The purpose of this research study is to pilot a 2-arm RCT of a game-based intervention to improve help-seeking behaviors and productive coping strategies to reduce substance use, victimization, and mental health issues among SGMY. The study is led by a team with expertise in SGMY research at the Center for LGBT Health Research in the University of Pittsburgh’s Graduate School for Public Health, University of Pittsburgh (Principal Investigators: Friedman and Egan). We engage in team science by partnering with an expert in bullying research, help-seeking research, an interventionist, a biostatistician, a health and game researcher, and a professional game development company. The study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health (R21HD083561) and is registered as a clinical trial (NCT03501264) [
All study procedures related to screening, consenting, surveying, and reminding are completed using REDCap, a free and secure Health Insurance Portability and Accountability Act-compliant website for managing Web-based surveys and databases. Study participant flow is depicted in
First, to determine eligibility, respondents completed a brief Web-based self-reported screening questionnaire before entering in this study. Respondents were eligible if they were English literate, lived in the United States of America, were aged between 14 to 18 years, had experienced bullying or cyberbullying victimization in the past year, had a sexual minority identity (ie, gay, lesbian, bisexual, or queer) or a gender minority identity (ie, considered themselves to be transgender or nonbinary), had a personal computer or Mac laptop or desktop computer where they could download games, and had an email address. Eligible respondents were then directed to a Web-based informed consent form. Participants voluntarily consented using a
Once eligible respondents agreed to voluntarily participate in the study, they were emailed a link to the baseline (T1) survey to complete. The T1 survey contained 24 pages with a median of 8.5 items per page (mean 10.3; range 3-26). After completion of the T1 survey, the study team randomized participants to intervention or control conditions (full descriptions of conditions are provided in later sections). Immediately after randomization, participants in the intervention condition automatically received an email with a REDCap survey link containing information that guided participants through the procedures for downloading and installing the game intervention onto their desktop or laptop computers with Microsoft Windows or Apple Mac operating systems. Every 3 days thereafter, participants were automatically sent up to 5 email reminders to download the game. Moreover, 1 day after randomization, participants in both the intervention and control conditions were automatically sent a list of resources related to study outcomes.
The first follow-up (T2) survey was activated 4 weeks after T1 survey completion and remained open for 4 weeks. The T2 survey was similar to the T1 survey; however, participants in the intervention condition who self-reported having played the game also completed questions about their gaming experience. The T2 survey contained 26 pages with a median of 8.5 items per page (mean 11.4; range 3-47).
The final follow-up survey (T3) is activated 8 weeks after T1 survey completion and remains open for 8 weeks. The T3 survey is similar to the T1 survey; however, intervention condition participants who do not complete the gaming experience questions at T2 but self-report having played the game in the T3 survey will be asked questions about their gaming experience at T3. The T3 survey contained 26 pages with a median of 8.5 items per page (mean 11.4; range 3-47).
For each survey, up to 5 email reminders to complete surveys are automatically emailed to participants every 4 days. While completing each survey, participants were able to change their answers by clicking a
Participants were conveniently sampled and recruited throughout the United States using website advertisements posted on social media platforms. This passive approach allowed SGMY from multiple geographic locations (eg, rural and urban, and East and West) to enroll in the study without overextending our limited resources. Facebook was our primary recruitment site. Facebook is an appropriate recruitment platform because it is highly utilized by adolescents; approximately 71% of teens use Facebook [
We used permuted block allocation (using blocks of several sizes) to randomize individual participants to the intervention or control conditions. The permuted blocks were created using the ralloc package for Stata. Randomization was performed in REDCap using the Randomization Module.
