Psychiatrist, Behavioral Health Service Line, 
and Investigator
St. Luke’s Health System
Kaiser Permanente & Kaiser Permanente Washington Health 
Research Institute
208-381-8468
206-287-2979
radina@slhs.org
Gregory.E.Simon@kp.org 
IRB and Compliance
IRB
St. Luke’s IRB: 208-381-1406
St. Luke’s IRB is the IRB of record 
for this research study.
Compliance
St. Luke’s 24/7 Compliance 
Hotline: 1-800-729-0966
St. Luke’s Health System maintains 
a compliance hotline that is 
available 24/7 to take compliance-
related calls.
16.15.1 Data and Safety Monitoring Board
A Data and Safety Monitoring Board (DSMB) will convene at the beginning of the study to review the 
protocol, develop a charter and data reporting tables.  The DSMB will meet again approximately five 
times after enrollment begins and ad hoc as needed to review safety or scientific issues.
16.16 Quality Assurance & Quality Control
Study staff perform internal quality management of study conduct, data collection, and documentation.  
Data reports will be routinely reviewed by study staff in consultation with the PI to monitor study 
adherence to the study protocol, study enrollment rate, completeness of data, and documentation of 
required processes such as informed consent
Quality control (QC) measures will be implemented as follows

Informed consent – Study staff and others in the Department such as the Compliance 
Coordinator will review documentation of the consenting process and completed consent 
documents.  This review will evaluate compliance with procedures described in this protocol, 
accuracy, and completeness.  

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
Intervention fidelity – Study staff will monitor the degree to which CC1 and CC2 from the Hotline 
are delivered with fidelity to specified content and cadence (scheduled/standard outgoing texts) 
and to Motto’s principles of Caring Contacts (replies to incoming texts).  

Protocol deviations – The study team will review protocol deviations on an ongoing basis and 
will implement corrective actions when the quantity or nature of deviations are deemed to be in 
need of remediation.
Should independent monitoring of the study become necessary, the PI will provide direct access to all 
trial-related sites, source data/documents, and reports for the purpose of monitoring and auditing by 
internal SLHS auditing bodies, AFSP, and inspection by local and regulatory authorities, in compliance 
with SLHS legal guidance.
17
Institutional Roles
17.1 St. Luke’s Health System, Boise, ID – Primary Research Institution
St. Luke’s Health System (SLHS), based in Boise, Idaho, is the primary research institution. As the only 
Idaho-based, not-for-profit, community-owned, and community-led health system, St. Luke’s Health 
System (SLHS) is well-positioned to take a leadership role in the region’s population health. SLHS has a 
history of conducting rigorous suicide prevention research focused on Caring Contacts and a robust 
Research Department, which includes 76 staff supporting 286 currently approved studies. SLHS will be 
responsible for the majority of research administration, including recruitment, informed consent, and 
data collection through administration of surveys.  The SLHS IRB is responsible for reviewing, approving, 
and overseeing research involving human subjects at SLHS to ensure that participants’ safety, rights, and 
welfare are protected. 
17.2 Idaho Crisis and Suicide Hotline (Hotline), Boise, ID – Intervention Delivery
The Hotline will be responsible for delivering the Caring Contacts interventions to study 
participants.  The Hotline supports Idahoans statewide and is accredited through the International 
Council of Helplines. The Hotline will develop and adhere to standard operating procedures to ensure 
consistency in the delivery of the intervention, and a robust system of quality controls to ensure every 
participant receives the best possible support.  The Hotline is familiar with delivering Caring Contacts 
interventions in the context randomized controlled trials and is uniquely prepared to support the 
proposed study.
17.3 University of Washington (UW), Seattle, WA – Subject Matter Expertise and 
Biostatistics Support
UW is a premier research institution that includes more than 270 specialized research centers. UW will 
contribute subject matter expertise from the Department of Psychiatry and Behavioral Sciences and the 

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Center for Suicide Prevention & Recovery.  Faculty and Staff from UW will support the REDCap build and 
maintenance, and advise on all aspects of the study, from operational considerations to research 
methods and participant safety considerations.  Faculty and staff from the Department of Biostatistics 
will lead data cleaning and data analysis work, as well as advising on study design and other methods 
considerations throughout the study.

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Appendix A: C-SSRS Screening Questions & Scoring Criteria
Question #
Category
Question
Score
1.
Category 1. Wish to be dead
Have you [ever] wished you were dead 
or wished you could go to sleep and not
wake up?
1
2.
Category 2. Non-specific Active 
Suicidal Thoughts
Have you had any actual thoughts of
killing yourself?
2
3.
Category 3 – Active Suicidal 
Ideation with Any Methods (Not 
Plan) without Intent to Act
Have you thought about how you might 
do this?
(For example, “I thought about taking an 
overdose but I never worked out the details 
about when, where, and how I would do that 
and I would never act on these thoughts.”)
3
4.
Category 4 – Active Suicidal 
Ideation with Some Intent to 
Act, without Specific Plan
Have you had any intention of acting on 
these thoughts of killing yourself, as 
opposed to you have the thoughts but 
you definitely would not act on them?
(For example, “I had the thought of killing 
myself by taking an overdose and am not 
sure whether I would do it or not.”)
4
5.
Category 5 – Active Suicidal 
Ideation with Specific Plan
and Intent
Have you started to work out or worked 
out the details of how to kill yourself? 
Do you intend to carry out this plan?
(For example, “I am planning to take 3 bottles 
of my sleep medication this Saturday when 
no one is around to
stop me.”)
5
6.
[Lifetime- 
Recent]
Category 6 – Preparatory Acts or 
Behavior (lifetime)
Have you done any of the following:

Attempted to kill yourself, even if 
ending your life was only part of your 
motivation

Started to do something to end your 
life but someone or something 
stopped you before you actually did 
anything?

