An Open-Label Study of the Feasibility and Usability of a Digital Psychoeducational Social Network Intervention for Suicidal Adolescents
Phase: NA
Conditions: Suicide
Sponsor: University of Michigan

Digital Youth-Nominated Support Team 
(YST) Program 
 
NCT05900700 
 
Date of IRB Approval: February 22, 2024 

 
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Title: 
Digital Youth-Nominated Support Team (YST)Program-      
 
Brief Title: 
Digital YST Program      
 
Date:   
 
January 6, 2023 
 
Sponsor:  
 
National Institute of Mental Health (NIMH) 
 
 
Protocol Number:  
2022-Oui-002 
 
 
 
Version Number: 1.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CONFIDENTIALITY STATEMENT  
The confidential information in this document is provided to you as an Investigator or consultant 
for review by you, your staff, and the applicable Institutional Review Board (IRB) or Ethics 
Committee (EC). Your acceptance of this document constitutes agreement that you will not 
disclose the information contained herein to others without written authorization from Oui 
Therapeutics, Inc.

 
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STATEMENT OF COMPLIANCE 
This trial will be conducted in compliance with the protocol, International Council on 
Harmonization Good Clinical Practice (ICH GCP) and applicable state, local and federal 
regulatory requirements. Each investigational site must provide this protocol and the associated 
informed consent documents and recruitment materials for review and approval by an appropriate 
Institutional Review Board (IRB) or Ethics Committee (EC). Any amendments to the protocol or 
consent materials must also be approved before implementation.  
 
 

 
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Sponsor Protocol Approval Page 
STUDY TITLE: 
Digital Youth-Nominated Support Team (YST) Program     
PROTOCOL NUMBER: 
2022-Oui-002 
VERSION NUMBER: 
1.1 
  
We, the undersigned, have read and approve the protocol specified above and agree on its 
content. 
  
Patricia Simon 
VP, Clinical 
  
  
  
Date: 01/06/2023 
Brian Keenaghan 
VP, Operations 
  
 
 
Date: 01/06/2023 
 
  
 
 

 
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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, as described in the Statement of 
Compliance above. 
 
PI or Clinical Site Investigator: 
 
Signed: 
 
Date: 
01/06/2023 
Name: 
 
Alejandra Arango, PhD 
 
Title: 
 
Clinical Site Investigator 
 
 
 
Investigator Contact Information 
 
Affiliation: Department of Psychiatry, University of Michigan 
 
Address: 4250 Plymouth, Ann Arbor, MI 48105 
 
Email: arango@med.umich.edu  
 
 
 
   

 
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1. PROTOCOL SUMMARY 
1.1 
ABBREVIATIONS 
AE 
Adverse Event 
AIM 
Acceptability of Intervention Measure 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
CFIR 
Consolidated Framework for Implementation Research 
CFR 
Code of Federal Regulations 
CHCQ 
Chronic Health Conditions Questionnaire 
COREQ 
Consolidated Criteria for Reporting Qualitative Research Checklist 
CSC 
Clinically Significant Change 
CSI 
Cornell Services Index 
CSQ-I 
Client Satisfaction Questionnaire 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
ED 
Emergency Department 
EDC 
Electronic data capture 
ED-STARS 
Emergency Department Screen for Teens at Risk for Suicide 
E-REP 
Enhanced Replicating Effective Programs 
FDA 
Food and Drug Administration 
FIM 
Feasibility of Intervention Measure 
FSPC 
Family, School, and Peer Connectedness 

 
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GCP 
Good Clinical Practice 
GP 
General Practitioner 
HIPAA 
Health Insurance Portability and Accountability Act 
IAM 
Intervention Appropriateness Measure 
ICH 
International Council on Harmonization 
IEC 
International Electrotechnical Commission 
IRB 
Institutional Review Board 
MedDRA 
Medical Dictionary for Regulatory Activities 
NIMH 
National Institute of Mental Health 
PHI 
Protected Health Information 
PHQ-2 
Patient Health Questionnaire-2 
PHQ-9 
Patient Health Questionnaire-9 
PI 
Principal Investigator 
PO 
Program Official 
RE-AIM 
Reach, Effectiveness, Adoption, Implementation, and Maintenance 
RCT 
Randomized clinical trial 
SA 
Suicide attempt 
SAE 
Serious Adverse Event 
SI 
Suicide ideation 
SIQ-JR 
Suicide Ideation Questionnaire Jr 

 
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SPS 
Social Provisions Scale 
SUS 
System Usability Scale 
TAU 
Treatment as usual 
YST 
Youth-Nominated Support Team 
YST-Is 
Youth-Nominated Support Team intervention specialists 
 
 
 

 
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1.2 STUDY SCHEMA 
 
Screening 
Week 0 
 
 
 
 
 
 
Weeks 1-12 
 
 
 
 
 
 
 
 
 
 
Weeks 12-14 
 
 
 
Total N: 20 
Screen potential participants by inclusion and exclusion criteria. Conduct 
informed consent/assent process 
Baseline assessments: Demographics, Support Adult Information Form, 
Psychiatric history, Medication use, SIQ-JR, PHQ-2, FSPC, SPS, Sources of 
Strength Coping Scale, C-SSRS, CSI, CHCQ 
Enroll in eYST 
 
Implement eYST 
Week 4/8 assessments: SUS, User feedback questions, FIM, AIM, IAM, 
CSQ-I, CSI, SUS  
Post-intervention Assessments: Medication use, SIQ-JR, PHQ-2, FSPC, 
SPS, Sources of Strength Coping Scale,  User feedback questions 
Adolescents’ use of adult support, C-SSRS 

 
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1.3 
SCHEDULE OF ACTIVITIES 
Table 1. Schedule of Assessments 
 
Study Periods 
Screening 
Intervention  
Week (W) 
W0 
W1 
W2  
W3 
W4  
W5  
W6 
W7  
W8  
W9 
W10  
W11 
W12* 
Informed Consent / 
Assent 
Y, P, A 
  
  
  
  
  
  
  
  
  
  
  
  
Demographics, 
Contact, and 
Information Form 
Y, P, A 
  
  
  
  
  
  
  
  
  
  
  
  
Medical Chart 
Abstraction 
(Completed by study 
staff) 
Y 
  
  
  
  
  
  
  
  
  
  
  
  
Medication use  
Y* 
  
  
  
  
  
  
  
  
  
  
  
Y* 
Chronic Health 
Conditions 
Questionnaire 
(CHCQ) 
Y* 
 
 
 
 
 
 
 
 
 
 
 
 
Enrollment in eYST 
Y, P, A 
  
  
  
  
  
  
  
  
  
  
  
  
Suicide Ideation 
Questionnaire Jr 
(SIQ-JR) 
Y 
  
  
  
  
  
 
  
  
  
  
  
Y 
Patient Health 
Questionnaire-2 
(PHQ-2) 
Y 
  
  
  
  
  
 
  
  
  
  
  
Y 

 
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Study Periods 
Screening 
Intervention  
Week (W) 
W0 
W1 
W2  
W3 
W4  
W5  
W6 
W7  
W8  
W9 
W10  
W11 
W12* 
Family, School, and 
Peer Connectedness 
(FSPC) 
Y 
  
  
  
  
  
 
  
  
  
  
  
Y 
Social Provisions 
scale (SPS) 
Y 
  
  
  
  
  
 
  
  
  
  
  
Y 
Sources of Strength 
Coping Scale 
Y 
  
  
  
  
  
 
  
  
  
  
  
Y 
System Usability 
Scale (SUS) 
  
  
  
  
Y, P  
  
 
  
A 
  
  
  
 
User feedback 
questions  
  
  
  
  
 Y, P 
  
 
  
A  
  
  
  
A 
Feasibility of 
Intervention 
Measure (FIM) 
  
  
  
  
 Y, P  
  
 
  
 A 
  
  
  
 
Acceptability of 
Intervention 
Measure (AIM) 
  
  
  
  
 Y, P 
  
 
  
 A 
  
  
  
 
Intervention 
Appropriateness 
Measure (IAM) 
  
  
  
  
Y, P  
  
 
  
 A 
  
  
  
 
Client Satisfaction 
Questionnaire (CSQ-
I) 
  
  
  
  
Y, P  
  
 
  
 A 
  
  
  
 
Cornell Services 
Index (CSI) 
Y*  
  
  
  
 
  
 
  
  
  
  
  
Y* 

 
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Study Periods 
Screening 
Intervention  
Week (W) 
W0 
W1 
W2  
W3 
W4  
W5  
W6 
W7  
W8  
W9 
W10  
W11 
W12* 
Columbia-Suicide 
Severity Rating 
Scale (C-SSRS) 
Y 
 
 
 
 
 
 
 
 
 
 
 
Y 
Adolescents’ use of 
‘caring adult’ support 
(quality, amount) 
  
  
  
  
  
  
 
  
  
  
  
  
Y 
Measures Administered via eYST 
Presenting Concerns 
Y* 
 
 
 
 
 
 
 
 
 
 
 
 
eYST Check ins 
 
A 
A 
A 
A 
A 
A 
A 
A 
A 
A 
A 
A 
 
Y = Youth | P = Parent | A = Support Adult |  
                        * = Parent Reported 
 
 
 

 
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2. INTRODUCTION 
Suicide is the second leading cause of death among adolescents in the US (Heron, 
2021). Adolescents hospitalized for suicide ideation (SI) or suicide attempt (SA) are at risk for 
future SAs (Miranda et al., 2014) and early mortality (Kapur et al., 2015); rates of death by 
suicide may be as high as 10% by 15 years post discharge (Kapur et al., 2015). Despite these 
known risks, many suicidal adolescents do not obtain recommended treatments after hospital 
discharge (Chung et al., 2017) because of barriers to access, stigma (Arora & Persaud, 2020; 
Moskos et al., 2007), and the unavailability of enough providers trained to deliver effective 
suicide prevention (Institute of Medicine (US) Committee on Pathophysiology and Prevention of 
Adolescent and Adult Suicide, 2002; Substance Abuse and Mental Health Services 
Administration (SAMHSA), 2020). Additionally, although suicide can be preventable when timely 
intervention is available (King, Arango, et al., 2019), few treatment interventions have been 
developed for adolescents and even fewer have demonstrated impact on morbidity or mortality. 
Thus, there is an urgent need to develop scalable suicide prevention methods.  
Youth-Nominated Support Team (YST) is a three-month program that pairs adolescents, 
who are being discharged from a healthcare facility after a suicide attempt, with adults (known 
as support adults) whom the patient selects to become their support network (King et al., 2009). 
YST provides tailored education and ongoing support to these adults who, in turn, encourage 
youth to adhere to recommended treatments and make positive behavioral choices (King, 
Arango, et al., 2019). Although associated with reduced self-injury mortality and designated a 
promising intervention (Substance Abuse and Mental Health Services Administration 
(SAMHSA), 2020), YST is not readily scalable as it requires significant time commitment from 
mental health professionals, known as YST intervention specialists (YST-Is), and necessitates 
engagement and coordination from multiple personnel. To mitigate these limitations, we 
propose to build eYST, a digitized version of YST, which will streamline YST’s operational 
processes. 
 
