A Randomized Controlled Trial of a Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth
Phase: NA
Conditions: Alcohol Problem, Harm Reduction, Alcohol-Related Harm
Sponsor: University of Pittsburgh

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A Randomized Controlled Trial of a Game-Based Intervention to Reduce Alcohol Use 
among Sexual and Gender Minority Youth 
 
Protocol Number: STUDY23030071 
National Clinical Trial (NCT) Identified Number: NCT06215664 
Principal Investigator: Robert W.S. Coulter and James E. Egan 
Sponsor: University of Pittsburgh 
Grant Title: A Randomized Controlled Trial of a Game-Based Intervention to Reduce 
Alcohol Use among Sexual and Gender Minority Youth 
Grant Number: R01AA030017 
 
Funded by: National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
Version Number: v1.0 
4/7/2025 
 
 
 
 

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Scientific Background 
 
Alcohol is the most commonly used substance among youth,1 and is disproportionately used by 
sexual and gender minority youth (SGMY; e.g., lesbian, gay, bisexual, transgender, nonbinary, 
and gender expansive people <18 years old).1-30 Alcohol use is 123-155% higher among sexual 
minority youth than heterosexual youth and up to 250% higher among gender minority youth 
than cisgender youth.2,5-7 SGMY are more likely to drink alcohol at earlier ages.1-30 SGMY 
alcohol use inequities are linked to alcohol-related consequences, morbidity, and mortality 
inequities later in life (e.g., HIV, substance use disorders).31-38 This suggests reducing SGMY 
alcohol use may mitigate related disparities later in the life-course.  
 
Interventions for preventing and reducing SGMY alcohol use inequities are lacking.3,39 Without 
developing and rigorously testing scalable interventions, these inequities will likely persist. 
Despite researchers and national agencies calling for interventions to reduce SGMY alcohol 
use,3,40,41 our team’s systematic review39 revealed that out of all alcohol use intervention studies, 
only 2 included efficacy testing among SGMY. Those studies42,43 had overall poor methodology 
per a valid checklist,44 so their results must be interpreted cautiously. One study found 16 
sessions of coordinated mental health services reduced substance use and abuse/dependence 
symptoms, but this study lacked a comparison group.43 The other study conducted an RCT and 
found that a brief online intervention reduced drug use, but not alcohol use.42 To achieve U.S. 
federal agencies’ goals of reducing alcohol use inequities for SGMY,3,40,41 rigorous efficacy tests 
of new interventions are needed. 
 
Game-based interventions have a well-established role in health promotion and behavior 
change. Games designed to educate, train, or change behavior as they entertain players (also 
known as “serious games”45) have been shown to improve health outcomes in youth (e.g., 
smoking, depression, and anxiety).46-73 Serious games can also enhance players’ emotional 
intelligence and mastering of coping strategies.74-76 Game-based interventions are unique in that 
they offer opportunities for simulated role play, a highly effective approach for situated 
learning.77 Role play allows players to practice skills in an entertaining way78,79 and can 
influence healthy attitudes and behaviors.80,81 This “hands on” approach to learning allows for 
the acquisition and rehearsal of new skills that can then be transferred to real life situations.82 
Serious games can create contextualized learning experiences that are meaningful to the 
player, which are known to create long-term retention of new knowledge and cognitive skills.83 
Other advantages of games include increased fidelity and cost-effectiveness.84-90 While the 
potential for game-based interventions are promising, there continues to be a great need for the 
development and rigorous testing of theory-driven game-based interventions.63 
 
Web-accessible game-based interventions can improve health among SGM populations and 
can overcome barriers associated with effectively reaching the growing population of SGMY. 
Game-based interventions with young men who have sex with men have improved HIV-related 
outcomes using choose-your-own adventure narratives to help them navigate barriers in a safe 
space.91-93 Competition-based games using personalized normative feedback have reduced 
alcohol use among sexual minority adult women.94 Also, game-based cognitive behavioral 
therapy components have taught sexual minority youth behavioral change skills to improve 
depression.95 Web-based game interventions are also an effective way to reach large numbers 
of SGMY, including those living in rural and high structural stigma locations (i.e., areas with less 
SGM-inclusive policies, institutions, and attitudes), who may be insufficiently supported by face-
to-face programs.96,97 Though web-accessible game interventions are effective and overcome 
common impediments of face-to-face interventions, there is a lack of games aimed at 
preventing and reducing SGMY alcohol use. 

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Discrimination, stigma, and minority stressors are primary contributors to SGMY alcohol use 
inequities. Stigma Theory98,99 posits that SGMY experience multiple forms of discrimination 
(related to their sexual or gender minority statuses) at multiple levels of the social ecological 
model. Such discrimination includes internalized stigma (i.e., when SGMY internalize negative 
stereotypes about themselves), interpersonal stigma (i.e., direct or enacted forms of verbal, 
physical, and sexual harassment because of one's sexual identity or gender,100,101 occurring in-
person or online), and structural stigma (i.e., locales with fewer SGM-inclusive policies, 
institutions, and attitudes). Minority Stress102,103 posits that these multiple forms of discrimination 
lead SGMY to experience chronic and acute psychological distress, which in turn lead some to 
cope via alcohol use. Much empirical research, including our own, has confirmed these theories, 
and identified discrimination and minority stress as primary contributors of SGMY alcohol use 
inequities.104-109 Therefore, interventions for SGMY must aim to prevent discrimination and/or 
teach SGMY to cope with stress to efficaciously reduce their alcohol use. Such interventions 
may be particularly useful for SGMY who have multiple minoritized identities (e.g., racial/ethnic 
minority SGMY) because they face compounding intersectional stigma, discrimination, and 
stress. 
 
