A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse (Formative Work and Pilot Study)
Phase: NA
Conditions: Substance Misuse, Suicide
Sponsor: Yale University

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
CLINICAL STUDY PROTOCOL
A digital game targeting suicide prevention 
in adolescents who report substance 
misuse 
(Formative Work and Pilot Study) 
Principal Investigator
 Claudia-Santi F. Fernandes, Ed.D., LPC
Sponsor
CTSA Grant Number KL2 TR001862 from the National Center for Advancing Translational 
Science (NCATS)/National Institutes of Health (NIH). 
Protocol Version
01 February 2023
version 16
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
2
Study Personnel
Principal Investigator
Claudia-Santi F. Fernandes
Email: claudiasanti.fernandes@yale.edu
 
Key Study Personnel:
Fran Giannattasio
Email: francesca.giannattasio@yale.edu
Trucy Truong-Phan
Email: Trucy.Truong-Phan@yale.edu
 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
3
Synopsis
Purpose
Suicide is the second leading cause of death in adolescents aged 14-18 years. In this age 
group substance use is a risk factor for suicidal thoughts and behaviors. Specifically, 
adolescents who misused prescription opioids were more likely to experience suicidal 
thoughts and behaviors than adolescents who did not. The role of school-based health 
centers (SBHCs) holds promise as they offer accessible medical and behavioral health 
services. However, there is a lack of research on effectiveness of behavioral health 
services delivered in SBHCs, including those that target suicidal thoughts and behaviors. 
Compelling evidence shows “serious games” (i.e., games for a purpose other than solely 
entertainment), as digital experiences, can promote health, reduce risk factors, enhance 
protective factors through skill-building, and target prevention. To date, no serious game 
focused on suicide and opioid misuse has been developed or evaluated in schools. 
Therefore, we will create supportED focused on suicide prevention.
Objectives
Formative Work: Our primary aim is to design and develop a digital game that models the 
process of a safety planning intervention. To do so, we will explore and better understand 
peer or student perceptions around potential warning signs, coping strategies, and 
seeking help among youth who may be at greater risk of suicide due to misuse of 
substances. We will conduct focus groups with adolescents, college-aged youth, and 
school-based mental health providers. In addition, we will aim to conduct approximately 
10 individual interviews with adults who may have misused substances during their youth 
and will be able to reflect on what they wish they knew during then (aged 18-80). 
Interviews will last approximately 60-90 minutes for one session and will be conducted via 
Zoom. Findings will inform the development of a digital game to reduce the risk of suicide 
among adolescents who misuse opioids. Once a prototype of the game is developed, we 
will conduct play-test focus groups with adolescents and school-based mental health 
providers to finalize the game. 
Pilot Study: In year 2, we will assess user experience, acceptability, and feasibility of the 
game experience as well as explore the following proximal outcomes such as but not 
limited to adolescent well-being, intentions to use a safety planning intervention, coping 
strategies, substance misuse in last 30 days, and associated risk factors related to 
suicidal risk (e.g., hopelessness, impulsivity, etc.).
Study Population
Formative Work: High-school-aged students between the ages of 16-19, college-aged 
youth between the ages of 18-22, adults aged 18-80 and school-based mental health 
providers aged 18-80.
Pilot Study: Sixty (60) high-school-aged students between the ages of 13-19.
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
4
Number of Participants
Formative Work: We will conduct six focus groups with a total of 30 participants (10 high-
school aged adolescents [aged 16-19], 10 college-aged youth [aged 18-22], and 10 adult 
school-based behavioral health providers [aged 18-80]) during development. We will also 
conduct approximately 10 interviews with adults who may have misused substances 
during their youth and will be able to reflect on what they wish they knew during then 
(aged 18-80). We will conduct play-testing focus groups with input from adolescents 
and/or college-aged youth each (n=10-20), high school youth aged 16-22, and focus 
groups of school-based mental health providers and/or providers who specialize in 
addiction who are aged 18-80 (n=10-20) to assess user experience (e.g., acceptability 
and usability) and feasibility of protocol to prepare for a larger pilot STUDY that will 
require a new protocol (N=60). 
Pilot Study: We will conduct a pilot study with a total of 60 high-school aged adolescents 
[aged 13-19], who attend a high school with a school-based provider.
Study Design
Formative Work: The protocol will be conducted over the course of two years. The outline 
below highlights the study design. We will conduct focus groups to inform the 
development of a digital game and discuss approaches to enhance user experiences, 
acceptability, and feasibility of the game experience. First, we will conduct six focus 
groups with a total of 30 participants, including 10 high-school-aged adolescents,10 
college-aged youth [aged 18-22], 10 providers. In addition, we will conduct approximately 
10 interviews with adults [aged 18-80] who may have misused substances and will be 
able to reflect on what they wish they knew during their adolescence to inform the content 
of the videogame with a focus on content related to potential warning signs, coping 
strategies, and seeking help to prevent suicidal thoughts and behaviors among youth who 
misuse opioids. Focus groups/interviews will occur in-person or via Zoom over the course 
of six months. Each group/interview will meet for approximately 1-1.5 hours after school 
hours. The study will be introduced to parents/guardians and students and then, if 
interested, information sheets will be provided in paper form or electronically. When the 
study is introduced to parents/guardians and students, we have always stressed that a 
stipulation of our studies requires reliable transportation to/from our studies if conducted in 
person. If COVID-19 restrictions apply, we may modify this process and share flyers with 
educators who will share with their students and/or parents/guardians or email information 
sheets to parents/guardians when email is provided. No forms will be signed in our 
procedures. In certain cases where transportation is not available by family or school, we 
will provide a bus pass.
Focus groups/interviews will be approximately 60-90min. A semi-structured focus 
group/interview guide will be developed, pilot tested, and used in focus groups/interviews. 
The focus group/interview guide will align with constructs from a safety planning 
intervention,a,b a well-recognized, evidence-based suicide prevention intervention, and 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
5
include questions related to potential warning signs of emotional distress, coping 
strategies, and seeking help to prevent suicidal thoughts and behaviors among youth who 
misuse opioids. Focus groups/interviews will be led by a facilitator, who is also a certified 
school counselor and licensed professional counselor, and a co-facilitator who will take 
field notes. Focus groups/interviews will be audio-recorded. Transcripts will be transcribed 
verbatim by a third-party transcription service who our Lab has worked with prior. All 
participants will receive instructions on not using identifiable information (e.g., names, 
school, peer/colleague names, etc.) while being audiotaped and will be provided a study 
number prior to the start of audiotaping. Participants will be instructed to state their study 
number prior to speaking. Audiotapings will be transcribed and will be destroyed 24 
months after the completion of the study and after review of their content has been 
completed. Transcriptions will not be sent to other institutions and will not be used for 
purposes other than this study and future publications related to this study. Should any 
identifiable information be shared in the focus groups, it will be redacted from transcripts. 
Participants will receive a $25 gift card to participate.
We will follow the same protocol for play-testing focus groups in order to finalize the 
game.
Pilot Study: Once the prototype of a game is ready, we will conduct a pilot study to 
evaluate the usability and acceptability of the game, and feasibility of delivering the game 
in schools. We will enroll 60  who attend one of our partner school sites. We will also 
explore proximal outcomes such as but not limited to adolescent well-being assessment, 
intentions to use a safety planning intervention, coping strategies, substance misuse in 
last 30 days, and associated risk factors related to suicidal risk (e.g., hopelessness, 
impulsivity, etc.). See below for additional details on measures. Our research team will be 
trained by Dr. Blumberg’s team and a Pitt Methods workshop on suicide prevention 
research prior to commencing the study in all procedures, risk and protection methods, 
and safety related to conducting suicide prevention research as well as attend a summer 
workshop on best practices in conducting suicide prevention research. Eligible individuals 
will be assigned to either the 1) supportED group (n=30) or 2) control group (n=30). Both 
groups will also receive NIDA and NIMH pamphlets on substance misuse and mental 
health at the end of the session. Prior to receiving pamphlets, those in the supportED 
group will engage with the game for one session (~45min) while the control group will 
engage with a non-health-related game for the same duration. Given schools do not have 
a standardized approach to address suicide prevention, we opted to use an attention/time 
control condition. Participants will use a dedicated device (e.g., tablet, laptop, or desktop) 
to access their digital experience on the web. The research staff will be present to monitor 
gameplay, to provide support, if needed, and to field questions in person. There will also 
be a school-based provider on site for direct referrals, as needed, given the sensitive 
topic. The total duration of the game and number of sessions is consistent with those 
found in safety planning and with the amount adolescents engaged with our empowerED 
game.
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
6
The Yale University Human Subjects Committee (the committee that reviews, approves, 
and monitors research on human subjects) may inspect study records. All published 
results will be group data. Information that will be collected during the focus group 
interviews will be erased 24 months after the completion of the study and after review of 
their content has been completed.
Formative and development work: (1 year)

We will work iteratively with our target audience of 16-19-year old adolescents 
within schools, college-aged youth for their reflections of their 16-19 year selves,  
and school-based mental health providers to develop videogame content, 
collecting qualitative data for the videogame and refining our logic model with input 
from 2 focus groups of 5 high school adolescents each (n=10), aged 16-19, 2 
focus groups of 5 college-aged youth each (n=10), aged 18-22  and 2 focus 
groups of 5 school-based mental health providers aged 18-80 (n=10), and 
approximately 10 interviews with adults who may have misused substances during 
their youth and will be able to reflect on what they wish they knew during then 
(n=10).

We will create the "Game Playbook" specific to this new digital Game Playbooks 
are our game manuals. We create behavior change gameplay manuals to 
accommodate the specific needs of a multi-disciplinary game development team. 
The playbooks outline the theoretical foundations and gameplay elements. This 
ensures targeted theoretical principles and behavior change mechanisms and 
constructs are included in the videogame.

We will build the new digital game by creating new content, developed from focus 
groups and from the suicide and opioid/substance misuse prevention literature, for 
our game development team, DigitalMill, Inc.

We will conduct play-testing focus groups with input from adolescents and/or 
college-aged youth each (n=10-20), high school youth aged 16-22, and focus 
groups of school-based mental health providers and/or providers who specialize in 
addiction who are aged 18-80 (n=10-20) to assess user experience (e.g., 
acceptability and usability) and feasibility of protocol to prepare for a larger pilot 
study that will require a new protocol (N=60).