2.1 
BACKGROUND 
2.1.1 
Summary of Clinical Findings for Youth-Nominated Support Team (YST) 
YST is a three-month psychoeducational, social support program for adolescents at risk 
for suicide, which aims to strengthen each adolescent’s supportive network of adults (King, 
Arango, et al., 2019). YST is the only youth suicide prevention program that has been associated 
with reduced mortality and, specifically, self-injury mortality. YST’s association with reduced 
mortality was not only statistically significant, but also clinically meaningful. With a conservative 
estimate based on the lowest end of the confidence interval, YST reduced mortality by at least 
50%. Moreover, YST was associated with a more rapid reduction in SI and with obtaining more 
mental health treatment, a hypothesized mediator of improved outcomes. However, YST is not 
widely implemented, and few healthcare staff have formal training in this method. Thus, scaling 
YST (through eYST), while including features that track and support implementation fidelity, has 
the potential to save lives and reduce suffering among the many youth who are suicidal. eYST 
will reduce the need for provider time and help youth develop a robust support network. 
Oui Therapeutics (through its telehealth business) and Dr. Cheryl King (the developer of 
eYST) are administering YST. Through a pilot study of YST in our telehealth business (with no 
digital automation), we have learned that health plans are willing to pay for YST, care managers 

 
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will refer patients to YST, parents will enroll their children in YST, and support adults will agree to 
participate in YST. We have also determined the need to increase efficiency by 1) digitizing 
components of the psychoeducational training delivered to youth, parents and support adults; and 
2) reducing administrative burden on the YST-Is by automating the nomination and contact 
processes. 
 
2.1.2 
Overall Rationale for the Study 
The purpose of this study is to digitize The Youth Nominated Support Team (YST) by 
developing eYST and conducting a single arm feasibility and acceptability trial. This intervention 
will be nationally scalable and accessible to suicidal youth and has strong potential to lead to a 
reduction in the youth suicide rate. 
 
2.2  
PRODUCT 
2.2.1 
Platform Overview 
The product of this project will be a functional platform (called eYST) which will digitize 
and optimize the operational processes of the YST intervention. eYST will allow Oui Therapeutics 
to nationally scale YST with fidelity. The long-term goal of eYST is to markedly increase access 
of a proven intervention and deliver a digital and scalable solution that can be easily integrated 
with the existing infrastructure of behavioral health programs, ultimately aiding in reducing the 
likelihood of youth attempting suicide. 
We will build eYST, which follows the key steps of YST (See Table 1). YST is a three-
month psychoeducational, social support program for adolescents at risk for suicide, which aims 
to strengthen each adolescent’s supportive network of adults. It is based in a conceptual model 
of social support that emphasizes how relationships with caring adults may positively impact 
adolescents’ mental health by: 1) improving their connectedness; 2) providing helpful 
information/facilitating problem-solving; 3) framing experiences and problems in a constructive 
way; and 4) encouraging healthy behaviors (e.g., treatment adherence) (Substance Abuse and 
Mental Health Services Administration (SAMHSA), 2020). YST is also based in health behavior 
theories that emphasize attitudes and support related to treatment seeking (Gipson & King, 2012). 
Adolescents nominate caring adults in their lives to serve as support persons after hospitalization. 
These adults attend a psychoeducational session to learn about the youth’s treatment plan, 
suicide warning signs, communicating with adolescents, and how to support the youth’s treatment 
adherence and other healthy behaviors. They meet with the adolescent at least weekly to provide 
emotional support and encourage positive behavioral choices. YST-Is then provide nominated 
adults with weekly consultation for three months to address questions and concerns. Building on 
these findings, eYST includes automations in 6 parts of YST. 
 
Table 1. Comparison of Traditional Youth Nominated Support Team (YST) implementation to eYST implementation.  
 
YST intervention specialists (YST-Is) tasks 
eYST tasks 

 
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Launch 
1. 
nintroduce parents and youth to program 
1. 
iintroduce parents and youth to program via website 
(text/video)* 
Nomination 
process 
2. 
hhelp youth nominate up to 4 supportive 
adults 
3. 
oobtain parent/guardian approval  
 
2. 
hhelp youth nominate up to 4 supportive adults via 
website* 
3. 
oobtain parent/guardian approval via website* 
 
Initial Contacts 
with Nominated 
adults 
5. 
eestablish contact 
6. 
eexplain role of YST support adult 
7. 
oobtain written informed consent 
8. 
aassist with re-nomination if a support adult 
declines 
9. 
ccomplete YST support adult information 
forms 
10. sschedule psychoeducation session  
5. 
eestablish contact via automated SMS text and email (sent 
at nomination) 
6. 
eexplain role of YST support adult via website (text/video) 
and provide contact information of YST-Is for questions 
7. 
ssupport adults opt into the study electronically 
8. 
aassist with re-nomination if a support adult declines 
9. 
hhelp adult complete YST support adult information forms 
10. ssupport adult schedules telephone/video call  
Psycho- 
education  
11. dduring meeting provide psychoeducation 
covering suicide risk, emergency contacts, 
communication best practices (i.e., style of 
language) and frequency of contact  
12. dduring meeting discuss youth’s treatment 
plan 
11. pprior to meeting provide and track completion of 
asynchronous psychoeducation via website text and videos 
covering suicide risk, emergency contacts, communication 
best practices (i.e., style of language) and frequency of 
contact 
12. dduring telephone/video call YST-Is discuss youth’s 
treatment plan 
Support Check-
ins 
13. ccheck-in with YST support adult via 
telephone 
14. ddocument check-in with support person  
13. ccheck-in with YST support adult, scheduled via eYST 
platform, will occur weekly     across the 12 weeks. With 
opportunities for additional check-ins if needed  
14. ddocument check-in with support person automatically 
through eYST 
*=done in the presence of a clinician/YST intervention specialist 
 
1) Launch. Video and text content on the website introduce parents and youth to YST in the 
presence of a clinician. 
2) Nomination. Video and text content on the website explains the qualities of appropriate, 
and inappropriate, support adults. Youth enter the names and contact information, if they 

 
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have, for possible support adults into eYST. Parents approve support adults via the 
website and complete any missing information for them.  
3) Initial contacts with nominated adults. Once the parent approves the nominated adults, an 
automated SMS text and email is then sent to each support adult. These messages 
contain a link to a program introduction that explains the role of the support adult. After 
the support adult opts into the study, they schedule a telephone/video call with the YST-
Is through eYST.  
4) Psychoeducation. Prior to meeting with the YST-Is, support adults will review brief 
introductory psychoeducation videos and related text content (e.g., adolescent mental 
health information) on the website. After completion of psychoeducation is confirmed, the 
YST-Is will have a telephone/video call with the support adult to discuss the youth’s 
individualized treatment plan, communication with adolescents, and strategies for 
encouraging the youth’s treatment adherence and healthy behaviors. 
5) Support check-ins. Support persons will provide information about how their check-ins 
with the youth are progressing (see assessments above) via the eYST platform, as well 
as schedule weekly      check-ins with the intervention specialist across 12 weeks.  
 
2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 Known Potential Risks  
 
Aims 1 & 2: There is the risk that confidentiality may be broken. We will take appropriate 
measures (see Section 14. Data Security for eYST) to minimize this risk. 
 
Aim 2: There are risks of emotional discomfort and distress from talking about suicide and other 
sensitive topics. Participants will be informed of voluntary participation. At the baseline, youth 
will be in the psychiatric inpatient unit. If distressed, participants will be directed to speak with 
clinical staff on the unit. At each follow-up assessment, youth will be provided with crisis 
emergency information (number to Psychiatric Emergency Services (PES) and Suicide 
Prevention Lifeline) to be used as needed. This information will also be provided to youth’s 
parent/legal guardians and adult support persons at the onset of the study. A risk management 
action plan (see below) will be implemented as needed.   
2.3.2 Known Potential Benefits 
The benefits of YST and follow-up after a hospital visit for suicidal ideation have been 
well-documented (King et al., 2018; King, Arango, et al., 2019; King et al., 2009) in the research 
of Dr. King and colleagues. A digital approach will provide this intervention and support systems 
to individuals who otherwise might go without them. 
 
2.3.3  Assessment of Potential Risks and Benefits 
This study presents a minimal risk because the digital platform does not involve any 
invasive or risky medical procedures and can be considered no greater risk than ordinarily 
encountered in daily life. 
 
3. OBJECTIVES AND HYPOTHESES  

 
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3.1 
PRIMARY OBJECTIVES AND HYPOTHESES 
This study has two primary aims: 1) develop eYST, a platform to support more efficient 
implementation of YST; and 2) test the feasibility and acceptability of eYST in a single-group, 
open-label trial. 
 
SPECIFIC AIM 1: Develop eYST. Development of eYST will be informed by key 
stakeholder interviews (conducted by Oui Therapeutics) and will include complete quality 
assurance. The benchmark for success for this aim is to develop a functional app that is 
consistent with YST. 
 
SPECIFIC AIM 2: Test the feasibility and acceptability of eYST in a single-group, 
open-label trial (conducted at UM). Participants will be hospitalized youth patients who 
have acute suicide risk, their respective parents/guardians, and the support adults each 
youth nominates. The primary objective of this 12 week, single-group clinical trial, is to test 
the usability and feasibility of eYST. The benchmark for success is for eYST to be rated 
as usable (i.e. average System Usability Scale (SUS) score = 68 or above). We will also 
capture frequency of eYST app use for each participant, as well as the duration of app 
use.  
 
      
 
3.2 
SECONDARY OBJECTIVES AND HYPOTHESES 
The secondary outcome measures will include Feasibility of Intervention Measure (FIM), 
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and 
Client Satisfaction Questionnaire (CSQ-I).  
We will also collect exploratory clinical outcomes, including suicidal thoughts and 
behaviors, mental healthcare service utilization, and perception of adult social support, to examine 
the range and variability of outcomes associated with YST.  
 
 
4. STUDY DESIGN 
4.1  
OVERALL DESIGN 
AIM 1: To develop eYST, we (i.e., Oui Therapeutics team) will complete the following 
activities: stakeholder (e.g. youth, parents, mental health providers, clinical administrators, and 
health plan providers) interviews, wireframe development, software design, software engineering, 
quality assurance, and training content development.  
We will use implementation science frameworks listed below to understand the needs of 
stakeholders and to examine system-level factors. Concurrently, we will gather product 
requirements for the wireframes of the entire eYST workflow. This will be completed within 90 
days. (See Study Timeline in Appendix A.) 
1) Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE- AIM): We will use 
the first components of RE-AIM (Glasgow et al., 1999) to ensure that eYST is designed 
for ease of implementation and aligns with practice priorities. 

 
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2) Consolidated Framework for Implementation Research (CFIR): We will use the CFIR 
(Damschroder et al., 2009) to identify and address barriers and facilitators to eYST uptake 
across multiple stakeholder levels and within a particular implementation context. 
3) Enhanced Replicating Effective Programs (E-REP): We will use E-REP (Kilbourne et al., 
2019; Kilbourne et al., 2007) to produce an eYST intervention package that facilitates the 
adoption and widespread dissemination of eYST. The eYST intervention package, which 
will be accessible to and useable for clinical administrators, will include: 1) a stakeholder 
guide that describes the implementation context and process; 2) a user-friendly manual; 
and 3) a fidelity measurement tool. 
 
