Clinical trial NCT05443750: Digital Motivational Behavioral Economic Intervention to Reduce Risky Drinking Among Community-Dwelling Emerging Adults
Official title: Digital Motivational Behavioral Economic Intervention to Reduce Risky Drinking Among Community-Dwelling Emerging Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Keywords: risky drinking reduction, emerging adults, social networks
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-07-05
Enrollment: 806
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: brief web-based motivational behavioral economic alcohol intervention compared to web-based health education control materials
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Timeline Followback (TLFB) at 6 months post-baseline
timeFrame: 6 months post-baseline
measure: Change from baseline Timeline Followback (TLFB) at 12 months post-baseline
timeFrame: 12 months post-baseline
measure: Change from baseline Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) at 6 months post-baseline
timeFrame: 6 months post-baseline
measure: Change from baseline Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) scores at 12 months post-baseline
timeFrame: 12 months post-baseline
Secondary outcomes:
measure: Change from baseline Adolescent Reinforcement Survey Schedule-Substance Use Version (ARSS-SUV) at 6 months post-baseline
timeFrame: 6 months post-baseline
measure: Change from baseline Adolescent Reinforcement Survey Schedule-Substance Use Version (ARSS-SUV) at 12 months post-baseline
timeFrame: 12 months post-baseline
measure: Change from baseline Minute Discounting Task at 6 months post-baseline
timeFrame: 6 months post-baseline
measure: Change from baseline Minute Discounting Task at 12 months post-baseline
timeFrame: 12 months post-baseline
measure: Change from baseline Alcohol Purchase Task (APT) at 6 months post-baseline
timeFrame: 6 months post-baseline
measure: Change from baseline Alcohol Purchase Task (APT) at 12 months post-baseline
timeFrame: 12 months post-baseline
measure: Change from baseline Relative Discretionary Expenditures on Alcohol (RDEA) at 6 months post-baseline
timeFrame: 6 months post-baseline
measure: Change from baseline Relative Discretionary Expenditures on Alcohol (RDEA) at 12 months post-baseline
timeFrame: 12 months post-baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Health & Human Performance
state: Florida
Study officials:
affiliation: University of Florida
name: Jalie A Tucker, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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