Pilot Study (Year 2):

We will conduct a pilot study with (N=60) adolescents between the ages of 13-19. 
We will examine the usability and acceptability of the game experience among 
adolescents, and the feasibility of protocols and procedures in delivering the game 
experience by piloting assessment measures in schools.

We will also explore proximal outcomes as potential means for behavior change in 
supportED vs. control group at 3 months. Examples include but are not limited to 
the following measures on: 1) intentions to use safety plan; 2) coping strategies; 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
7
and, 3) suicidal thoughts and associated risk factors (e.g., pessimism, 
helplessness, limited social support, and despair).
Study Duration
The anticipated duration of this study will be two years. 
Year 1: Participants will engage in twelve focus groups and approximately 10 interviews 
over one-year period for approximately 60-90 minutes each.
Year 2: Participants will engage with the gameplay or a non-health-related game over 
one-year period for approximately 45 minutes each.
Outcome Variables
The outcomes are exploratory and preventative by nature. 
Formative Work: We will explore participants' perceptions on their peers' or students' 
potential triggers, coping strategies, and resources related to opioid misuse and suicide 
prevention as outlined in safety planning.5 
Pilot Study: We will ask questions about user experience, including usability and 
acceptability. We will ask questions about feasibility. Feedback on what they view as 
acceptable/feasible will be critical to developing successful technological gameplay 
experience targeting mental health supports and suicide prevention among youth who 
have misused substances. 
Locations/Facilities
Formative Work: The study will be conducted virtually with participants from across the 
United States via Zoom and/or at previously long-standing and established partner school 
sites. We will also recruit from existing partnerships in Connecticut and Miami-Dade 
County Public schools, such as but not limited to Maloney (Meriden, CT; N=1191), 
Hamden (Hamden, CT; N=1598), and Platt (Meriden, CT: N=970), Ronald W. Reagan 
Doral (Miami, FL; N= 1440), Miami Lakes Educational Center (Miami, FL; N= 1015), 
Alonzo and Tracy Mourning (Miami, FL; N=1528), School for Advanced Studies West 
(Miami, FL; N=119), and Barbara Goleman (Miami, FL; N=2882).
Pilot Study: The study will be conducted among high schools with school-based 
behavioral providers, including previously long-standing and established partner school 
sites. We will also recruit from existing partnerships in Connecticut and Miami-Dade 
County Public schools, such as but not limited to Maloney (Meriden, CT; N=1191), 
Bassick High School (Bridgeport, CT; N=970), Ronald W. Reagan Doral (Miami, FL; N= 
1440), Miami Lakes Educational Center (Miami, FL; N= 1015), Alonzo and Tracy 
Mourning (Miami, FL; N=1528), School for Advanced Studies West (Miami, FL; N=119), 
and Barbara Goleman (Miami, FL; N=2882). See letters of support.
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
8
Table of Contents
Synopsis...................................................................................................................................3
Purpose ................................................................................................................................3
Objectives .............................................................................................................................3
Study Population...................................................................................................................3
Number of Participants .........................................................................................................4
Study Design ........................................................................................................................4
Study Duration ......................................................................................................................7
Outcome Variables ...............................................................................................................7
Locations/Facilities ...............................................................................................................7
1 - Background/Literature Review..........................................................................................10
1.1 Background...................................................................................................................10
2 - Rationale/Significance/Problem Statement.......................................................................11
2.1 Rationale.......................................................................................................................11
2.2 Significance ..................................................................................................................12
3.1 Purpose ........................................................................................................................12
3.2 Hypothesis ....................................................................................................................13
3.3 Objectives .....................................................................................................................13
4 - Study Participants.............................................................................................................14
4.1 Study Population...........................................................................................................14
4.2 Number of Participants .................................................................................................14
4.3 Selection Criteria ..........................................................................................................14
4.4 Recruitment Procedures ...............................................................................................15
4.5 Risks .............................................................................................................................15
4.6 Anticipated Benefits ......................................................................................................17
4.7 Vulnerable Populations.................................................................................................17
4.8 Consent/Assent Procedures .........................................................................................17
5 - Study Design.....................................................................................................................19
5.1 Study Design ................................................................................................................19
5.2 Study Duration ..............................................................................................................22
5.3 Outcome Variables .......................................................................................................22
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
9
5.4 Study Procedures .........................................................................................................22
5.5 Withdrawal Procedures.................................................................................................23
5.6 Locations/Facilities .......................................................................................................23
5.7 Data Collection .............................................................................................................24
5.8 Data Collection Sources ...............................................................................................24
5.9 Standard Tools .............................................................................................................24
6 - Statistical Analysis ............................................................................................................25
6.1 Sample Size..................................................................................................................25
6.2 Planned Analyses .........................................................................................................25
6.3 Data Relevance ............................................................................................................26
6.4 Data Coding..................................................................................................................26
6.5 Data Analysis Tools ......................................................................................................26
6.6 Data Monitoring ............................................................................................................26
7 - Data Handling and Record Keeping .................................................................................27
7.1 Subject Data Confidentiality..........................................................................................27
7.2 Data Quality Assurance ................................................................................................27
7.3 Data Storage/Security...................................................................................................27
7.4 Study Records ..............................................................................................................27
7.5 Retention of Records ....................................................................................................27
8 - Study Considerations........................................................................................................28
8.1 Research Personnel Training .......................................................................................28
8.2 Unanticipated Problems and Protocol Deviations.........................................................28
8.3 Study Modification and Discontinuation........................................................................28
8.4 Study Completion .........................................................................................................28
8.5 Funding Source ............................................................................................................28
8.6 Publication Plan ............................................................................................................28
References.............................................................................................................................29
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
10
1 - Background/Literature Review
1.1 Background
Suicide is the second leading cause of death in adolescents aged 14-18 yearsa.  In this age 
group, substance use is a risk factor for suicidal thoughts and behaviors.  Specifically, 
adolescents who misused prescription opioids were more likely to experience suicidal 
thoughts and behaviors than adolescents who did notb.The role of school-based health 
centers (SBHCs) holds promise as they offer accessible medical and behavioral health 
services. However, there is a lack of research on effectiveness of behavioral health services 
delivered in SBHCs, including those that target suicidal thoughts and behaviorsc. Safety 
Planning, a brief psychosocial intervention that identifies coping strategies and sources of 
support, is considered a best practice to alleviate suicidal crisis in the emergency 
department settingd-m; however, to date, there are no studies that evaluate safety planning in 
schools. In addition, compelling evidence shows "serious games" (i.e., games for a purpose 
other than solely entertainment), as digital game, can promote health, reduce risk factors, 
enhance protective factors through skill-building, and target preventionn-p. To date, no 
serious game in the form of a safety planning intervention focused on suicide and opioid 
misuse has been developed or evaluated in schools. Therefore, we will conduct formative 
research (e.g., focus groups) to build a digital game focused on suicide prevention among 
youth who misuse opioids. Research demonstrates that asking youth about suicide does not 
increase risk for suicidal behaviors and ideation.ff
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
11
2 - Rationale/Significance/Problem Statement
2.1 Rationale
Suicide is the second leading cause of death in adolescents aged 14-18 years.a  In this age 
group, substance use is a risk factor for suicidal thoughts and behaviors.f  Specifically, 
adolescents who misused prescription opioids were more likely to experience suicidal 
thoughts and behaviors than adolescents who did not.b The role of school-based health 
centers (SBHCs) holds promise as they offer accessible medical and behavioral health 
services. However, there is a lack of research on effectiveness of behavioral health services 
delivered in SBHCs, including those that target suicidal thoughts and behaviors.c Compelling 
evidence shows "serious games" (i.e., games for a purpose other than solely entertainment), 
as digital games, can promote health, reduce risk factors, enhance protective factors through 
skill-building, and target preventionn-p .To date, no serious game focused on the intersection 
of suicide and opioid misuse has been developed or evaluated in schools.
Our specific aims include the following:
Aim 1: Adaptation Activities (Year 1): Aim 1a: Using methods developed by our 
multidisciplinary team, who has extensive experience developing videogames for 
adolescents, we will conduct six focus groups with 30 participants including 10 high school-
aged adolescents, 10 college-aged youth, and 10 school-based behavioral health providers 
as well as approximately 10 interviews with adults who may have misused substances 
during their youth and will be able to reflect on what they wish they knew during then. We will 
learn about their experiences related to their peers' or students' potential warning signs, 
coping strategies, and resources in seeking support related to youth who misuse opioids and 
suicide prevention. We will extract themes using rapid analytic techniques to inform content 
and storylines. Aim 1b: In collaboration with our long-standing partnership with DigitalMill 
and the national School-Based Health Alliance (SBHA), we will adapt a theory- and 
evidence-based videogame that will be called supportED by integrating constructs from 
self-determination theory and social cognitive theory, as well as techniques from Motivational 
Interviewing to enhance engagement. It will model the evidence-informed practice of safety 
planning.m 
Aim 2: Evaluation Activities (Year 2): In collaboration with CT and MDCP schools, where 
we have partnerships, we will conduct a pilot study with 60 adolescents (aged 13-19). We 
will examine usability and acceptability of the gameplay experience, and feasibility of 
delivering the game and piloting protocols in schools. We will also explore proximal 
outcomes as potential means for behavior change in supportED vs. control group at 3 
months on: 1) intentions to use safety plan; 2) coping strategies; and, 3) suicidal thoughts 
and associated risk factors (e.g., pessimism, helplessness, limited social support, and 
despair). 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
12
Completion of these aims will generate an evidence-informed, novel approach to addressing 
the intersection of suicide and prescription opioid/substance misuse among adolescents 
and, ideally, reduce the risk of suicide among a population who may experience greater risk
2.2 Significance
Suicide is the second leading cause of death among adolescents ages 14 through 18, 
accounting for 2,039 deaths annually in the U.S in 2018.a In the last 10 years, the incidence 
of suicide among high school-aged students increased by 62%.e By grade, a significant 
increase in having attempted suicide was observed for 12th-grade students (4% to 9%). 
