CClinicalTrials.gg
TerminatedNCT06215664Updated Mar 12, 2026Results posted

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

An interventional study of Singularities Game and Food4Thought in Alcohol Problem, Harm Reduction and Alcohol-Related Harm, sponsored by University of Pittsburgh. Terminated at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention

Why this study was terminated
Grant was terminated by NIH.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Problem
  • Harm Reduction
  • Alcohol-Related Harm
03

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Cisgender heterosexuals.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Singularities Game

    Singularities is an online game.

    Behavioral: Singularities Game

  • 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

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.

05

What researchers measure

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)

    Time frame: 3 months

Secondary outcomes

  1. Drinking Quantity

    Number of drinks consumed on a typical day of drinking in the past three months via Quantity-Frequency items

    Time frame: 3 months

  2. Drinking Frequency

    Number of days on which one or more drinks were consumed in past month via Quantity-Frequency items.

    Time frame: 3 months

  3. 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

    Time frame: 3 months

  4. Alcohol Use Initiation

    Survey item from the Youth Risk Behavior Survey assessing lifetime alcohol use.

    Time frame: 3 months

  5. 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

    Time frame: 3 months

  6. 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

    Time frame: 3 months

  7. 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

    Time frame: 3 months

  8. 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

    Time frame: 3 months

  9. Healthy Social Media Use

    Endorsement of beliefs and thoughts about social media, using MetroWest Adolescent Health Survey items

    Time frame: 3 months

06

Results

Posted Mar 12, 2026
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.

Participant flow

Participant flow — Overall Study
MilestoneSingularities GameFood4Thought
Started1310
Completed00
Not completed1310

Outcome measures

PrimaryAlcohol-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)

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryDrinking Quantity

Number of drinks consumed on a typical day of drinking in the past three months via Quantity-Frequency items

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryDrinking Frequency

Number of days on which one or more drinks were consumed in past month via Quantity-Frequency items.

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryBinge 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

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryAlcohol Use Initiation

Survey item from the Youth Risk Behavior Survey assessing lifetime alcohol use.

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryAlcohol 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

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryBystander 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

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryEmotional 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

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryEmotion 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

Time frame:
3 months

No measurements were reported for this outcome.

SecondaryHealthy Social Media Use

Endorsement of beliefs and thoughts about social media, using MetroWest Adolescent Health Survey items

Time frame:
3 months

No measurements were reported for this outcome.

Adverse events

Collected over From enrollment until termination of trial, approximately 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Singularities Game0/13 (0%)0/13 (0%)0/13 (0%)
Food4Thought0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Trial was terminated before all enrolled participants were randomized.

Age, Categorical
Age, Categorical(Participants)Singularities GameFood4ThoughtTotal
<=18 years131023
Between 18 and 65 years000
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Singularities GameFood4ThoughtTotal
Female10818
Male325
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Singularities GameFood4ThoughtTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American112
White9615
More than one race022
Unknown or Not Reported202
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Singularities GameFood4ThoughtTotal
Hispanic or Latino213
Not Hispanic or Latino11920
Unknown or Not Reported000
07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 7, 2025
  • Informed consent form · Sep 27, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data sharing plan and archiving of de-identified data as required by NIH

Supporting information: Study protocol, Sap, Icf

09

Registry details

Key details

Study ID
NCT06215664
Lead sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Robert Coulter (Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Jan 22, 2024
Start date
Feb 19, 2025
Primary completion
Mar 21, 2025
Completion
Mar 21, 2025
Results posted
Mar 12, 2026
Last update
Mar 12, 2026

Study contacts

Robert WS Coulter, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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