Complete design, engineering, and quality assurance of the eYST beta version will follow and 
is expected to take up to 90 days (partially in concordance with and) following stakeholder 
interviews and wireframe development. The beta version will focus on content of eYST and the 
User Interface (UI). Content will be developed with existing YST materials. The digital platform 
will include robust engagement features for youth users, support adult users and YST-Is users to 
reduce and prevent implementation drift (and thus maintain fidelity). 
 
AIM 2: To test the feasibility and acceptability of eYST in a single-group, open-label trial 
(conducted at UM), youth participants will be recruited and enrolled while on the child and 
adolescent psychiatric inpatient unit in the Department of Psychiatry at Michigan Medicine, or 
following discharge via phone or email. After youth assent and parent/guardian consent, the youth 
and parents will be directed to the eYST website where eYST will be delivered as described above 
in Section 2.2.1 Platform Overview. Assessment data from multiple stakeholders (i.e., youth, 
parents, and support adults) will be collected at baseline, 4 weeks, 8 weeks, and 12 weeks via 
self-report and semi-structured interviews. Feasibility and acceptability of implementation will be 
assessed by collecting data on recruitment, retention, usability, and satisfaction. We will review 
characteristics of youth, parents, support adults, and the program that may contribute to uptake, 
in addition to the exploratory clinical outcomes noted above in Section 3.2 Secondary Objectives 
and Hypotheses.  
 
4.2  
DEFINITION OF END OF TRIAL  
The end of trial is the date of the last visit/telephone follow up of the last participant. A 
participant is considered to have completed the study if they have completed the baseline 
assessment, all intervention tasks, and all follow-up assessments. 
5. RESEARCH LOCATION 
AIM 1: Stakeholder interviews will be conducted by Oui Therapeutics via video calls, 
telephone, and/or email. Platform development will be facilitated by Github (for code version 
control), Sentry (for issue reporting and tracking), Firebase App Distribution (for beta/internal 
releases), and Detox (for automated app testing). To work on the products interface, Oui will 
use Figma, a web-based design tool that allows for fast wireframing, development of mock-ups 
and rapid prototyping. 
 

 
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AIM 2: The trial will be conducted at The University of Michigan/Michigan Medicine. 
Study procedures may occur on site and remotely. Study enrollment will occur in person and 
virtually at the University of Michigan’s child and adolescent inpatient psychiatry unit, or 
remotely following discharge from the unit. Study follow-up will occur primarily via 
telephone/video calls, survey tools (such as Qualtrics), and the eYST platform.  
 
A Research Agreement between Oui Therapeutics, Inc. and The University of Michigan will be 
executed prior to study start. 
 
6. STUDY POPULATION 
AIM 1: Participants will be youth, parents, mental health providers, clinical administrators, 
and representatives from health plan providers that can inform and provide feedback on the 
development, uptake, implementation, and sustainability of eYST. 
 
YOUTH PARTICIPANT INCLUSION CRITERIA 
 
1) Patients of any gender age 13 to 17 years. 
2) Understand written and spoken English. 
3) Willing and able to complete study procedures. 
4) Patients presenting to the emergency department (ED), observation, or hospitalized for 
suicide risk OR seeking other mental health services regardless of suicide risk. 
 
YOUTH PARTICIPANT EXCLUSION CRITERIA 
 
1) Patients with active psychosis. 
2) Patients experiencing substance withdrawal. 
3) Patient unwilling or unable to wear a mask during in person study procedures, if 
mandated due to current COVID/health safety guidelines. 
4) Any other psychiatric or medical condition or custody arrangement that in the 
investigators’ opinion would preclude informed consent or assent or participation in the 
trial. 
 
 
Inclusion criteria for parents/guardians includes: 18+ years, understand written and 
spoken English, parent/guardian of a child participating in Aim 1, and willing and able to 
complete study procedures. 
 
Inclusion criteria for mental health providers, clinical administrators and representatives 
from health plan providers includes: 18+ years, understand written and spoken English, 
and willing and able to complete study procedures. 
 
AIM 2: Participants are hospitalized youth patients who have acute suicide risk, their 
respective parents/guardians, and the support adults each youth nominates. 
 

 
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YOUTH PARTICIPANT INCLUSION CRITERIA 
 
1) Patients of any gender age 13 to 17 years. 
2) Inpatient psychiatric patients who have attempted suicide or have documented SI and a 
plan to harm themselves at admission. 
3) Understand written and spoken English. 
4) Own a smartphone or mobile phone. 
5) Willing and able to complete enrollment procedures. 
6) Parent or guardian and youth able to understand the nature of the study and provide 
written informed consent and assent for youth 
7) Patients who are able to provide at least one verifiable contact for emergency or tracking 
purposes. 
 
YOUTH PARTICIPANT EXCLUSION CRITERIA 
 
1) Patients with active psychosis. 
2) Patients experiencing substance withdrawal. 
3) Currently enrolled in other treatment studies for the symptoms and behaviors targeted. 
4) Patient unwilling or unable to wear a mask during in person study procedures, if 
mandated due to current COVID/health safety guidelines. 
5) Patients who in the judgment of the investigator would have an unfavorable risk or 
benefit profile with respect to eYST. 
6) Any other psychiatric or medical condition or custody arrangement that in the 
investigators’ opinion would preclude informed consent or assent or participation in the 
trial. 
 
Inclusion criteria for parents/guardians includes: 18+ years, understand written and 
spoken English, own a smartphone or mobile phone, parent/guardian of a child 
participating in Aim 2, and willing and able to complete study procedures. 
 
Inclusion criteria for support adults includes: 18+ years, understand written and spoken 
English, own a smartphone or mobile phone, nominated by a child participating in Aim 2, 
and willing and able to complete study procedures. 
 
7. PARTICIPANT RECRUITMENT 
AIM 1: Four youth, four parents, four mental health providers and four clinical 
administrators/health plan representatives will be recruited from clinical sites that our study team 
is affiliated with in Connecticut and Michigan (e.g., Psychiatric Emergency Services, Michigan 
Medicine). 
At Michigan Medicine, the study team will work with clinical/hospital staff to identify 
potentially eligible participants. After verifying inclusion criteria, the study team will reach out to 
potentially eligible participants and provide a brief introduction about the study (verbally in-
person/virtual meeting or via email/phone). Those who express interest will be provided with 

 
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additional study information (e.g., time duration, compensation, the voluntary nature of their 
participation etc.).  
Providers, hospital staff, or health care representatives will be contacted via 
email/phone/in person.  
If the potential participant does not respond , the staff at Michigan Medicine will send 
additional reminders (via email or phone), up to three times 
Parents and youth will be recruited in person (or during a virtual meeting) while the youth 
is in care. If research staff cannot connect with parent while they are visiting the unit (virtually or 
in-person), research staff will reach out to the parent via phone or email (information attained from 
medical record). If the parent does not respond, up to two additional attempts will be made to 
reach them.  
 
If a potential participant indicates interest, they will be given information so that they can reach 
out to the staff at Oui Therapeutics. Additionally, the study team at Michigan will attain contact 
information from eligible participants (including name, email, phone number) and provide this 
information to Oui Therapeutics. Oui Therapeutics staff will reach out to potential participants (or 
potential participants will reach out to Oui Therapeutics). Oui Therapeutics staff will then conduct 
the remaining procedures of Aim 1 (under WCG IRB approval) including consent/assent 
procedures and the stakeholder interviews.  
 
AIM 2: Twenty youth, 20 parents/guardians, and up to 80 supporting adults will be enrolled 
in the trial (up to 120 participants total). 
The study team will work with hospital staff in the psychiatric inpatient unit at Michigan 
Medicine to identify eligible participants. Eligible participants will be invited to participate in the 
study while they are patients in the psychiatry unit, or following discharge. The detailed 
recruitment procedures are as follows: 
1) Eligible parents (as identified by the research staff) will be invited to meet with a study 
clinician virtually via telephone/video call or in a private room located in the facility 
(depending on preference and feasibility). The parent will be provided information about 
the study’s purpose, procedures, risks and benefits. If the parent/guardian is interested 
in having the youth participate in the study, they will be asked for permission to talk to 
the patient about the study. The parent may or may not be part of the discussion 
between the adolescent and study clinician.  The study staff will share the study’s 
purpose, procedures, and risks and benefits with the patient. 
a. If research staff cannot connect with parent while they are visiting the unit 
(virtually or in-person), research staff will reach out to the parent via phone or 
email (information attained from medical record). If the parent does not respond, 
up to two additional attempts will be made to reach them. If the parent does 
respond and expresses interest, a time will be set aside to talk to teen (via video 
or call) and the “Aim 2 YST recruitment script for youth and parents (verbal in-
person or via telephone/video call)” will be used.   
2) If the patient is willing to be part of the study, both the parent and patient must provide 
consent and assent, respectively. The consent forms will include a discussion of 
confidentiality and that the support adult will receive information on the youth’s diagnosis 

 
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and treatment plan. A copy of the signed assent and consent forms will be given to the 
participants and a signed copy will be retained at the study site. 
3) Enrolled patients will undergo baseline assessments (see Section 8.1 Assessments) 
before the intervention begins. 
4) The research staff will provide patients and parents with a link to the eYST website and 
a unique code to create their profiles. 
5) Research staff may reach out to parents and youth via telephone/video and complete 
portions of the recruitment/enrollment process fully virtual (depending on family 
preference and feasibility). 
6) Through the patient profile, the patient will be asked to nominate up to four adults (who 
will become support adults, if they opt into the study). Youth will be encouraged to 
choose adults from different spheres of life (e.g. family member, teacher, and religious 
leader, etc.) who have a good and supportive relationship with the patient. 
7) The parent will receive a notification to review and approve the nominated support 
adults. The notification will have a link to their parent profile where they may click to 
approve or disapprove of the nominated support adults.. If the parent disapproves of any 
of the nominees, the parent will be asked to discuss their decision with the patient and 
the patient may be given the opportunity to identify a suitable substitute. 
8) Following parental approval, an automated email and/or text communication will be sent 
to the nominated adults (up to four attempts), which will contain a link where study 
information is presented (i.e., required elements of informed consent as part of informed 
consent waiver requested). After reviewing this information, they will have an option to 
accept or deny the invitation to participate in the eYST research study. If the nominated 
adult does not respond to the invitation, the YST intervention specialist (YST-Is) may 
reach out via phone (up to two attempts) to ensure communication was received and 
address any questions. 
9) Support Adults who accept the invite may have a call with a member of the research 
team to further discuss the study, responsibilities, benefits and risks. Additionally, at the 
start of the orientation session, Support Adults will have an opportunity to ask any 
questions about the eYST research study.  If the research team determines that a 
support adult is not suitable for the role, the YST-Is will report that concern to the 
Principal Investigator (PI) and Co-Investigators.  
 
Given that our population will include patients who may have arrived at the hospital in crisis 
and our procedures have the potential to cause emotional distress, participants will not be 
recruited for the study on the first day of admission. 
 
