Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying
Phase: NA
Conditions: Bullying of Child
Sponsor: University of Pittsburgh

STUDY DESIGN STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying 
 
NCT: NCT03501264 
IRB ID: PRO17060347 
 
Most Recent Renewal: 10/25/2018 
 
 

STUDY DESIGN 
 
PARTICIPANT TIMELINE 
 
  
DESCRIPTION OF PARTICIPANT FLOW 
1. Advertisements direct potential participants to Screener survey 
2. Participants complete screener (in REDCap) 
3. If eligible, participants complete informed assent/consent (in REDCap) 
o If ineligible, participants are thanked for their time and no more contact is 
made with them. 
4. If consent is provided, participants are emailed/texted a link to the baseline 
survey (T1) to complete (in REDCap) 
o Incentive: $10 when T1 survey is completed 
5. Researchers then randomize participants to intervention or control (in REDCap) 
6. All participants (both intervention and control groups) receive a list of website 
resources related to study outcomes. 
7. Intervention group receives Intervention Download Instructions (via Redcap)  
o Until participants download the game, email reminders (5 maximum) will 
be emailed to participants every 3 days (automatically performed in 
REDCap). If participants also provided a phone number where we can text 
them, we will remind them via text message to complete the REDCap 
survey. 
8. Participants complete first follow-up survey (T2) (in REDCap) 
o Incentive: $25 when T2 survey is completed 
o Survey will activate 4 weeks after T1 survey completion 
o Survey will be open until 7 weeks after T1 survey completion  
o All participants will complete survey similar to baseline survey (minus 
demographics and potential confounder variables) 
o Intervention group will also complete questions about satisfaction with the 
game. 
o Until participants complete the survey, email reminders (5 maximum) will 
be emailed to participants every 4 days (automatically performed in 
REDCap). If participants also provided a phone number where we can text 
them, we will remind them via text message to complete the REDCap 
survey. 
9. Participants complete second/final follow-up survey (T3) (in REDCap) 
o Incentive: $50 when T3 survey is completed 
o Survey will activate 8 weeks after T1 survey completion 
o Survey will be open until 11 weeks after T1 survey completion  
Provide  
Informed Consent 
& 
Complete  
Baseline Survey 
(Time 1) 
Randomization 
Intervention 
Download and Play Game;  
& Provided with Resources 
Complete  
1st Follow-up Survey 
(Time 2) 
4 Weeks after Time 1 
Complete  
2nd Follow-up Survey 
(Time 3)  
8 Weeks after Time 1 
Control 
Provided with Resources 

o Until participants complete the survey, email reminders (5 maximum) will 
be emailed to participants every 4 days (automatically performed in 
REDCap). If participants also provided a phone number where we can text 
them, we will remind them via text message to complete the REDCap 
survey. 
 
MAIN OUTCOMES 
 
The primary outcomes of this study are related to feasibility. This includes the domains of 
acceptability, demand, implementation, practicality, integration, adaptation, expansion, and 
preliminary efficacy testing (based on Bowen, et al., 2009, Am J Prev Med). Below, we present each of 
the feasibility domains, how they will be measured, and corresponding hypotheses (in parentheses). 
 
ACCEPTABILITY 
- Measured using the Gaming Experience Questionnaire (average ≥2 in each domain) 
- Would you recommend that your friends play this game? (≥75%) 
- How likely would you be to tell your friends about this game? (≥80%) 
 
DEMAND 
- The number of hours the game was played (≥75% who played for ≥1 hour) 
- Intervention group’s self-reported use of the game in hours (≥75% who played for ≥1 hour) 
 
IMPLEMENTATION 
- How many participants in in the intervention arm downloaded the game? (≥80%) 
- How many people played the game? (≥80%) 
- How many people completed surveys at T1, T2, T3? (≥80% each survey wave) 
- How many people completed ALL surveys? (≥75%) 
- How many people completed at least 2 surveys? (≥85%) 
- How many reminders before people completed the surveys? (exploratory) 
- How well they did in the game? Did they meet the milestones in the game? (exploratory) 
- How many times texted before they completed survey? (exploratory) 
- How many times contacted? (exploratory) 
- Percent of people who consented post screening (80%) 
- How long does it take to get 240 people to enroll in the study? (exploratory) 
- Did randomization work? (yes, we hypothesize no group differences in demographics at baseline) 
- How many got randomized? (240 participants) 
- How many people recruited from which venue? (exploratory) 
 
PRACTICALITY 
- How many people have PC or Mac computers in our screening procedures (exploratory) 
- Screening based on having an email address (exploratory) 
- How easily was the game downloaded without contacting our research coordinator? (exploratory) 
- Feelings of safety with regards to password protection? (exploratory) 
- Feelings of safety with regards to having other people see the game? (exploratory) 
- Did the game interfere with other activities? (exploratory) 
 
INTEGRATION 
- How could this better fit into the youth’s life? (exploratory) 
- How well does this fit into youth’s life now? (exploratory) 
- How could the game be improved? (exploratory) 
 
ADAPTATION 
- Would you want to be able to play this game on your phone (an app)? (exploratory) 
- Did you like this game on the computer? (exploratory) 
- This game may not be appropriate for older kids. (how much do they agree with this? Exploratory) 
- We will examine the Gaming Experience Questionnaire scores by gender, sexual orientation, 
race/ethnicity, age (exploratory) 

 
EXPANSION 
- How could the game be improved? (exploratory) 
- What would you like to be added to the game? (exploratory) 
- What would you like removed from the game? (exploratory) 
 
PRELIMINARY EFFICACY TESTING 
We hypothesize that the intervention group (versus control group) will have greater levels of change 
over time in the following outcomes: 
1. Increased help-seeking self-efficacy, intentions, and behaviors 
2. Increased coping strategies and coping flexibility 
3. Increased knowledge and use of online resources 
4. Decreased bullying and cyberbullying victimization 
5. Decreased loneliness 
6. Decreased mental health problems (anxiety, depression, suicidality) 
7. Decreased substance use (alcohol, tobacco, and other drugs) 
8. Decreased internalized sexual and gender minority stigma 
 
 
 
STATISTICAL ANALYSIS 
 
For the measures of acceptability, demand, implementation, practicality, integration, adaptation, and 
expansion, we will report results using descriptive statistics (i.e., percentages and frequencies for 
categorical variables, or means and standard deviations for continuous variables). 
 
For the preliminary efficacy testing outcomes, we will use repeated measures (i.e., multilevel) 
statistical models using logistic or linear regression, depending on the distribution of the outcomes. To 
examine whether there were greater improvements over time in the intervention group versus control 
group, we will test the interaction term of time by group. While we are powered to find medium effects 
(based on Cohen), our primary interest is in estimating the effect size and confidence interval width, 
which will help us power a future, larger randomized controlled trial. 
 
 
 
 
IRB PROTOCOL 
 
 

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Section: Triage
     [reviewer notes¬] 
Provide a short title for this study (200 characters or less):
RCT of Help-Seeking Intervention 
T1.0
Select the type of application:
New Research Study  
 
T2.0
Is the proposed research study limited to the inclusion of deceased individuals? 
* No
T2.1
Are any research activities being conducted at the VA Pittsburgh Healthcare
System or with VA funds? 
* No
 
  

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Section: Triage
     [reviewer notes¬] 
T3.0
What is the anticipated risk to the research participants?
Minimal Risk
 
T3.1
Why do you feel that all aspects of this research study, including screening and
follow-up, involve no more than minimal risk to the research subjects?
The probability and magnitude of harm or discomfort anticipated in our research study are
not greater in and of themselves than those ordinarily encountered in daily life (i.e., of the
general population). 
Asking sexual and gender minority (SGM) youth questions about help-seeking behaviors,
bullying experiences, mental health, substance use experiences, and their experience with
the game intervention should be regarded as minimal risk. The probability and magnitude
of harm or discomfort anticipated in our research study are not greater in and of
themselves than those ordinarily encountered in daily life (i.e., of the general population). 
The survey questions to be asked are questions and discussions that youth normally have.
Additionally, these survey questions are routinely as part of the Youth Risk Behavioral
Surveillance Survey (YRBSS) throughout the United States as part of their high-school
experience. 
It should also be mentioned that the confidential nature of the surveys greatly reduces risk
to participant.
T4.0
Does the proposed study qualify for 'exempt' IRB review or for a determination of
either 'not research' or 'no human subject' involvement?
* No
 
T5.0
Does the proposed research study qualify for 'expedited' IRB review status?
* Yes
  

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Section: Cover Sheet
     [reviewer notes¬] 
CS1.0
What is the reason for this submission?
New Research Protocol Submission
CS1.1
Has this research study been approved previously by the University of Pittsburgh
IRB?
*  No
CS1.1.1
Has this research study (or a substantially similar research study) been previously
disapproved by the University of Pittsburgh IRB or, to your knowledge, by any other
IRB?
*  No
 
    [reviewer notes¬] 
CS2.0
Title of Research Study:
Pilot Randomized Controlled Trial of a Help-Seeking Intervention Game for Sexual
and Gender Minority Adolescents
CS2.0.1
   
Requested approval letter wording:
CS2.1
Research Protocol Abstract:
The purpose of this research study is to conduct a pilot randomized controlled trial of a
game-based intervention is able to increase help-seeking-related knowledge, attitudes, and
behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and
gender minority (SGM) youth. The goals of the proposed study are to: (1) Test the
feasibility and acceptability of a game-based intervention to increase help-seeking-related
knowledge, attitudes, and behaviors among SGM youth; and (2) Using a randomized
controlled trial, test the efficacy of a game-based intervention to increase help-seeking-
related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and
increase resiliencies among SGM youth.
 
 
CS2.2
Select the category that best describes your research:
Social, behavioral, educational, and/or public policy research
     [reviewer notes¬] 
CS3.0
Name of the Principal Investigator:
James Egan
Note: Adjunct faculty of the University, including lecturers and instructors, are not
permitted to serve as a PI or Faculty Mentor but may serve as co-investigators. Refer to
Chapter 4 on the HRPO website for more information.

