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

NCT06215664 | Terminated Results DMC

• 2 other identifiers: STUDY23030071R01AA030017
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Harm Reduction; Alcohol-Related Harm; Alcohol Problem

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Drinking Quantity

  3 months

• Drinking Frequency

  3 months

• Binge Drinking

  3 months

• Alcohol Use Initiation

  3 months

• Alcohol Harm Reduction Skills

  3 months

Study Arms (2)

Singularities Game

EXPERIMENTAL

Singularities is an online game.

Behavioral: Singularities Game

Food4Thought

ACTIVE COMPARATOR

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

Interventions

Singularities Game BEHAVIORAL

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.

Singularities Game

Food4Thought BEHAVIORAL

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.

Food4Thought

Eligibility Criteria

• Age: 14 Years - 18 Years
• Gender Eligibility Details: Any gender minorities are eligible as are any cisgender sexual minority people.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Able to participate in English
• Live in the U.S.,
• 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.

You may not qualify if:

• Cisgender heterosexuals.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Alcohol-Related Disorders; Harm Reduction

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Limitations and Caveats

The effect of the intervention cannot be determined due to termination of the trial by NIH before any outcome data were collected.

Results Point of Contact

• Title: Robert Coulter
• Organization: University of Pittsburgh

rwc19@pitt.edu

412.624.0647

Study Officials

• Robert WS Coulter, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-armed parallel randomized controlled trial

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 22, 2024
• Study Start: February 19, 2025
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after end of study
• Access Criteria: Public

Locations

US (1)