Waiver of HIPAA Authorization 
A waiver of HIPAA Authorization will be requested so that the study team can review medical 
records of potentially eligible patient participants. Research staff will be trained on specific steps 
and procedures for collecting data from patient participants’ medical record (e.g., search for self-
injury and suicide attempt ICD codes) and the patients’ care team. 
 
8. STUDY ASSESSMENTS AND PROCEDURES 

 
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AIM 1: The following procedures will be completed by Oui Therapeutics (under WCG 
IRB approval): After providing informed consent or assent, parents and youth will complete 45-
60 minute interviews separately. Other stakeholders will choose a 45-60 minute individual or 
group interview with their peers. Interviewers will follow semi-structured interview guides to 
gather information on factors that influence uptake, implementation, and sustainability of eYST. 
Interviews will be conducted via video call or telephone. If feasible and preferred, 
interviews may be conducted in person. Interviews will be audio/video recorded to aid in data 
analysis. Participants will complete a standard demographics form after the interview.  
 
AIM 2: Adolescents who are eligible to participate and assent and whose parents 
provide consent will formally start eYST by completing the support person nomination process 
while receiving inpatient care. This step can also be completed following discharge, as needed. 
Study participants will also be asked to complete baseline assessments (described below in 
Section 8.1 Aim 2 Assessments) while receiving inpatient care. 
Once support adults enroll into the study, they are asked to watch a training video to 
learn about psychosocial health for youth. They will then have a telephone/video call with a 
member of the research team to learn about the patient’s specific psychosocial needs and how 
to best engage the patient during the intervention. The telephone/video call will be audio/video 
recorded for fidelity purposes. 
eYST implementation. During inpatient hospitalization, the youth and parent are 
directed to the eYST website by a clinician. eYST will be delivered as described above in 
Section 2.2.1 Platform Overview. During follow-up, support adults will be able to use the eYST 
website to communicate with the Intervention Specialist at their leisure throughout the study, in 
addition to the 12      automatic check-ins. At the 12      eYST automatic check-ins, support 
adults will be asked to select preferred times for the Intervention Specialist to schedule a 
telephone/video call with support adults to provide additional support (12      expected 
video/telephone check-ins during the 12-week intervention). The telephone/video calls will be 
audio/video recorded for fidelity purposes. 
Adolescents, parents, and support adults will complete follow-up assessments at weeks 
4, 8, and, 12, as described in Assessment Table 1.  
In addition to follow-up assessments, support adults will be asked to complete 12      
electronic progress forms (via the eYST platform) regarding their social support of the 
adolescent during the intervention period.  
8.1 
AIM 2 ASSESSMENTS 
We will collect assessment data from multiple stakeholders (youth, parents, and support 
adults). In addition to self-report scales, semi-structured interviews will be completed with a 
clinician and/or study staff via telephone/video call (see Assessments table below; Assessment 
schedule described in Table 1). Each youth assessment session will begin by confirming via 
telephone/video whether the youth and guardian are together. If they are not, the YST-Is will 
schedule another assessment session.  
 

 
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Assessment 
Construct 
Description 
Primary Effectiveness Outcome 
System Usability 
Scale (SUS) 
 
Usability 
 
We will use the SUS and also conduct a semi-structured user feedback 
interview to systematically capture usability and acceptability. The SUS is a 
valid and reliable, 10-item measure that can be used to effectively 
differentiate between usable and unusable systems by youth and adults. 
Scores range from 0 to 100. We will calculate the mean score. A mean score 
of 68 is the minimal indicator of usability. 
Frequency and 
Duration of App 
Use 
Usability 
Frequency and duration of app use will be tracked for each participant. We 
will record the number of logins and duration of logins. 
Secondary Outcomes  
Feasibility of 
Intervention 
Measure (FIM) 
Feasibility 
A 5-item scale that measures the extent to which a new treatment, or an 
innovation, can be successfully used or carried out within a given agency or 
setting. 
Acceptability of 
Intervention 
Measure (AIM) 
Acceptability 
A 5-item scale that measures the perception among implementation 
stakeholders that a given treatment, service, practice, or innovation is 
agreeable, palatable, or satisfactory. 
Intervention 
Appropriateness 
Measure (IAM) 
Perceived 
Intervention 
Appropriateness 
A 5-item scale that measures the perceived fit, relevance, or compatibility of 
the innovation or evidence-based practice for a given practice setting, 
provider, or consumer, and/or perceived fit of the innovation to address a 
particular issue or problem. 
Client 
Satisfaction 
Questionnaire 
(CSQ-I) 
Satisfaction 
The CSQ-I is a valid and reliable scale for measuring overall satisfaction with 
health and human services, including digital or internet-based interventions 
(Boss et al., 2016; Miglietta et al., 2018). This will be adapted for 
use with youth, parents and support adults. 
Exploratory Outcomes  

 
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Assessment 
Construct 
Description 
User feedback 
questions  
 
 
Usability 
All stakeholders will answer open-ended questions related to the eYST 
website features to obtain feedback regarding the social support program 
for future improvements.  
Suicide Ideation 
Questionnaire Jr 
(SIQ-JR) 
Suicide Ideation 
The SIQ - JR is a 15-item, validated self-report scale that is part of the 
PhenX Toolkit (Reynolds, 1987). It assesses suicidal thoughts over the 
past month. Items are rated on a 0-6 scale that captures the frequency of 
the thoughts of adolescents. 
Patient Health 
Questionnaire-2 
(PHQ-2) 
Depression 
 
The PHQ-2 is a self-administered and validated tool to measure depressive 
symptoms (Kroenke et al., 2003). The PHQ-2 inquires about the 
frequency of depressed mood and anhedonia over the past two weeks. The 
PHQ-2 includes the first two items of the PHQ-9 (Kroenke et al., 2001). 
Family, School, 
and Peer 
Connectedness 
(FSPC) 
Connectedness 
We will use the three 2-item scales to assess Family, Peer and School 
connectedness, which have shown predictive validity for adolescent suicide 
attempt outcomes (King, Grupp-Phelan, et al., 2019). This brief 
scale was adapted from the previously validated Parent-Family 
Connectedness Scale (Resnick et al., 1997), the School Connectedness 
Scale (Resnick et al., 1997) and the Adolescent Connectedness Scale 
(Karcher & Sass, 2010). 
Social Provisions 
scale (SPS) 
Connectedness 
Connectedness will be assessed using the validated SPS (Cutrona & 
Russell, 1987). This scale is a 24-item scale that consists of six subscales 
to measure the availability of social support: emotional support or 
attachment, social integration, reassurance of worth, tangible help, 
orientation, and opportunity for nurturance. 
Sources of 
Strength Coping 
Scale 
Connectedness 
The Sources of Strength Coping Scale (Wyman et al., 2010) assesses 
the extent to which youth view resources (e.g. family, friends, adult 
mentors, services, etc.) as helpful to them. We will use this scale to assess 
adolescents’ perceptions of the availability of guidance, attachment, and 
reassurance of worth from adults in their lives. 

 
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Assessment 
Construct 
Description 
Columbia-Suicide 
Severity Rating 
Scale (C-SSRS) 
Adverse Events 
related to 
Suicidal Ideation 
and/or Behaviors 
Adverse event monitoring will be assessed with the Columbia-Suicide 
Severity Rating Scale (C-SSRS). The C-SSRS is a semi-structured, rater-
based interview to assess the severity and intensity of SI and behaviors 
(Mundt et al., 2013). 
 
Demographics, 
Contact, and 
Information 
Form 
Interviewer will ask participants their age, gender identity, sex, 
race/ethnicity 
 
Medical 
Abstraction Form 
Current psychiatric diagnoses will be obtained by reviewing admission 
reports and electronic medical records. 
 
Medication use 
Youth medication use will be recorded using a combination of medical record 
review and parent/youth interview. The following information will be 
recorded for each medication: name, indication, dose, frequency, start, and 
end date. 
Cornell Services 
Index (CSI) 
Treatment 
Utilization 
Treatment utilization will be assessed using the CSI, an interview-based 
method that assesses engagement in health treatment (e.g., outpatient 
psychotherapy, inpatient hospitalization). 
Chronic Health 
Conditions 
Questionnaire 
(CHCQ) 
Chronic Health 
Conditions 
A 31-item questionnaire adapted from the National Survey of Children’s Health (2022) to obtain 
current and past chronic health conditions and their severity among youth participants. 
Adolescents’ use 
of ‘caring adult’ 
support 
Quality/Frequenc
y of support 
The Adolescents’ use of ‘caring adult’ support will ask youth about their 
interactions with their support adults to better understand how they are 
using eYST for social support. 
eYST platform 
measures 
Youth concerns 
and support 
progress 
Parents will provide information about current concerns for youth.  
Support persons will complete 12      weekly check-ins via the eYST 
platform to indicate progress with youth.  
 
8.2. 
INFORMED CONSENT 
IRB-approved study staff will inform potential participants about the voluntary nature of 
their participation and that their data will remain confidential. We will inform participants that we 

 
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have an NIH certificate of confidentiality. We will communicate the limits of confidentiality, which 
include reports of imminent suicide risk, homicide risk, abuse of vulnerable individuals (e.g., 
minors, elderly, and individuals with intellectual disability), and compliance with federal, state, or 
local laws. In these instances, we will report to the appropriate authorities and/or provide 
participants with referrals for immediate treatment. Participants will also be informed that they 
have the right to not participate, or to stop participating in the study at any time. Participants will 
be allowed as much time as needed to consider the information, and the opportunity to question 
the PI, his/her General Practitioner (GP) or other independent parties to decide whether they will 
participate in the study. 
Written consent will be obtained by means of a dated signature of the participant and a 
dated signature of the person who presented and obtained the informed consent. The person who 
obtained the consent must be suitably qualified and experienced and have been authorized to do 
so by the PI. A copy of the signed Informed Consent/Assent will be given to the participant. A 
signed copy will be retained at the study site. 
 
AIM 1 (completed by Oui Therapeutics): 
Youth participants must assent to the study. Assent may be given in person on hard copies 
or electronically. 
All other participants 18+ years of age (i.e., parents, mental health providers, clinical 
administrators, and health plan representatives) must provide written consent. Written consent 
may be given in person on hard copies or electronically. 
 
AIM 2 (completed by UM Team): 
Youth participants must assent to the study. Assent may be given in person on hard copies 
or electronically. Youth participants who turn 18 years old while still enrolled in the study will 
provide consent after they turn 18, prior to any further study assessments. Written consent may 
be given electronically. 
Parents/guardians of patients must provide written consent. Written consent may be given 
in person on hard copies or electronically. 
 
Waiver of Written Consent 
We are requesting a waiver of written consent for the adult support persons only. Given 
that we will not be collecting health-related information (only collecting basic demographic 
information and perspective on the usability and functionality of the eYST platform for support 
persons) and that this research presents minimal risk, we plan to reach out to support persons 
(via text/email or call) and provide a link that details study and program information. After 
reviewing this information, support persons will be provided with an option to opt into the study 
and the eYST program. Information provided will specify the elements required for informed 
consent. Participants will be provided with study contact information to use if they wish to 
discuss questions and concerns. Additionally, an opportunity for questions and to discuss 
details of the eYST study will be provided at the support person orientation session.  
 