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Section: Cover Sheet
CS3.1
Affiliation of Principal Investigator:
UPitt faculty member 
 
If you chose any of the Pitt options, please indicate the specific campus:
Main Campus - Pittsburgh
 If you chose the UPiƩ faculty member opƟon, provide the PI’s University Faculty Title:
Assistant Professor  
CS3.2
Address of Principal Investigator:
4138 Parran Hall 
130 De Soto Street
Pittsburgh, PA 15261 
CS3.3
Recorded Primary Affiliation of the Principal Investigator:
U of Pgh | Graduate School of Public Health | Behavioral and Community Health Sciences 
CS3.4
Identify the School, Department, Division or Center which is responsible for
oversight of this research study:
U of Pgh | Graduate School of Public Health 
 
 
CS3.5
Telephone Number of Principal Investigator:
412-624-2255 
CS3.6
Recorded Current E-mail Address of Principal Investigator to which all
notifications will be sent:
JEE48@pitt.edu
CS3.7
Fax Number:
CS3.8
Does this study include any personnel from Carnegie Mellon University, and/or
use any CMU resources or facilities (e.g., Scientific Imaging and Brain Research
Center (SIBR)?
*  No
CS3.9
Is this your first submission, as PI, to the Pitt IRB?  
*  No
 

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Section: Cover Sheet
     [reviewer notes¬] 
CS4.0
List of Co-Investigators: 
Last
First
Organization
Coulter Robert U of Pgh | Graduate School of Public Health | Behavioral and Community
Health Sciences
 
 
 
    [reviewer notes¬] 
CS5.0
Name of Primary Research Coordinator:
Robert Coulter
 
 
 
CS5.1
Address of Primary Research Coordinator:
Children's Hospital Office Building (CHOB)
Children's Hospital of Pittsburgh, UPMC
3414 Fifth Avenue, Room 101
CS5.2
Telephone Number of Primary Research Coordinator:
7165238564
CS6.0
Name of Secondary Research Coordinator:
Jordan Sang
CS6.1
Address of Secondary Research Coordinator: 
 
4138 Parran Hall
130 DeSoto St
Pittsburgh PA 15261
CS6.2
Telephone Number of Secondary Research Coordinator:
 
9176368446
CS6.3
Key Personnel/Support Staff (Only list those individuals who require access to
OSIRIS): 
Last
First
Organization
There are no items to display
     [reviewer notes¬] 
CS7.0
Will this research study use any Clinical and Translational Research Center (CTRC)
resources?
No
  

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Section: Cover Sheet
     [reviewer notes¬] 
CS8.0
Select the entity responsible for scientific review.
 
Department Review - (a dean, department chair, division chief, or center head) 
Note: DoD funded studies require departmental review 
 
CS8.1
Select the school, department or division which is responsible for scientific review
of this submission.
U of Pgh | Graduate School of Public Health | Behavioral and Community Health Sciences
 
 
  
     [reviewer notes¬] 
CS9.0
Does this research study involve the administration of an investigational drug or
an FDA-approved drug that will be used for research purposes?
* No  
CS10.0
Is this research study being conducted under a University of Pittsburgh-based,
sponsor-investigator IND or IDE application?
 
*  No 
If YES, you are required to submit the IND or IDE application and all subsequent FDA
correspondence through the Office for Investigator-Sponsored IND and IDE Support
(O3IS).  Refer to applicable University policies posted on the O3IS website
 (www.O3IS.pitt.edu).
  
     [reviewer notes¬] 
CS11.0
Use the 'Add' button to upload one or more of the following:
the sponsor protocol (including investigator initiated studies) and/or
other brochures
the multi-center protocol and consent form template, if applicable
Name Modified Date
Is this research study supported in whole or in part by industry?  This includes the
provision of products (drugs or devices).  
 
*  No
Is this a multi-centered study?
*  No
 
 

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Section: Cover Sheet
     [reviewer notes¬] 
CS12.0
Does your research protocol involve the evaluation or use of procedures that emit
ionizing radiation?
*  No 
CS13.0
Does this research study involve the deliberate transfer of recombinant or
synthetic nucleic acid molecules into human subjects?
 
*  No
Upload Appendix M of NIH Guidelines:
Name
Modified Date
 
CS14.0
Are you using UPMC facilities and/or UPMC patients during the conduct of your
research study?
 
*  No 
If Yes, upload completed Research Fiscal Review Form:
Name
Modified Date
 

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Section: Cover Sheet
     [reviewer notes¬] 
CS15.0
Indicate the sites where research activities will be performed
and/or private information will be obtained.
Choose all sites that apply and/or use Other to include sites not listed:
Sites:
University of Pittsburgh
 
University of Pittsburgh
Campus:
Main Campus - Pittsburgh
List university owned off-campus research sites if applicable:
 
 
If you selected School, International or Other, list the sites:
 
*For research being conducted at non Pitt or UPMC sites, upload a
site permission letter granting the researcher permission to
conduct their research at each external site:
Name Modified Date
 
CS15.1
Have you, James Egan , verified that all members of the research
team have the appropriate expertise, credentials, and if
applicable, hospital privileges to perform those research
procedures that are their responsibility as outlined in the IRB
protocol?
*  Yes
 
CS15.2
Describe the availability of resources and the adequacy of the
facilities to conduct this study:
*  Dr. Egan's office in the Graduate School of Public Health has locked
filing cabinets, secure password protected computers, printers, fax
machines and photocopiers with work space for each team member. Dr.
Egan and his team have up-to-date computer equipment with relevant
statistical software and access to large secure servers for managing data.
Dr. Egan's computer support is more than adequate to carry out the
proposed research plan. The computer networking is supported 24/7 by
highly trained computer staff.
 
  

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Section: Cover Sheet
     [reviewer notes¬] 
CS16.0
Special Research Subject Populations: 
Categories
Children (age < 18 years old)
    [reviewer notes¬] 
CS17.0
Does your research involve the experimental use of any type of human stem cell?
*  No
 
    [reviewer notes¬] 
 
NIH Definition of a Clinical Trial
A research study1 in which one or more human subjects2 are prospectively
assigned3 to one or more interventions4 (which may include placebo or other
control) to evaluate the effects of those interventions on health related biomedical
or behavioral outcomes.5
1 See Common Rule definition of research at 45 CFR 46.102(d) .
2 See Common Rule definition of human subject at 45 CFR 46.102(f) .
3 The term “prospectively assigned” refers to a pre-defined process (e.g.,
randomization) specified in an approved protocol that stipulates the assignment of
research subjects (individually or in clusters) to one or more arms (e.g., intervention,
placebo, or other control) of a clinical trial.
4 An intervention is defined as a manipulation of the subject or subject’s environment
for the purpose of modifying one or more health-related biomedical or behavioral
processes and/or endpoints.  Examples include:  drugs/small molecules/compounds;
biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g.,
telemedicine, face-to-face interviews); strategies to change health-related behavior
(e.g., diet, cognitive therapy, exercise, development of new habits); treatment
strategies; prevention strategies; and, diagnostic strategies.
5 Health-related biomedical or behavioral outcome is defined as the pre-specified
goal(s) or condition(s) that reflect the effect of one or more interventions on human
subjects’ biomedical or behavioral status or quality of life.  Examples include: 
positive or negative changes to physiological or biological parameters (e.g.,
improvement of lung capacity, gene expression); positive or negative changes to
psychological or neurodevelopmental parameters (e.g., mood management
intervention for smokers; reading comprehension and /or information retention);
positive or negative changes to disease processes; positive or negative changes to
health-related behaviors; and, positive or negative changes to quality of life.
CS18.0
* Based on the above information, does this study meet the NIH definition of a
clinical trial?
  
Yes 
No 
 
 
If Yes, click Save and then Click Here For Study Team's CITI Training Records .  Please
ensure all personnel's training is up to date

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Section: Section 1 - Objective, Aims, Background and Significance
     [reviewer notes¬] 
1.1
Objective: What is the overall purpose of this research study?  (Limit response to 1-
2 sentences.)
The purpose of this research study is to assess the feasibility, acceptability, and preliminary
efficacy of a randomized controlled trial of a game-based intervention is able to increase
help-seeking-related knowledge, attitudes, and behaviors, reduce health risk
factors/behaviors, and increase resiliencies among sexual and gender minority (SGM)
youth. 
 
 
1.2
Specific Aims: List the goals of the proposed study (e.g., describe the relevant
hypotheses or the specific problems or issues that will be addressed by the
study).
The goals of the proposed study are to: 
1) Test the feasibility and acceptability of a game-based intervention to increase help-
seeking-related knowledge, attitudes, and behaviors among sexual and gender minority
(SGM) youth; and 
2) Using a randomized controlled trial, test the preliminary efficacy of a game-based
intervention to increase help-seeking-related knowledge, attitudes, and behaviors, reduce
health risk factors/behaviors, and increase resiliencies among SGM youth.
 
