Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care

Alcohol use is prevalent in U.S. adolescents and contributes to adverse health outcomes in this population. Care for adolescent alcohol use is lacking in most pediatric primary care settings (PPC). This project is a pragmatic comparative effectiveness and implementation study that employs a superiority, two-arm, randomized, prospective, observer-blinded, controlled trial design to compare the effectiveness of a patient-centered brief motivational interviewing-based alcohol intervention (BMAI) alone to the same BMAI augmented with adjunctive smartphone app-delivered mindfulness training (MT) for alcohol use in adolescents receiving primary care in PPC clinics across a regional health network. Main effectiveness outcomes will be alcohol use and alcohol related problems assessed over a one-year follow-up period. Implementation outcomes and mediators and moderators of intervention response will also be examined as part of the study.

NCT Number	NCT07059078
Lead Sponsor	Johns Hopkins University Collaborators: Patient-Centered Outcomes Research Institute
Conditions	Adolescent Alcohol Use
Enrollment	1,500 participants
Start Date	2025-09-03
Primary Completion	2029-02-01 (estimated)
Study Completion	2030-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-16