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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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06215664
Enrollment
28
Registered
2024-01-22
Start date
2025-02-19
Completion date
2025-03-21
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Problem, Alcohol-Related Harm, Harm Reduction

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.

Interventions

BEHAVIORALSingularities 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.

BEHAVIORALFood4Thought

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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Two-armed parallel randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Alcohol-related Harms3 monthsPrimary 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)

Secondary

MeasureTime frameDescription
Drinking Quantity3 monthsNumber of drinks consumed on a typical day of drinking in the past three months via Quantity-Frequency items
Drinking Frequency3 monthsNumber of days on which one or more drinks were consumed in past month via Quantity-Frequency items.
Binge Drinking3 monthsNumber 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
Alcohol Use Initiation3 monthsSurvey item from the Youth Risk Behavior Survey assessing lifetime alcohol use.
Alcohol Harm Reduction Skills3 monthsWhich 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
Bystander Alcohol Harm Reduction Skills3 monthsTotal # 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
Emotional Distress Tolerance Skills3 monthsBeliefs 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
Emotion Regulation and Decentering Practices3 monthsHow 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
Healthy Social Media Use3 monthsEndorsement of beliefs and thoughts about social media, using MetroWest Adolescent Health Survey items

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRobert WS Coulter, PhD

University of Pittsburgh

Participant flow

Pre-assignment details

Trial was terminated before all enrolled participants were randomized.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
23 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
15 Participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 10
other
Total, other adverse events
0 / 130 / 10
serious
Total, serious adverse events
0 / 130 / 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026