Alcohol ProblemNCT06215664
Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth
A study testing Singularities Game and Food4Thought in people with Alcohol Problem and Harm Reduction, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Problem, Harm Reduction, Alcohol-Related Harm
- What is being tested?
- Singularities Game and Food4Thought
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2025to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Cisgender heterosexuals.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
- Conditions
- Alcohol Problem, Harm Reduction, Alcohol-Related Harm
- Being tested
- Singularities Game, Food4Thought
- Medical subject headings
- Alcohol-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singularities GameBehavioural
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.
Food4ThoughtBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Singularities Game | Experimental | Singularities is an online game. Receives: 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. Receives: Behavioral: Food4Thought |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (9)
Drinking Quantity
Number of drinks consumed on a typical day of drinking in the past three months via Quantity-Frequency items
Measured: 3 months
Drinking Frequency
Number of days on which one or more drinks were consumed in past month via Quantity-Frequency items.
Measured: 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
Measured: 3 months
Alcohol Use Initiation
Survey item from the Youth Risk Behavior Survey assessing lifetime alcohol use.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Healthy Social Media Use
Endorsement of beliefs and thoughts about social media, using MetroWest Adolescent Health Survey items
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start19 Feb 2025
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Why it stopped: Grant was terminated by NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol ProblemStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-armed parallel randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Robert Coulter, University of Pittsburgh
- Investigators
- Robert WS Coulter, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215664
- Sponsor's protocol ID
- STUDY23030071
- Other IDs
- R01AA030017
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2023
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing plan and archiving of de-identified data as required by NIH
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth
- ClinicalTrials.gov ID
- NCT06215664
- Acronym / sponsor ID
- STUDY23030071
- Conditions
- Alcohol Problem, Harm Reduction, Alcohol-Related Harm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant was terminated by NIH.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-armed parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Singularities Game | Experimental | Behavioral: Singularities GameSingularities is an online game. |
| Food4Thought | Active comparator | Behavioral: Food4ThoughtFood4Thought 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (1 listed)
- Cisgender heterosexuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Singularities GameSingularities 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. | Behavioural | Singularities Game |
| Food4ThoughtFood4Thought 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. | Behavioural | Food4Thought |
Primary outcome
Alcohol-related Harms
Time frame: 3 months
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)
9 secondary outcomes
Drinking Quantity
Time frame: 3 months
Drinking Frequency
Time frame: 3 months
Binge Drinking
Time frame: 3 months
Alcohol Use Initiation
Time frame: 3 months
Alcohol Harm Reduction Skills
Time frame: 3 months
Bystander Alcohol Harm Reduction Skills
Time frame: 3 months
Emotional Distress Tolerance Skills
Time frame: 3 months
Emotion Regulation and Decentering Practices
Time frame: 3 months
Healthy Social Media Use
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data sharing plan and archiving of de-identified data as required by NIH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert WS Coulter, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singularities Game and Food4Thought in people with Alcohol Problem and Harm Reduction, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol-related Harms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.