All participants randomized into the control condition received a list of national SGM-inclusive resources. This list included general lesbian, gay, bisexual, transgender, and queer (LGBTQ) resources (eg, GLAAD resource list), LGBTQ bullying resources (eg, The Trevor Project), general bullying victimization resources (eg, StopBullying.gov), child abuse resources (eg, Child Abuse Resource Center), dating violence resources (eg, National Domestic Violence Hotline), suicide and mental health resources (National Suicide Prevention Lifeline), substance use resources (eg, National Institute of Drug Abuse for Teens), LGBTQ homelessness (eg, True Colors Fund), and LGBTQ emergency hotlines (eg, Gay, Lesbian, Bisexual, and Transgender National Help Center Hotline). These materials were delivered via email the day after participants were randomized to the control condition. In addition, after completion of the final T3 survey, control participants were offered a free download of the intervention game. No additional follow-up was initiated to assess their game use, game satisfaction, or changes in outcomes.
Participants assigned to the intervention condition received a list of SGM-inclusive resources (the same as the control condition materials) and the game intervention. After randomization, intervention condition participants received an email with a link and instructions on how to download the game. Participants were asked to download the game to their computer to play it. The game intervention was based on empirical interviews with SGMY about their gaming preferences, undergirded by etiologic and behavioral change theories and built in collaboration with expert educational game developers.
Before developing the game, we conducted one-on-one, in-depth interviews with 20 SGMY about their gaming preferences (publication of these results is currently underway). Most SGMY enjoyed playing action-oriented games, and when asked what they liked about their favorite games, the most common response concerned the ability to personalize characters. Therefore, in the game, we incorporated selection of pronouns (
2-Arm randomized controlled trial design and data collection schedule.
Game intervention name and pronoun selection.
Game intervention character customization.
The conceptual model of the game intervention (
Elements of these theories are embedded in the game in unique ways. First, the game encourages help-seeking behaviors by having players create a team with other nonplayable characters and to pair a lonely nonplayable character with an appropriate mentor (
Game intervention conceptual model.
Interaction with a nonplayable character who is lonely.
Interaction with a nonplayable character who is angry.
Virtual notebook page about bullying.
Virtual notebook page about the importance of making contact after being bullied.
The game was developed in collaboration with Schell Games, an education and entertainment game development company located in Pittsburgh, Pennsylvania, United States. The intervention game is a role-playing game inspired by Japanese role-playing games, which typically involve exploring a space, talking to nonplayable characters, and fighting enemies through turn-based battles. The game runs standalone on desktops and laptops with Windows or Mac operating systems. Before implementation, we user-tested the intervention using think-aloud interviews with 3 SGMY, who found technical bugs and recommended password protection. Prior research shows that user testing with 3 participants results in finding at least 60% of major usability problems [
In the game, the player takes on the role of a Singular, a superhuman individual with special gifts, who is located in a school. The player is told that because of their uniqueness, Singulars face prejudice, often driven by fear and misunderstanding. After customizing their character, the player is tasked with finding a team to help them complete their final mission, which is to become a world-class superhero by defeating the robots in the Holochamber Challenge. The player then explores the school, talking to potential peers (ie, nonplayable characters) who can join their team. Some peers deal with problems related to bullying, confidence issues, and anger, which prevent them from performing properly or from wanting to join the player’s team. The player’s mini objectives are to do the following for each of their peers: (1) best identify the nonplayable characters’ problems, (2) find the best individuals or resources to help the nonplayable characters, and (3) help the nonplayable characters properly communicate or utilize their newfound resources. If the player is successful and finds the best way to help the nonplayable characters, then the nonplayable characters will join their team or help them by giving them an item or ability that will help them achieve success in the final Holochamber Challenge (
We are collecting data in 2 distinct ways. First, we use self-administered surveys via REDCap, where participants completed surveys on their computer, tablet, or phone. Participants complete surveys at T1, T2, and T3 (see the section Study Population and Study Flow for more details). Surveys were created based on the Checklist for Reporting Results of Internet E-Surveys [
To answer our primary aim, we will assess the following primary feasibility outcomes: success of the implementation procedures used in our RCT, game demand, and game acceptability.