Substance use in this age group is a significant risk factor for suicidal thoughts and 
behaviors. Specifically, adolescents who misuse prescription opioids are one and a half 
times more likely to have suicidal ideation, to make a suicide plan, or to attempt suicide.b 
School-based health centers (SBHCs) increase access to and reduce barriers to behavioral 
health services, and are positioned well to address this work. For this stage of our study, the 
goal is to design a videogame to reduce the risk of suicide in adolescents who are at greater 
risk due to lifetime prescription opioid misuse. To achieve this goal, we will create a digital 
game, modeling the process of safety planning. Using the methods developed by our 
multidisciplinary team that has extensive experience developing videogame for adolescents, 
we will conduct six focus groups, including four focus groups with 10 high school-aged 
adolescents and 10 college-aged youth, as well as two focus groups with 10 SBHC 
providers. We will also conduct approximately 10 interviews with adults who may have 
misused substances during their youth and will be able to reflect on what they wish they 
knew during then. Data from focus groups will inform relatable stories that are engaging and 
offer opportunities for skill development. To assess user experience (e.g., acceptability and 
usability) and feasibility of protocol, we will conduct a total of six focus groups for play 
testing: focus groups with adolescents and/or college-aged youth each (n=10-20), high 
school youth aged 16-22, and focus groups with school-based mental health providers 
and/or providers who specialize in addiction who are aged 18-80 (n=10-20) to assess user 
experience (e.g., acceptability and usability) and feasibility of protocol to prepare for a larger 
pilot study that will require a new protocol (N=60).
3.1 Purpose
Through the use of focus groups, we will better understand and explore participant's 
perceptions of their peers' or students' related to potential warning signs, coping strategies, 
and resources to seek help in an effort to reduce the risk of suicide among their peers or 
students who misuse opioids. We will extract themes using rapid analytic techniques to 
inform content and storylines. Additionally, in collaboration with our long-standing 
partnership with DigitalMill and schools, we will adapt a theory- and evidence-based 
videogame that will be called supportED by integrating constructs from self-determination 
theory and social cognitive theory, as well as techniques from Motivational Interviewing to 
enhance engagement. It will model the evidence-informed practice of safety planning.d 
3.2 Hypothesis
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
13
We will test the hypothesis that individuals who engage with supportED will find the 
prototype engaging and acceptable (e.g., easy to use, relatable, and helpful) among youth. 
We will also test if the prototype is feasible to deliver in schools. We also hope to report 
decreases in outcomes in comparison to the control group through our exploratory findings 
although the sample is not large enough to correlate.
3.3 Objectives
Our primary aim is to develop and pilot-test a videogame to reduce suicide risk in 
adolescents who report substance misuse. The approach follows well-established guidelines 
using rigorous methods to develop theory-informed videogames with demonstrated benefits 
in proximal outcomes (e.g., knowledge, beliefs, attitudes, and behaviors),56-59 utilizes long-
standing successful partnerships in schools doing this work, and integrates robust expertise 
in suicide prevention research. Using the successful methods from prior studies, we will 
design and adapt a previously developed game (empowerED) informed by focus group data 
for content (Aim 1). We will then pilot test this game (Aim 2). 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
14
4 - Study Participants
4.1 Study Population
Formative Work: The study will enroll high-school-aged adolescents (aged 16-19), college-
aged youth (aged 18-22), and adult school-based behavioral health providers (aged 18-80). 
Study enrollment and focus groups/interviews will be conducted virtually with participants 
across the United States and in collaboration with previous partnership in Connecticut and 
Miami-Dade County Public schools, such as but not limited to Maloney (Meriden, CT; 
N=1191), Bassick (Bridgeport, CT; N=970), Ronald W. Reagan Doral (Miami, FL; N= 1440), 
Miami Lakes Educational Center (Miami, FL; N= 1015), Alonzo and Tracy Mourning (Miami, 
FL; N=1528), School for Advanced Studies West (Miami, FL; N=119), and Barbara Goleman 
(Miami, FL; N=2882).
Pilot Study: The study will enroll high-school-aged adolescents (aged 13-19) who report 
substance misuse (n=60). Study enrollment be conducted with participants in collaboration 
with previous partnership in Connecticut and Miami-Dade County Public schools, such as 
but not limited to Maloney (Meriden, CT; N=1191), Bassick (Bridgeport, CT; N=970), Ronald 
W. Reagan Doral (Miami, FL; N= 1440), Miami Lakes Educational Center (Miami, FL; N= 
1015), Alonzo and Tracy Mourning (Miami, FL; N=1528), School for Advanced Studies West 
(Miami, FL; N=119), and Barbara Goleman (Miami, FL; N=2882)
4.2 Number of Participants
Formative Work: We will conduct six focus groups with a total of 30 participants (10 high-
school aged adolescents [aged 16-19], 10 college-aged youth {aged 18-22], and 10 adult 
school-based behavioral health providers [aged 18-80]) during development. We will 
conduct approximately 10 interviews with adults who report misuse of substances in their 
youth. We will conduct approximately 6 play-testing focus groups with input from 
adolescents and/or college-aged youth each (n=10-20), high school youth aged 16-22, and 
focus groups of school-based mental health providers and/or providers who specialize in 
addiction who are aged 18-80 (n=10-20) to iteratively improve and finalize the game. 
Pilot Study: The study will enroll 60 high-school-aged adolescents (aged 13-19) (n=60).
4.3 Selection Criteria
Formative Work: 
High-school aged adolescent participants must: 1) attend a high school; 2) be aged 16-19; 
3) English-speaking; 4) be willing to engage in discussions around mental health (e.g., 
potential warning signs, coping strategies, and help-seeking behaviors) related to suicide 
prevention and opioid misuse; and 5) if attending via Zoom, have access to Internet and a 
device for Zoom.
College-aged participants must: 1) attend a college/university; 2) be aged 18-22; 3) English-
speaking; 4) be willing to engage in discussions around mental health (e.g., potential 
warning signs, coping strategies, and help-seeking behaviors) related to suicide prevention 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
15
and opioid misuse; and 5) if attending via Zoom, have access to Internet and a device for 
Zoom.
Adult school-based behavioral health provider and/or providers with expertise in addiction 
medicine participants must: 1) provide behavioral health services in a high school (if school-
based) or provide addiction medicine services (if expertise in addiction medicine), 2) be aged 
18-80, 3) English-speaking, 4) be willing to engage in discussions around mental health 
(e.g., potential warning signs, coping strategies, and help-seeking behaviors) related to 
suicide prevention and opioid misuse; and 5) if attending via Zoom, have access to Internet 
and a device for Zoom.
Pilot Study: 
Inclusion criteria: For the pilot study, participants must: 1) attend a high school that has a 
school-based provider; 2) be between the ages of 13-19; 3) fluent in reading English during 
the consent process; 4) be willing to sit for a single session to complete pre-/post-
assessments, engage with the game (~45min), and participate in a post-gameplay focus 
group (if in the experimental group) for 60min; and 5) provide assent and parental/guardian 
consent (if<age 18).
Exclusion criteria: Any student who is actively suicidal and/or moderately severe to severely 
depressed will not be eligible and will be immediately referred to the school-based provider 
on site to who will follow school protocol (e.g., contact 211, notify parent/guardian, and/or 
contact their local emergency department, etc.), as needed. Student may return to rescreen 
for participation according to the criteria on page 16.   
Rescreening: Participants will not have to repeat the questions related to static variables ( 
such as demographics and past experiences), but the baseline assessment of dynamic 
variables will need to be repeated and meet eligibility requirements .
4.4 Recruitment Procedures
Formative Work: Participants will receive a $25 gift card to participate in focus groups and 
playtesting sessions. Flyers will be circulated throughout schools.
Pilot Study: For the pilot study, participants will receive a $25 gift cards as compensation for 
completion of assessments at each time point. We will share with educators, school-based 
providers, and our youth advisory board who will share with students. Students may then 
share with other students (e.g., snowball sampling). The flyers contain a QR code for 
students to input their first/last name, phone number, and email address. If they are younger 
than 18, they must input  parent/guardian first and last name, phone number, and email 
address. Research staff will then contact them to obtain consent/e-consent. When needed, 
study staff will be available to parents/guardians for information sessions should they have 
any questions. 
4.5 Risks
The potential risks associated with this study have to do with maintenance of the 
confidentiality of the identities of the participants enrolled in the study and information 
relating to them. As with all of our studies, we will train study researchers in maintaining 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
16
confidentiality. Prior to the start of the focus groups, researchers will discuss potential risks 
including breach of confidentiality.
Given engagement in discussions with the research team about its content may pose a 
potential psychological risk in that we address sensitive issues around mental health, 
substance use, and its consequences, Dr. Fernandes (who is a Certified School Counselor 
and Licensed Professional Counselor, and has extensive expertise working with 
adolescents, college-aged youth, and schools) will be on site for all study sessions in Miami 
and Connecticut with research staff, when available, to connect participants to school-based 
personnel as a resource should any distress or concern arise. Dr. Fernandes has a long-
standing relationship with school partners and will refer students to their school-based 
personnel for additional support.
If there are additional concerns raised with regards to active substance use or mental health, 
or if participants need additional or more intensive attention, the research staff will seek 
medical advisement from Dr. L. Fiellin, a medical doctor with expertise in addiction medicine, 
or Dr. H. Blumberg, a psychiatrist. All students will receive resources for support and hotline 
information from NIDA and NIMH. Students who report moderate to high suicide risk and/or 
depression will be directly connected immediately to the on-site school-based provider who 
will follow their school’s protocol to help navigate care or file a referral (examples include 
conducting a safety planning intervention, connecting to outpatient clinic, notifying 
parent/guardian, and/or contact with local crisis intervention team and transport via 
ambulance to local emergency department as deemed necessary). Students will be flagged 
by our RedCap system as moderate-/high-risk as a result of their answers on the PHQ-8, 
GAD-7, CHRT, or ASQ measures, which will result in an immediate email notification to 
research staff on site who will immediately refer or connect the student to the on-site school-
based provider.
If a student indicates moderately severe to severe symptoms of depression, student will be 
flagged and immediately connected to the school-based provider for a risk assessment and 
follow school protocol. If student is cleared by the school social worker, student may 
continue in the study and the school social worker will follow up with student in two weeks. 
