Digital Motivational Behavioral Economic Intervention to Reduce Risky Drinking Among Community-Dwelling Emerging Adults

NCT ID: NCT05443750

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

806 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2027-08-31

Brief Summary

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Emerging adult risky drinkers living in disadvantaged communities often have limited access to rewarding activities and adult roles that offer alternatives to heavy drinking. Guided by behavioral economics, this cluster randomized controlled trial will evaluate a brief behavioral intervention aimed at increasing future orientation and engaging pro-social alternatives to drinking delivered using a peer-driven sampling method and digital platform well suited for accessing their social networks.

Detailed Description

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Brief motivational interventions (BMIs) to reduce risky drinking in college students are well established as beneficial, but the needs of emerging adult (EA) risky drinkers who live in disadvantaged communities and are not fulltime college students have been neglected. They tend to have more constrained access to rewarding opportunities, adult roles, and activities that present pro-social alternatives to heavy drinking. When coupled with the foreshortened time horizons typical of many EAs, this suggests the need for interventions that not only enhance motivation to reduce drinking, but guide EAs to engage in alternatives to heavy drinking and orient their behavior toward longer-term positive goals. Guided by behavioral economics (BE), this study will disseminate and evaluate a brief motivational BE intervention that combines BMI elements with the Substance Free Activity Session shown to reduce drinking by increasing future orientation and engagement in pro-social alternatives. The intervention will be delivered using a digital platform appropriate for EAs whose social networks operate through such communications. Because peers influence substance use, a peer-driven sampling method (Respondent Driven Sampling \[RDS\]) will be used to recruit 500 community-dwelling EAs ages 18-28 for a cluster randomized controlled trial that compares the intervention with a health education control condition. Additional EA target population members ("seed" participants, n = 250) will start RDS recruitment but are not part of the intervention evaluation sample. The evaluation study will assess participants' drinking practices and problems, BE outcome predictors, and social networks at enrollment and at 1, 6, and 12-month follow-ups. Intervention efficacy and behavior change mechanisms will be examined. Reduced alcohol demand and delay discounting and favorable post-intervention shifts in future orientation, substance-free vs. substance-involved activities, and use of protective behavioral strategies to reduce drinking-related harms are predicted to mediate intervention effects. Social network analysis will assess whether the intervention attenuates network promotion of individual drinking. The study will be the first to test a web-based alcohol reduction intervention focused on BE principles and to use digital RDS to reach community-dwelling EAs for intervention. The study will translate and test BE mediators and moderators of change, and the digital intervention has high potential for reach and scalability with under-served community risk groups.

Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

brief web-based motivational behavioral economic alcohol intervention compared to web-based health education control materials
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
All study procedures are web-based so delivery of intervention or control materials are fully automated, as are the outcomes assessments. The consent form informs participants they will be assigned to either a brief intervention focused on reducing risks of drinking and promoting healthy futures or an alcohol and health education intervention; they may be able to discern which condition they received upon implementation. Of necessity, the investigators know which condition they receive to initiate the proper web-based program.

Study Groups

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Motivational Behavioral Economic Intervention

Web-based alcohol risk reduction brief intervention

Group Type EXPERIMENTAL

Motivational Behavioral Economic Alcohol Intervention

Intervention Type BEHAVIORAL

The intervention combines an alcohol brief motivational intervention (US-THRIVE \[Tertiary Health Research Intervention via Email\]) with the Substance-Free Activity Session (SFAS), shown to reduce drinking and related negative consequences by increasing future orientation and engagement in pro-social alternatives to drinking. The intervention will be delivered using a web-based platform appropriate for the young adult target population whose social networks operate through such communications.

Health Education

Web-based health education material

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

Participants view web-based health educational material about alcohol, sleep, and nutrition of a similar length and style to the experimental intervention materials.

Interventions

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Motivational Behavioral Economic Alcohol Intervention

The intervention combines an alcohol brief motivational intervention (US-THRIVE \[Tertiary Health Research Intervention via Email\]) with the Substance-Free Activity Session (SFAS), shown to reduce drinking and related negative consequences by increasing future orientation and engagement in pro-social alternatives to drinking. The intervention will be delivered using a web-based platform appropriate for the young adult target population whose social networks operate through such communications.

Intervention Type BEHAVIORAL

Health Education

Participants view web-based health educational material about alcohol, sleep, and nutrition of a similar length and style to the experimental intervention materials.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Males and females ages 18-28 who are not enrolled fulltime in 4-year colleges/universities and who reside in disadvantaged North and Central Florida communities
* Past 30-day alcohol use exceeding NIAAA (2005) single day limits for lower risk drinking (4 drinks for males; 3 drinks for women) and one or more alcohol-related negative consequences in the past 90 days
* Web access via smartphone or computer; and (4) minimum 8th grade education, the level necessary to use study materials.

Exclusion Criteria

* Age out of range
* Blood relatives of previously enrolled participants
* Invalid enrollment referral number
* Fulltime college students
* Absence of above drinking risk indicators
* Lack of smartphone or computer availability
* Education less than 8th grade
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jalie A Tucker, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida College of Health & Human Performance

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Related Links

Access external resources that provide additional context or updates about the study.

http://sourceforge.net/projects/egonet/

Link to access the Egonet software (McCarty \& Smith, 2014)

http://www.niaaa.nih.gov/publications

Link to access the NIAAA's "Helping patients who drink too much: A clinician's guide."

https://www.samhsa.gov/data/report/2020-nsduh-detailed-tables

Link to access National Survey on Drug Use and Health 2020

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01AA028230-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202201411

Identifier Type: -

Identifier Source: org_study_id

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