Intervention efficacy for preventing and reducing alcohol use may be moderated by minority 
stressors. With sexual minority adults, 2 sexuality-affirming interventions had greater efficacy for 
reducing alcohol use among participants with higher levels of baseline internalized stigma.110,111 
Said differently, higher internalized stigma was associated with greater treatment benefit for 
reducing alcohol. Authors speculated men with greater internalized stigma may use alcohol to 
cope with internalized negative beliefs, and through the intervention they learned alternative 
coping skills to decrease their drinking behaviors.110,111 To build on the rigor of prior research, 
this R01 will: (1) investigate, for the first time, minority stressors as moderators of intervention 
efficacy among SGMYs; (2) examine multiple minority stressors at multiple levels of the social 
ecological model, including structural stigma, interpersonal stigma, and racism; and (3) use 
mixed methods to quantify the moderating effects and triangulating these data with participant 
descriptions about why and how minority stress affects intervention efficacy. A mixed methods 
study investigating whether, how, and why minority stress moderates the impact of interventions 
for reducing SGMY alcohol use can inform the field about for whom SGMY-affirmative 
interventions are most beneficial and illuminate for whom additional interventions are needed. 
 
Study Objectives 
 
Aim 1. Test the efficacy of a game-based intervention for reducing alcohol-related harms among 
SGMY. 
 
Aim 2. Describe how baseline minority stressors (across proximal and distal domains) affect 
intervention efficacy. 
 
Study Design & Methods 
 
This study is a randomized controlled trial with SGMY (n=1,992) who are recruited via social 
media from across the United States. Participants will be randomized after baseline to the 
Intervention or Control condition. We will conduct surveys with SGMY at baseline, 3-, 6-, and 
12-month follow-up. All study procedures related to screening, consenting, and surveying will be 
completed using REDCap, a free and secure HIPAA-compliant website for managing Web-
based longitudinal survey studies. 
 

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This study will test the efficacy of our game-based intervention, Singularities, for preventing and 
reducing SGMY alcohol-related harms (primary outcome) and other health risk behaviors. We 
will examine whether minority stressors at multiple levels of the social ecological moderate 
intervention efficacy.  
 
Intervention Condition: Singularities  
Singularities is a theory-based, community-informed, web-accessible, roleplaying game-based 
intervention incorporating primary components: reducing alcohol-related harms; fostering 
healthy identity development in a safe environment; encouraging help-seeking behaviors; 
encouraging use of productive coping; and encouraging healthy internet and social media use. 
 
Control Condition: Food4Thought 
We will compare Singularities against an attention control condition (ACC) in which we will 
provide participants with similar amounts of research team contact and program contact, but 
without the active ingredients of Singularities intervention, namely the educational content that 
aims to enhance SGMY’s alcohol protective behavioral strategies, distress tolerance skills, 
emotional regulation strategies, and healthy social media usage. The ACC will be asked to play 
a game, titled Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian 
Science Education Center. Participants are instructed to build healthy meals using cuisine from 
around the world while ensuring they stick to a budget and meet all their nutritional needs. 
Importantly, this game does not include alcohol. In addition, they will be provided with 
educational modules based on USDA’s nutritional materials, including MyPlate, that teach teens 
about healthy nutrition. The game and educational modules will be similar in length to the 
Singularities game and website, but with a different health focus. After their completion in the 
RCT, we will provide the game at no cost to control participants. 
 
Eligibility Criteria  
 
Inclusion: Individuals will be eligible if they are comfortable participating in English, live in the 
U.S., are 14-18 years old, have a sexual minority identity (i.e., gay, lesbian, bisexual, or queer) 
or a gender minority identity (i.e., consider themselves to be transgender or nonbinary), have an 
internet-accessible computer, smart phone, or tablet, and provide an email address; have drank 
alcohol in their lifetime or intend to in the next year. 
 
Exclusion: We exclude people who are cisgender heterosexuals. 
 
Statistical Considerations 
 
We will use StataSE. Type I error will be set at 5% for all analyses. We will examine whether 
baseline characteristics are associated with study arm. We will control for variables (potential 
confounders) that differ meaningfully across study arms and are prognostic with the outcome. 
 
Our primary analyses will use generalized linear mixed models (i.e., multilevel repeated-
measures models) with a random effect for observations nested within persons and a link 
function dependent on the outcome distribution. Using a parallel two-group design, we will test 
whether the Poisson event rate ratio (λintervention / λcontrol) for alcohol-related harms reported 
at T2 (primary outcome) is different from 1. To examine whether there are greater 
improvements over time in the intervention versus control conditions, we will test the interaction 
term of time by condition. We will conduct our primary analyses as intent-to-treat, wherein all 
participants are included according to the condition they were randomized to (i.e., 
1=intervention 0=control). Time will be categorical (T1, T2, T3, T4).  

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To explore how participants’ pre-intervention minority stress levels and demographics moderate 
the intervention effects on outcomes (e.g., how outcomes differ across subgroups), we will use 
similar modeling techniques to those used above with some exceptions. Our primary effects of 
interest in Aim 2 are the 3-way interactions between time × study arm × potential effect 
modifiers. These multivariable models will contain the 3-way interaction term, all 2-way 
interaction terms, main effects of time, study arm, potential effect modifier, and any variables 
that meaningfully differ between study arms at baseline. We will conduct both intent-to-treat and 
intensity-adjusted analyses. A significant 3-way interaction suggests the presence of 
intervention effect heterogeneity; we will follow the approach of Kraemer112,113 by focusing on 
effect size derivation rather than formal hypothesis testing. We will use Stata’s postestimation 
“margins” command to probe the 3-way interaction terms to provide simpler meaningful results.  
 
 
 
 

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