Success of our implementation procedures are assessed using a variety of measures. We hypothesize the following: 240 participants will enroll in our trial and complete the first survey, greater than or equal to 80% of eligible participants will consent to participate in the study, 120 participants will be randomized to the intervention condition and 120 to the control condition, greater than or equal to 80% of enrolled participants will complete the T2 survey, greater than or equal to 80% of enrolled participants will complete the T3 survey, and greater than or equal to 75% of participants will complete all surveys. Testing the feasibility of our implementation procedures is essential to inform the design of our future larger-scale RCT.
The player’s final mission: defeat the Holochamber Challenge with their teammates.
Primary outcomes, assessments, and hypotheses.
| Primary outcome | Assessment | Hypothesis | |
| Study population | Measured as the total number of participants who were consented and who completed T1a | 240 participants | |
| Participation rate | Measured as the total number of people who agreed to participate in the study divided by the total number of people who were eligible to participate in the study | ≥80% | |
| Number of randomized participants | Measured as the total number of participants randomized | 240 participants | |
| Randomization success | Assessed by comparing intervention and control conditions across all demographic and potential confounding variables at baseline | No differences between intervention and control condition at baseline | |
| Retention rate for T2b | Measured as the total number of participants who completed T2 divided by the total number of participants enrolled in the study | ≥80% | |
| Retention rate for T3c | Measured as the total number of participants who completed T3 divided by total number of participants enrolled in the study | ≥80% | |
| Retention rate in T2 and T3 | Measured as the total number of participants that completed both T2 and T3 surveys divided by the total number of participants enrolled in the study | ≥75% | |
| Game download | Assessed on T2 and T3 surveys: did you download the game titled “Singularities”?—Yes; No; Unsure | ≥80% selected “Yes” | |
| Any game play | Assessed on T2 and T3 surveys: did you play the game titled “Singularities”?—Yes; No; Unsure | ≥80% selected “Yes” | |
| Any game play | Total number people who played the game based on game play data from the secure file-transfer-protocol system divided by total number of participants randomized to intervention condition | ≥80% played | |
| Total time of game play | Assessed on T2 and T3 surveys: in the past month, about how long did you play the game “Singularities”?—I did not play the game; Less than 1 hour; 1 hour; 2 hours; 3 hours; 4 hours; 5 hours; 6 hours; 7 hours; 8 hours or more | ≥75% selected 1 hour or greater | |
| Total time of game play | The number of hours the game was played based on game play data from the secure file-transfer-protocol system | ≥75% played 1 hour or greater | |
| Gaming experience [ |
Assessed on T2 and T3 surveys: response options used a 5-point Likert scale (range: 0-4)—Not at all, Slightly, Moderately, Fairly, Extremely; Question stem was “Please indicate how you felt while playing the game for each of the questions below”; |
Mean scores ≥2 for each subscale separately | |
| Desire to play game again | Assessed on T2 and T3 surveys: I would like to play this game again—Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree | ≥75% of intervention condition participants selected “Agree” or “Strongly Agree” | |
| Likelihood to recommend game to friends | Assessed on T2 and T3 surveys: how likely would you be to recommend that your friends play this game?—Definitely; Very Probably; Probably; Possibly; Probably Not; Definitely Not | ≥75% of intervention condition participants selected “Definitely,” “Very Probably,” or “Probably” | |
aT1: baseline.
bT2: first follow-up.
cT3: final follow-up.
Game demand is assessed among the intervention condition participants in 2 ways, via downloading and playing the game. Download of the game is assessed via self-reported surveys (T2 and T3). We hypothesize ≥80% of intervention condition participants will download the game. Game play is assessed via self-reported surveys (T2 and T3) and game play data. We hypothesize ≥80% of intervention condition participants will play the game and ≥75% of intervention participants will play the game for 1 hour or greater.
