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

Binge Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215664
• Other study ID #: STUDY23030071
• Secondary ID: R01AA030017
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: Robert WS Coulter, PhD
• Phone: 4126240647
• Email: robert.ws.coulter[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial to examine the efficacy of a game-based intervention to reduce alcohol use among sexual and gender minority youth.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2298
• Est. completion date: June 30, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• Live in the U.S.,
• 14-18 years old
• Have a sexual minority identity (i.e., gay, lesbian, bisexual, or queer) or a gender minority identity (i.e., consider themselves to be transgender or nonbinary),
• Have an internet-accessible computer, smart phone, or tablet,
• Provide an email address.

Exclusion Criteria:

• Cisgender heterosexuals.

Related Conditions & MeSH terms

• Binge Drinking

Intervention

Behavioral:
• Singularities Game
Singularities is a theory-based, community-informed, web-accessible, roleplaying game-based intervention incorporating 4 primary components: fostering healthy identity development in a safe environment; encouraging help-seeking behaviors; encouraging use of productive coping; alcohol-harm reduction; and encouraging healthy internet and social media use.
• Psychosocial Education
Psychoeducational core components of the Singularities intervention delivered in an instructional text format to participants through a Qualtrics-based training program.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge drinking frequency	Primary outcome is past-month frequency of binge drinking, defined as consuming 5+ drinks in a two-hour period (regardless of assigned/biological sex at birth to be inclusive of gender minorities) assessed via NIAAA-recommended quantity-frequency alcohol survey items.	3 months
Secondary	Drinks Per Week	Sum of the # of drinks consumed each day of a typical week in the past three months via the Daily Drinking Questionnaire. Higher scores indicate worse outcome (greater drinker per week). The lower limit of the range is zero and there is no upper limit.	3 months
Secondary	Drinking Frequency	Number of days on which one or more drinks were consumed in past month via Quantity-Frequency items.	3 months
Secondary	Maximum # of Drinks	Largest # of drinks consumed on days when drinking occurred in past month via Quantity-Frequency items.	3 months
Secondary	High-Intensity Binge Drinking Frequency	Number of days in past month in which 8+ and 10+ drinks (regardless of assigned/biological sex at birth to be inclusive of gender minorities) were consumed, assessed via Quantity-Frequency items.	3 months
Secondary	Total Volume Consumed	Quantity-Frequency items multiplying drinking frequency (past-month # of drinking days) by quantity (average number of drinks consumed per drinking day in past month)	3 months
Secondary	Alcohol Use Initiation	Survey item from the Youth Risk Behavior Survey assessing lifetime alcohol use.	3 months
Secondary	Binge Drinking Initiation	Survey item from the Youth Risk Behavior Survey assessing lifetime binge drinking.	3 months
Secondary	Alcohol-Related Consequences:	Rutgers Alcohol Problems Index (RAPI) assessing frequency of negative alcohol-related problems	3 months
Secondary	Cigarette Smoking	Frequency × Quantity using 2 items assessing past-month frequency of cigarette smoking (in days) and average number of cigarettes smoked per day.	3 months
Secondary	Electronic Nicotine Delivery System Use	1 item assessing the frequency of electronic nicotine delivery system use in the past 30 days.	3 months
Secondary	Marijuana Use	1 item about frequency of marijuana use in the past month.	3 months
Secondary	Stress	Summative score of 10 items assessing past-month stress (Perceived Stress Scale). Possible range is 0-40, wherein higher scores indicate worse outcomes (i.e., higher perceived stress).	3 months
Secondary	Anxiety Symptoms	Average of 10 items assessing past-week symptoms of anxiety (Severity Measure for Generalized Anxiety Disorder Child Age 11-17 years).	3 months
Secondary	Depressive Symptoms	Summative score of 9 items assessing past-week symptoms of depression (Patient Health Questionnaire-9 for Adolescents). Possible range is 0-27, wherein higher scores indicate worse outcomes (i.e., greater depression severity).	3 months
Secondary	Loneliness	Average of 8 items assessing symptoms of loneliness (University of California, Los Angeles Loneliness Scale). Possible range is 0-3, wherein higher scores indicate worse outcomes (i.e., greater loneliness).	3 months