If a student screens positive for suicide (but is not acutely suicidal), student will be flagged 
and immediately connected to school-based provider for a risk assessment and follow 
school protocol. If student is cleared by school social worker, student may continue in study 
and the school social worker will follow up with student in two weeks. If student is acutely 
suicidal, student will be flagged and immediately connected to school-based provider who 
will follow school protocol (e.g., contact 211, contact parent/guardian, etc.). They will be 
ineligible to participate in the study on this day. Student may not return to rescreen for 
participation for at least 2 weeks and only when they are no longer actively suicidal. Eligibility 
for rescreening will be based on the resolution of the moderate or severe suicidality and may 
include being on active treatment, clearance by the school social worker according to school 
policy, or completion of brief treatment.  Documentation of the resolution of the acute 
suicidality state will be documented upon assessment for eligibiligty for rescreening.  
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
17
If any student were to become triggered as a result of the sensitive nature of the topics, the 
school-based provider will be able to offer and/or refer to school-based emotional support 
and/or referral services. The school-based provider will not be a part of handling any of the 
research protocols; however, the provider will be present and available for support services, 
as needed. They will receive a $75.00 gift card for their time.
This study presents minimal risks to the participants and adverse events or other problems 
are not anticipated.
Adverse Events (AEs):
Violation of confidentiality: Any breach of confidentiality.
Discomfort due to assessment procedures: Discomfort created by answering survey 
questions. Embarrassment in disclosing sensitive personal information.
Disclosure of information about current and/or intended physical harm to persons; current 
and/or intended abuse of children that would be reported to a child welfare agency; and/or 
an investigation of such allegations(s) that could ensue.
Dissatisfaction with the game activities: In this case it would be the gameplay experience. 
While gaming addiction is a recognized entity, it is very rare and, in the setting of playing a 
serious game, very unlikely. If there are any concerns of developing serious addictive 
behaviors in our pilot study participants, we have team members who are experts in the field 
of addiction medicine and will address these issues immediately.
Serious Adverse Events (SAEs):
SAEs include death, life threatening injury or condition, hospitalization, persistent or 
significant disability/incapacity, and other conditions which in the judgment of the 
investigators represent significant hazards. In the rare evident of an SAE, we do not expect 
them to be related to our study.
Procedures for research team management of AEs, SAEs and other study risks such as 
mandatory reporting requirements:
This study presents minimal risks to the participants and adverse events or other problems 
are not anticipated. In the unlikely event that such events occur, Reportable Adverse Events 
(which are events that are serious or life-threatening and unanticipated (or anticipated but 
occurring with a greater frequency than expected) and possibly, probably, or definitely 
related) or unanticipated problems involving risks to subjects or others will be reported in 
writing within five calendar days to the IRB (using the appropriate forms from the website 
and electronic submission system) and the NCATS PO. The PI will apprise fellow 
investigators and study personnel of all adverse events that occur during the conduct of this 
research project through regular study meetings and via email as they are reviewed by the 
PI. We will use procedures to detect and respond to adverse events that ensure prompt 
discovery of any adverse events and to minimize their effects. There is adequate 
surveillance and protections to discover adverse events promptly and keep their effects 
minimal.
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
18
Procedures for training and supervision of all research personnel have been developed as 
part of our previous and current studies. All members of the research team are familiar with 
procedures for identifying and reporting possible adverse reactions. All members of the 
research team are trained in mandatory reporting and will notify the PI immediately of any 
concerns raised about participant mental health (suicidality), substance use, abuse of any 
kind, and so forth.
If an adverse event occurs study personnel will notify the PI as well as the appropriate 
Information Security Officer (ISO) and follow all necessary procedures. All adverse events 
are reported using the Yale Institutional Review Board (IRB) standard template for reporting 
adverse events. The PI reviews all adverse events, classifies the attribution of adverse 
events (e.g., definitely, probably, possibly related; unlikely or unrelated) and grades the 
severity of the event, utilizing the FDA’s definition of serious adverse events, on a 6-point 
scale (0=no adverse event or within normal limit; 1=mild; 2=moderate; 3=severe; 4=life-
threatening; 5=fatal). Serious unanticipated or anticipated adverse events will be reported 
promptly to the IRB within five calendar days and to the NCATS PO within 24 hours by 
phone and/or email and will submit a written report to the PO no more than two days later. 
The PI will evaluate all adverse events and determine whether the event affects the 
Risk/Benefit ratio of the study and whether modifications to the protocol (e.g., Risks to 
Subjects) or consent form (e.g., Risks and Inconveniences) are required.
The PI will be responsible for monitoring the data and conducting performance and safety 
reviews, at the specified frequency. Either the PI or the IRB have the authority to stop or 
modify the study. The monitoring by the IRB will occur annually at the time of re-approval. 
The PI will conduct data and safety review at least quarterly and at any time a serious 
adverse event occurs. During the review process, the PI will evaluate whether the study 
should continue unchanged, requires modification or amendment to continue, or should be 
closed to enrollment.
4.6 Anticipated Benefits
The study may have no direct benefits to the participants, but may help researchers find out 
something that will help educators, clinicians, and/or adolescents.
4.7 Vulnerable Populations
Given participants will include minors (aged 13 through 17) who will participate in focus 
groups, information sheets will be shared prior to enrollment with minors and their 
parents/guardians.
For the pilot study, adolescent assent and parent/guardian consent/e-consent will be 
required for minors.
4.8 Consent/Assent Procedures
Formative Work: Given our study focuses on prevention and aims to better understand 
perceptions of peers and students, this protocol is eligible for a waiver of documentation of 
consent. The study will be introduced to parents/guardians and students and then, if 
interested in participating, information sheets will be provided via paper form or 
electronically. For participants under the age of 18, parents/guardians who do not wish for 
their children to participate will communicate disapproval to the research staff or remain 
silent/walk out for the purpose of demonstrating no interest to participate without 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
19
communicating to staff. Both options will result in non-participation by the adolescent. If 
COVID-19 restrictions apply, we may modify this process and share flyers with educators 
who will share with their students and/or parents/guardians. No forms will be signed in our 
procedures. This protocol is one we have used in our previous qualitative work and has 
been approved by the Yale IRB.
Pilot Study: For the pilot study, we will obtain informed written or digital consent from 
adolescents above the age of 18 and informed written or digital consent from parents or 
guardians with adolescents under the age of 18. We will obtain informed written or digital 
assent from all participants. We will share flyers with educators, school-based providers, and 
our youth advisory board who will share the flyer with students. Students may then share 
with other students (e.g., snowball sampling). The flyer contains a QR code where students 
will input their first/last name, age, grade, and email address and parent/guardian first and 
last name, phone number, and email address. Research staff will then contact them to 
obtain consent/e-consent. When needed, study staff will be available to parents/guardians 
should they have any questions. 
5 - Methods
Pilot Study: Treatment – Device 
5.1 Intended Use for Device (provide the following information for each device being 
investigated in the study)
supportED is a digital prevention game focused identifying warning signs, coping strategies, and 
resources for seeking help. The overall goal is to prevent suicide in youth who may be at risk due to 
substance misuse. The formative work of this game included focus groups and playtesting to develop 
a prototype of the game. In the subsequent pilot study, we will be investigating the usability/ feasibility 
of delivering the game in schools. This is not a pivotal study, as it is not powered to demonstrate 
efficacy of the game (n=60). For this reason, preliminary outcomes will only be exploratory in nature. 
Given the preliminary nature of the research, and primary outcomes of usability, feasibility, and 
acceptability we anticipate supportED to be classified as a non-significant risk device. 
supportED is not designed to be a replacement for or of substantial importance in diagnosing, 
mitigating, or treating mental health, substance misuse, and suicidal thoughts and behaviors in youth. 
It is an external web-based game that does not present potential for serious risk. supportED models 
the process of a safety planning approach, an evidence-based approached to prevent suicide in 
emergency departments, through interactive storylines presented in the game. The game focuses on 
identifying warning signs, coping strategies, and resources for support with the goal to promote youth 
mental health and prevent the initiation or escalation of substance misuse. 
5.2 Device Administration and Schedule
Eligible individuals will be assigned to either the 1) supportED group (n=30) or 2) control 
group (n=30). Both groups will also receive NIDA pamphlets on substance misuse for youth 
at the end of the session. Prior to receiving pamphlets, those in the supportED group will 
engage with the game for one session (~45min) while the control group will engage with a 
non-health-related game for the same duration. Given schools do not have a standardized 
approach to address suicide prevention, we opted to use an attention/time control condition. 
Participants will use a dedicated device (e.g., tablet, laptop, or desktop) to access their 
digital experience on the web. The research staff will be present to monitor gameplay, to 
provide support, if needed, and to field questions in person. Dedicated devices will be 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
20
prepped prior to sessions with participants (programmed as control or game). The school-
based provider will be present for immediate referrals, if needed. 
Currently our game does not record ANY personal information or even individual game 
information. We do not ask for a personal registration or login.
Twine by default does save information locally to the device running the Twine game off the 
Web server. No information is saved server-side and local information can be removed by 
deleting local-storage using the Web browser command to do so.
We envision most, if not all, players playing through an entire sitting in one session so saving 
locally shouldn't be a need, and devices will have local saves wiped if under-the-control of 
the research team.
We are considering disabling saves as well. However, Twine does maintain some saved 
state during play and it likely is cached (locally of course)
5.3 Method of Assignment/Randomization (if applicable)
Using a 1:1 randomization procedure, eligible individuals will be assigned to either the 1) 
supportED group (n=30) or 2) control group (n=30). Randomization will be stratified by 
assigned sex at birth (male or female). 
5.4 Device Calibration 
There is no necessary calibration process as supportED is a webbased game. If there are 
any concerns or issues with the functionality of the game, Ben Sawyer of Digital Mill will be 
available to assist. Participants will answer study related questions through a secured data 
management system, RedCap. The game itself will not be utilized to record any data. 
5.5 Storage Conditions
supportED is a web-based game that will be delivered to participants via tablets, phones, or 
desktops. Participants will engage with the game under the supervision of the study team to 
ensure proper use of the game and care for the devices. Although our game does not collect 
any identifiable data, tablets will be locked and stored in a secure location. 
5.6 Concomitant therapy
N/A there are no restrictions
5.7 Restrictions
Participants will engage with the device for a restricted period of 45 minutes (one-time 
session). 