1.3
Background: Briefly describe previous findings or observations that provide the
background leading to this proposal. 
Sexual and gender minority (SGM) youth experience high rates of bullying. Based on 28
school-based studies of randomly selected youth, Friedman et al., 61 found that 44.4% of
lesbian, 39.9% of bisexual female, 43.2% of gay male, and 50.2% of bisexual male
teenagers reported physical assault by a peer at school (prior year), rates that far exceeded
those of heterosexual youth. SGM youth also disproportionately experience negative health
outcomes. Meta-analyses by our group show that SGM youth, compared to young
heterosexuals, were 190% more likely to use illicit drugs 57, 85% and 200% more likely to
experience depression and suicidality respectively 107, and 91% more likely to combine sex
and alcohol (p values <.01) 108. HIV prevalence among young men who have sex with
men is an astounding 7.2% 109. Bullying appears to be a driver of these health disparities.
School-based studies found associations between peer victimization and suicidality, drug
use, and sexual risk among SGM youth 62-64. 
Making matters worse, anti-bullying programs that focus on perpetrators have shown small
to moderate effects 65,110. SGM youth will therefore enter toxic school environments on an
ongoing, daily basis. 
The prevalence of bullying victimization, health outcomes, and associations between
victimization and health outcomes are similar among SGM youth. Further, the needs of SGM
youth who are bullied appear to be unique. For example, bullied SGM youth have less
access to coping resources. Beyond typical fears of disclosing bullying, SGM youth often
fear reactions by school staff and parents due to being SGM 16,17. The gay-related shame
many SGM youth internalize 19,20 may make it more likely for them to blame themselves
for bullying thus impacting their ability to cope. 
We seek to improve health and academic outcomes of SGM youth through a game-based
intervention they can easily access. Playing a game is advantageous as SGM youth are
often “out” to no or few others off-line 111,112. The game will therefore be accessible to
SGM youth who are insufficiently supported in offline programs 60,88,113. The game-based
environment is relatively safe for SGM youth to gain coping skills 94,95. Game-based
programs about sex 86,87, mental health114, alcohol use 72-75,115, asthma 116-119, and
smoking 76-78 are effective for youth. It is important to note that while face-to-face
interventions and game-based interventions incorporating contact with individuals usually,
though not always, produce greater effects than “stand-alone” game-based interventions
120-127, our review suggests that “stand-alone” game-based programs produce significant
change with respect to various health issues 72-74,76-85,87,128-134. Other advantages of
 

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Section: Section 1 - Objective, Aims, Background and Significance
“stand-alone” game-based interventions are increased fidelity, cost-effectiveness and the
ability to reach far larger numbers of individuals 133,135-140. 
We chose a game format as 78% of teens play games 141. Games have promoted behavior
change in asthma and cancer treatment, and weight control 90,91,93,142. Primary school
students who problem solved in virtual situations were more likely to end real-life bullying
than controls 3. Grade 7-10 students who experienced cognitive restructuring, graded
exposure to and coaching in simulated situations were more likely than controls to stop
bullying 4,143. These programs’ effects were however moderate and short-term. 
 
1.4
Significance: Why is it important that this research be conducted? What gaps in
existing information or knowledge is this research intended to fill? 
We believe our game-based intervention will produce larger and longer-term effects than
the above programs because: 1) Our game will utilize more engaging storylines. 2) Prior
programs primarily focused on bullying whereas our game also focuses on social and
emotional learning (S&EL). S&EL programs build self-management, interpersonal, and
problem solving skills, and produce more confident 144 and socially connected 99 youth
and such youth report less bullying 105,106. 3) The above games did not address
subgroups’ needs. We will address experiences of SGM youth (e.g., gay-related shame; fear
of “double victimization”) 19,145. 4) Our game design and testing are based on state-of-
the-art methods 90,146-150. It has been developed by an expert in game-based programs
and experts in adolescence, SGM youth, bullying, and game-based programs. 5) The game
is informed by an evidence-based logic model ensuring it will attend to behavior change
theory and posited mediators. 
To our knowledge, this game-based intervention is the:
• First online program targeting SGM youth who are bullying victims, a format that has the
potential to reach far greater numbers of SGM youth than traditional face-to-face
interventions.
• First bullying prevention program to utilize a gaming format to attract participation and
build retention.
• First intervention addressing social and emotional learning with respect to help-seeking
among SGMyouth.
• First online intervention with 14-18 year olds - as opposed to the typical focus on SGM
“youth” who are 18+. 
  

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.1
Does this research study involve the use or evaluation of a drug, biological, or
nutritional (e.g., herbal or dietary) supplement?
*  No
 
    [reviewer notes¬] 
2.2
Will this research use or evaluate the safety and/or effectiveness of one or
more devices?
 
*  No 
 
 
    [reviewer notes¬] 
2.3
Summarize the general classification (e.g., descriptive, experimental) and
methodological design (e.g., observational, cross-sectional, longitudinal,
randomized, open-label single-blind, double-blind, placebo-controlled, active
treatment controlled, parallel arm, cross-over arm) of the proposed research
study, as applicable.
Experimental randomized controlled trial
2.3.1
Does this research study involve a placebo-controlled arm?
*  No
    [reviewer notes¬] 
2.4
Will any research subjects be withdrawn from known effective therapy for the
purpose of participating in this research study?
*  No 
 
 
    [reviewer notes¬] 
2.5
Will screening procedures (i.e., procedures to determine research subject
eligibility) be performed specifically for the purpose of this research study?
*  Yes
2.5.1
List the screening procedures that will be performed for the purpose of this
research study.  Do NOT include the inclusion/exclusion criteria in this section as
they will be addressed in section 3; questions 3.13 and 3.14.
To determine eligibility, potential participants will complete a brief online screening
questionnaire before being entered into this study.
  
     [reviewer notes¬] 

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Section: Section 2 - Research Design and Methods
 
2.6
Provide a detailed description of all research activities (e.g., all drugs or devices;
psychosocial interventions or measures) that will be performed for the purpose of
this research study. 
This description of activities should be complete and of sufficient detail to permit
an assessment of associated risks.  
At a minimum the description should include:
all research activities
personnel (by role) performing the procedures
location of procedures
duration of procedures
timeline of study procedures
DESCRIPTION OF PARTICIPANT FLOW
1. Advertisements direct potential participants to Screener survey
2. Participants complete screener (in REDCap)
3. If eligible, participants complete informed assent/consent (in REDCap)
o If ineligible, participants are thanked for their time and no more contact is made with
them.
4. If consent is provided, participants are emailed/texted a link to the baseline survey (T1)
to complete (in REDCap)
o Incentive: $10 when T1 survey is completed
5. Researchers then randomize participants to intervention or control (in REDCap)
6. All participants (both intervention and control groups) receive a list of website resources
related to study outcomes. [This document is located in the 'Supporting Documentation
Section' of this IRB Protocol.]
7. Intervention group receives Intervention Download Instructions (via Redcap) [This
document is located in the 'Supporting Documentation Section' of this IRB Protocol. IRB
Reviewers can use this document to download the game.]
o Until participants download the game, email reminders (5 maximum) will be emailed to
participants every 3 days (automatically performed in REDCap). If participants also
provided a phone number where we can text them, we will remind them via text message
to complete the REDCap survey.
8. Participants complete first follow-up survey (T2) (in REDCap)
o Incentive: $25 when T2 survey is completed
o Survey will activate 4 weeks after T1 survey completion
o Survey will be open until 7 weeks after T1 survey completion 
o All participants will complete survey similar to baseline survey (minus demographics and
potential confounder variables)
o Intervention group will also complete questions about satisfaction with the game.
o Until participants complete the survey, email reminders (5 maximum) will be emailed to
participants every 4 days (automatically performed in REDCap). If participants also
provided a phone number where we can text them, we will remind them via text message
to complete the REDCap survey.
9. Participants complete second/final follow-up survey (T3) (in REDCap)
o Incentive: $50 when T3 survey is completed
o Survey will activate 8 weeks after T1 survey completion
o Survey will be open until 11 weeks after T1 survey completion 
o Until participants complete the survey, email reminders (5 maximum) will be emailed to
participants every 4 days (automatically performed in REDCap). If participants also
provided a phone number where we can text them, we will remind them via text message
to complete the REDCap survey.
 
2.6.1
Will blood samples be obtained as part of this research study?

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*  No 
*If submitting a protocol for expedited review, it should be clear that the planned blood
draws are within the parameters described here:
http://www.hhs.gov/ohrp/policy/expedited98.html  (see Expedited Research Category #2)
If Yes, address the frequency, volume per withdrawal, the total volume per visit, and the
qualifications of the individual performing the procedure:
 
 
Study Flow Chart:
Name
Modified Date
StudyDesignProcedures_v2_121817.docx
12/18/2017 1:52 PM
     [reviewer notes¬] 
2.7
Will follow-up procedures be performed specifically for research purposes? 
Follow-up procedures may include phone calls, interviews, biomedical tests or
other monitoring procedures.
*  Yes
Detailed procedures listed in the textbox below:
Participants will be emailed or texted follow-up surveys immediate post-intervention (time 2;
1 month after baseline survey) and 1-month post-intervention (time 3; 3.5 months after
baseline survey). Participants will be reminded up to five times via email/text to complete
follow-up surveys.
  
     [reviewer notes¬] 
2.8
Does this research study involve the use of any questionnaires, interview or
survey instruments?
*  Yes
 
 
Upload a copy of all materials except for the SCID or KSADS which are on file at
the IRB.  The use of all instruments must be addressed in question 2.6 and/or
question 2.7 (except for an exempt submission where they should be addressed
on the appropriate uploaded exempt form).
Name
Modified Date
T3Survey_v2_121817.docx
2/21/2018 3:02 PM
T2Survey_v2_121817.docx
2/21/2018 3:01 PM
T1Survey_v2_121817.docx
2/21/2018 3:00 PM
Previously the name and publisher for commercially available materials
were listed in the textbox below but effective 9/1/2015, all materials (except for
the SCID and KSADS) must be uploaded using the Add button above.

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     [reviewer notes¬] 
2.9
If subjects are also patients, will any clinical procedures that are being used for
their conventional medical care also be used for research purposes?
*  n/a
 
If Yes, describe the clinical procedures (and, if applicable, their frequency) that will be
used for research purposes: 
2.10
The blood sample question was moved to 2.6.1.
    [reviewer notes¬] 
2.11
What is the total duration of the subject's participation in this research study
across all visits, including follow-up surveillance?
*  3 months
    [reviewer notes¬] 
 
2.12
Does this research study involve any type of planned deception? 
If Yes, you are required to request an alteration of the informed consent process (question
4.7)
*  No
 
    [reviewer notes¬] 
 
2.13
Does this research study involve the use of UPMC/Pitt protected health
information that will be de-identified by an IRB approved "honest broker"
system?
 
*  No
 

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
 
2.14
Will protected health information from a UPMC/Pitt HIPAA covered entity be
accessed for research purposes or will research data be placed in the UPMC/Pitt
medical record?
*  No
 
2.14.1
Will protected health information from a non-UPMC/Pitt HIPAA covered entity be
obtained for research purposes or will research data be placed in the non-
UPMC/Pitt medical record?  
*  No
 
    [reviewer notes¬] 
2.15
Does this research study involve the long-term storage (banking) of biological
specimens? 
 
