ClinicalTrials.gg
RecruitingNCT07463118Updated Jul 16, 2026

Game-Based Intervention to Reduce Alcohol Use Among Youth

An interventional study of Food4Thought and Singularities in Alcohol Problem, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

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

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,992
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
01

Study summary

This is a randomized controlled trial to learn if the Singularities, a game-based intervention, works to reduce alcohol-related harms among youth. It will also learn if Singularities reduces alcohol use behaviors and improves alcohol protective behavioral strategies, adaptive coping skills, and healthy social media use. The main questions it aims to answer are:

  • Does Singularities reduce the frequency of experiencing alcohol-related harms and alcohol use behaviors?
  • Does Singularities improve alcohol protective behavioral strategies, adaptive coping skills, and healthy social media use?

Researchers will compare Singularities to an attention control program, Food4Thought, a game-based intervention about nutrition, physical activity, and teen well-being, to see if Singularities works to reduce alcohol-related harms.

Participants will:

  • Partake in either Singularities or Food4Thought, both of which will be completed over the course of one month
  • Take 4 online surveys over the course of one year
  • Complete an optional online interview after the surveys
02

Conditions studied

  • Alcohol Problem
03

In context

Alcohol-Related Disorders

156 studies on the registry are indexed under Alcohol-Related Disorders; 23 are open to participants now.

This study's planned enrollment of 1,992 is above the median of 101 across 131 interventional studies indexed under Alcohol-Related Disorders.

Browse Alcohol-Related Disorders studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Able to comfortably participate in English
  • Live in the U.S.
  • 14-18 years old
  • 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:

- None

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,992 participants (estimated)

Study arms

  • Experimental
    Singularities

    Singularities is a theory-based, community-informed, web-accessible intervention that includes a game, discussion board, and resources that incorporate 3 components for encouraging use of adaptive coping skills, alcohol protective behavioral strategies, and healthy internet and social media use.

    Behavioral: Singularities

  • Active comparator
    Food4Thought

    Food4Thought is an attention control condition in which participants receive similar amounts of research team contact and program contact as the Singularities intervention. Participants will play the game Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian Science Education Center, and learn about resources and respond to questions about nutrition, physical activity, and teen well-being (without the mention of anything pertaining to alcohol use).

    Behavioral: Food4Thought

Interventions

  • BehavioralFood4Thought

    Food4Thought is an attention control condition in which participants receive 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.

  • BehavioralSingularities

    Singularities is a theory-based, community-informed, web-accessible intervention that includes a game, discussion board, and resources that incorporate 3 components for encouraging use of adaptive coping skills, alcohol protective behavioral strategies, and healthy internet and social media use.

06

What researchers measure

Primary outcomes

  1. Alcohol-related harms

    Participants report how many times they experienced 19 different alcohol-related harms, based on the measure from the the School Health and Alcohol Harm Reduction Project (SHAHRP). Example harms include hangover after drinking, inability to remember what happened after drinking, having sex that they later regretted, trouble with parent(s) because of drinking, physical fight because they were affected by alcohol, and drove in a vehicle after drinking. Response options for each harm range from "never" (0) to "12 times or more" (12). Scores range from 0 to 228, with higher scores indicating more alcohol-related harms.

    Time frame: Baseline, 3 months, 6 months, and 12 months

Secondary outcomes

  1. Drinking quantity

    Number of drinks consumed on a typical day of drinking assessed via Quantity-Frequency items

    Time frame: Baseline, 3 months, 6 months, and 12 months

  2. Drinking frequency

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

    Time frame: Baseline, 3 months, 6 months, and 12 months

  3. Binge drinking frequency

    Number of times when 4 or 5+ drinks (asking both regardless of assigned/biological sex at birth) were consumed in a 2-hour period assessed via National Institute on Alcohol Abuse and Alcoholism (NIAAA) items.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  4. Alcohol use initiation

    Participants report whether or not they drank alcohol, which is assessed via the Youth Risk Behavior Survey item about lifetime alcohol use.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  5. Alcohol protective behavioral strategies

    Which alcohol protective behavioral strategies 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: Baseline, 3 months, 6 months, and 12 months

  6. Bystander alcohol risk reduction skills

    Total number of times specific strategies were 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: Baseline, 3 months, 6 months, and 12 months

  7. Emotional distress tolerance skills

    Ability to endure negative emotional states, measured with the Distress Tolerance Scale (DTS). Scores range from 15 to 75, with higher scores indicating better distress tolerance.

    Time frame: Baseline, 3 months, 6 months, and 12 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: Baseline, 3 months, 6 months, and 12 months

  9. Healthy social media use

    Using MetroWest Adolescent Health Survey items, this self-report measure assesses adolescents' perceptions of the social, emotional, and behavioral impacts of social media use. Participants indicate their level of agreement with 11 statements on a 5-point Likert scale, with higher average scores reflecting healthier social media use.

    Time frame: Baseline, 3 months, 6 months, and 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: IPD will be available 12 months after the end of the study. There is no end date.

Access criteria: Anyone who wishes to access the data and supporting information from the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAA DA).

Data sharing details ↗ · nda.nih.gov

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.

Of 49 non-industry interventional studies with no phase under Alcohol-Related Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 44. This study's planned 24 months is below that.

Counting every sponsor, half of 49 studies reached it within 30 months; a quarter within 17 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2026
First posted
Mar 11, 2026
StartActual
Jun 10, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07463118
Responsible party
Robert Coulter (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Mar 11, 2026
Start date
Jun 10, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jul 16, 2026

Study contacts

Robert WS Coulter, PhD, MPH
Contact
robert.ws.coulter@pitt.edu
412-624-0647
James E Egan, PhD, MPH
Contact
jee48@pitt.edu
412-624-2255
Robert WS Coulter, PhD, MPH
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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