  
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
21
6 - Study Design
6.1 Study Design
The protocol will be conducted over the course of two years. The outline below highlights the 
study design. 
Formative Work: We will conduct focus groups to inform the development of a digital game 
and discuss approaches to enhance user experiences, acceptability, and feasibility of the 
game. First, we will conduct six focus groups with a total of 30 participants, including 10 
high-school-aged adolescents, 10 college-aged youth, and 10 providers, to inform the 
content of the videogame with a focus on content related to potential warning signs, coping 
strategies, and seeking help to prevent suicidal thoughts and behaviors among youth who 
misuse opioids. Focus groups will occur in-person or via Zoom over the course of six 
months. Each group will meet for approximately 1-1.5 hours after school hours. The study 
will be introduced to parents/guardians and students and then, if interested in participating, 
information sheets will be provided via paper form or electronically. When the study is 
introduced to parents/guardians and students, we have always stressed that a stipulation of 
our studies requires reliable transportation to/from our studies if conducted in person. In 
certain cases where transportation is not available by family or school, we will provide a bus 
pass.
Focus groups will be approximately 60-90 minutes. A semi-structured focus group guide will 
be developed, pilot tested and used in focus groups. The focus group guide will align with 
constructs from a safety planning intervention,5,6 a well-recognized, evidence-based suicide 
prevention intervention, and include questions related to potential warning signs of emotional 
distress, coping strategies, and seeking help to prevent suicidal thoughts and behaviors 
among youth who misuse opioids. Focus groups will be led by a facilitator, who is also a 
certified school counselor and licensed professional counselor, and a co-facilitator who will 
take field notes. Focus groups will be audio-recorded. Transcripts will be transcribed 
verbatim by a third-party transcription service who our Lab has worked with prior. All 
participants will receive instructions on not using identifiable information (e.g., names, 
school, peer/colleague names, etc.) while being audiotaped and will be provided a study 
number prior to the start of audiotaping. Participants will be instructed to state their study 
number prior to speaking. Audiotapings will be transcribed and will be destroyed 24 months 
after the completion of the study and after review of their content has been completed. 
Transcriptions will not be sent to other institutions and will not be used for purposes other 
than this study and future publications related to this study. Should any identifiable 
information be shared in the focus groups, it will be redacted from transcripts. Participants 
will receive a $25 gift card to participate.
We will follow the same protocol for play-testing focus groups to finalize the game.
Pilot Study: To examine usability, acceptability, and feasibility, we will conduct a pilot study. 
We will enroll 60 high-risk adolescents who attend one of our partner school sites. We will 
also explore proximal outcomes. 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
22
Our research team will be trained by Dr. Blumberg’s team and the Pitt Methods workshop 
prior to commencing the study in all procedures, risk and protection methods, and safety 
related to conducting suicide prevention research. Eligible individuals will be assigned to 
either the 1) supportED group (n=30) or 2) control group (n=30). Both groups will also 
receive NIDA/NIMH pamphlets on substance misuse and mental health for youth at the end 
of the session. Prior to receiving pamphlets, those in the supportED group will engage with 
the game for one session (~45min) while the control group will engage with a non-health-
related game for the same duration. Given schools do not have a standardized approach to 
address suicide prevention, we opted to use an attention/time control condition. 
Participants will use a dedicated device (e.g., tablet) to access their digital experience on the 
web. The research staff with Dr. Fernandes always there will be present to monitor 
gameplay, to provide support, if needed, and to field questions in person. A school-based 
provider will be present for direct referrals, as needed. The total duration and number of 
sessions is consistent with those found in safety planning and with the amount adolescents 
engaged with our empowerED game.q To pilot the feasibility of protocols, we will collect 
proximal outcomes, as possible mechanisms for behavior change. Proximal outcomes 
include but are not limited to the following measures: 1) intention to use safety planning; 2) 
coping strategies; and 3) severity of suicidal thoughts and associated risk factors (e.g., 
pessimism, helplessness, limited social support, and despair). We will also measure severity 
of suicidal ideation and attempts
We will collect participant demographic data including self-reported sex at birth, gender 
identity, sexual orientation, race, and ethnicity to determine subgroup similarities and/or 
differences. We will collect assessment data before and immediately after the participants 
engage with the game as well as at 3 months following gameplay. The primary outcomes of 
the proposed study are to examine: 1) the usability (e.g., ease of use) and acceptability 
(e.g., gameplay satisfaction) of the game among adolescents; and 2) the feasibility of 
delivering the game and piloting protocols in schools. To assess usability, acceptability, and 
feasibility, directly following supportED game completion, we will collect focus group data on 
participants’ experiences. The following proximal outcomes, as mechanisms for behavior 
change, will be measured: 1) intentions to use safety plan;r 2) coping strategies through 
adaptive and maladaptive subscales;s and 3) severity of suicidal thoughts and associated 
risk factors using the Concise Health Risk Tracking Self-Report (CHRT-SR) comprised of the 
following subscales: Propensity (including domains of Pessimism, Helplessness, Limited 
Social Support, and Despair), Impulsivity, and Suicidal Thoughts.t We will measure 
substance misuse in past 30u days as a possible mediator. These scales will be self-
reported by adolescents. 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
23
All of our data will be self-reported data; therefore, we will use data collection methods such 
as confidential self-administration that have been effective in our trials to minimize social 
desirability bias in self-reported data. Participants will receive $25 gift cards as 
compensation for completion of assessments at each timepoint (e.g., baseline/post-game 
and 3-month follow up)
The Yale University Human Subjects Committee (the committee that reviews, approves, and 
monitors research on human subjects) may inspect study records. All published results will 
be group data. Information that will be collected during the focus group interviews will be 
erased 24 months after the completion of the study and after review of their content has 
been completed.
 
1.
Formative and development work: (1 year)
2.
We will work iteratively with our target audience of 16-19-year old adolescents within 
schools, college-aged youth for a reflection of that age range, and school-based 
mental health providers to develop videogame content, collecting qualitative data for 
the videogame and refining our logic model with input from 4 focus groups of 5 high 
school-/college-aged youth each (n=20), aged 16-19 and 2 focus groups of 5 school-
based mental health providers aged 18-80 (n=10).
3.
We will create the “Game Playbook” specific to this new digital game. Game 
Playbooks are our game manuals. We create behavior change gameplay manuals to 
accommodate the specific needs of a multi-disciplinary game development team. The 
playbooks outline the theoretical foundations and gameplay elements. This ensures 
targeted theoretical principles and behavior change mechanisms and constructs are 
included in the videogame.
4.
We will build the new digital game by creating new content, developed from focus 
groups and from the suicide and opioid misuse prevention literature, for our game 
development team, DigitalMill, Inc.
5.
We will conduct play-testing focus groups with input from focus groups of 5 high 
school-/college-aged youth each (n=20), aged 13-19 and focus groups with adults 
who specialize in addiction medicine 18-80 (n=10) to assess user experience (e.g., 
acceptability and usability) and feasibility of protocol to prepare for a larger pilot study 
that will require a new protocol (N=60).
6.
Pilot Study: 
7.
We will conduct a pilot study with (N=60) adolescents between the ages of 13-19. 
We will examine the usability and acceptability of the game among adolescents, and 
the feasibility in conducting the study in schools.
Inclusion criteria: For the pilot study, participants must: 1) attend a high school that 
has a school-based behavioral provider; 2) be between the ages of 13-19; 3) be 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
24
fluent in reading English as determined in consent process; 4) be willing to sit for a 
single session to complete pre-/post-assessments, engage with the game (~45min), 
and participate in a post-gameplay focus group (if in the experimental group) for 
60min; and 5) provide assent and parental/guardian consent (if<age 18).
8.
We will also assess proximal outcomes as potential means for behavior change in 
supportED vs. control group at 3 months. Examples include but are not limited to: 1) 
intentions to use safety plan; 2) coping strategies; and, 3) suicidal thoughts and 
associated risk factors (e.g., pessimism, helplessness, limited social support, and 
despair).
6.2 Study Duration
The anticipated duration of this study will be two years. Participants will engage in focus 
groups over one-year period for approximately 60-90 minutes each. Participants will 
participate in a pilot study in year 2. 
6.3 Outcome Variables
Formative Work: Our study is qualitative by nature. We will explore participants’ perceptions 
on their peers’ or students’ warning signs, coping strategies, and resources to seek help 
related to substance misuse and suicide prevention as outlined in safety planning. We will 
also ask questions about what they would like in a technological game with regard to 
usability and acceptability. We will ask providers questions about feasibility. Feedback on 
what participants view as acceptable/feasible will be critical to developing successful 
technological games targeting suicide.v 
Pilot Study: 
The findings from the proposed study have strong potential for positively impacting 
adolescents who report opioid/substance misuse and who may be at greater risk for suicidal 
thoughts and behaviors. It will be the first to provide evidence that a suicide prevention 
videogame offers an engaging approach and is feasibly conducted in schools with 
adolescents. With schools seeking technology-based approaches and videogames providing 
an engaging platform for adolescents, the proposed study has the potential to serve as a 
necessary first step for long-lasting implications on the health and well-being of adolescents.
6.4 Study Procedures
Formative Work: Participants will engage in six 60-90-minute focus groups led by a licensed 
professional counselor, and a co-facilitator who will observe and take notes. Focus groups 
will be audio-recorded and held in a private room within the school if conducted in a school 
or held via Zoom if conducted virtually. Participants will be asked questions developed from 
a semi-structured focus group guide, which will first be pilot tested. Questions will be 
grounded in constructs of a safety planning intervention, as well as self-determination,w and 
social cognitive theories,x and techniques used in Motivational Interviewing.y Participants will 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
25
be asked to not share any identifiable information. Should any be shared, it will be redacted 
from transcripts. Participants will receive a $25 gift card to participate. Same procedures will 
be in place for play-testing focus groups.
Pilot Study: We will pilot test supportED to examine usability, acceptability, and feasibility. 