*  No
 
    [reviewer notes¬] 
2.16
Will research participants be asked to provide information about their family
members or acquaintances?
*  No
 
    [reviewer notes¬] 
2.17
What are the main outcome variables that will be evaluated in this study?
The primary outcomes of this study are related to feasibility. This includes the domains of
acceptability, demand, implementation, practicality, integration, adaptation, expansion, and
preliminary efficacy testing (based on Bowen, et al., 2009, Am J Prev Med). Below, we
present each of the feasibility domains, how they will be measured, and corresponding
hypotheses (in parentheses).
ACCEPTABILITY 
- Measured using the Gaming Experience Questionnaire (average ≥2 in each domain)
- Would you recommend that your friends play this game? (≥75%)
- How likely would you be to tell your friends about this game? (≥80%)
DEMAND 
- The number of hours the game was played (≥75% who played for ≥1 hour)
- Intervention group’s self-reported use of the game in hours (≥75% who played for ≥1
hour)
IMPLEMENTATION
- How many participants in in the intervention arm downloaded the game? (≥80%)
- How many people played the game? (≥80%)
- How many people completed surveys at T1, T2, T3? (≥80% each survey wave)

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Section: Section 2 - Research Design and Methods
- How many people completed ALL surveys? (≥75%)
- How many people completed at least 2 surveys? (≥85%)
- How many reminders before people completed the surveys? (exploratory)
- How well they did in the game? Did they meet the milestones in the game? (exploratory)
- How many times texted before they completed survey? (exploratory)
- How many times contacted? (exploratory)
- Percent of people who consented post screening (80%)
- How long does it take to get 240 people to enroll in the study? (exploratory)
- Did randomization work? (yes, we hypothesize no group differences in demographics at
baseline)
- How many got randomized? (240 participants)
- How many people recruited from which venue? (exploratory)
PRACTICALITY
- How many people have PC or Mac computers in our screening procedures (exploratory)
- Screening based on having an email address (exploratory)
- How easily was the game downloaded without contacting our research coordinator?
(exploratory)
- Feelings of safety with regards to password protection? (exploratory)
- Feelings of safety with regards to having other people see the game? (exploratory)
- Did the game interfere with other activities? (exploratory)
INTEGRATION 
- How could this better fit into the youth’s life? (exploratory)
- How well does this fit into youth’s life now? (exploratory)
- How could the game be improved? (exploratory)
ADAPTATION
- Would you want to be able to play this game on your phone (an app)? (exploratory)
- Did you like this game on the computer? (exploratory)
- This game may not be appropriate for older kids. (how much do they agree with this?
Exploratory)
- We will examine the Gaming Experience Questionnaire scores by gender, sexual
orientation, race/ethnicity, age (exploratory)
EXPANSION
- How could the game be improved? (exploratory)
- What would you like to be added to the game? (exploratory)
- What would you like removed from the game? (exploratory)
PRELIMINARY EFFICACY TESTING 
We hypothesize that the intervention group (versus control group) will have greater levels of
change over time in the following outcomes:
1. Increased help-seeking self-efficacy, intentions, and behaviors 
2. Increased coping strategies and coping flexibility
3. Increased knowledge and use of online resources
4. Decreased bullying and cyberbullying victimization
5. Decreased loneliness
6. Decreased mental health problems (anxiety, depression, suicidality)
7. Decreased substance use (alcohol, tobacco, and other drugs)
8. Decreased internalized sexual and gender minority stigma 
 
2.18
Describe the statistical approaches that will be used to analyze the study data.
*  Addressed below:
For the measures of acceptability, demand, implementation, practicality, integration,
adaptation, and expansion, we will report results using descriptive statistics (i.e.,
percentages and frequencies for categorical variables, or means and standard deviations for
continuous variables).
For the preliminary efficacy testing outcomes, we will use repeated measures (i.e.,
multilevel) statistical models using logistic or linear regression, depending on the distribution

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Section: Section 2 - Research Design and Methods
of the outcomes. To examine whether there were greater improvements over time in the
intervention group versus control group, we will test the interaction term of time by group.
While we are powered to find medium effects (based on Cohen), our primary interest is in
estimating the effect size and confidence interval width, which will help us power a future,
larger randomized controlled trial.
     [reviewer notes¬] 
2.19
Will this research be conducted in (a) a foreign country and/or (b) at a site (e.g.,
Navajo Nation) where the cultural background of the subject population differs
substantially from that of Pittsburgh and its surrounding communities?
*  No
Note that copies of training records, licenses, certificates should be maintained in the
study regulatory binder and are subject to audit by the Research Conduct and Compliance
Office (RCCO).
In addition, individuals planning to conduct human subject research outside the United
States must complete an optional module on the CITI training website: International
Studies.  Click here to access the instruction sheet for accessing optional CITI modules.
 
 
  
     [reviewer notes¬] 
2.21
Will this research study be conducted within a nursing home located in
Pennsylvania?
*  No 
 
 

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Section: Section 3 - Human Subjects
     [reviewer notes¬] 
Section 3 - Human Subjects
3.1
What is the age range of the subject population?
14-18 
 
3.2
What is their gender?
*  Both males and females 
 Provide a justification if single gender selected:
3.3
Will any racial or ethnic subgroups be explicitly excluded from participation?
*  No  
If Yes, identify subgroups and provide a justification: 
 
3.4
For studies conducted in the U.S., do you expect that all subjects will be able to
comprehend English?
*  Yes 
 
    [reviewer notes¬] 
3.5
Participation of Children: Will children less than 18 years of age be studied?
*  Yes
 
3.5.1
Specify the age range of the children to be studied.  
(Check all that apply below:)
*
Choices
14-17 years of age
3.5.2
Provide a rationale for the specific age ranges of the children to be studied:
This is an intervention designed specifically for young sexual and gender minority (SGM)
youth. All game development procedures have been conducted in consult with SGM aged
14-17 and experts in the field of SGM youth.
Please see the background section of this IRB protocol. Generally, SGM youth are at far
higher risk to be bullied by peers. There is very little systematic support available for these
youth to help them cope with such bullying. Our program will focus on this age range to
decrease negative outcomes associated with bullying victimization among this population.
3.5.3
Describe the expertise of the study team for conducting research with children
within this age range:
Drs. Egan and Coulter have studied SGM youth for the past 10 years including the
assessment of sexual orientation, gender identity, bullying victimization, protecting SGM
youth in schools, and longitudinal assessment of SGM populations. They have led
qualitative and quantitative studies of SGM youth including the assessment of sexual

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Section: Section 3 - Human Subjects
orientation, gender identity, bullying, mental health, substance use, HIV risks among SGM
youth. 
3.5.3.1
Have you obtained the following clearances from all research staff who may have
direct contact with children under the age of 18?  Direct contact under the law
includes face-to-face, and telephonic or electronic, contact with minors.  Please
see the Child Clearances guidance document for further explanation?
Pennsylvania Department of Public Welfare Child Abuse History Clearance;
Pennsylvania State Police Criminal Record Check; and
FBI Criminal Background Check
Yes
Note: If No, once all clearances are obtained, a modification must be submitted.
If you selected N/A, please explain: 
It is important to note that “direct contact” refers not only to face-to-face meetings but
also extends to communication via phone (including text messaging), social media or
internet.   Direct contact also includes the care, guidance, supervision or control, or
routine interaction with, minors.  Conversely, a participating investigator or support
staff member who does not have direct contact, either electronically or in person, with
children does not need to obtain clearances (e.g., statistician, non-clinical laboratory
personnel, etc.).  If your research study provides babysitting services, the babysitters
must have the required child clearances. 
* Note: It is the responsibility of the principal investigator to ensure that all
research staff have these clearances prior to any interaction with children. Contact
Human Resources at 412-624-8150 for assistance with this process. 
 
 
3.5.4
Describe the adequacy of the research facilities to accommodate children within
this age range:*
Not applicable; research will be conducted in the child's normal environment.
Note: Experts and non-experts alike consider the use of computers and games to be a part
of the normal environment for children. Various studies have implemented game-based
intervention studies in this environment.
3.5.5
Permitted Categories of Research: The Federal Policy and FDA regulations
governing human subject protections specify that research involving children
must fall into one of the following permitted categories. 
*
The research does not involve greater than minimal risk [45 CFR 46.404/21 CFR 50.51].
45 CFR 46.406
The risk represents only a minor increase over minimal risk.
The research procedures present experiences to the subjects that are reasonably
commensurate with those inherent in their actual or expected medical, dental,
psychological, social, or educational situations.
The research procedures are likely to yield generalizable knowledge about the
subjects’ disorder or condition which is of vital importance for understanding or
amelioration of the subjects’ disorder or condition.
 
 

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Section: Section 3 - Human Subjects
45 CFR 46.407
The risk is justified by the anticipated benefit to the subjects; and the relation of
the anticipated benefit to the risk is at least as favorable to the subjects as that
presented by available alternative approaches.
Provide a justification which must address all considerations related to the
designated category of research:
The probability and magnitude of harm or discomfort anticipated in our research study are
not greater in and of themselves than those ordinarily encountered in daily life (i.e., of the
general population). 
Asking sexual and gender minority (SGM) youth questions about help-seeking behaviors,
bullying experiences, mental health, substance use experiences, and their experience with
the game intervention should be regarded as minimal risk. The probability and magnitude
of harm or discomfort anticipated in our research study are not greater in and of
themselves than those ordinarily encountered in daily life (i.e., of the general population). 
The survey questions to be asked are questions and discussions that youth normally have.
Additionally, these survey questions are routinely as part of the Youth Risk Behavioral
Surveillance Survey (YRBSS) throughout the United States as part of their high-school
experience. 
We should reiterate that all participants will be given information about contacting the PI
Dr. Egan should they have questions or concerns about the study or their reactions to it.
The participants will also be provided with national hotlines for SGM youth should they
require support. Of note, ALL individuals will automatically be given information about the
Trevor Project which is a well respected hotline that can be accessed either online or by
phone that specializes in the support of suicidal SGM youth. 
It should also be mentioned that the confidential nature of the surveys greatly reduces risk
to participant.
  