8.3  
SCREENING AND ELIGIBILITY ASSESSMENT 

 
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AIM 1: At the University of Michigan, the study team will work with clinical/hospital staff 
to identify potentially eligible participants. 
At Oui Therapeutics, researchers will work with their business associates to identify 
potentially eligible adult participants for the interviews with mental health providers, clinical 
administrators, and health plan representatives. 
 
AIM 2 (conducted by UM team):  The research staff will identify eligible patients by 
working with clinical staff on the psychiatric inpatient unit and reviewing hospital records daily, 
and invite the patients’ parents to learn about the study. 
 
8.4  
PARTICIPANT ENROLLMENT 
AIM 1 (conducted by Oui Therapeutics): Eligible participants interested in study 
participation will schedule their interview with the Oui study team. Oui will share the consent form 
with participants prior to their interview. Consent may be given prior to the interview or at the 
beginning of the interview. Participants will be reminded of any audio/video recording at the 
beginning of the interview. 
 
AIM 2 (conducted by UM team): 
After 
providing 
informed 
consent/assent, 
the 
research team will administer a structured clinical interview focused on medical and suicide 
attempt history. Participants will also be directed to the eYST website to begin the trial with an 
eYST introduction and support adult nominations, as described above in Section 2.2.1 Platform 
Overview. 
 
8.5  
CONCOMITANT MEDICATIONS/PSYCHOTHERAPY 
All concomitant medications will be recorded at the Baseline Visit. The following 
information will be recorded for each medication: name, indication, dose, frequency, start date, 
and end date. Participation in outpatient psychotherapy will also be recorded with the Cornell 
Services Index (CSI). 
 
8.6  
RETENTION METHODS 
Patient and parent/guardian:  
1) When the adolescent does not show up to scheduled meetings with their support adults, 
the support adult will be encouraged to reach out to the adolescent to determine the best 
way to engage the adolescent. The support adult can also consult with YST-Is during the 
check in calls with the specialist to determine the best way to keep the adolescent 
engaged. 
2) Patients will receive gift cards at the end of each follow-up session as compensation for 
their participation, as described below in Section 8.7 Participant Remuneration. 
3) Parents will also receive a gift card as compensation for their participation in the 
feasibility testing, as described below in 8.7 Participant Remuneration. 
 
Support Adults:  

 
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1) We have intentionally excluded the adolescent’s peers in this role. Prior research by Dr. 
King shows that peers have a higher dropout rate than adults. 
2) Support Adults will have 12      scheduled check in meetings with the YST-Is. This 
communal expectation and coordination are expected to lower the dropout rate. 
3) The frequent meetings with the YST-Is will provide abundant support and guidance for 
the support adults. This too will minimize dropout rate because the YST-Is may quickly 
assuage any frustration and uncertainty that the support adult may have.  
4) Support adults will receive a gift card as compensation for their participation in the 
feasibility testing, as described below in 8.7 Participant Remuneration. 
 
8.7  
PARTICIPANT REMUNERATION 
AIM 1: 
Participants will be remunerated with a $25 gift card for completing a feedback form 
following their interview. 
 
AIM 2: 
All youth participants will be remunerated with a $25 gift card for completing the baseline 
assessment, a $25 gift card for completing the 4 week follow-up and $35 for completing the final 
12-week assessment. The maximum total payment amount is $85 in gift cards per participant.  
Parents will be remunerated with a $25 gift card for completing the 4 week assessment 
and a $35 gift card after completing the 12 week follow up assessment. The maximum total 
payment amount is $60 in gift cards per parent. Support persons will receive a $35 gift card for 
participation in the 12     -week follow. All disbursement will be documented. 
 
9. STUDY DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL 
9.1  
DISCONTINUATION OF STUDY SITE OR STUDY 
 
The Sponsor has the right to terminate the study at any time. Reasons for site 
discontinuation include: 
● Conduct of the study is not in accordance with the GCP guidelines 
● Repeated failure to complete documentation (source documents or eCRFs) / 
quality of data 
● Failure to obtain Informed Consent 
● Failure to report Serious Adverse Events (SAEs) within 24 hours of knowledge 
● Repeated protocol deviations 
● Failure to enroll an adequate number of subjects 
 
The Study Sponsor also reserves the right to discontinue the entire study. Reasons the 
entire study could be discontinued include, but are not limited to: 
● SAEs or if special circumstances concerning the eYST intervention or the company 
itself occur, making further treatment of subjects impossible 
 

 
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In the event of site or study discontinuation, the study investigator(s) will be informed of 
the reason for study termination. Study materials must be returned, disposed of or retained as 
directed by the Study Sponsor. 
 
9.2  
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants (patients, parents, or support adults) may voluntarily withdraw from the 
study at any time. Patients may notify the study clinician by calling the phone number(s) listed 
on the informed consent document. Support adults may do the same or contact the YST-Is. An 
exit interview to gather information about their experience with study may be conducted. 
Participants may be withdrawn from the study by the PI if they are unable to be contacted (lost 
to follow-up), become incarcerated or incapacitated, or are determined to be adversely affected 
by the program.  
 
10. SAFETY 
10.1  SAFETY HYPOTHESIS 
eYST is safe for use by individuals with a previous history of suicidal ideation and 
attempts and their support network (i.e., parents and nominated adults). 
 
10.2 
ADVERSE EVENTS 
 
Adverse Events (AEs) will be monitored and documented at each study visit. Reporting 
of AEs will follow Michigan Medicine Institutional Review Board Policy and NIMH policy. Given 
that all enrolled participants will have a history of suicidal ideation with plan, AEs related to 
suicidal thoughts/behaviors will be categorized as “expected”.  
 
10.3 
RATIONALE FOR IDENTIFICATION OF ADVERSE CLINICAL EVENTS 
The proposed study protocol is based on previous trials of YST. Anticipated adverse 
clinical events are therefore derived from these previous trials. The YST developers have 
observed the following adverse events in their studies: 
● suicidality 
● suicidality-related hospitalization 
 
10.4 
EXPECTED ADVERSE EVENTS IN PARTICIPANTS 
Given that all enrolled patient participants will have a history of suicidal ideation with 
plan, AEs related to suicidal thoughts/behaviors will be categorized as “expected”. 
Therefore, primary anticipated events include: 
● increased suicidal ideation and behavior 
● suicide-related hospitalization 
 
Any study participation related adverse events are to be followed until there is evidence 
of resolution or permanent change. 

 
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The determination of whether an adverse event is classified as a SAE is based on the 
definitions below, taking into account the clinical judgment of the investigator. 
 
10.5 
SERIOUS ADVERSE EVENTS 
AEs meeting any of the following criteria will be categorized as “Serious”:  
● results in death 
● is life-threatening (places the subject at immediate risk of death from the event as 
it occurred) 
● requires inpatient hospitalization or prolongation of existing hospitalization 
● results in a persistent or significant disability/incapacity 
● results in a congenital anomaly/birth defect 
● an important medical event, based upon appropriate medical judgment, may 
jeopardize the subject’s health and may require medical or surgical intervention 
to prevent one of the other outcomes listed in this definition, or 
● results in a severely debilitating situation for the subject, such as psychological 
distress, financial hardship or damaging impact on social standing or 
employability 
 
 
Suicidal behavior is an expected outcome of preexisting psychiatric illness. Suicidal 
behaviors that occur as a result of preexisting psychiatric illness will not be classified as an SAE 
unless they are associated with the use of the eYST website and also meet the SAE criteria listed 
above. 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, they 
may jeopardize the participants’ ability to participate and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. 
 
Planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol, without serious deterioration in health, is not considered a SAE. 
 
A SAE may or may not be considered related to study participation. 
 
10.6 
REPORTING OF ADVERSE EVENTS 
AEs which are unexpected, related, and serious will be reported to the Michigan 
Medicine IRB within 7 calendar days and to the NIMH PO within 10 business days. Death 
related to the study will be reported to the NIMH PO within 5 business days. All other AEs will 
be documented and reported to Michigan Medicine IRB and NIMH PO at the time of the 
respective annual progress reports. 
 
10.7 
REPORTING PERIOD 
In this study, all adverse events are collected starting at the time informed consent has 
been signed. AEs are collected until the last study visit and exit from the study. 
 
10.8 
SAFETY MONITORING AND REPORTING 

 
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Suicidal ideation/behaviors and other clinical outcomes will be assessed at the Week 0 
and Week 12 follow-up assessments. Week 0 is the study baseline assessment, which occurs 
while the participant is housed in an inpatient treatment facility. For purposes of risk 
management, results of the study assessment at Week 0 will be shared with the inpatient 
treatment team in order to provide information relevant to their treatment/discharge planning. 
The 12 week follow up assessment is conducted by phone. In order to facilitate risk 
management during study interview calls, we will do the following: 
1) Only enroll participants who are able to provide at least one verifiable contact for 
emergency or tracking purposes; 
2) Obtain location information at the start of each phone assessment; and  
3) Schedule assessments at a time when the parent/guardian is present at the same 
location as the participant.  
 
Each youth assessment session will begin by confirming via telephone/video whether the 
youth and guardian are together. Increases in suicide risk will be communicated to the 
parent/guardian and outpatient provider (see Appendix B). . In addition, interviewers will engage 
in risk management interventions as clinically indicated following the guidelines outlined in the 
Risk Management Plan (see Appendix B). Participants will be informed that information they 
input to the digital platform is not monitored for purposes of risk assessment. 
 
11. CLINICIAN TRAINING AND SUPERVISION 
The original YST manual and measure will be updated to fit the eYST procedures. The 
eYST platform will provide explicit guidelines (including model scripts) to clinicians regarding 
intervention components (e.g., facilitating youth nominations, conducting the support adult 
psychoeducation sessions and check-ins). YST-Is will be licensed mental health professionals 
with training and experience in adolescent mental health and suicide risk assessment. YST-Is 
will complete YST-specific training and must successfully complete a certification exam that 
assesses knowledge of YST components and intervention competencies (via roleplays of 
psychoeducation session units and telephone check-ins). Additionally, weekly supervision will 
be provided (individually or in small groups) to YST-Is by a clinical psychologist. 
All psychoeducation and weekly check-in sessions will be taped with 25% of sessions 
reviewed by Dr. Arango and/or Dr. King for clinical supervision and for coding of the successful 
completion of key components. In addition, YST-Is will complete session checklists following 
each psychoeducation session as a self-check for coverage of key components. 
 
12. STATISTICAL CONSIDERATIONS  
12.1 
STATISTICAL PROCEDURES AND DATA ANALYSIS 
12.1.1 Primary Effectiveness: Definition of Success (or Failure) of the Endpoint 
 
AIM 1: We will use content analysis to identify themes from qualitative data(Hsieh & 
Shannon, 2005). Using two raters, transcribed responses will be grouped into themes and a 
summary of lessons learned. Our team will identify required adaptations for implementing and 
adopting eYST and use these findings to advise on all subsequent eYST development. We will 

 
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use the Consolidated Criteria for Reporting Qualitative Research Checklist (COREQ) (Tong et al., 
2007) to provide a detailed report of all qualitative research methods used in our project. 
 