We will enroll 60 adolescents who attend one of our partner school sites. To determine 
feasibility in piloting protocols, we will also explore proximal outcomes. Eligible individuals 
will be assigned to either the 1) supportED group (n=30) or 2) control group (n=30). Both 
groups will also receive NIDA/NIMH pamphlets on substance misuse for youth at the end of 
the session. Prior to receiving pamphlets, those in the supportED group will engage with the 
game for one session (~45min) while the control group will engage with a non-health related 
game for the same duration. Given schools do not have a standardized approach to address 
suicide prevention, we opted to use an attention/time control condition. Participants will use 
a dedicated device (e.g., tablet) to access their digital experience on the web. The research 
staff with Dr. Fernandes always there will be present to monitor gameplay, to provide 
support, if needed, and to field questions in person. A school-based provider will be present 
for immediate referrals, as needed.
The total session lasting approximately 90 minutes. The facilitator will ask adolescents to 
sign assent form and provide clarification or answer any questions about the study 
procedure. Prior to the session, we will share flyers with educators, school-based providers, 
and our youth advisory board who will share with participants. Students may then share with 
other students (e.g., snowball sampling). The flyers contain a QR code for students to input 
their first/last name, phone number, and email address. If they are younger than 18, they 
must input  parent/guardian first and last name, phone number, and email address. 
Research staff will then contact them to obtain consent/e-consent. When needed, study staff 
will be available to parents/guardians should they have any questions. Before students are 
able to participate in the research study, they must have a signed assent and 
parent/guardian consent if under 18.
When the gameplay portion of the session begins, participants will play the game on an iPad 
or desktop device. A member of the research team or the facilitator will be there to provide 
assistance at all times. After completing the game, adolescents will be asked to participate in 
a questionnaire session and focus group about their overall gameplay experience. This will 
be facilitated by one of the members of the research team. The responses of the participants 
will be gathered and documented as data, which will be kept confidential. If at any point a 
student is flagged as moderate to high risk due to concerns related to substance misuse, 
depression, and/or suicide, they will be immediately referred to the school-based provider 
who will be on site during baseline and 3-month follow up. If a student is triggered by the 
sensitive nature of the topics, their school-based provider will be able to provide emotional 
support and/or referral to services. These same procedures will be utilized in local CT 
schools and in Miami-Dade County public schools. 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
26
DATA COLLECTED: We will collect name of student and parent/guardian if under 18, their 
email addresses and phone numbers to obtain assents/consents. This information will be de-
identified prior to the start of research. We will collect participant demographic data including 
self-reported sex at birth, gender identity, sexual orientation, race, and ethnicity to determine 
subgroup similarities and/or differences. We will collect assessment data before and 
immediately after the participants engage with the game as well as at 3 months following 
gameplay. The primary outcomes of the proposed study are to examine: 1) the usability 
(e.g., ease of use) and acceptability (e.g., gameplay satisfaction) of the game among 
adolescents; and 2) the feasibility of delivering the protocols and procedures of conducting 
the study in schools. To assess usability, acceptability, and feasibility, directly following 
supportED game completion, we will collect focus group data on participants’ experiences. 
The following proximal outcomes, as mechanisms for behavior change, will be measured 
including but not limited to: 1) intentions to use safety plan;74 2) coping strategies through 
adaptive and maladaptive subscales; 75 and 3) severity of suicidal thoughts and associated 
risk factors using the Concise Health Risk Tracking Self-Report (CHRT-SR) comprised of the 
following subscales: Propensity (including domains of Pessimism, Helplessness, Limited 
Social Support, and Despair), Impulsivity, and Suicidal Thoughts. We will measure 
substance misuse in past 30 days as a possible mediator. These scales will be self-reported 
by adolescents. Participants will receive $25 gift cards as compensation for completion of 
assessments at each timepoint (e.g., baseline/post-game and 3-month follow up).
6.5 Withdrawal Procedures
Participation in the formative work and pilot study is voluntary. Participants may withdrawal 
at any point. This will be explicitly stated prior to the start of each focus group, interview, or 
research session.
6.6 Locations/Facilities
Formative: The study will be conducted virtually via Zoom and/or at previously long-standing 
and established partner school sites. We will recruit from existing partnerships in 
Connecticut and Miami- Dade County schools, such as but not limited to Maloney (N=1191), 
Bassick (N=970), Ronald W. Reagan Doral (N= 1440), Miami Lakes Educational Center (N= 
1015), Alonzo and Tracy Mourning (N=1528), School for Advanced Studies West (N=119), 
and Barbara Goleman (N=2882).
Pilot Study: The study will be conducted virtually via Zoom and/or at previous long-standing 
and established partner school sites. We will recruit from existing partnerships in 
Connecticut and Miami-Dade County schools, such as but not limited to Maloney (N=1191), 
Bassick (N=970), Ronald W. Reagan Doral (N= 1440), Miami Lakes Educational Center (N= 
1015), Alonzo and Tracy Mourning (N=1528), School for Advanced Studies West (N=119), 
and Barbara Goleman (N=2882).
6.7 Data Collection
Formative Work: A research assistant will take notes during the focus groups, and a third-
party transcription service, who our lab has worked with prior, will transcribe audio 
recordings verbatim. We will review field notes and focus group transcripts.
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
27
Pilot Study: 
Currently our game does not record ANY personal information or even individual game 
information. We do not ask for a personal registration or login.
Twine by default does save information locally to the device running the Twine game off the 
Web server. No information is saved server-side and local information can be removed by 
deleting local-storage using the Web browser command to do so.
We envision most, if not all, players playing through an entire sitting in one session so saving 
locally shouldn't be a need, and devices will have local saves wiped if under-the-control of 
the research team.
We are considering disabling saves as well. However, Twine does maintain some saved 
state during play and it likely is cached (locally of course)
We MAY however implement the following depending on further IRB guidance:
1. A 'simple' password that blocks the site where the game is played from the public internet. 
This password would not be individual but would be a simple single password that any 
participant would need to know to enter the page.  
This password would be changed periodically and would cease to work overall when the site 
was closed after initial trials.
2. We may add server-side recording of event-based analytics (i.e. user choices)
This data would be de-identified automatically because there would still be no initial login 
using an personally identifiable account or token.
We are considering using Google Analytics for this purpose or saving data to a Google 
Sheet.
In all cases of such analytics recording we would include a page accessible to all player 
(perhaps even requiring an acknowledgement) that their gameplay data is saved but is not 
identifiable.
There are no other plans or default actions that record player actions / data. There is no 
personalized login system that could enable such identifiable data.
Specific practices would be made to reduce the proliferation or retention of even 
unidentifiable game data in the short term (e.g. wiping local browser storage) and on a long 
term basis deleting long-term analytics data once its use for research and analysis is 
completed.
6.8 Data Collection Sources
Formative Work: The focus group guide will be organized based on the constructs of a 
safety planning intervention (e.g., potential warnings signs related to emotional distress, 
coping strategies, and resources for seeking support). 
Pilot Study: We will assess the user experiences (e.g., acceptability and usability) as well as 
feasibility of delivering protocols of the digital game. From our playtesting focus groups (i.e., 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
28
where we obtained feedback to finalize the prototype), will modify two approaches: the think-
aloud method and cognitive interviewing. The think-aloud method and cognitive interviewing 
are mainly used to analyze how human participants perform and interact with a prototype or 
interface of a product. By conducting either of these methods when testing the usability of a 
product, issues with the prototype can be identified and fixed. The think-aloud method 
specifically requires participants to speak aloud their thought processes and ideas as they 
perform a specific task or solve a problem. Sometimes the method is carried out one-on-one 
with a participant and a research/note taker, while other times video recordings can be 
used.z  By having the participants verbally articulate their thought process, the researchers 
will be able to gain insight on potential issues or complications with the game design and/or 
playtesting process. In context of the Pilot Study, aspects from the think aloud method and 
cognitive interviewing will be applied simultaneously in our post-gameplay focus group, 
which allows for feedback and discussion on the content of the game, as well as the process 
through which the game is being presented for playtesting. Along with the use of these 
methods to gather feedback on the digital game, quantitative measures are also being 
gathered through the use of the User Engagement Scale- Short Form (UES-Short Form), 
and Acceptability of Intervention Measure (AIM) as examples. These scales along with 
qualitative data collection and observation will assess the usability, acceptability, and 
feasibility of the game.  
The User Engagement Scale-Short Form (UES-Short Form) is a validated, 12-item self-
report measure that assesses six domains of engagement where responses are measured 
on a 5-point Likert scale where 1= strongly disagree and 5= strongly agree. 
The Acceptability of Intervention Measure (AIM) is a validated, 4-item self-report measure of 
perceived acceptability where responses are measured on a 5-point Likert scale where 1 = 
completely disagree and 5= completely agree. 
Lastly, feasibility of delivering protocols and procedures will be measures through 
observation of modifications to conduct study, duration of gameplay, and reasons if did not 
finish game to end. Participants will also answer qualitative questions (e.g. does the game 
work? can the game be implemented in schools?) that will be developed by the study team. 
By gathering both qualitative and quantitative data and feedback on the protocol design of 
the digital game, appropriate revisions can be made to future versions of the game. 
We will also explore proximal outcomes such as but not limited to adolescent well-being, 
intentions to use a safety planning intervention, coping strategies, substance misuse in last 
30 days, and associated risk factors related to suicidal risk (e.g., hopelessness, impulsivity, 
etc.). Our specific measures and proximal outcomes are outlines below: 
Coping Strategies
Change in coping strategies will be assessed using the brief COPE scale at baseline and 3-
months follow-up. Brief COPE adaptive and maladaptive subscales are validated, 28- item, 
4-point self-report measures. Brief COPE measures assess 14 conceptually different coping 
reactions. Responses are measured on a 4-point likert scale where 1= I haven’t been doing 
this at all and 5= I’ve been doing this a lot. 
Mindfulness
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
29
To assess facets of mindfulness, we will utilize The Five Facet Mindfulness Questionnaire 
(FFMQ). The FFMQ is a validated, 15-item self-report measure that assesses facets of 
mindfulness. Responses are measured on a 5 point-likert scale where 1= never or very 
rarely true, and 5= very often or always true.
Emotion Regulation
Emotion regulation will be assessed using the State-Difficulties in Emotion Regulation (S-
DERS) scale, a 21-item self-report measure. Responses are measured on a 5-point likert 
scale where 1= almost never and 5= almost always. 
Adolescent Well-Being
Adolescent well-being will be measured using The Adolescent Well-Being assessment, 
which is a validated, 16-item school-based, self-report measure with 11-items focused on 
well-being, and 5-items focused on student demographics. 