Started to do something to end your 
life but you stopped yourself before 
you actually did anything
[Not 
scored at 
baseline]

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
Taken any steps towards making a 
suicide attempt or preparing to kill 
yourself
(Examples: Collected pills, obtained a gun, 
gave away valuables, wrote a will or suicide 
note, took out pills but didn’t swallow any, 
held a gun but changed your mind or it was 
grabbed from your hand, went to the roof but 
didn’t jump; or actually took pills, tried to 
shoot yourself, cut yourself, tried to hang 
yourself, etc.)
6A. 
[Lifetime-
Recent]
Category 6 – Preparatory Acts or 
Behavior
[In your lifetime]
[Not 
scored at 
baseline]
6B.
[Lifetime- 
Recent]
Category 6 – Preparatory Acts or 
Behavior
[In the past 3 months]
6
6.
[Since last 
contact]
Category 6 – Preparatory Acts or 
Behavior
In the past 3/6 months, have you done 
anything, started to do anything, or 
prepared to do anything to
end your life?
(For example: Collected pills, obtained a gun, 
gave away valuables, wrote a will or suicide 
note, took out pills but didn’t swallow any, 
held a gun but changed your mind about 
hurting yourself or it was grabbed from your 
hand, went to the roof to jump but didn’t; or 
actually took pills, tried to shoot yourself, cut 
yourself, tried to hang yourself, etc.)
6
7.
Category 7 – Aborted Attempt
Has there been a time when you started 
to do something to try to end your life 
but you stopped yourself before you 
actually did anything?
An aborted or self-interrupted attempt is 
when a person begins to take steps toward 
making a suicide attempt but stops 
themselves before they actually do anything 
that could be harmful.
7

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8.
Category 8 – Interrupted 
Attempt
Has there been a time when you started 
to do something to end your life but 
someone or something stopped you 
before you actually did anything?
An interrupted attempt is when a person is 
interrupted (by an outside person or 
circumstance) from starting the potentially 
self-injurious act (if not for that, actual 
attempt would have occurred).
8
9.
Category 9 – Actual Attempt 
(non-fatal)
Have you made a suicide attempt?
A suicide attempt is any act where a person 
had any intent or desire to die, even if they 
were not hurt.
9
10.
Category 10 – Completed Suicide
Note: Completed suicide will be assessed 
using vital records and electronic health 
records; not included as a survey question
10

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Appendix B: SPRING Brief Assessment of Capacity to Consent (S-BACC)
Last reviewed/updated: 7/27/2023
When to use:
Use the S-BACC any time it is not clear whether a potential participant is capable of providing informed 
consent.  This may include but is not limited to:
1.
Any time a potential participant’s chart includes any indication of cognitive impairment or 
intellectual disability in either the referring provider’s note, or in the problem list.
a.
The following is a non-exhaustive list of examples of terms or conditions that would be 
considered cognitive impairment:
i.
Cognitive impairment, intellectual disability, Alzheimers, dementia, amnesia, 
delirium, Asperger’s, memory loss, cognitive delay, developmental delay, 
intellectual delay, severe traumatic brain injury TBI) 
b.
The following conditions if occurring in the absence of one of the cognitive impairments 
listed above would not independently necessitate use of the S-BACC: Attention Deficit 
Hyperactivity Disorder (ADHD), Attention Deficit Disorder (ADD), learning disabilities, 
and Autism Spectrum Disorder (ASD / Autism), mild Traumatic Brain Injury (TBI)
c.
Please err on the side of caution and complete the S-BACC if you are unsure whether 
something you see in the chart falls into the categories of cognitive impairment or 
intellectual disability, or if you have any concerns about the individual’s capacity to 
provide informed consent.  
2.
Any time a potential participant seems distracted during the informed consent process or gives 
any indication that they are confused or not following the discussion.
3.
Consult the PI for direction if you are unsure and remember: it is always okay to complete an S-
BACC if you are unsure.
How to introduce the S-BACC
The S-BACC has been built into the REDCap ICF framework and Research Coordinators will be prompted 
to indicate whether or not they need to implement the S-BACC during each enrollment.  When 
appropriate, consider the following scripting:
Thank you. I will send a link to you with an informed consent form that describes the study in 
more detail. We can review the document together, and I will answer any questions you may 
have. I will also ask you a few questions to confirm that you have fully understood the study 
before you decide whether or not to participate. As we go through this, please wait for my 
instructions to continue onto the next page on the iPad, especially when you see a “STOP” at the 
top of the screen.  Would you prefer me to email or text the link to you?”