     [reviewer notes¬] 
3.6
Does this research study involve prisoners, or is it anticipated that the research
study may involve prisoners?
*  No
 
 
    [reviewer notes¬] 
3.7
Will pregnant women be knowingly and purposely included in this research study?
*  No
 

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Section: Section 3 - Human Subjects
     [reviewer notes¬] 
3.8
Does this research study involve neonates of uncertain viability or nonviable
neonates?
*  No
 
 
    [reviewer notes¬] 
3.9
Fetal Tissues: Does this research involve the use of fetal tissues or organs?
*  No
 

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Section: Section 3 - Human Subjects
     [reviewer notes¬] 
--->
3.10
What is the total number of subjects to be studied at this site, including subjects
to be screened for eligibility?
Note: The number below is calculated by summing the data entered in question 3.11. Any
additions or changes to the values entered in 3.11 will be reflected in 3.10.
*  480
 
3.11
Identify each of the disease or condition specific subgroups (include healthy
volunteers, if applicable) that will be studied.  
Click on the "Add" button and specify for each subgroup:
1) how many subjects will undergo research related procedures at this site; and
2) if applicable, how many subjects will be required to undergo screening
procedures (e.g., blood work, EKG, x-rays, etc.) to establish eligibility.  Do Not
include subjects who will undergo preliminary telephone screening.
* 
 
Subgroup
Number to undergo research
procedures
Number to undergo screening
procedures
View Control
120
240
View Intervention 120
240
 
 
 
3.12
Provide a statistical justification for the total number of subjects to be enrolled
into this research study at the multicenter sites or this site.
*  Described below: 
 
This is a feasibility study, which is primarily being conducted to inform a larger randomized
controlled trial. For a majority of our outcomes, we are reporting simple descriptive
statistics (e.g., how long the game was played by participants). For preliminary efficacy
testing, we are primarily interested in effect size and confidence interval estimation; we are
NOT necessarily interested in finding statistically significant effects (see Bowen, 2009, Am J
Prev Med). Nevertheless, we are powered to find medium effect sizes (based on Cohen,
1988).
 

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Section: Section 3 - Human Subjects
     [reviewer notes¬] 
3.13
Inclusion Criteria: List the specific criteria for inclusion of potential subjects.
- Aged 14 to 18 years old
- English literate
- Lives in the United States
- Identifies as Sexual or Gender Minority
- Has a PC or Mac that is able to download games
- Has an email address
- Has been bullied or cyberbullied in the past 12 months 
 
3.14
Exclusion Criteria: List the specific criteria for exclusion of potential subjects from
participation.
- Not bullied or cyberbullied in the past 12 months
- Identifies as cisgender (i.e., their assigned sex at birth matches their current gender
identity) and heterosexual
- Identifies as cisgender and is unsure of their sexual identity 
3.15
Will HIV serostatus be evaluated specifically for the purpose of participation in
this research study?
*  No 
If Yes, provide a justification:
 

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Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.1
Select all recruitment methods to be used to identify potential subjects:
Advertisements
Pitt + Me
 
Advertisements  
Upload the advertisements for review:
Name
Modified Date
VideogamersAdWithoutPic_v2_121817.docx
12/18/2017 2:44 PM
Final R21 Facebook pics for trans youth.docx
11/13/2017 10:14 AM
VideogamerAd_v2_121817.docx
12/18/2017 2:44 PM
Finalized Facebook ads-RCT_v2_122017.docx
12/20/2017 9:49 AM
Final R21 Facebook pics for lesbian youth.docx 11/13/2017 10:13 AM
IRB modification - new pictures.docx
5/8/2018 4:06 PM
Finalized R21 Facebook pics for gay youth.docx 11/13/2017 10:14 AM
 
 
 
 
 
4.2
Provide a detailed description of your recruitment methods, including identifying
and initiating contact with participants:  
We will advertise on Facebook to a wide audience of SGM youth. We intend to create a
formal Facebook ad. It is a side-bar ad. We are not using an in-line ad. An individual who is
interested in participating will click on the advertisement (see 4.1). 
We will also recruit participants from SGM-related online gaming groups, such as
geeksout.org, Gay Geeks (Facebook group), GaymerX (Facebook group), Transmission
Gaming, and the following Reddit Gaymer forums:
https://www.reddit.com/r/gaymers/
https://www.reddit.com/r/Gaymer/
https://www.reddit.com/r/LGBTFC/
https://www.reddit.com/r/transgamers/
https://www.reddit.com/r/lgbt/)
All potential participants will be taken to a REDCap survey page that will present the
screening questions. See the screening consent script in section 4.6.3. 
We will also have a Facebook page, where we will advertise our study. No one, except us, is
able to post comments on the Facebook page. We will continue to monitor this page to
ensure that this setting remains constant.
  

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Section: Section 4 - Recruitment and Informed Consent Procedures
Note: Questions jump from 4.2 to 4.6 as questions 4.3-4.5 have been removed and the information is now
captured in 4.1
     [reviewer notes¬] 
4.6
Are you requesting a waiver to document informed consent for any or all
participants, for any or all procedures? (e.g., a verbal or computerized consent
script will be used, but the subjects will not be required to sign a written informed
consent document.  This is not a waiver to obtain consent.
*  Yes
4.6.1
Identify the specific research procedures and/or the specific subject populations
for which you are requesting a waiver of the requirement to obtain a signed
consent form.
All research procedures and all subject populations
If not all, identify the specific procedures and/or subject populations for which you are
requesting a waiver: 
4.6.2
Indicate which of the following regulatory criteria is applicable to your request for
a waiver of the requirement to obtain a signed consent form.
  45 CFR 46.117(c)(2)
45 CFR 46.117(c)(1) That the only record linking the subject and the research would be
the consent document and the principal risk would be potential harm resulting from a
breach of confidentiality. Each subject will be asked whether the subject wants
documentation linking the subject with the research, and the subject's wishes will govern;
or
45 CFR 46.117(c)(2) That the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is normally required outside
of the research context.
4.6.2.1
Address why the specific research procedures for which you are requesting a
waiver of the requirement to obtain a signed consent form present no more than
minimal risk of harm to the research subjects:
Asking sexual and gender minority (SGM) youth questions about help-seeking behaviors,
bullying experiences, mental health, substance use experiences, and their experience with
the game intervention should be regarded as minimal risk. The probability and magnitude of
harm or discomfort anticipated in our research study are not greater in and of themselves
than those ordinarily encountered in daily life (i.e., of the general population). 
The survey questions to be asked are questions and discussions that youth normally have.
Additionally, these survey questions are routinely as part of the Youth Risk Behavioral
Surveillance Survey (YRBSS) throughout the United States as part of their high-school
experience. 
We should reiterate that all participants will be given information about contacting the PI Dr.
Egan should they have questions or concerns about the study or their reactions to it. The
participants will also be provided with national hotlines for SGM youth should they require
support. Of note, ALL individuals will automatically be given information about the Trevor
Project which is a well respected hotline that can be accessed either online or by phone that
specializes in the support of suicidal SGM youth. 

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Section: Section 4 - Recruitment and Informed Consent Procedures
It should also be mentioned that the confidential nature of the surveys greatly reduces risk
to participant.
4.6.2.2
Justify why the research listed in 4.6.1 involves no procedures for which written
informed consent is normally required outside of the research context:
None of the research procedures including the playing of a computer game and answering
survey questions contain any risk that is greater than any risk ordinarily encountered in daily
life. 
4.6.3
Address the procedures that will be used and the information that will be provided
(i.e., script) in obtaining and documenting the subjects' verbal informed consent
for study participation:
The study will use a 'click to consent' procedure. Potential participants will be directed to an
online script describing the project and instructed to "click to consent" to participate. Those
who click, and thereby consent, will be then directed to the survey. Those who do not click,
thereby not consenting, will be directed to a page that will thank them for their time.
Upload Scripts:
Name
Modified Date
00. Screener for IRB Submission - v2.docx 10/5/2017 10:12 AM
Assent_Consent Form_v2_121817.docx
12/18/2017 2:27 PM
  
     [reviewer notes¬] 
4.7
Are you requesting a waiver to obtain informed consent or an alteration of the
informed consent process for any of the following? 
 
* Yes
 
4.7.1
If Yes, select the reason(s) for your request:
Parental permission and/or child assent
General Requirements: The Federal Policy [45 CFR 46.116 (d)] specifies in order for a
waiver of consent to be approved, the request must meet four criteria. For each request,
you will be asked to provide a justification addressing how each of these criterion is met.
 
 
 
Parental Permission and/or Child Assent
The research
involves no
more than
The probability and magnitude of harm or discomfort anticipated in our
research study are not greater in and of themselves than those ordinarily
encountered in daily life (i.e., of the general population). 