AIM 2: For quantitative data, descriptive statistics will be calculated to examine feasibility 
and acceptability, including rates of recruitment and eligibility, completion of eYST tasks (for each 
user type) and completion of assessment appointments. The benchmark for success is for eYST 
to be rated as usable (i.e. average System Usability Scale (SUS) score = 68 or above). Also, 
eYST’s feasibility measures, such as percentage of nominated adults agreeing to participate in 
the study and percentage of youth having 3 or more adults participating in the psychoeducation 
session, must be comparable to metrics from prior YST studies.  
 
12.1.2 Rationale 
 
A single arm design (vs. a controlled design) is appropriate as the workflow for eYST has 
not been implemented elsewhere. At the end of this study, we will know how to support 
implementation fidelity, which is key for a future RCT. 
 
Missing data: For missing post-tests, we will use a last observation carried forward imputation, as 
more sophisticated missing data methods are not appropriate for our sample size. 
 
12.1.3 Justification of sample size-suicide attempts 
No power calculation was used to determine sample size because this is an exploratory 
feasibility study (Jones et al., 2003). Research shows that 5 participants are sufficient to detect 
80% of usability issues (Bailey, 2005; Nielsen & Faber, 1996)  and 15 are sufficient to detect 
serious usability issues (Spool & Schroeder, 2001). Therefore, we plan to recruit 20 youth 
participants, accounting for dropouts.  
We will not make conclusive statements about intervention effects due to the small 
sample size, the single arm design and the fact that clinical improvement may be expected with 
the passage of time (i.e., without eYST), especially post inpatient admission. 
 
12.1.5 Secondary Endpoints 
Analysis of our exploratory outcomes associated with YST including suicidal thoughts 
and behaviors, healthcare service utilization, and perception of social support will be conducted 
only to document the extent and variation of change across subjects. The results of these 
analyses will be interpreted with great caution given the small sample size and single arm 
design. Clinically Significant Change (CSC) is a metric that can be applied to assess within 
patient change at the individual level. We will document the percentage of participants who 
experience CSC from baseline to 12 weeks on the outcomes of interest using procedures 
described by Morley and Dowzer (Morley & Dowzer, 2014). We will compare patterns of change 
from baseline to follow-up periods to parallel data from a former RCT of YST (King et al., 2009). 
 
 
12.2 
ADDITIONAL CONSIDERATIONS 
Staff training at study initiation 
1. Trained/Designated Staff: There will be designated research staff who will be trained to 
collect study outcomes. 

 
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2. Clear Definitions and Electronic Data Capture: We will use a structured method for 
obtaining all study outcomes. For variables assessed, there will be clear definitions. Staff 
will receive training in how to apply those definitions and record them in the study 
electronic data capture (EDC) system. 
 
During study monitoring and support 
1. Study Monitoring and Data Fidelity Checks: The sponsor or its representative may visit 
the study facilities at any time (remotely and /or in person) in order to maintain current 
and personal knowledge of the study through review of the records, comparison with 
source documents, observation and discussion of the conduct and progress of the study. 
The clinical site will permit trial-related monitoring, audits, IRB/IEC review, and 
regulatory inspection(s) by providing direct access to source data/documents.  
2. Fidelity Checks: As part of study monitoring, we will conduct ongoing fidelity checks for 
the primary outcomes (and other variables of interest). During fidelity checks, records 
will be pulled randomly. If errors in coding the variables are observed, the nature of the 
error will be evaluated to determine whether study procedures need to be updated to 
improve clarity (though unlikely as we are using methodologies established in prior work) 
and/or staff require additional training in how to capture the study variables.  
 
Procedures for participants who drop out or are lost to follow-up 
If subjects drop out or are lost to follow-up, there will be agreements with the subject per 
the Informed Consent that the research staff can access different sources of information other 
than medical records. Additional sources of information will be the persons listed as individuals 
the research staff may reach out to if the research staff cannot contact the participants. The 
study team may also attempt to obtain final study assessments if possible before withdrawal of 
consent, as previously mentioned in Section 9.2 Participant Discontinuation/Withdrawal From 
The Study. 
 
13. APPROACH TO ENSURE INTEGRITY OF DATA TO SUPPORT PRIMARY ENDPOINTS 
13.1 
REDUCE LIKELIHOOD OF INACCURATE OR BIASED PATIENT REPORTS DURING 
ASSESSMENTS 
● Participants will be instructed to schedule their phone call during a time when 
they are free from distractions and can provide reliable and accurate responses. 
● Data will be collected by research staff or via the eYST platform. The Clinicians 
(PIs) may be responsible for patient care during study participation, so having 
independent research staff helps mitigate the risk of potential bias. 
13.2 
REDUCE LIKELIHOOD OF STAFF DEVIATING FROM THE DATA COLLECTION 
PROTOCOL 
● The data collectors will be trained on conducting the interviews and recording 
data. The training may include role-playing and simulations. Training will cover 
how to respond to adverse events. 

 
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● The data safety and monitoring plan will be shared with the clinicians. For 
example, they will be trained on how to differentiate an active suicide crisis from 
a person who has suicide intent. 
● Data collectors will receive ongoing supervision. 
● The study team will make appointments for assessments when there will not be 
distractions for the participants. 
● The EDC system will be programmed to validate data where feasible to ensure 
accurate reporting and to reduce data entry errors and incomplete data 
 
14. DATA SECURITY FOR EYST 
14.1 
CYBERSECURITY AND DATA COLLECTION 
Participant data (including electronic consent forms) will be stored on Michigan 
Medicine’s HIPAA compliant servers. Participants will be given an identification number, which 
will be matched to participant names in a password-protected electronic document, which will 
only be accessible to IRB-approved study staff. Only coded, de-identified data will be shared 
with our company through secure data transfer. 
The team at Oui has developed and implemented certain measures to ensure cybersecurity 
and data protection on previous digital platforms. eYST is built on the fundamental principle of 
anonymity with security and privacy engineered into the core design. This includes (1) applying 
a security framework, and (2) ensuring data segregation of Protected Health Information (PHI). 
The data will not retain participant names when entered into our system and will only be 
accessible by authorized users. Our measures to ensure cybersecurity and data protection 
include:  
1) Unique password-protected user accounts. 
2) Detailed user account enrollment. When users begin the enrollment process and have 
provided their access code, they will be prompted to fill in their identity information, 
including their name, date of birth, email address, etc., and a personal password to 
protect their account. The combination of both their enrolled phone number and personal 
password will authorize them access to the application on a supported mobile device. 
3) Strong password requirements. User passwords will be required to be 8 or more 
characters in length. 
4) Security and penetration testing. 
 
 
14.2 
SECURITY CULTURE 
The technology group’s primary tool to ensure security for the users will be by starting 
with a security culture. All server-side processes will be run in docker containers with minimal 
privileges. Access to non-development environments will be restricted to a few employees and 
our policy will require it to be used only in emergency measures and with oversight. 
14.3 
COMMUNICATION 
 
Connectivity to and within eYST will be severely restricted, and all communication will be 
encrypted. 

 
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14.4 
ROLE-BASED PRODUCTION ACCESS 
 
Access across all deployment tiers (development, beta, production) leverages a role-
based entitlement system that associates privileges with a certain role, which will be then 
associated with appropriate users to ensure comprehensive access management. 
14.5 
DATA ENCRYPTION 
 
All personally-identifiable information will be decrypted only in-memory and encryption 
keys provide a second check on access controls. 
 
eYST data is stored using Google Cloud Platform which ensures that all our data is 
encrypted in transit and at rest. 
14.6 
AUDITING 
 
All activity within, access of, and attempted access of eYST will be monitored, logged, and 
stored for anomaly detection and auditing. 
14.7 
TESTING 
eYST will be declaratively provisioned and will have an extensive testing process run with 
automated scripts. 
 
15. DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
Direct access will be granted to authorized representatives from the sponsor, host 
institution and the regulatory authorities to permit trial-related monitoring, audits and 
inspections.  
 
16. QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES 
The study will be conducted in accordance with the current approved protocol, ICH GCP, 
relevant regulations and standard operating procedures. Regular monitoring will be performed 
according to ICH GCP. Data will be evaluated for compliance with the protocol and accuracy in 
relation to source documents. Following written standard operating procedures, the monitors will 
verify that the clinical trial is conducted, and the data generated, documented and reported in 
compliance with the protocol, GCP and applicable regulatory requirements.  
 
17. KEY STUDY PERSONNEL 
OUI THERAPEUTICS, INC.: 
Patricia Simon, PhD (Principal Investigator) 
Dr. Simon will be responsible for the overall supervision and administration of the project. She 
will support this project by coordinating the clinical trial protocol and communicating with Co-
Investigators. As the Principal Investigator, Dr. Simon will assume primary responsibility for all 
aspects of the research project and will assure that milestones are met in a timely manner. 
 
Brian Keenaghan, MS (Operations Lead) 
Mr. Keenaghan will be responsible for coordinating project activities and managing different 
stakeholders. He will also coordinate meetings with research partners at the University 

 
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Michigan, facilitate team meetings, track progress and report on key milestones. Mr. Keenaghan 
will also assist Drs. Feuerstein and Simon with writing research reports, patent filings and 
papers that will result from this project.  
 
UNIVERSITY OF MICHIGAN/MICHIGAN MEDICINE: 
 
Alejandra Arango, Ph.D. UM Principal Investigator/Clinical Psychologist/Study Manager  
Dr. Arango is an Assistant Professor in the Department of Psychiatry at Michigan Medicine and 
a clinical child and adolescent psychologist. She has advanced training in intervention science 
and is a former doctoral student and ongoing scientific collaborator with Dr. King. Dr. Arango 
has multiple years of clinical experience working with youth at risk for suicide and is a trained 
YST intervention specialist. Dr. Arango will oversee the integrity of pilot study implementation 
with adolescents at the University of Michigan, train the YST-Is, and provide leadership for 
financial, personnel, and regulatory management of study activities at the University of 
Michigan. Dr. Arango will also have the following responsibilities: 1) provide day-to-day project 
management for the pilot study, assisting with the preparation of study operational guidelines, 
IRB applications, study protocol and assessment surveys, and risk management; 2) provide 
direct supervision to the clinical social worker, providing backup as needed; 3) supervise the 
research assistant in the completion of study follow-up assessments, assisting Dr. King with 
implementation of the risk management protocol; and 4) contribute to the interpretation of data 
and the preparation of the pilot study report.  
 
Cheryl King, PhD, Co-Investigator 
Dr. Cheryl King is a Professor and Director of the Youth and Young Adult Depression and 
Suicide Prevention Research Program in the Department of Psychiatry at Michigan Medicine. 
Her research focuses on the development of evidence-based practices for suicide risk 
screening, assessment, and intervention. She is currently the Principal Investigator of the NIMH-
funded project 24-Hour Risk for Suicide Attempts in a National Cohort of Adolescents. A clinical 
educator and research mentor, Dr. King has served as Director of Psychology Training and 
Chief Psychologist in the Department of Psychiatry. She is the lead author of Teen Suicide Risk: 
A Practitioner Guide to Screening, Assessment, and Management; has provided testimony in 
the U.S. Senate on youth suicide prevention; and is a Past President of the American 
Association of Suicidology, the Association of Psychologists in Academic Health Centers, and 
the Society for Clinical Child and Adolescent Psychology. Dr. King will provide ongoing input 
and expertise regarding the YST intervention and the implementation of the pilot and work with 
Dr. Simon to develop study operational guidelines, consider study protocol changes, interpret 
study findings, and prepare study reports.  
 