Game acceptability among the intervention condition participants is assessed via self-reported surveys at T2 and T3. If participants reported playing the game, we ask about their overall impressions of the game using the Gaming Experience Questionnaire. The Gaming Experience Questionnaire is a multidimensional scale that assesses the following domains about the participants’ feelings and thoughts during the game: competence, sensory and imaginative immersion, game flow, game tension and annoyance (reverse coded), negative affect (reverse coded), and positive affect. We hypothesize that the mean score for each subscale will be greater than 2, representing a moderately good gaming experience. In addition, we ask participants if they would be interested in playing the game again, and whether they would recommend the game to their friends. We hypothesize ≥75% of participants will “agree” or “strongly agree” that they would like to play the game again, and ≥75% would “definitely,” “very probably,” or “probably” recommend the game to their friends.
To answer our secondary aim, we will measure the following short-term outcomes: help-seeking intentions, self-efficacy, and behaviors; productive coping strategy usage and coping flexibility; and knowledge and use of Web-based resources. All secondary outcomes are assessed via self-reported surveys at all time points.
Help-seeking intentions are assessed using adapted version of the General Help Seeking Questionnaire [
We adapted the original items by adding “Phone or text/chat help line (such as the National Suicide Prevention Lifeline or the Trevor Project)” and “teacher.” We will create 2 separate overall mean scores for how likely participants are to reach out concerning (1) emotional problems and (2) suicidal ideation. In addition, we will create a score for each help source individually. Higher mean scores indicate greater likelihood of seeking help from these sources.
Help-seeking self-efficacy is assessed using 2 subscales from Bandura’s Multidimensional Scales of Perceived Self Efficacy [
Help-seeking behaviors are assessed using items adapted from the Help-Seeking Behaviors Scale [
Coping skill usage is assessed using the Adolescent Coping Scale Second Edition Short Form [
Coping flexibility is assessed using the Coping Flexibility Scale [
Knowledge and use of Web-based resources are measured using 2 different scales developed by the investigative team. We created a list of SGM-inclusive resources that match what was provided in the game-based intervention and control materials, such as the Trevor Project. Use of Web-based resources is measured for the past month. We will create 1 summary score for knowledge and 1 for use; each summary score adds together all “yes” response options.
Secondary outcomes, items, response options, and coding procedures.
| Secondary outcome | Items | Response options | Coding procedure | |
| Help-seeking intentions for personal or emotional problems, adapted from [ |
If you were having a personal or emotional problem, how likely is that you would seek help from the following people?—parent or guardian; other relative or family member; teacher; intimate partner (such as girlfriend or boyfriend); friend (someone not related to you); mental health professional (such as a psychologist, social worker, counselor); phone or text/chat help line (such as the National Suicide Prevention Lifeline or the Trevor Project); website help resources (such as StopBullying.gov); doctor or primary care provider; minister or religious leader (eg, priest, rabbi, chaplain); I would not seek help from anyone; I would seek help from another person/place not listed above | 7-point Likert scale, ranging from “extremely unlikely” (1) to “extremely likely” (7) | Mean score averaged across all items and for each item individually | |
| Help-seeking intentions for suicidality, adapted from [ |
If you were experiencing suicidal thoughts, how likely is that you would seek help from the following people?—parent or guardian; other relative or family member; teacher; intimate partner (such as girlfriend or boyfriend); friend (someone not related to you); mental health professional (such as a psychologist, social worker, counselor); phone or text/chat help line (such as the National Suicide Prevention Lifeline or the Trevor Project); website help resources (such as StopBullying.gov); doctor or primary care provider; minister or religious leader (eg, priest, rabbi, and chaplain); I would not seek help from anyone; I would seek help from another person/place not listed above | 7-point Likert scale, ranging from “extremely unlikely” (1) to “extremely likely” (7) | Mean score averaged across all items and for each item individually | |
| Help-seeking self-efficacy [ |
Please rate how certain you are that you can do each of the things described; |
7-point Likert scale, ranging from “not at all well” (1) to “very well” (7) | Mean score for each subscale separately | |
| Help-seeking behaviors, adapted from [ |
In the past month, how often have you: |
5-point Likert scale: Never; Rarely; Occasionally; A moderate amount; A great deal | Mean score for each subscale separately | |
| Coping skill usage [ |
Assessed using the Short form of the Adolescent Coping Scale Second Edition Short Form (ACS-2) [ |
5-point Likert Scale, ranging from “never” (1) to “very often” (5) | Mean score for each subscale separately | |
| Coping flexibility [ |
Please indicate how these situations apply to you by choosing one of the following for each situation: |
4-point Likert Scale: Not applicable; Somewhat applicable; Applicable; Very applicable | Mean score for each subscale separately | |
| Knowledge of Web-based resources | Have you heard of any of these websites?—The Trevor Project; It Gets Better; GLAAD; Accredited Schools online; Teen Line; GSAa Network. (Links to each website were provided for reference.) | Yes; No; Unsure | Summary score that adds together all “yes” response options | |
| Use of Web-based resources | Have you visited any of these websites in the past month?—The Trevor Project; It Gets Better; GLAAD; Accredited Schools online; Teen Line; GSAa Network. (Links to each website were provided for reference.) | Yes; No; Unsure | Summary score that adds together all “yes” response options | |
aGSA: gay-straight alliance or gender and sexuality alliance.