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Section: Section 4 - Recruitment and Informed Consent Procedures
minimal risk
to the
subjects;
[45 CFR
46.116 (d)
(1)]
Asking sexual and gender minority (SGM) youth questions about help-
seeking behaviors, bullying experiences, mental health, substance use
experiences, and their experience with the game intervention should be
regarded as minimal risk. The probability and magnitude of harm or
discomfort anticipated in our research study are not greater in and of
themselves than those ordinarily encountered in daily life (i.e., of the general
population). 
The survey questions to be asked are questions and discussions that youth
normally have. Additionally, these survey questions are routinely as part of
the Youth Risk Behavioral Surveillance Survey (YRBSS) throughout the
United States as part of their high-school experience. 
We should reiterate that all participants will be given information about
contacting the PI Dr. Egan should they have questions or concerns about the
study or their reactions to it. The participants will also be provided with
national hotlines for SGM youth should they require support. Of note, ALL
individuals will automatically be given information about the Trevor Project
which is a well respected hotline that can be accessed either online or by
phone that specializes in the support of suicidal SGM youth. 
It should also be mentioned that the confidential nature of the surveys
greatly reduces risk to participant.
The waiver
or alteration
will not
adversely
affect the
rights and
welfare of
the subjects;
[45 CFR
46.116 (d)
(2)]
A description of the risks to subjects and procedures for protecting against
these risks follows as a demonstration that the waiver or alteration will not
adversely affect the rights and welfare of the subjects. 
Potential risks to subjects:
1) Risk of being “outed.” It is possible that someone will see what the
individual is answering questions or playing a game with SGM content.
2) Risk to confidentiality. 
3) Difficult feelings could arise due to answering questions. 
4) Will not obtaining parental consent for minors place these youth at risk? 
Procedures for Protecting Against Risk:
Note: This is an confidential survey. 
1) Risk of being “outed.” It is possible that someone will see what the
individual is answering questions or playing a game with SGM content.
Youth will be told in the assent/consent pages that this is a risk and will be
told how to protect against this. Specifically, they will be told that it is
important to be aware of their surroundings during the survey while
answering questions and while playing the game. They will be told that it is
prudent to be concerned in the same way as they normally are concerned
when engaging in any SGM-related content online (to the extent that being
“outed” is a concern to each individual). Additionally, the game will have
login procedures in which only the participants are given unique information
(username and password) for logging into the game.
2) Risk to confidentiality. 
An Internet study has a slightly different risk to confidentiality than
conventionally-based studies. On the one hand, there is an inherent risk to
confidentiality in conventional studies just by subjects being required to go
to a site (e.g., a hospital, service organization, University) where someone
might see them and intuit why they are there. Similarly, mail surveys may
be intercepted by third parties’ snooping. By comparison, Internet studies
can be conducted at any location chosen that the individual feels most
comfortable (e.g., at home, school, coffee-house) thus providing the

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Section: Section 4 - Recruitment and Informed Consent Procedures
individual with more choices and control over this element of risk. Since our
recruitment strategy is through Facebook, by definition, all potential
participants in this study will have engaged in a level of risk to confidentiality
that is comparable to their regular Internet usage by publicly declaring
themselves to be sexual or gender minority youth. 
Our study has in place a number of safe-guards to protect participants. All
data will be stored on fire-walled servers. Please remember that the data
collection will be done in a confidential fashion. Administrative accounts will
use strong passwords. Additionally, the game will have login procedures in
which only the participants are given unique information (username and
password) for logging into the game.
3) Difficult feelings could arise due to answering questions. 
Will difficult feelings arise due to answering questions about experiences of
help-seeking, bullying, substance use, and mental health problems? We have
argued to our IRB previously that asking SGM youth questions of these types
should be regarded as minimal risk. The University of Pittsburgh IRB has
agreed with this. The probability and magnitude of harm or discomfort
anticipated in our research study are not greater in and of themselves than
those ordinarily encountered in daily life (i.e., of the general population). 
Asking sexual and gender minority (SGM) youth questions about help-
seeking behaviors, bullying experiences, mental health, substance use
experiences, and their experience with the game intervention should be
regarded as minimal risk. The probability and magnitude of harm or
discomfort anticipated in our research study are not greater in and of
themselves than those ordinarily encountered in daily life (i.e., of the general
population). 
The survey questions to be asked are questions and discussions that youth
normally have. Additionally, these survey questions are routinely as part of
the Youth Risk Behavioral Surveillance Survey (YRBSS) throughout the
United States as part of their high-school experience. 
We should reiterate that all participants will be given information about
contacting the PI Dr. Egan should they have questions or concerns about the
study or their reactions to it. The participants will also be provided with
national hotlines for SGM youth should they require support. Of note, ALL
individuals will automatically be given information about the Trevor Project
which is a well respected hotline that can be accessed either online or by
phone that specializes in the support of suicidal SGM youth. 
4) Will not obtaining parental consent for minors place these youth at risk? 
We have received waivers of parental consent for prior studies of SGM youth.
We have successfully argued that by requiring consent it would be possible
to place youth at risk because of situations in which youth “come out” to
their parents in order to participate in studies, without considering the
potential consequences of “coming out” (see IRB Protocol PRO16020455).
Further, by requiring parental consent the study would necessarily have
participants that are in least need of support as the sample would be biased
in the direction of having supportive and accepting parents. And SGM youth
who are being bullied and who have supportive and accepting parents are
probably at less risk for negative outcomes as compared to those youth who
are bullied with rejecting and even abusive parents. 
Finally, the assent/consent process described in other parts of this
application describe a process for ensuring that participants have understood
the risks associated with the study and the voluntary nature of the study
before they agree to participate.
The research SGM youth are at significant risk for rejection and even abuse by parents.

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Section: Section 4 - Recruitment and Informed Consent Procedures
could not
practicably
be carried
out without
the waiver or
alteration;
[45 CFR
46.116 (d)
(3)]
We know based on the research and our work with these youth that many
such youth would not participate in a study because they are not "out" to
their parents and requiring parental support for such a study would
necessitate them coming out to their parents and facing potential rejection.
Restricting our study to SGM youth who are "out" to their parents will would
be a huge impediment with respect to achieving the aims of the study (e.g.,
understanding help-seeking behaviors of youth who are closeted. Further, we
need youth who have been bullied to participate in this study and many such
bullying incidents are related to these adolescents' sexual orientation. Again,
revealing this to their parents could put these youth in harms way.
Whenever
appropriate,
the subjects
will be
provided
with
additional
pertinent
information
after
participation.
[45 CFR
46.116 (d)
(4)]
We should reiterate that all participants will be given information about
contacting the PI Dr. Egan should they have questions or concerns about the
study or their reactions to it. The participants will also be provided with
national hotlines for SGM youth should they require support. Of note, ALL
individuals will automatically be given information about the Trevor Project
which is a well respected hotline that can be accessed either online or by
phone that specializes in the support of suicidal SGM youth.
 
 
 
4.7.2
Under what circumstances (if any) will you obtain consent from some of these
subjects?
We will obtain individuals' assent for this study. 
The assent process is described in detail above, including the provision of the assent script.
  
     [reviewer notes¬] 
4.8
Are you requesting an exception to the requirement to obtain informed consent
for research involving the evaluation of an 'emergency' procedure?
Note: This exception allows research on life-threatening conditions for which available
treatments are unproven or unsatisfactory and where it is not possible to obtain informed
consent.
*  No
 

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Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.9
Upload all consent documents for watermarking:
Draft Consent Forms for editing:
Name Modified Date
Approved Consent Form(s):
Name Modified Date
 
     
    [reviewer notes¬] 
4.10
Will all potential adult subjects be capable of providing direct consent for study
participation? 
* 
Yes 
 
  
     [reviewer notes¬] 
4.11
At what point will you obtain the informed consent of potential research subjects
or their authorized representative?
After performing certain of the screening procedures, but prior to performing any of the
research interventions/interactions 
 
4.11.1
Address why you feel that it is acceptable to defer obtaining written informed
consent until after the screening procedures have been performed.
Screening procedures are quite brief, composed of minimal risk, and have little burden
compared to the assent/consent procedures. We decrease participant burden by having
them wait to complete the assent/consent procedures until after the short screening
questions.
4.11.2
Taking into account the nature of the study and subject population, indicate how
the research team will ensure that subjects have sufficient time to decide whether
to participate in this study.  In addition, describe the steps that will be taken to
minimize the possibility of coercion or undue influence.
Please see the assent process and the assent script described above. We believe that this is
a very thorough and non-coercive process that will provide potential participants will
sufficient time to decide whether to participate in this study. The assent script makes it clear
that there is little possibility of coercion or undue influence. Actually, the fact this this is an
online study makes these possibilities quite low. However, the nature of the dialogue in the
assent script makes it clear that potential participants will have every possibility of declining
to participate without undue coercion or influence.
  

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Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.12
Describe the process that you will employ to ensure the subjects are fully
informed about this research study. 
*  Addressed below: 
This description must include the following elements:
who from the research team will be involved in the consent process (both
the discussion and documentation);
person who will provide consent or permission; 
information communicated; and
any waiting period between informing the prospective participant about the study
and obtaining consent
In addition, address the following if applicable based on your subject population:
process for child assent and parental permission
continued participation if a child subject turns 18 during participation
process for obtaining proxy consent and assent for decisionally impaired subjects
continued participation if subject regains capacity to consent
The study will use a "click to consent" procedure. Potential participants will be directed to
an online script describing the project and instructed to "click to consent" to participation.
Those who click, and thereby consent, will be then directed to the survey. Those who do not
click, thereby not consenting, will be directed to a page that will thank them for their time.
An email address for the PI (Dr. Egan) will be made available for participants to use to ask
any questions that they may have. There will be no waiting period. 
 
4.13
Are you requesting an exception to either IRB policy related to the informed
consent process?
For studies involving a drug, device or surgical procedures, a licensed physician who
is a listed investigator is required to obtain the written informed consent unless an
exception to this policy has been approved by the IRB 
For all other studies, a listed investigator is required to obtain consent (Note: In
order to request an exception to this policy, the study must be minimal risk)
*  No
If Yes, provide a justification and describe the qualifications of the individual who will
obtain consent:
 
 
4.14
Will you inform research subjects about the outcome of this research study
following its completion?
*  No 
 
If Yes, describe the process to inform subjects of the results:

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Section: Section 5 - Potential Risks and Benefits
     [reviewer notes¬] 
5.1
Describe potential risks (physical, psychological, social, legal, economic or
other) associated with screening procedures, research interventions/interactions,
and follow-up/monitoring procedures performed specifically for this study: 
* 
View
Research Activity:
Intervention Game Play 
Common Risks:
No Value Entered 
Infrequent Risks:
1) Risk of being “outed.” It is possible that someone will see what
the individual is answering questions or playing a game with SGM
content. 2) Risk to confidentiality. 3) Difficult feelings could arise due
to answering questions. 4) Will not obtaining parental consent for
minors place these youth at risk?  
Other Risks:
No Value Entered 
View
Research Activity:
Questionnaire Completion 
Common Risks:
No Value Entered 
Infrequent Risks:
1) Risk of being “outed.” It is possible that someone will see what
the individual is answering questions or playing a game with SGM
content. 2) Risk to confidentiality. 3) Difficult feelings could arise due
to answering questions. 4) Will not obtaining parental consent for
minors place these youth at risk?  
Other Risks:
No Value Entered 
 