Social Worker/YST Intervention Specialist  
The Intervention Specialist will work under the direct supervision of Dr. Arango, an experienced 
YST intervention specialist, to implement YST with the 20 pilot study participants. 
Responsibilities include: 1) participation in YST intervention training and weekly supervision; 2) 
conduct support person nomination sessions with study participants; 3) conduct 
psychoeducation sessions with nominated adult support persons; 4) maintain weekly contact 
with nominated adults support persons; 5) implement risk management protocol. 

 
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Research Assistant 
The Research Assistant will work under the direct supervision of Drs. King and Arango and 
have primary responsibility for the following activities: 1) assist in preparation of IRB applications 
and required progress reports; 2) schedule and implement follow-up assessments for 20 pilot 
study participants; 3) assist in the preparation of preliminary data reports, poster and oral 
presentations, and manuscripts; and 4) assist with literature reviews and preparation of other 
study materials.  
 
18. ETHICS 
18.1 
DECLARATION OF HELSINKI 
 
The Investigator will ensure that this study is conducted in accordance with the principles 
of the Declaration of Helsinki.  
18.2 
ICH GUIDELINES FOR GOOD CLINICAL PRACTICE 
 
The Investigator will ensure that this study is conducted in full conformity with relevant 
regulations and with the ICH Guidelines for Good Clinical Practice (CPMP/ICH/135/95) July 1996. 
18.3 
APPROVALS  
 
The protocol, informed consent form, participant information sheet and any proposed 
advertising material will be submitted to an appropriate Institutional Review Board (IRB), 
regulatory authorities, and host institution(s) for written approval. The Investigator will submit and, 
where necessary, obtain approval from the above parties for all substantial amendments to the 
original approved documents.  
18.4 
PARTICIPANT CONFIDENTIALITY 
The trial staff will ensure that the participants’ anonymity is maintained. The participants 
will be identified only by a participant’s ID number on the eCRF and in any electronic database. 
All documents will be stored securely and only accessible by trial staff and authorized personnel. 
The study will comply with the Data Protection Act 1998 which requires data to be anonymized 
as soon as it is practical to do so. 
18.5 
OTHER ETHICAL CONSIDERATIONS 
Digital therapy: Concerns raised regarding the digital delivery of psychotherapy include 
confidentiality (Borcsa & Pomini, 2017; Martinez-Martin & Kreitmair, 2018; VA/DOD, 2019) and 
the absence of a mental health professional (Martinez-Martin & Kreitmair, 2018; Spence et al., 
2011). Therefore, the benefits (e.g., convenience, accessibility, and effectiveness) of digital 
psychotherapy must be assessed in contrast to associated risk of potential disadvantages and 
harms (Lawlor-Savage & Prentice, 2014). 
 
Research with vulnerable populations: In alignment with 45 CFR 46 subpart D, we include 
the additional safeguards below to protect the rights and welfare of children during this study. 
● Assent and Consent: Youth between the ages of 13 years and 17 years must give 
assent and at least one of their parents/guardians must consent to the study before 

 
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they are enrolled. Patients who turn 18 years old while still enrolled in the study 
will provide consent when they turn 18 years of age. Both assent and consent 
forms will be documented following the guidelines of the Institutional Review Board 
at the University of Michigan’s Child and Adolescent Psychiatry. 
● Additional risk: This study presents risks no greater than those of treatment as 
usual (TAU). This is because eYST digitalizes the coordination and training 
materials of the YST program. The YST program supports suicidal youth by 1) 
improving their treatment adherence and 2) addressing their negative perception 
of family and social support. These activities can be part of patients’ treatment as 
usual. 
19. DATA HANDLING AND RECORD KEEPING 
All study data will be entered on a HIPAA compliant software. ICH GCP requires that 
electronic data entry systems are validated, and that Standard Operating Procedures are 
maintained. The participants will be identified by a study specific participants number and/or code 
in any database. The name and any other identifying detail will NOT be included in any analytical 
data electronic file.  
20. FINANCING AND INSURANCE 
The funding for this study comes from the National Institute for Mental Health (NIMH). The 
sponsor has insurance arrangements and product liability in place.  
21. PUBLICATION POLICY 
Publication of study results is governed by the Research Agreement with The University 
of Michigan. 
 

 
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20. REFERENCES  
 
Arora, P. G., & Persaud, S. (2020). Suicide among Guyanese youth: Barriers to mental health 
help-seeking and recommendations for suicide prevention. International Journal of 
School & Educational Psychology, 8(sup1), 133-145. 
https://doi.org/10.1080/21683603.2019.1578313  
Bailey, B. (2005). The Value of Iterative Design. Get Involved. https://www.usability.gov/get-
involved/blog/2005/07/iterative-design.html 
Boss, L., Lehr, D., Reis, D., Vis, C., Riper, H., Berking, M., & Ebert, D. D. (2016). Reliability and 
Validity of Assessing User Satisfaction With Web-Based Health Interventions. J Med 
Internet Res, 18(8), e234. https://doi.org/10.2196/jmir.5952  
Child and Adolescent Health Measurement Initiative. National survey of children’s health (2022). 
Data Resource Center for Child and Adolescent Health supported by the U.S. 
Department of Health and Human Services, Health Resources and Services 
Administration (HRSA), Maternal and Child Health Bureau (MCHB). 
https://www.census.gov/content/dam/Census/programs-surveys/nsch/tech-
documentation/questionnaires/2022/NSCH-T2.pdf 
Chung, D. T., Ryan, C. J., Hadzi-Pavlovic, D., Singh, S. P., Stanton, C., & Large, M. M. (2017). 
Suicide Rates After Discharge From Psychiatric Facilities: A Systematic Review and 
Meta-analysis. JAMA Psychiatry, 74(7), 694-702. 
https://doi.org/10.1001/jamapsychiatry.2017.1044  
Cutrona, C. E., & Russell, D. W. (1987). The provisions of social relationships and adaptation to 
stress. Advances in personal relationships, 1, 37-67.  
Damschroder, L. J., Aron, D. C., Keith, R. E., Kirsh, S. R., Alexander, J. A., & Lowery, J. C. 
(2009). Fostering implementation of health services research findings into practice: a 
consolidated framework for advancing implementation science. Implement Sci, 4, 50. 
https://doi.org/10.1186/1748-5908-4-50  
Gipson, P., & King, C. (2012). Health Behavior Theories and Research: Implications for Suicidal 
Individuals' Treatment Linkage and Adherence. Cogn Behav Pract, 19(2), 209-217. 
https://doi.org/10.1016/j.cbpra.2010.11.005  
Glasgow, R. E., Vogt, T. M., & Boles, S. M. (1999). Evaluating the public health impact of health 
promotion interventions: the RE-AIM framework. Am J Public Health, 89(9), 1322-1327. 
https://doi.org/10.2105/ajph.89.9.1322  
Heron, M. (2021). Deaths: Leading Causes for 2019. Natl Vital Stat Rep, 70(9), 1-114. 
https://www.ncbi.nlm.nih.gov/pubmed/34520342  
Hsieh, H. F., & Shannon, S. E. (2005). Three approaches to qualitative content analysis. Qual 
Health Res, 15(9), 1277-1288. https://doi.org/10.1177/1049732305276687  
Institute of Medicine (US) Committee on Pathophysiology and Prevention of Adolescent and 
Adult Suicide. (2002). Barriers to Effective Treatment and Intervention. In S. K. 
Goldsmith, T. C. Pellmar, A. M. Kleinman, & W. E. Bunney (Eds.), Reducing Suicide: A 
National Imperative. National Academies Press (US). 
https://www.ncbi.nlm.nih.gov/books/NBK220944/  
Jones, S. R., Carley, S., & Harrison, M. (2003). An introduction to power and sample size 
estimation. Emerg Med J, 20(5), 453-458. https://doi.org/10.1136/emj.20.5.453  

 
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Kapur, N., Steeg, S., Turnbull, P., Webb, R., Bergen, H., Hawton, K., Geulayov, G., Townsend, 
E., Ness, J., Waters, K., & Cooper, J. (2015). Hospital management of suicidal 
behaviour and subsequent mortality: a prospective cohort study. Lancet Psychiatry, 2(9), 
809-816. https://doi.org/10.1016/S2215-0366(15)00169-8  
Karcher, M. J., & Sass, D. (2010). A multicultural assessment of adolescent connectedness: 
testing measurement invariance across gender and ethnicity. J Couns Psychol, 57(3), 
274-289. https://doi.org/10.1037/a0019357  
Kilbourne, A. M., Goodrich, D. E., Miake-Lye, I., Braganza, M. Z., & Bowersox, N. W. (2019). 
Quality Enhancement Research Initiative Implementation Roadmap: Toward 
Sustainability of Evidence-based Practices in a Learning Health System. Med Care, 57 
Suppl 10 Suppl 3, S286-S293. https://doi.org/10.1097/MLR.0000000000001144  
Kilbourne, A. M., Neumann, M. S., Pincus, H. A., Bauer, M. S., & Stall, R. (2007). Implementing 
evidence-based interventions in health care: application of the replicating effective 
programs framework. Implement Sci, 2, 42. https://doi.org/10.1186/1748-5908-2-42  
King, C., Arango, A., Kramer, A., Busby, D., Czyz, E., Foster, C. E., & Gillespie, B. (2018). 
Effect of a Youth-Nominated Support Team on 10- to 12-Year Mortality Outcomes of 
Suicidal Adolescents: An RTC. Journal of the American Academy of Child & Adolescent 
Psychiatry, 57(suppl), S260. https://doi.org/10.1016/j.jaac.2018.09.396  
King, C. A., Arango, A., Kramer, A., Busby, D., Czyz, E., Foster, C. E., Gillespie, B. W., & Team, 
Y. S. T. S. (2019). Association of the Youth-Nominated Support Team Intervention for 
Suicidal Adolescents With 11- to 14-Year Mortality Outcomes: Secondary Analysis of a 
Randomized Clinical Trial. JAMA Psychiatry, 76(5), 492-498. 
https://doi.org/10.1001/jamapsychiatry.2018.4358  
King, C. A., Grupp-Phelan, J., Brent, D., Dean, J. M., Webb, M., Bridge, J. A., Spirito, A., 
Chernick, L. S., Mahabee-Gittens, E. M., Mistry, R. D., Rea, M., Keller, A., Rogers, A., 
Shenoi, R., Cwik, M., Busby, D. R., Casper, T. C., & Pediatric Emergency Care Applied 
Research, N. (2019). Predicting 3-month risk for adolescent suicide attempts among 
pediatric emergency department patients. J Child Psychol Psychiatry, 60(10), 1055-
1064. https://doi.org/10.1111/jcpp.13087  
King, C. A., Klaus, N., Kramer, A., Venkataraman, S., Quinlan, P., & Gillespie, B. (2009). The 
Youth-Nominated Support Team-Version II for suicidal adolescents: A randomized 
controlled intervention trial. J Consult Clin Psychol, 77(5), 880-893. 
https://doi.org/10.1037/a0016552  
Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: validity of a brief depression 
severity measure. J Gen Intern Med, 16(9), 606-613. https://doi.org/10.1046/j.1525-
1497.2001.016009606.x  
Kroenke, K., Spitzer, R. L., & Williams, J. B. (2003). The Patient Health Questionnaire-2: validity 
of a two-item depression screener. Med Care, 41(11), 1284-1292. 
https://doi.org/10.1097/01.MLR.0000093487.78664.3C  
Lawlor-Savage, L., & Prentice, J. (2014). Digital Cognitive Behaviour Therapy (CBT) in Canada: 
Ethical Considerations. Canadian Psychology/Psychologie canadienne, 55, 231-239. 
https://doi.org/10.1037/a0037861  
Martinez-Martin, N., & Kreitmair, K. (2018). Ethical Issues for Direct-to-Consumer Digital 
Psychotherapy Apps: Addressing Accountability, Data Protection, and Consent. JMIR 
Ment Health, 5(2), e32. https://doi.org/10.2196/mental.9423  