Intentions to Use a Safety Plan
Intentions to use a safety plan is a 7-item measure adapted from Addis et al., 2013. 
Responses are measured on a 5-point likert scale where 1= strongly disagree and 5= 
strongly agree. 
Knowledge about the Safety Planning 
Participants will complete surveys through a secured, data management system (RedCap). 
6-items will assess learning goals of the game developed by the study team (e.g. warning 
signs, coping strategies, resources for support).
Concise Health Risk Tracking - Self Report 
Concise Health Risk Tracking Self-Report (CHRT-SR) is a validated, 14 item, 5-point self 
report measures comprised of the following subscales: Propensity, Impulsivity, and Suicidal 
Thoughts. Responses are measured on a 5-point likert scale where 1= strongly disagree and 
5= strongly agree. We will also utilize the Ask Suicide-Screening Questions (ASQ), a 
validated set of 4 questions to assess suicide risk.  
Change in Symptoms of Anxiety 
The General Anxiety Disorder-7 (GAD-7) is a validated, 7-item self report measure that 
assesses symptoms of anxiety. Responses are measured on a 4-point likert scale where 
0=not at all and 3=nearly everyday.
Change in Symptoms of Depression
The Patient Health Questionnaire (PHQ-9) is a validated, 9-item self-report measure that 
assesses symptoms of depression. Responses are measured on a 4-point likert scale where 
0=not at all and 3=nearly everyday. 
Help-Seeking Behavior
The General Help Seeking Questionnaire (GHSQ) is a validated, 20-item self-report 
measure that assesses professional and non professional help seeking behaviors. 
Responses are measured on a 7-point likert scale where 1=extremely unlikely and 
7=extremely likely. 
Substance Misuse in the Past 30-Days
Substance misuse of alcohol, tobacco/vaping, cannabis, legal and illegal opioids in the past 
30-days will be measured as a possible mediator. These measures are self-reported.
Suicidal thoughts and behaviors in Past 30-days – Self-Report
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
30
The Ask Suicide Screening Questions (ASQ) has used a self-reported 4-item questionnaire 
with youth to measure the occurrence of suicidal thoughts and behaviors. The 4 questions 
asked targeted a different aspect of suicidal thoughts: past wishes of death (“wish you were 
dead?”), suicidal ideation (“have thoughts of killing self?”), suicidal thoughts with a plan (“had 
a suicidal plan?”), and suicidal behavior (“tried to kill self?”). 
6.9 Standard Tools
N/A
7 - Statistical Analysis
7.1 Sample Size
For Content: 30 participants, including 20 high-school/college-aged youth and 10 adult 
providers, will make up our six focus groups. Approximately 10 interviews with adults who 
may have misused substances during their youth and will be able to reflect on what they 
wish they knew during then. 
For Play Testing: 30 participants, including 10-20 high-school/college-aged youth and 10-20 
adult providers, will make up our six focus groups.
For Pilot Study: 60 participants, high-school aged youth [ages 13-19], across 6-10 high 
schools with school-based behavioral providers. 
7.2 Planned Analyses
Formative Work: Data will be analyzed using rapid analytic techniques to ensure timely 
analysis.cc We will review field notes and focus group transcripts. We will develop a 
templated table to summarize each transcript.dd We will then create a codebook outlining the 
components of safety planning to code each summary. Three team members will code each 
summary for researcher triangulation. We will consolidate summaries into two matrixes 
(adolescents and providers) to capture similar/different themes with supporting quotations. 
When there are discrepancies, we will discuss until full consensus. We will keep 
documentation of decisions, meetings, peer debriefings, and a reflexive journal as part of our 
audit trail to enhance the rigor and meet the trustworthiness criteria.ee Data collected in the 
study will reside in our computerized database and electronic storage mechanisms. All data 
analyses will be performed under IRB approved protocols. 
Pilot Study: We will assess usability, acceptability, and feasibility gathered through the use of 
the User Engagement Scale- Short Form (UES-Short Form) and Acceptability of 
Intervention Measure (AIM). These are validated scales that will determine the reactions to 
the gameplay experience. We will also assess the usability, acceptability, and feasibility of 
the game in our post gameplay focus groups. We will also explore proximal outcomes of 
supported by comparing scores in intentions, coping strategies, and suicidal thoughts and 
associated risk factors by changes in response rating from before to after. We will also 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
31
compare scores in the severity of suicidal ideation and attempts. We will test the hypothesis 
that individuals who engage with supportED will report decreases in outcomes in comparison 
to the control group. We will conduct a longitudinal analysis using a hierarchical linear mixed 
model approach to compare participants in the game group to participants in the control on 
reported outcomes from baseline to 3-month follow-up assessments (i.e., baseline, post-
gameplay, and three months). We will also use logistic regression models to determine if any 
relevant baseline variables are associated with changes in outcomes. We will also examine 
whether changes in outcomes varied by treatment group, sex at birth, sexual orientation, 
race, ethnicity, gameplay duration, and/or gameplay experience to determine similarities 
and/or differences among subgroups. All of these analyses will be exploratory. P-values 
smaller than 0.05 will be considered statistically significant.
7.3 Data Relevance
n/a
7.4 Data Coding
Formative Work: The data will be coded using an inductive qualitative data analysis 
approach. We will create a codebook outlining the components of safety planning to code 
each summary. Three team members will code each summary for researcher triangulation. 
We will consolidate summaries into two matrixes (adolescents and providers) to capture 
similar/different themes with supporting quotations. When there are discrepancies, we will 
discuss until full consensus. We will keep documentation of decisions, meetings, peer 
debriefings, and a reflexive journal as part of our audit trail to enhance the rigor and meet 
the trustworthiness criteria. For playtesting we will use Qualtrics to collect their feedback 
through cognitive interviewing and the think aloud methods. We will also have a note-taker 
complete a debrief summary after each session. Participant experience will be collected and 
analyzed using rapid analytic techniques to quickly draft a report for the game development 
company with suggested revisions to finalize the prototype for the pilot study. 
Pilot Study: For the pilot study, qualitative data will be analyzed using techniques from a 
reflexive thematic analysis approach and rapid analysis. Coding is organic and allows for the 
researchers’ subjective skills and experience to be highlighted. Debrief summaries will be 
completed after each session. 
7.5 Data Analysis Tools
Formative Work: We will use a qualitative analysis software (e.g., NVIVO or Dedoose) to 
analyze the data.
Pilot Study: A web-based computer system (RedCap) will be used for data collection, 
management, and monitoring. The web-based data system Clinical Trial Management 
System (CTMS) is under the auspices of the Yale Center for Medical Informatics who is 
responsible for data management.
7.6 Data Monitoring
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
32
Formative Work: Because this study has minimal risk, a Data and Safety Monitoring Board 
will not be established.
Pilot Study: A Data and Safety Monitoring Board will be established. We are in the process 
of establishing a Data and Safety Monitoring Board (DSMB). The DSMB will be comprised of 
two experts in clinical trials (one with expertise in substance use prevention and/or 
adolescents) trials and will provide oversight in a number of areas including for the selection, 
enrollment, or consenting of participants, or determination of eligibility.
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
33
8 - Data Handling and Record Keeping
8.1 Subject Data Confidentiality
Participants will be asked to not share any identifiable information during focus groups. 
Should any identifiable information be shared in the focus groups, it will be redacted from 
transcripts.
A number of precautions will be actively integrated into the research procedures to protect 
the confidentiality and anonymity of all participants. All research study staff will be required 
to complete training in research ethics. All data entry and analyses will be completed with ID 
numbers only. The research staff will follow standard confidentiality procedures for research 
programs.
A web-based computer system (RedCap) will be used for data collection, management, 
and monitoring. The web-based data system Clinical Trial Management System (CTMS) 
is under the auspices of the Yale Center for Medical Informatics who is responsible for 
data management. It is a web-accessible, multi-disciplinary database for study- or 
disease-specific clinical research data designed to store the focused data required for 
clinical trials and clinical research studies. This system has proven to be very efficient 
and reliable in other clinical trials. It will be used by the research assistant to administer 
the research instruments from any computer with Internet access. The CTMS will be 
used to generate a number of web accessible reports and reminders to help monitor and 
manage the data collection process to assure completeness of evaluation. The system 
can check for data inconsistencies, omissions, and errors regularly. Data questions or 
problems will trigger data queries and analyses of missing data will be done periodically 
to assure that all forms are entered and available for analysis. CTMS staff have received 
HIPAA training and Human Subjects Protection training. Users will certify that they are 
HIPAA trained and will act in full compliance of HIPAA regulations. Specifically, 
individual profile data and data on application use by study participants will be collected 
and de-identified through irreversible hashing methods prior to storage to ensure privacy 
protection is satisfied. De-identified data will be encrypted in transit and securely 
transferred for storage and analyses.
The web data-entry interface allows data entry to be performed from anywhere on the 
Internet and uses 128-bit secure sockets layer security to protect the confidentiality of 
the data. The CTMS maintains an electronic audit trail of all modifications to a study’s 
data, including the user who made the change, date and time, each data item changed 
and its previous value and new value. Yale houses and maintains the security and 
backup of all servers and workstations. The CTMS’s Oracle database is housed in a 
central machine room maintained by Yale. Passwords and subject identifying data will 
be stored encrypted in the database server. Several levels of database backup are 
performed regularly, including full daily and incremental backup.
8.2 Data Quality Assurance
We will keep documentation of decisions, meetings, peer debriefings, and a reflexive journal 
as part of our audit trail to enhance the rigor and meet the trustworthiness criteria.
The organizational structure used to ensure quality of data in this project include: 1) 
Extensive training and close supervision of research personnel in data collection and 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
34
management; 2) Preliminary review of all data for completeness and coding errors by data 
manager/analyst; and 3) Utilization of error-checking statistical procedures. The PI 
supervises data procedures. All error corrections are fully documented in the research 
records of the study. All research personnel are required to participate in and document 
training in protection of human subjects and the responsible conduct of scientific research. In 
addition, the Clinical Trials Management System (CTMS) will be used to generate a number 
of web accessible reports and reminders to help monitor and manage the data collection 
process to assure completeness of evaluation. The system can check for data 
inconsistencies, omissions, and errors regularly.