 
5.1.1
Describe the steps that will be taken to prevent or to minimize the severity of the
potential risks:
 
A description of the risks to subjects and procedures for protecting against these risks
follows as a demonstration that the waiver or alteration will not adversely affect the rights
and welfare of the subjects. 
Potential risks to subjects:
1) Risk of being “outed.” It is possible that someone will see what the individual is
answering questions or playing a game with SGM content.
2) Risk to confidentiality. 
3) Difficult feelings could arise due to answering questions. 
4) Will not obtaining parental consent for minors place these youth at risk? 
Procedures for Protecting Against Risk:
Note: This is an confidential survey. 
1) Risk of being “outed.” It is possible that someone will see what the individual is
answering questions or playing a game with SGM content.
Youth will be told in the assent/consent pages that this is a risk and will be told how to
protect against this. Specifically, they will be told that it is important to be aware of their
surroundings during the survey while answering questions and while playing the game.
They will be told that it is prudent to be concerned in the same way as they normally are
concerned when engaging in any SGM-related content online (to the extent that being
“outed” is a concern to each individual). Additionally, the game will have login procedures in
which only the participants are given unique information (username and password) for
 

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Section: Section 5 - Potential Risks and Benefits
logging into the game.
2) Risk to confidentiality. 
An Internet study has a slightly different risk to confidentiality than conventionally-based
studies. On the one hand, there is an inherent risk to confidentiality in conventional studies
just by subjects being required to go to a site (e.g., a hospital, service organization,
University) where someone might see them and intuit why they are there. Similarly, mail
surveys may be intercepted by third parties’ snooping. By comparison, Internet studies can
be conducted at any location chosen that the individual feels most comfortable (e.g., at
home, school, coffee-house) thus providing the individual with more choices and control
over this element of risk. Since our recruitment strategy is through Facebook, by definition,
all potential participants in this study will have engaged in a level of risk to confidentiality
that is comparable to their regular Internet usage by publicly declaring themselves to be
sexual or gender minority youth. 
Our study has in place a number of safe-guards to protect participants. All data will be
stored on fire-walled servers. Please remember that the data collection will be done in a
confidential fashion. Administrative accounts will use strong passwords. Additionally, the
game will have login procedures in which only the participants are given unique information
(username and password) for logging into the game.
3) Difficult feelings could arise due to answering questions. 
Will difficult feelings arise due to answering questions about experiences of help-seeking,
bullying, substance use, and mental health problems? We have argued to our IRB
previously that asking SGM youth questions of these types should be regarded as minimal
risk. The University of Pittsburgh IRB has agreed with this. The probability and magnitude
of harm or discomfort anticipated in our research study are not greater in and of
themselves than those ordinarily encountered in daily life (i.e., of the general population). 
Asking sexual and gender minority (SGM) youth questions about help-seeking behaviors,
bullying experiences, mental health, substance use experiences, and their experience with
the game intervention should be regarded as minimal risk. The probability and magnitude
of harm or discomfort anticipated in our research study are not greater in and of
themselves than those ordinarily encountered in daily life (i.e., of the general population). 
The survey questions to be asked are questions and discussions that youth normally have.
Additionally, these survey questions are routinely as part of the Youth Risk Behavioral
Surveillance Survey (YRBSS) throughout the United States as part of their high-school
experience. 
We should reiterate that all participants will be given information about contacting the PI Dr.
Egan should they have questions or concerns about the study or their reactions to it. The
participants will also be provided with national hotlines for SGM youth should they require
support. Of note, ALL individuals will automatically be given information about the Trevor
Project which is a well respected hotline that can be accessed either online or by phone that
specializes in the support of suicidal SGM youth. 
4) Will not obtaining parental consent for minors place these youth at risk? 
We have received waivers of parental consent for prior studies of SGM youth. We have
successfully argued that by requiring consent it would be possible to place youth at risk
because of situations in which youth “come out” to their parents in order to participate in
studies, without considering the potential consequences of “coming out” (see IRB Protocol
PRO16020455). Further, by requiring parental consent the study would necessarily have
participants that are in least need of support as the sample would be biased in the direction
of having supportive and accepting parents. And SGM youth who are being bullied and who
have supportive and accepting parents are probably at less risk for negative outcomes as
compared to those youth who are bullied with rejecting and even abusive parents. 
Finally, the assent/consent process described in other parts of this application describe a
process for ensuring that participants have understood the risks associated with the study
and the voluntary nature of the study before they agree to participate.

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Section: Section 5 - Potential Risks and Benefits
5.2
What steps will be taken in the event that a clinically significant, unexpected
disease or condition is identified during the conduct of the study?
*  Not Applicable
5.3
All the risk questions (screening, intervention/interaction, follow-up) have been merged into
one question (5.1).
     [reviewer notes¬] 
5.4
Do any of the research procedures pose a physical or clinically significant
psychological risk to women who are or may be pregnant or to a fetus?
* No
 
    [reviewer notes¬] 
5.5
Do any of the research procedures pose a potential risk of causing genetic
mutations that could lead to birth defects?
*  No
 
    [reviewer notes¬] 
5.6
Are there any alternative procedures or courses of treatment which may be of
benefit to the subject if they choose not to participate in this study?
*  No
If Yes, describe in detail:
 
 
    [reviewer notes¬] 
5.7
Describe the specific endpoints (e.g., adverse reactions/events, failure to
demonstrate effectiveness, disease progression) or other circumstances
(e.g., subject's failure to follow study procedures) that will result in discontinuing
a subject’s participation?
*  Not applicable - There are no anticipated circumstances that would lead to discontinuing a
subject’s participation in this research study.
 

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     [reviewer notes¬] 
5.8
Will any individuals other than the investigators/research staff involved in the
conduct of this research study and authorized representatives of the University
Research Conduct and Compliance Office (RCCO) be permitted access to research
data/documents (including medical record information) associated with the
conduct of this research study?
*  Yes
  
5.8.1
Identify the 'external' persons or entity who may have access to research
data/documents and the purpose of this access:
We do not know of any 'external' persons who need immediate access to the data. Prior to
permitting anyone access to these data, we will notify and get approval from the Pitt IRB
and other appropriate Pitt offices about the permitting access to the 'external' persons.
5.8.2
Will these 'external' persons or entity have access to identifiable research
data/documents?
*
No; the research data/documents will be coded and subject identifiers removed prior to
access by the external persons
If Yes, describe how they will protect the confidentiality of the research data:
5.9
Has or will a Federal Certificate of Confidentiality be obtained for this research
study?
*  Yes
 
5.10
Question has been moved to 5.17
5.11
Question has been moved to 5.16
 

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     [reviewer notes¬] 
5.12
Does participation in this research study offer the potential for direct benefit to
the research subjects?
Yes - Describe the direct benefit that subjects may receive as a result of study participation.
Indicate if all, or only certain, of the subjects may derive this potential benefit. 
 
Describe the benefit:
There is no direct benefit from participating in the study, however, playing the game may be
helpful to youth.
 
5.13
Describe the data and safety monitoring plan associated with this study. If the
research study involves multiple sites, the plan must address both a local and
central review process.
The conduct of this study and the protection of the enrolled subjects are the responsibility
of the principal investigator. Accrual, confidentiality, subject complaints, subject
withdrawals, and any unanticipated problems will be reviewed on an ongoing basis by the
research coordinator and monthly by the principal and co-investigators. All breaches of
confidentiality or other unanticipated problems will be promptly reported to the Institutional
Review Board.
There is no central data and safety monitoring board associated with this minimal-risk
project. The local data and safety monitoring plan for this study will involve routine (i.e.,
monthly) monitoring by the principal investigator of any conditions that may negatively
impact the confidentiality of information contained within this study. The principal
investigator will be responsible for reporting aggregate data and risk/benefit summaries to
the IRB at the time of annual renewal unless the information contained in these reports
changes the benefit-to-risk ratio of study participation as defined in the currently approved
research protocol and consent form, in which case a modification will be immediately
submitted to the IRB as per the IRB Reference Manual.
 
 
     [reviewer notes¬] 
Section 5 - Potential Risks and Benefits of Study Participation
5.14
What precautions will be used to ensure subject privacy is respected? (e.g. the
research intervention will be conducted in a private room; the collection of sensitive
information about subjects is limited to the amount necessary to achieve the aims of the
research, so that no unneeded sensitive information is being collected, drapes or other
barriers will be used for subjects who are required to disrobe)
 
The surveys will be self-administered online via REDCap and game play will be completed
via the participant's own PC/Mac at the time of their choosing. Our assent/consent
procedures tell participants to select a private setting to complete surveys and game play.
The participants can complete all study procedures at any time of day, thereby allowing
them to choose a safe and private time.
 
5.15
What precautions will be used to maintain the confidentiality of the research data
during collection, transmission and storage? It is important that you indicate the
data security measures for all data types. 
Go to the A-Z Guidance, download the Data Security Assessment Form, complete, and
upload using the Add button below.  Depending on the data type, you may need to consult
with your data manager to address some of the sections.  Email irb@pitt.edu if you have
any questions.
 
 
 
 
 

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Section: Section 5 - Potential Risks and Benefits
* Upload Data Security Form:
Name
Modified Date
R21 Data Security Assessment Form - v2.docx 11/30/2017 2:18 PM
Address what precautions will be used to maintain the confidentiality of the
research data collected in paper format if applicable: 
N/A
5.15.1
Does your research study require a data security review? Answer Yes if any of the
following conditions are met:
Identifiable or *coded data will be collected, stored, or transmitted using any of the
following technologies: mobile app, web-based site or survey, wearable device, text
messaging, electronic audio, photographic, or video recording or
conferencing and/or
The IRB requested a data security review during their review of the study
*  Yes
*Coded: Identifying information (such as name) that would enable the investigator to
readily ascertain the identity of the individual to whom the private information or
specimens pertain has been replaced with a code (number, letter, symbol, or any
combination) and a key to decipher the code exists, enabling linkage of the identifying
information to the private information or specimens
5.16
If the subject withdraws from the study, describe what, if anything, will happen to
the subject’s research data or biological specimens.
If the subject withdraws from the study, we will delete all the subject's data from our
databases.  
5.17
Following the required data retention period, describe the procedures utilized to
protect subject confidentiality. (e.g., destruction of research records; removal of
identifiers; destruction of linkage code information; secured long-term retention)
Data will be devoid of all subject identifiers and stored in secure password-protected Pitt
BOX drive. De-identified data will be retained indefinitely.
  