To answer our tertiary aim, we will measure the following long-term outcomes: bullying and cyberbullying victimization, loneliness, mental health issues, substance use, and internalized SGM stigma. All tertiary outcomes are assessed via self-reported surveys at T1, T2, and T3.
Bullying victimization is measured using 2 different scales, 1 for traditional face-to-face bullying and 1 for cyberbullying. We assess past-month bullying victimization using an adapted version of the University of Illinois Victimization Scale [
Loneliness is measured via Robert’s Version of the University of California, Los Angeles Loneliness Scale [
Mental health issues include stress, anxiety, depression, and suicidality. Past-month stress is assessed using the Perceived Stress Scale [
Substance use includes alcohol, cigarette, electronic cigarette, and marijuana use. All items are assessed based on the YRBS and adapted to measure past-month use. Alcohol use is assessed via 2 questions: 1 measuring the frequency of past-month alcohol use and 1 item assessing frequency of binge drinking (having 5 or more drinks in a row). Similar to prior research [
Internalized SGM stigma is measured using 2 different scales. To assess internalized gender minority stigma, we use the Transgender Identity Survey [
Tertiary outcomes, items, response options, and coding procedures.
| Tertiary outcome | Items | Response options | Coding procedure | |
| Bullying victimization [ |
How many times did these things happen to you in the last 30 days?—other students picked on me; other students called me names; I got hit and pushed by other students; I was threatened by other students; students spread rumors or told lies about me; I was excluded or kept out of a group of friends on purpose. | Never; 1 or 2 times; 3 or 4 times; 5 or 6 times; 7 or more times | Mean score | |
| Cyberbullying victimization, adapted from [ |
How often did the following things happen to you in the last month?—someone made rude comments about me online; someone spread rumors about me online, whether they were true or not; someone made aggressive or threatening comments to me online; someone sent a text message that said rude or mean things about me | Not sure; Never; Rarely; Occasionally; Often | Mean score | |
| Loneliness [ |
Indicate how often each of the statements below is descriptive of you—I feel in tune with the people around me (reverse coded); I lack companionship; I do not feel alone (reverse coded); I feel part of a group of friends (reverse coded); I am no longer close to anyone; I feel left out; I feel isolated from others; I can find companionship when I want it (reverse coded) | 4-point Likert scale: Never; Rarely; Sometimes; Often | Mean score | |
| Stress [ |
For each item, mark the description that best represents how often you have felt or thought that way during the past month—Been upset because of something that happened unexpectedly; Felt that you were unable to control the important things in your life; Felt nervous and ― “stressed”; Felt confident about your ability to handle your personal problems; Felt that things were going your way; Found that you could not cope with all the things that you had to do; Been able to control irritations in your life; Felt that you were on top of things; Been angered because of things that were outside of your control; Felt difficulties were piling up so high that you could not overcome them | 5-point Likert scale: Never; Almost never; Sometimes; Fairly often; Very often | Mean score | |
| Anxiety [ |
During the past 7 days, I have: Felt moments of sudden terror, fear, or fright; Felt anxious, worried, or nervous; Had thoughts of bad things happening such as family tragedy, ill health, loss of a job, or accidents; Felt a racing heart, sweaty, trouble breathing, faint, or shaky; Felt tense muscles, felt on edge or restless, or had trouble relaxing or trouble sleeping; Avoided, or did not approach or enter situations about which I worry; Left situations early or participated only minimally because of worries; Spent lots of time making decisions, putting off making decisions, or preparing situations, because of worries; Sought reassurance from others because of worries; Needed help to cope with anxiety (eg, alcohol or medication, superstitious objects, or other people) | 5-point Likert scale: Never; Occasionally; Half the time; Most of the time; All of the time | Mean score | |