 
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Aviva (OTX-202) 
      
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Miglietta, E., Belessiotis-Richards, C., Ruggeri, M., & Priebe, S. (2018). Scales for assessing 
patient satisfaction with mental health care: A systematic review. J Psychiatr Res, 100, 
33-46. https://doi.org/10.1016/j.jpsychires.2018.02.014  
Miranda, R., Ortin, A., Scott, M., & Shaffer, D. (2014). Characteristics of suicidal ideation that 
predict the transition to future suicide attempts in adolescents. J Child Psychol 
Psychiatry, 55(11), 1288-1296. https://doi.org/10.1111/jcpp.12245  
Morley, S., & Dowzer, C. N. (2014). Manual for the Leeds Reliable Change Indicator: Simple 
Excel(tm) applications for the analysis of individual patient and group data.  
Moskos, M. A., Olson, L., Halbern, S. R., & Gray, D. (2007). Utah youth suicide study: barriers 
to mental health treatment for adolescents. Suicide Life Threat Behav, 37(2), 179-186. 
https://doi.org/10.1521/suli.2007.37.2.179  
Mundt, J. C., Greist, J. H., Jefferson, J. W., Federico, M., Mann, J. J., & Posner, K. (2013). 
Prediction of suicidal behavior in clinical research by lifetime suicidal ideation and 
behavior ascertained by the electronic Columbia-Suicide Severity Rating Scale. J Clin 
Psychiatry, 74(9), 887-893. https://doi.org/10.4088/JCP.13m08398  
Nielsen, J., & Faber, J. M. (1996). Improving system usability though parallel design. Computer, 
29(2), 29-35. https://doi.org/10.1109/2.485844  
Resnick, M. D., Bearman, P. S., Blum, R. W., Bauman, K. E., Harris, K. M., Jones, J., Tabor, J., 
Beuhring, T., Sieving, R. E., Shew, M., Ireland, M., Bearinger, L. H., & Udry, J. R. 
(1997). Protecting adolescents from harm. Findings from the National Longitudinal Study 
on Adolescent Health. JAMA, 278(10), 823-832. https://doi.org/10.1001/jama.278.10.823  
Reynolds, W. M. (1987). Suicidal ideation questionnaire (SIQ). In. Odessa, FL: Psychological 
Assessment Resources. 
Spence, S. H., Donovan, C. L., March, S., Gamble, A., Anderson, R. E., Prosser, S., & Kenardy, 
J. (2011). A randomized controlled trial of online versus clinic-based CBT for adolescent 
anxiety. J Consult Clin Psychol, 79(5), 629-642. https://doi.org/10.1037/a0024512  
Spool, J., & Schroeder, W. (2001). Testing web sites: five users is nowhere near enough CHI 
'01 Extended Abstracts on Human Factors in Computing Systems, Seattle, Washington. 
https://doi.org/10.1145/634067.634236 
Substance Abuse and Mental Health Services Administration (SAMHSA). (2020). Treatment for 
Suicidal Ideation, 
Self-harm, and Suicide Attempts Among Youth (PEP20-06-01-002). S. A. a. M. H. S. 
Administration. 
https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/PEP20-06-01-
002.pdf 
Tong, A., Sainsbury, P., & Craig, J. (2007). Consolidated criteria for reporting qualitative 
research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual 
Health Care, 19(6), 349-357. https://doi.org/10.1093/intqhc/mzm042  
Wyman, P. A., Brown, C. H., LoMurray, M., Schmeelk-Cone, K., Petrova, M., Yu, Q., Walsh, E., 
Tu, X., & Wang, W. (2010). An outcome evaluation of the Sources of Strength suicide 
prevention program delivered by adolescent peer leaders in high schools. Am J Public 
Health, 100(9), 1653-1661. https://doi.org/10.2105/AJPH.2009.190025  
 
 

 
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APPENDIX A 
Title: Study Timeline 
Project Activities 
MONTHS 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 12 
1
3 
14 15 16 17 18 
Specific Aim 1: Develop a Beta Version of eYST 
Stakeholder Interviews + 
Collate Product Feedback 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assemble Resources + 
Develop Wireframes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete Designs + 
Finalize Content 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Deploy Beta + 
Stakeholder Meetings + 
Study Start-Up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Specific Aim 2: Conduct Feasibility and Usability Testing of the eYST Beta Version 
Enrollment Period (rate of 
4 patients/month) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3-month Intervention  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Legend 
 
On-Going Study Activities 
 

 
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No On-Going Study Activities 
 
 

 
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APPENDIX B 
Title: Risk Management Plan 
 
GUIDELINES FOR ALL PARTICIPANTS 
1. Attentive Listening, Empathic Listening, and Calmness during Assessments and 
Interactions 
It is important to listen carefully and try to understand the participant. The goals are to pay close 
attention, try to understand the adolescent’s distress, and take concerns and suicidal thoughts 
seriously. Attentive listening shows that the staff member cares. Empathic listening (“It sounds 
like you are feeling really down about what happened.”) will help the patient feel validated. This 
can decrease stigma and the sense that it is shameful to talk about personal concerns or 
suicidal thoughts. It is most important that staff never ignore or minimize concerns. We do not 
want an escalation of their risk behaviors in an effort to communicate the severity of their 
distress or psychological pain. When appropriate, it is also important to provide a statement of 
positive affirmation of the participant being willing to share this information with the staff 
member, both to validate and acknowledge the disclosure and to reinforce future sharing of this 
type of information. 
  
2. Suicide Risk Assessment 
The research staff member will review all available assessment information before terminating 
the interview to determine if the participant meets high risk criteria. Any indication of increased 
suicide risk will be followed up on as soon as possible. If the participant meets high risk criteria 
(described below and in the Action Plan), the research staff member will follow steps described 
in the Acton Plan, including contacting the supervising clinician on call in order to make a 
decision about next steps to be taken to evaluate the participant’s risk status. 
  
For non-adult participants, a parent/guardian will always be contacted prior to the interview to 
ensure they are reachable if they need to be contacted for safety concerns or 
recommendations. If a minor meets High Risk criteria, we will discuss the details of our 
concerns with both adolescents and parents. 
  
3. Good Documentation 
Careful monitoring of risk status over time and solid clinical decision-making require up-to-date 
documentation of each adolescent’s risk status. These will be kept in secured files where they 
will be available to the Principal Investigator and research staff. In addition to follow-up if 
participant meets high risk criteria, a risk status review will be conducted by the study Principal 
Investigator and/or Co-Investigator (Dr. Cheryl King & Dr. Alejandra Arango) on a regular basis 
to ensure that each participant’s risk status was correctly identified and recorded. These review 
documents will be kept securely.  
  
DETERMINATION OF RISK STATUS AND DEFINITION OF HIGH RISK 
If the adolescent expresses suicidal ideation or behaviors consistent with one or more of the 
high-risk criteria outlined below at the time of the baseline assessment or 3-month follow-up 
assessment, research staff will notify the attending/treatment team of information learned (if 

 
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during psychiatric inpatient stay) or the senior on-call clinician (if assessment occurs outside of 
inpatient unit) immediately. Follow-up assessments will be completed by phone by a trained 
study team member who will contact supervising clinician (PhD level, licensed clinical 
psychologist) immediately if a youth meets high-risk criteria.  
  
Definition of High Risk 
(1) Suicidal ideation in the past week with thoughts of a method, plan, or intent (C-SSRS items 
3-5) 
(2) A suicide attempt since baseline assessment (per C-SSRS) and no psychiatric evaluation 
was conducted following this attempt (no ED visit or psychiatric hospitalization). 
(3) A verbal statement of clear suicidal intent or a plan to attempt suicide. 
  
MANAGEMENT OF HIGH RISK STATUS 
1.  Procedures 
If a participant meets one or more of the above criteria, the project staff member may ask one or 
more of the following additional questions to help in determining next steps. Responses are 
recorded in the Action Plan form. 
  
In the last week... 
- Has the participant experienced suicidal ideation? 
- Has the participant thought of a plan for how to kill self? 
- Has there been alcohol or drug use? 
- Have there been any psychotic signs or symptoms? 
  
And… 
- Has the participant talked about their past week suicidal ideation or behaviors with a provider 
or with a guardian? 
- Does the participant have access to a firearm?  
- Is the participant currently in treatment with a psychiatrist, psychologist or social worker? If 
yes, when was the most recent appointment and when is the next appointment? 
  
2. Action Plan 
The staff member will contact the Principal Investigator or on-call Senior Clinician by pager or 
telephone. Based on the information available, this individual will decide if sufficient information 
is available to make a determination of risk status, and if so, the degree of risk for suicide. It is 
possible that the Project Director or on-call Senior Clinician will recommend that the participant 
and/or parent/guardian go to an emergency room or schedule an appointment (with Access or 
current mental health professional) in the near future. For any adolescent with High Risk status, 
this information will be shared with the adolescent’s parent/guardian. The On-call Senior 
Clinician may recommend that the participant and/or parent/guardian call 988 or the PES crisis 
phone service (24-hour line: 734-936-5900) if they are High Risk.  
  
DETERMINATION AND MANAGEMENT OF MILD OR MODERATE RISK STATUS  
  
Definition of Mild or Moderate Risk 

 
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(1) Suicidal ideation in the past week (C-SSRS item 2) 
(2) Verbal statement of suicidal ideation  
  
Management of Mild or Moderate Risk 
If a participant meets one or more of the above criteria, the project staff member will share the 
information with the youth and parent, provide emergency contact information (e.g., 988, PES 
crisis phone service [24-hour line: 734-936-5900]), encouraging continued adherence to 
treatment plan, and encourage the use of the youth’s safety plan (i.e., bring up and reinforce 
efforts and strategies aim at maintaining safety).