Game-Based Intervention to Reduce Alcohol Use Among Youth

A Randomized Controlled Trial of a Game-Based Intervention to Reduce Alcohol Use Among Youth

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

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Problem
• Intervention / Treatment: Behavioral: Singularities; Behavioral: Food4Thought

• Study Type: Interventional
• Enrollment (Estimated): 1992
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert WS Coulter, PhD, MPH; Phone Number: 412-624-0647; Email: robert.ws.coulter@pitt.edu
• Study Contact Backup: Name: James E Egan, PhD, MPH; Phone Number: 412-624-2255; Email: jee48@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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:

- None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking quantity	Number of drinks consumed on a typical day of drinking assessed via Quantity-Frequency items	Baseline, 3 months, 6 months, and 12 months
Drinking frequency	Number of days on which one or more drinks were consumed assessed via Quantity-Frequency items.	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 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.	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Robert WS Coulter, PhD, MPH, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders
• Other Study ID Numbers: STUDY25100213; 5R01AA030017-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: IPD will be available 12 months after the end of the study. There is no end date.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No