| Depression [ |
How often have you been bothered by each of the following symptoms during the past 7 days?—Feeling down, depressed, irritable, or hopeless; Little interest or pleasure in doing things; Trouble falling asleep, staying asleep, or sleeping too much; Poor appetite, weight loss, or overeating; Feeling tired, or having little energy; Feeling bad about yourself—or feeling that you are a failure, or that you have let yourself or your family down; Trouble concentrating on things like school work, reading, or watching TV; Moving or speaking so slowly that other people have noticed; Or the opposite—being so fidgety or restless that you were moving around a lot more than usual; Thoughts that you would be better off dead, or of hurting yourself in some way | 4-point Likert scale: Not at all; Several days; More than half the days; Nearly every day | Mean score | |
| Suicidal ideation, adapted from [ |
During the past month, did you ever seriously consider attempting suicide? | Yes; No | Dichotomously as yes or no | |
| Suicide plan, adapted from [ |
During the past month, did you make a plan about how you would attempt suicide? | Yes; No | Dichotomously as yes or no | |
| Suicide attempt, adapted from [ |
During the past month, how many times did you actually attempt suicide? |
0 times; 1 time; 2 or 3 times; 4 or 5 times; 6 or more times | Dichotomously as yes or no, similar to prior research [ |
|
| Alcohol use [ |
During the past 30 days, on how many days did you have at least one drink of alcohol? | 0 days; 1 or 2 days; 3 to 5 days; 6 to 9 days; 10 to 19 days; 20 to 29 days; All 30 days | Count variable using midpoints (eg, “1 or 2 days” equals 1.5), similar to prior research [ |
|
| Binge alcohol use [ |
During the past 30 days, on how many days did you have 5 or more drinks of alcohol in a row (within a couple of hours)? | 0 days; 1 day; 2 days; 3 to 5 days; 6 to 9 days; 10 to 19 days; 20 or more days | Count variable using midpoints (eg, “1 or 2 days” equals 1.5), similar to prior research [ |
|
| Cigarette smoking [ |
During the past 30 days, on how many days did you smoke cigarettes? During the past 30 days, on the days you smoked, how many cigarettes did you smoke per day? | For the question pertaining to number of days: 0 days; 1 or 2 days; 3 to 5 days; 6 to 9 days; 10 to 19 days; 20 to 29 days; All 30 days. For the question pertaining to number of cigarettes: I did not smoke cigarettes during the past 30 days; Less than 1 cigarette per day; 1 cigarette per day; 2 to 5 cigarettes per day; 6 to 10 cigarettes per day; 11 to 20 cigarettes per day; More than 20 cigarettes per day | Continuously by multiplying frequency by quantity, similar to prior research [ |
|
| Electronic cigarette use [ |
During the past 30 days, on how many days did you use an electronic vapor product? | 0 days; 1 or 2 days; 3 to 5 days; 6 to 9 days; 10 to 19 days; 20 to 29 days; All 30 days | Count variable using midpoints (eg, “1 or 2 days” equals 1.5) | |
| Marijuana use [ |
During the past 30 days, how many times did you use marijuana? (Marijuana is also called grass, pot, or weed.) | 0 times; 1 or 2 times; 3 to 9 times; 10 to 19 times; 20 to 39 times; 40 or more times | Count variable using midpoints (eg, “1 or 2 days” equals 1.5) | |
| Internalized gender minority stigma, adapted from [ |
Pride subscale contains 8 items (reverse coded); Passing subscale contains 7 items; Alienation subscale contains 3 items; Shame subscale contains 8 items; To obtain the specific scale items, please contact Robert WS Coulter and Walter O Bockting | 7-point Likert Scale: Strongly disagree; Disagree; Somewhat disagree; Neither agree nor disagree; Somewhat agree; Agree; Strongly agree | Mean score for each subscale separately | |
| Internalized Sexual Minority Stigma, adapted from [ |
Pride subscale contains 8 items (reverse coded); Passing subscale contains 7 items; Alienation subscale contains 3 items; Shame subscale contains 8 items; To obtain the specific scale items, please contact Robert WS Coulter and Walter O Bockting | 7-point Likert Scale: Strongly Disagree; Disagree; Somewhat Disagree; Neither Agree nor Disagree; Somewhat Agree; Agree; Strongly Agree | Mean score for each subscale separately | |
