Trial Outcomes & Findings for Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth (NCT NCT06215664)

NCT ID: NCT06215664

Last Updated: 2026-03-12

Results Overview

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)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

3 months

Results posted on

2026-03-12

Participant Flow

Trial was terminated before all enrolled participants were randomized.

Participant milestones

Participant milestones
Measure
Singularities Game
Singularities is an online game.
Food4Thought
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.
Overall Study
STARTED
13
10
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
13
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Singularities Game
n=13 Participants
Singularities is an online game.
Food4Thought
n=10 Participants
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.
Total
n=23 Participants
Total of all reporting groups
Age, Categorical
<=18 years
13 Participants
n=9 Participants
10 Participants
n=9 Participants
23 Participants
n=18 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=9 Participants
0 Participants
n=9 Participants
0 Participants
n=18 Participants
Age, Categorical
>=65 years
0 Participants
n=9 Participants
0 Participants
n=9 Participants
0 Participants
n=18 Participants
Sex: Female, Male
Female
10 Participants
n=9 Participants
8 Participants
n=9 Participants
18 Participants
n=18 Participants
Sex: Female, Male
Male
3 Participants
n=9 Participants
2 Participants
n=9 Participants
5 Participants
n=18 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=9 Participants
0 Participants
n=18 Participants
Race (NIH/OMB)
Asian
1 Participants
n=9 Participants
1 Participants
n=9 Participants
2 Participants
n=18 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=9 Participants
0 Participants
n=18 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=9 Participants
1 Participants
n=9 Participants
2 Participants
n=18 Participants
Race (NIH/OMB)
White
9 Participants
n=9 Participants
6 Participants
n=9 Participants
15 Participants
n=18 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
2 Participants
n=9 Participants
2 Participants
n=18 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=9 Participants
0 Participants
n=9 Participants
2 Participants
n=18 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=9 Participants
1 Participants
n=9 Participants
3 Participants
n=18 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
n=9 Participants
9 Participants
n=9 Participants
20 Participants
n=18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=9 Participants
0 Participants
n=18 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

Number of drinks consumed on a typical day of drinking in the past three months via Quantity-Frequency items

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

Survey item from the Youth Risk Behavior Survey assessing lifetime alcohol use.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Trial was terminated before the outcome measure data were collected.

Endorsement of beliefs and thoughts about social media, using MetroWest Adolescent Health Survey items

Outcome measures

Outcome data not reported

Adverse Events

Singularities Game

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Food4Thought

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Coulter

University of Pittsburgh

Phone: 412.624.0647

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place