Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth

A Randomized Controlled Trial of a Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth

This is a randomized controlled trial to examine the efficacy of a game-based intervention to reduce alcohol-related harms among sexual and gender minority youth.

Study Overview

• Status: Terminated
• Conditions: Harm Reduction; Alcohol Problem; Alcohol-Related Harm
• Intervention / Treatment: Behavioral: Singularities Game; Behavioral: Food4Thought

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able to participate in English
• Live in the U.S.,
• 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,
• Provide an email address.
• Have drank alcohol in their lifetime or intend to in the next year.

Exclusion Criteria:

• Cisgender heterosexuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Singularities Game; Singularities is an online game.	Behavioral: Singularities Game; Singularities is a theory-based, community-informed, web-accessible, roleplaying game-based intervention incorporating 4 primary components: fostering healthy identity development in a safe environment; encouraging help-seeking behaviors; encouraging use of productive coping; alcohol-harm reduction; and encouraging healthy internet and social media use.
Active Comparator: Food4Thought; Food4Thought is an attention control condition in which we provide participants with similar amounts of research team contact and program contact as the intervention. Participants will play the game 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. Food4Thought will be delivered via Qualtrics.	Behavioral: Food4Thought; Food4Thought is an attention control condition in which we provide participants with similar amounts of research team contact and program contact as the intervention. Participants will play the game 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. Food4Thought will be delivered via Qualtrics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol-related Harms	Primary outcome is alcohol-related harms defined as the frequency of 19 total harms (e.g., Hangover after drinking, Unable to remember what happened after drinking, Had sex that you later regretted, Trouble with parent(s) because of drinking Physical fight because you were affected by alcohol, Drove in a vehicle after drinking) as measured in the School Health and Alcohol Harm Reduction Project (SHAHRP)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking Frequency	Number of days on which one or more drinks were consumed in past month via Quantity-Frequency items.	3 months
Alcohol Use Initiation	Survey item from the Youth Risk Behavior Survey assessing lifetime alcohol use.	3 months
Alcohol Harm Reduction Skills	Which behaviors are engaged in while drinking or partying, measured with the Protective Behavioral Strategies Scale (PBSS). Scores range from 20 to 120, with higher scores indicating more skills used	3 months
Bystander Alcohol Harm Reduction Skills	Total # of times a specific strategy was used to help others before, during, or after drinking, using the Strategies subscale of the Bystanders to Alcohol Risk Scale (BARS). Scores range from 0 to 27, with higher scores indicating more skills used	3 months
Drinking Quantity	Number of drinks consumed on a typical day of drinking in the past three months via Quantity-Frequency items	3 months
Binge Drinking	Number of times where 4 or 5+ drinks (asking both, regardless of assigned/biological sex at birth to be inclusive of gender minorities) were consumed in a 2-hour period over the past 3 months, via NIAAA items	3 months
Emotional Distress Tolerance Skills	Beliefs about feeling distressed or upset, measured with the Distress Tolerance Scale (DTS). Scores range from 15 to 75, with higher scores indicating a poorer outcome	3 months
Emotion Regulation and Decentering Practices	How often mindfulness practices are used, measured with the Applied Mindfulness Process Scale (AMPS). Scores range from 0 to 60, with higher scores indicating a better outcome	3 months
Healthy Social Media Use	Endorsement of beliefs and thoughts about social media, using MetroWest Adolescent Health Survey items	3 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Robert WS Coulter, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Alcohol-Related Disorders; Harm Reduction
• Other Study ID Numbers: STUDY23030071; R01AA030017 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing plan and archiving of de-identified data as required by NIH
• IPD Sharing Time Frame: 12 months after end of study
• IPD Sharing Access Criteria: Public
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No