To answer our exploratory aim, we assess several outcomes meant to better our understanding of participants’ responses to the game and how to improve the game in the future. Our exploratory aim concerns implementation procedures, intervention integration, and intervention adaptation and expansion outcomes.
Multiple implementation procedures will be explored to inform our future research. These include the following: how long it takes to enroll participants on the internet, which venues participants were recruited from, how long it takes participants to complete the surveys, how many participants complete the game, and which game milestones are achieved by participants. These data are obtained from multiple sources, including the self-reported surveys in REDCap and the game play data.
Implementation integration—or how well the game fits into the participants’ lives—will be assessed in a variety of ways. We will examine how many participants were excluded from our study based on not having access to a computer or not having an email address. We will examine if the participants had any problems downloading or playing game and how easy it was for them to participate in the RCT. We will also explore if participants had issues with game security, privacy, or interference. These outcomes are tracked using participants’ responses to the screening questionnaire, T2 survey, and T3 surveys, as well as from participants’ correspondences with the project email address.
Adaptation and expansion of the game intervention will be assessed via the T2 and T3 surveys. We will ask participants if they prefer to play the game on a different format (eg, on their phones), their favorite and least favorite parts of the game, how they would change and improve the game, and whether they think other SGMY would be interested in the game. Finally, we will explore whether the responses to the Gaming Experience Questionnaire [
Exploratory outcomes, research questions, and assessments.
| Exploratory outcome | Exploratory question | Assessment | |
| Enrollment period | How long does it take to get 240 people to enroll in the study? | Measured as number of months between enrollment of first and last participant. | |
| Recruitment venues | How many people were recruited from which venue? | Assessed using unique links that track the number of clicks on each advertisement. | |
| Survey completion time | How many days before participants completed each survey? | Measured as the number of days between the first survey invitation was sent to the participant and the day they completed the survey. | |
| Game completion | How many intervention condition participants completed the game? | Assessed via game play data from the secure file-transfer-protocol (FTP) system as well as T2a and T3b surveys: Did you complete the game? Yes; No; Unsure | |
| Game milestones | What milestones did the participants achieve in the game? | Assessed via game play data from the secure file-transfer-protocol (FTP) system. | |
| Computer access | How many youths were excluded because they were without a personal computer or Mac? | Assessed via the screening questionnaire: Do you have a laptop or desktop computer (either personal computer or Mac) where you can download games? Yes; No; Unsure | |
| Email address access | How many youths were excluded because they were without an email address? | Assessed via the screening questionnaire: do you have an email address? Yes; No | |
| Ease of download | How easily was the game downloaded without contacting our research coordinator? | Assessed via the number of emails to our project email address. | |
| Personal computer versus Mac use | What participants used personal computer and Mac computers to download the game? | Assessed as percentages via the game download materials in REDCap. | |
| Ease of participation | How many times was the research staff contacted by participants with questions about surveys or intervention materials? | Assessed via the number and types of emails to our project email address. | |
| Game problems | How many problems and what types of problems did participants encounter with the game? | Assessed via T2 and T3 surveys: Did you have any problems in the game?—Yes; No; If yes, please describe; Open-ended text box | |
