NCT07463118

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,992

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Jun 2028

First Submitted

Initial submission to the registry

March 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

March 2, 2026

Last Update Submit

July 14, 2026

Conditions

Alcohol Problem

Outcome Measures

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.

    Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (9)

  • Drinking quantity

    Baseline, 3 months, 6 months, and 12 months

  • Drinking frequency

    Baseline, 3 months, 6 months, and 12 months

  • Binge drinking frequency

    Baseline, 3 months, 6 months, and 12 months

  • Alcohol use initiation

    Baseline, 3 months, 6 months, and 12 months

  • Alcohol protective behavioral strategies

    Baseline, 3 months, 6 months, and 12 months

  • +4 more secondary outcomes

Study Arms (2)

Singularities

EXPERIMENTAL

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

Food4Thought

ACTIVE COMPARATOR

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

Food4ThoughtBEHAVIORAL

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.

Food4Thought
SingularitiesBEHAVIORAL

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.

Singularities

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Robert WS Coulter, PhD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert WS Coulter, PhD, MPH

CONTACT

412-624-0647robert.ws.coulter@pitt.edu

James E Egan, PhD, MPH

CONTACT

412-624-2255jee48@pitt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-armed parallel randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 11, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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).
More information

Locations

US(1)