Alcohol ProblemNCT07463118
Game-Based Intervention to Reduce Alcohol Use Among Youth
A study testing Food4Thought and Singularities in people with Alcohol Problem, run by University of Pittsburgh at 1 site in United States.
Trial 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… 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
- What is being tested?
- Food4Thought and Singularities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,992 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Robert WS Coulter, PhD, 4126240647, robert.ws.coulter@pitt.edu
James E Egan, PhD, 4126242255, jee48@pitt.edu
About this study
Official title: 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?
Read more
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
- Conditions
- Alcohol Problem
- Being tested
- Food4Thought, Singularities
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food4ThoughtBehavioural
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.
SingularitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Food4Thought |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, and 12 months
Secondary outcomes (9)
Drinking quantity
Number of drinks consumed on a typical day of drinking assessed via Quantity-Frequency items
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start10 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,992 participants (estimated)
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, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463118
- Sponsor's protocol ID
- STUDY25100213
- Other IDs
- 5R01AA030017-03
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 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 Use Among Youth
- ClinicalTrials.gov ID
- NCT07463118
- Acronym / sponsor ID
- STUDY25100213
- Conditions
- Alcohol Problem
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,992 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
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 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 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 | Experimental | Behavioral: SingularitiesSingularities 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. |
| Food4Thought | Active comparator | Behavioral: Food4ThoughtFood4Thought 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). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Food4ThoughtFood4Thought 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. | Behavioural | Food4Thought |
| SingularitiesSingularities 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. | Behavioural | Singularities |
Primary outcome
Alcohol-related harms
Time frame: Baseline, 3 months, 6 months, and 12 months
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.
9 secondary outcomes
Drinking quantity
Time frame: Baseline, 3 months, 6 months, and 12 months
Drinking frequency
Time frame: Baseline, 3 months, 6 months, and 12 months
Binge drinking frequency
Time frame: Baseline, 3 months, 6 months, and 12 months
Alcohol use initiation
Time frame: Baseline, 3 months, 6 months, and 12 months
Alcohol protective behavioral strategies
Time frame: Baseline, 3 months, 6 months, and 12 months
Bystander alcohol risk reduction skills
Time frame: Baseline, 3 months, 6 months, and 12 months
Emotional distress tolerance skills
Time frame: Baseline, 3 months, 6 months, and 12 months
Emotion regulation and decentering practices
Time frame: Baseline, 3 months, 6 months, and 12 months
Healthy social media use
Time frame: Baseline, 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Robert WS Coulter, PhD, MPH 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 Food4Thought and Singularities in people with Alcohol Problem, 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 6 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: looking for participants now, as of the sponsor's last update on 16 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert WS Coulter, PhD, MPH (412-624-0647, robert.ws.coulter@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol-related harms (time frame: Baseline, 3 months, 6 months, and 12 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 16 Jul 2026.