| Game security | How important was the use of password protection in the game? | Assessed via T2 and T3 surveys: How important was it to have the game be protected by a password?—Very Important; Important; Moderately Important; Slightly Important; Not Important | |
| Game privacy | How safe did our participants feel playing the game? | Assessed via T2 and T3 surveys: How often were you concerned about other people seeing you play the game?—Always; Very Often; Sometimes; Rarely; Never | |
| Game interference | Did the gaming intervention interfere with participants’ regular activities? | Assessed via T2 and T3 surveys: During the past 30 days, how many times did playing the game interfere with school, work, or other responsibilities (like being late, missing school, or making it hard to concentrate)—Never; 1 time; 2 times; 3 times; 4 times; 5 or more times | |
| Future gaming platforms | Would our participants like to play the game on other platforms, such as phone? | Assessed via T2 and T3 surveys: In the future where would you like to play this game? My computer only; My phone only; Both my computer and phone | |
| Gaming experience [ |
Were there certain groups that had better or worse experiences with the game? | We will examine whether the Gaming Experience Questionnaire [ |
|
| Future appeal to sexual and gender minority youth | Will other sexual and gender minority youth enjoy the game? | Assessed via T2 and T3 surveys: Do you think other LGBTQ people your age would like to play this game? Definitely; Very Probably; Probably; Possibly; Probably Not; Definitely Not | |
| Recommended game changes | What would participants change about the game? | Assessed via T2 and T3 surveys: What would you change about the game? Open-ended text box | |
| Favorite parts of game | What did participants like best about the game? | Assessed via T2 and T3 surveys: What were your favorite parts of the game? Open-ended text box | |
| Least favorite arts of game | What did participants like least about the game? | Assessed via T2 and T3 surveys: What were your least favorite parts of the game? Open-ended text box | |
| Recommended game improvements | How would participants improve the game? | Assessed via T2 and T3 surveys: How would you improve the game? Open-ended text box | |
aT2: first follow-up.
bT3: final follow-up.
Demographic variables include age, grade in school, race, ethnicity, parent’s highest education level, and eligibility for free or reduced-price lunch at school. We also measure gender using the 2-step process assessing current gender identity and sex assigned at birth [
In addition to demographic variables, we assess variables that may confound the relationship between the intervention and our outcomes. Structural stigma is assessed by collecting participant’s residential zip code. Each zip code will then be given a state-level structural stigma score using Hatzenbuehler scale [
For the measures of implementation procedures, demand, acceptability, integration, and adaptation and expansion (ie, primary and exploratory outcomes), we will report results using descriptive statistics (ie, percentages and frequencies for categorical variables or means and SDs for continuous variables) along with 95% CIs. We will compare our results against our a priori benchmarks (see
For the open-ended questions, we will conduct qualitative data analysis. First, a group of investigators will read all of the participants’ responses and inductively identify the main themes for each item. Second, using these themes, we will develop a codebook with code names and definitions. Finally, 2 independent coders will code the qualitative data using Dedoose. If the 2 coders cannot reach consensus, a third coder will resolve any disagreements.
This is a feasibility study, which is primarily being conducted to inform a larger RCT. As such, we powered this study based on our primary outcomes [
All study procedures were approved by the Human Research Protection Office at the University of Pittsburgh. To protect participants from having to reveal their sexual or gender minority identities to their caregivers, thereby potentially putting them in harm’s way, we received a waiver of parental consent [