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Assessment Item
Score 1 (Correct)
Score 0 (Incorrect)
1.
Why are you considering doing this 
study?
Mentions suicide, support, 
someone checking in, someone 
to talk to, wanting to help 
others, wanting to participate in 
research, etc.  Demonstrates 
understanding of why they were 
referred and what the study is 
about. Note: if they mention gift 
cards, please probe for other 
reasons to ensure they 
understand the purpose of the 
study.
Clearly does not understand 
the purpose of the study or 
why they were referred 
2.
Are you required to be in this study?
No
Yes
3.
If you decide not to participate in this 
study, can you still receive normal care 
from St. Luke’s and the Idaho Crisis and 
Suicide Hotline?
Yes
No
4.
If you participate in this study, what are 
some things you may be asked to do?
Receive phone calls / texts or 
emails; complete surveys.
Does not mention phone calls 
or texts/emails, or surveys
5.
What are some of the risks or 
discomforts that people may experience 
in this study?
Discomfort, 
confidentiality/privacy
Cannot think of any risks or 
lists incorrect risks
6.
What should you do if you have 
questions or you change your mind 
about participating?
Contact [you]/study team; 
knows they can withdraw from 
study
Doesn’t know they can 
withdraw, can’t describe who 
they would contact with 
questions or how
Implementing and Scoring the S-BACC
Potential participants who are capable of providing informed consent may not answer the question 
completely on their first try.  It is okay for research coordinators to probe and re-word the question, or 
to remind them where in the informed consent form they can find that information.  However, 
participants must be able to correctly answer each item in order to be considered capable of providing 
informed consent for SPRING.  
When someone cannot correctly answer all questions on the S-BACC
Some potential participants will be unable to demonstrate capability to provide informed consent.  In 
these cases, they are not eligible to participate in the study.  Consider the following scripting:

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Thank you so much for your time today.  Unfortunately, you are not eligible to participate in the 
study at this time.  I want to make sure you know that you can still reach out to the Idaho Crisis 
and Suicide Hotline any time you may need someone to talk to, even if you are not in crisis.  It’s a 
great resource and is available 24/7. Call or text 988.
How to document use of the S-BACC
Any time you use the S-BACC, it’s important to include a detailed REDCap tracking note, outlining the 
following:

What made you decide to use the S-BACC?

Describe how the conversation went – were questions asked/answered? Did the participant 
seem to follow the conversation well?

Describe how they scored on the S-BACC, and include any questions missed, as well as your 
overall impression of the person’s capability to provide informed consent.

For minor participants, indicate whether you had concerns about the capacity to consent of the 
consenting adult, the assenting minor, or both.
Notes on development of the S-BACC
The S-BACC was developed based on the UBACC, which is a psychometrically sound instrument designed 
to assess capability to provide informed consent for research.  The UBACC developers recommend 
tailoring a sub-set of the items from the UBACC to the specific research study for which it is being used, 
which we have done for SPRING in creating the S-BACC.  We also consulted the list of critical items to 
review during informed consent from the St. Luke’s Health System Research Department’s “Consenting 
& Assessing Comprehension Quick Guide”, v. 3.27.19 and ensured those items were highlighted in the 
questions selected for inclusion in the S-BACC.  
The list of conditions considered as cognitive impairment, and those excluded, were developed together 
with one of the SPARC/SPRING study clinicians, Amelia Doty-Jones, LCSW.
The S-BACC was reviewed and revised in consultation with the SPARC/SPRING Lived Experience Advisory 
Board.
REFERENCE
Dilip V. Jeste, MD; Barton W. Palmer, PhD; Paul S. Appelbaum, MD; Shahrokh Golshan, PhD; Danielle 
Glorioso, BS; Laura B. Dunn, MD; Kathleen Kim, MD, MPH; Thomas Meeks, MD; Helena C. Kraemer, PhD.  
A New Brief Instrument for Assessing Decisional Capacity for Clinical Research.  Arch Gen Psychiatry/ Vol 
64 (no. 8), Aug 2007.
UCSD Brief Assessment of Capacity to Consent (UBACC) 
1.
What makes you want to consider participating in this study? 
2.
Do you believe this is primarily research or primarily treatment? 

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3.
Do you have to be in this study if you do not want to participate? 
4.
If you withdraw from this study, will you still be able to receive regular treatment? 
5.
If you participate in this study, what are some of the things that you will be asked to do? 
6.
Please describe some of the risks or discomforts that people may experience if they participate 
in this study. 
7.
Please describe the 2 serious risks associated with the study.
8.
Please describe some of the possible benefits of this study. 
9.
Is it possible that being in this study will not have any benefit to you? 
10. Who will pay for your medical care if you are injured as a direct result of participating in this 
study? 
Available at: https://irb.nyspi.org/themes/doc/Literature.Jeste.DecisionalCap.IRBmbr.Dec2017.pdf