8.3 Data Storage/Security
Names, phone numbers, addresses, email addresses, parent/guardian names, 
parent/guardian phone numbers, and parent/guardian email addresses will all be collected.
Data collection forms will be designated by ID numbers only. A separate master file of 
names, addresses, contact persons, and telephone numbers, along with the study ID 
numbers will be maintained in a locked file cabinet in the PI's research offices. All data entry 
and analyses will be completed with ID numbers only. The research staff will follow standard 
confidentiality procedures for research programs.
8.4 Study Records
Protocol
Information Sheets
Focus Group/Interview Guide
Audiotaped focus group recordings
Informed Written Assent/Consent 
Participant Assessments 
8.5 Retention of Records
Information that will be collected during the assessments and interviews will be erased 24 
months after the completion of the study and after review of their content has been 
completed.
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
35
9 - Study Considerations
9.1 Research Personnel Training
Procedures for training and supervision of all research personnel have been developed as 
part of our previous and current studies. All members of the research team are familiar with 
procedures for identifying and reporting possible adverse reactions. All members of the 
research team are trained in mandatory reporting and will notify the PI immediately of any 
concerns raised about participant mental health (suicidality), substance use, abuse of any 
kind, etc.
9.2 Unanticipated Problems and Protocol Deviations
Any protocol deviations or unanticipated problems will immediately be reported to the PI. 
Protocol deviations or unanticipated problems will be reported to the IRB as per their written 
policies and procedures.
If an adverse event occurs study personnel will notify the PI as well as the appropriate 
Information Security Officer (ISO) and follow all necessary procedures. All adverse events 
are reported using the Yale Institutional Review Board (IRB) standard template for reporting 
adverse events. The PI reviews all adverse events, classifies the attribution of adverse 
events (e.g., definitely, probably, possibly related; unlikely or unrelated) and grades the 
severity of the event, utilizing the FDA's definition of serious adverse events, on a 5-point 
scale (0=no adverse event or within normal limit; 1=mild; 2=moderate; 3=severe; 4=life- 
threatening; 5=fatal). Serious unanticipated or anticipated adverse events will be reported 
immediately to the IRB within five (5) calendar days by phone and/or email and will submit a 
written report to the PO no more than five (5) calendar days later.
Medical advisement will be available by the PI's primary mentor, Dr. Lynn Fiellin, and co-
primary mentor, Dr. Hilary Blumberg, as needed. 
9.3 Study Modification and Discontinuation
We will update the protocol any time a change has been made to the study and re-submit to 
IRB. Once approved by the IRB, changes will be implemented into the study.  
9.4 Study Completion
This phase of the study will complete within two years from the start date. 
9.5 Funding Source
This study was made possible by CTSA Grant Number KL2 TR001862 from the National 
Center for Advancing Translational Science (NCATS)/National Institutes of Health (NIH).
9.6 Publication Plan
At the end of the study and once data analysis has been completed, results will be submitted 
to a peer-reviewed journal and a community report may be shared with our partners.
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
36
References
a.
Ivey-Stephenson AZ, Demissie Z, Crosby AE, et al. Suicidal Ideation and Behaviors 
Among High School Students—Youth Risk Behavior Survey, United States, 2019. 
MMWR supplements. 2020;69(1):47.
b.
Baiden P, Graaf G, Zaami M, Acolatse CK, Adeku Y. Examining the association 
between prescription  opioid misuse and suicidal behaviors among adolescent 
high school students in the United States.  Journal of psychiatric research. 
2019;112:44-51.
c.
Bains RM, Diallo AF. Mental Health Services in School-Based Health 
Centers:Systematic Review. The  Journal of School Nursing. 2016;32(1):8-19. 
d.
 Stanley B, Brown GK, Brenner LA, et al. Comparison of the safety planning 
intervention with follow-up  vs usual care of suicidal patients treated in the 
emergency department. JAMA psychiatry.  2018;75(9):894-900. 
e.
Centers for Disease Control Prevention. Web-based Injury Statistics Query and 
Reporting System  (WISQARS). “Fatal and Non-Fatal Injury Reports.”2019. 
f.
Kõlves K, De Leo D. Suicide methods in children and adolescents. European 
child & adolescent  psychiatry. 2017;26(2):155-164.
g.
Seth P, Scholl L, Rudd RA, Bacon S. Overdose deaths involving 
opioids, cocaine, and  psychostimulants—United States, 2015–
2016. Morbidity and Mortality Weekly Report.  2018;67(12):349
h.
Hughes A, Williams MR, Lipari RN, Bose J, Copello E, Kroutil L. Prescription drug 
use and misuse in  the United States: Results from the 2015 National Survey on 
Drug Use and Health. NSDUH Data  Review. 2016:A1-A24. 
i.
Wilkins NJ, Clayton H, Jones CM, Brown M. Current Prescription Opioid 
Misuse and Suicide Risk  Behaviors Among High School Students. Pediatrics. 
2021. 
j.
Love HE, Schlitt J, Soleimanpour S, Panchal N, Behr C. Twenty Years Of School-
Based Health Care  Growth And Expansion. Health Affairs. 2019;38(5):755-764. 
k.
Amaral G, Geierstanger S, Soleimanpour S, Brindis C. Mental health characteristics 
and health-seeking  behaviors of adolescent school-based health center users and 
nonusers. Journal of School Health.  2011;81(3):138-145. 
l.
Knopf JA, Finnie RK, Peng Y, et al. School-based health centers to advance 
health equity: a  Community Guide systematic review. American journal of 
preventive medicine. 2016;51(1):114-126. 18. Katz C, Bolton SL, Katz LY, et al. 
A systematic review of school-based suicide prevention programs.  Depression 
and anxiety. 2013;30(10):1030-1045. 
m.  Stanley B, Brown GK. Safety planning intervention: a brief intervention to 
mitigate suicide risk.  Cognitive and Behavioral Practice. 2012;19(2):256-
264. 
n.
 Hieftje K, Edelman EJ, Camenga DR, Fiellin LE. Electronic media-based health 
interventions for  behavior change in youth: A systematic review. JAMA pediatrics. 
2013;1-7. doi:10.1001/jamapediatrics.  6. Fiellin LE, Hieftje KD, Pendergrass TM, et 
al. A videogame intervention for sexual risk reduction in  minority adolescents: A 
randomized controlled trial. Journal of medical Internet research.  2017;19(9):e314. 
o.
Fiellin LE, Kyriakides TC, Hieftje KD, et al. The design and implementation of a 
randomized controlled  trial of a risk reduction and HIV prevention videogame 
intervention in minority adolescents:  PlayForward: Elm City Stories. Clinical Trials: 
Journal of the Society for Clinical Trials. 2016:1-9 DOI:  
10.1177/1740774516637871. 
p.
 Pentz MA, Hieftje KD, Pendergrass TM, et al. A videogame intervention for 
tobacco product use  prevention in adolescents. Addictive behaviors. 
2019;91:188-192. 
q.
Fernandes CF, Taylor CK, Tran A, Pendergrass T, Hieftje K, Fiellin LE. A pilot 
randomized controlled  trial to evaluate a cognitive-behavioral intervention: 
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023

APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023
Protocol Number: 2000031180
01 February 2023 - version 16
37
empowerED: Think it through digital stories.  Unpublished manuscript 2020. 
r.
Czyz E, King C, Biermann B. Motivational interviewing-enhanced safety planning 
for adolescents at high suicide risk: A pilot randomized controlled trial. Journal of 
Clinical Child & Adolescent Psychology.  2019;48(2):250-262.
s.
Carver CS. You want to measure coping but your protocol’too long: 
Consider the brief cope.  International journal of behavioral medicine. 
1997;4(1):92.
t.
Mayes TL, Kennard BD, Killian M, et al. Psychometric properties of the concise 
health risk tracking  (CHRT) in adolescents with suicidality. Journal of affective 
disorders. 2018;235:45-51.
u.
Johnston LD, Miech RA, O’Malley PM, Bachman JG, Schulenberg JE, Patrick ME. 
Monitoring the  Future national survey results on drug use 1975-2019: Overview, 
key findings on adolescent drug use.  Ann Arbor, MI: University of Michigan;2020.  
v.
Kennard BD, Goldstein T, Foxwell AA, et al. As Safe as Possible (ASAP): a 
brief app-supported inpatient intervention to prevent postdischarge suicidal 
behavior in hospitalized, suicidal adolescents.  American journal of 
psychiatry. 2018;175(9):864-872. 
w. Deci EL, Ryan RM. The general causality orientations scale: Self-determination in 
personality. Journal  of research in personality. 1985;19(2):109-134. 
x.
Bandura A. Social Learning Theory. New York, NY: General Learning Press; 
1971.
y.
Miller WR, Rollnick S. Motivational interviewing: Helping people change. 
Guilford press; 2012. 
z.
Jaspers MWM. The Think Aloud Method and user interface design. Human 
Computer Interaction. 2004;73:781-795. 
aa. Chin JP, Diehl VA, Norman LK. Development of an instrument measuring 
user satisfaction of the human-computer interface. Proceedings of the 
SIGCHI conference on Human factors in computing systems  - CHI '88. 
1988. 
bb. McCall T, Ali MO, Yu F, Fontelo P, Khairat S. Development of a mobile app to 
support self-management of anxiety and depression in African American women: 
Usability study (preprint). 2020. 
cc. . Vindrola-Padros C, Johnson GA. Rapid techniques in qualitative research: A 
critical review of the  literature. Qualitative Health Research. 
2020;30(10):1596-1604. 
dd. Gale RC, Wu J, Erhardt T, et al. Comparison of rapid vs in-depth qualitative 
analytic methods from a  process evaluation of academic detailing in the 
Veterans Health Administration. Implementation  Science. 2019;14(1):1-12.
ee. Nowell LS, Norris JM, White DE, Moules NJ. Thematic analysis: Striving to meet 
the trustworthiness  criteria. International journal of qualitative methods. 
2017;16(1):1609406917733847.
ff.
Dazzi, T., Gribble, R., Wessely, S., & Fear, N. T. (2014). Does asking about 
suicide and related behaviours induce suicidal ideation? What is the 
evidence?. Psychological medicine, 44(16), 3361–3363. 
https://doi.org/10.1017/S0033291714001299
APPROVED BY THE YALE UNIVERSITY IRB 2/1/2023