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Section: Section 6 - Costs and Payments
     [reviewer notes¬] 
 
6.1
Will research subjects or their insurance providers be charged for any of the
procedures (e.g., screening procedures, research procedures, follow-up
procedures) performed for the purpose of this research study?
*  
No 
 
    [reviewer notes¬] 
6.2
Will subjects be compensated in any way for their participation in this research
study?
*  Yes
6.2.1
Describe the amount of payment or other remuneration offered for
complete participation in this research study.
Participants will be paid $10 for completing baseline (Time 1) survey, $25 for Time 2
survey, and $50 for Time 3 survey. 
We have received a man on the street waiver. Rather than WePay, we will pay participants
in iTunes or Google Play gift cards. Similar methods were approved in a previous protocol
(see PRO16020455).
6.2.2
Describe the amount and term of payment or other remuneration that will be
provided for partial completion of this research study.
Participants are able to skip as many survey questions as they would like in each of the
surveys. Therefore, upon hitting the REDCap 'submit' button, participants will be paid the
full amount of incentive for partially completed surveys. Upon hitting the REDCap 'submit'
button, participants will be paid $10 for partially completing baseline (Time 1) survey, $25
for partially completing Time 2 survey, and $50 for partially completing Time 3 survey. 
We have received a man on the street waiver. Rather than WePay, we will pay participants
in iTunes or Google Play gift cards. Similar methods were approved in a previous protocol
(see PRO16020455).
 
  

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Section: Section 7 - Qualifications and Source(s) of Support
     [reviewer notes¬] 
7.1
Summarize the qualifications and expertise of the principal investigator and listed
co-investigators to perform the procedures outlined in this research
study.               
DR. JAMES EGAN 
Dr. Egan holds a PhD from the Department of Behavioral and Community Health Sciences,
Graduate School of Public Health, University of Pittsburgh. He is currently an Assistant
Professor in the Department of Behavioral and Community Health Sciences in the Graduate
School of Public Health at the University of Pittsburgh. He has worked for over 15 years in
the HIV field. Dr. Egan is experienced in the design, implementation, data analysis, and
dissemination of findings for both qualitative and quantitative studies exploring substance
use and HIV risk and resilience among MSM. His dissertation work focused on the influences
of specific neighborhoods (e.g. home, social, and sexual) on HIV risk, mental health and
substance use among Gay, Bisexual and other MSM in New York City for which he was the
lead qualitative researcher. Dr. Egan’s current research interests include mixed-methods
bio-behavioral research investigating episodic PrEP use among MSM and research exploring
the production of resiliencies among Gay, Bisexual and other men who have sex with men,
the impact of resiliencies on health and their role in improving health-related interventions. 
DR. ROBERT COULTER
Dr. Coulter is currently a Postdoctoral Scholar in the Clinical and Translational Science
Institute at the University of Pittsburgh. Dr. Coulter completed his PhD at the University of
Pittsburgh's Graduate School of Public Health, where he is specialized in the health of
sexual and gender minority (SGM) young people. Dr. Coulter has experience in conducting
statistical analyses, implementing intervention studies, and working with SGM youth.
 

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Section: Section 7 - Qualifications and Source(s) of Support
     [reviewer notes¬] 
7.2
Indicate all sources of support for this research study.
* 
Selections
Federal: Upload a copy of the entire grant application (including the cover sheet) if our
site is the awardee institution; for federal contracts, upload a copy of the research plan
 
If Federal support, provide the sponsor information:
 
Federal
sponsor
Grant Title
Grant number Awardee
institution
Federal grant
application
View NIH/NICHD Online Intervention to Help
Gay Youth Cope with Bullying
R21HD083561
University
of
Pittsburgh
resubmission R21
March
2015.pdf(0.01)
 
For projects not supported by a federal grant, upload the research plan that was submitted
for funding:
Name Modified Date
If Industry support, provide the sponsor information and level of support:
If Foundation support, provide the sponsor information:
If Other support, provide the support information and level of support:
     [reviewer notes¬] 
 
7.3
Is this study funded in part or whole by a PHS Agency?
 *  Yes 
 
Does any investigator* involved in this study (select all that apply):
 
Name
A. Have a financial interest (aggregated value of equity and remuneration** during
the past or next twelve months) in a publicly-traded entity that either sponsors***
this research or owns the technology being evaluated or developed that exceeds
$5,000 but not $10,000?
B. Have a financial interest (aggregated value of equity and remuneration during the
past or next twelve months) in a publicly-traded entity that either sponsors this
research or owns the technology being evaluated or developed that exceeds $10,000?
C. Receive remuneration (during the past or next twelve months) from a non-publicly
traded entity that either sponsors this research or owns the technology being
evaluated or developed that exceeds $5,000 but not $10,000?

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Section: Section 7 - Qualifications and Source(s) of Support
 
Name
D. Receive remuneration (during the past or next twelve months) from a non-
publicly traded entity that either sponsors this research or owns the technology
being evaluated or developed that exceeds $10,000?
E. Have equity in a non-publicly traded entity that either sponsors this research or
owns the technology being evaluated or developed?
F. Receive reimbursement or sponsorship of travel expenses (for one trip or a series of
trips during the past or next twelve months) by an outside entity that either sponsors
this research or owns the technology being evaluated or developed that exceeds
$5,000?
G. Have rights as either the author or inventor of intellectual property being
evaluated or developed in this research that is the subject of an issued patent or has
been optioned or licensed to an entity?
H. Have an officer or management position**** with a Licensed Start-up Company
overseen by the COI Committee that either sponsors this research or owns the
technology being evaluated or developed?
I. Receive compensation of any amount when the value of the compensation would be
affected by the outcome of this research, such as compensation that is explicitly
greater for a favorable outcome than for an unfavorable outcome or compensation in
the form of an equity interest in the entity that either sponsors this research or owns
the technology being evaluated or developed?
None of the above options apply and there are no other financial conflicts of
interest in the conduct of this research.
*Investigator means the PI, co-investigators, and any other member of the study team,
regardless of title, who participates in the design, conduct, or reporting of this research, as
well as his/her spouse, registered domestic partner, dependents, or other members of
his/her household. The PI is responsible for ensuring that s/he and all other
relevant members of the study team review the above questions describing
Significant Financial Interests. 
**such as salary, consulting fees, honoraria, or paid authorship
***through the provision of funds, drugs, devices, or other support for this research
****Such as serving on the Board of Directors or Board of Managers or a position that
carries a fiduciary responsibility to the company (e.g., CEO, CFO, CTO, or CMO).
  

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Section: Supporting Documentation
     [reviewer notes¬] 
 
Supporting Documentation Section
References and Other Attachments
 
Additional documents:
Name
Modified Date Version
Instructions for
Downoading Game.docx
11/21/2017
9:19 AM
0.01
List of LGBT Resources
Nationwide.docx
11/21/2017
9:14 AM
0.01
References.pdf
9/17/2017
1:52 PM
0.01
 
Please use the Add button to the left to upload
additional documents if needed.
     [reviewer notes¬] 
ClinicalTrials.gov is a registry and results database of publicly and privately supported
clinical studies of human participants conducted around the world.
"Applicable clinical trials" are required by federal law to be registered in ClinicalTrials.gov.
Applicable Clinical Trials (ACTs) are studies that meet the following criteria:
The study is an interventional study AND 
The study intervention is a drug, biologic, medical device, radiation or genetic AND
The Study is not Phase 0 or 1 AND
The study has at least one site in the United States or is conducted under an investigational
new drug application or investigational device exemption
NIH Policy
Effective January 18, 2017, revised NIH Policy requires that all clinical trials funded in whole or in
part by the NIH be registered and results information posted on ClinicalTrials.gov. 
As defined by the NIH, a clinical trial is:
A research study in which one or more human subjects are prospectively assigned to one or
more interventions (which may include placebo or other control) to evaluate the effects of
those interventions on health related biomedical or behavioral outcomes.
The NIH Policy extends beyond the Food and Drug Administration Amendment Act (FDAAA 801)
requirements in that it requires registration and results reporting of:
clinical trials of behavioral, surgical and other types of health and medical interventions
phase 1 studies of drugs and biological products
small feasibility studies of device products 
Failure to submit all required registration and results information requested on ClinicalTrials.gov can
jeopardize University grant funding, the future funding of the grantee and subject the University of
Pittsburgh to future monetary penalties.
In addition, to promote transparency of the clinical trials process, the International Committee of
Medical Journal Editors (ICMJE) has established a policy requiring the entry of clinical trials in a
public registry, such as ClinicalTrials.gov, prior to subject enrollment as a condition of consideration
for publication of the trial results.

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Section: Supporting Documentation
* Based on the above information, will this study be registered in ClinicalTrials.gov?
Yes 
 
Who will serve as the Responsible Party? UPMC/Pitt Investigator or IND/IDE Pitt Sponsor 
Why are you registering your study? (Check all that apply)
It is strongly encouraged by the NIH
It is required for publication by the International Committee of Medical Journal Editors (
Registration is required in a publically available, searchable database system prior to informed
consent being obtained from the first study participant)
If you are not yet registered and need to establish an account for the PI or other research staff that
may need to access the record, please send an email to the  University of Pittsburgh PRS
administrator at ctgov@pitt.edu with the following information for each individual:
Full name
Telephone number
Pitt or UPMC email address
If you have any questions or concerns, please email us at ctgov@pitt.edu. 
To find out additional information about how to register your study go to:
https://www.clinicaltrials.gov/ct2/manage-recs/how-register