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Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care
PCORI Comparative Effectiveness Study: Comparative Effectiveness of Brief Motivational Interviewing +/- Adjunctive Smartphone App-delivered Mindfulness Training for Reducing Alcohol Use in Adolescents in Pediatric Primary Care Settings
Who can join
Ages 12 to 17 · All sexes
Full eligibility criteria
Inclusion Criteria: * 12-17 years old * Receiving pediatric primary care (PPC) services through the Johns Hopkins Medical Institute healthcare network * Screening positive for moderate or high alcohol use risk as indicated by a S2BI score (i.e., showing any monthly alcohol use in the past 12 months) * Able to speak, understand, and read in English or Spanish * Able to provide assent, and receiving parental consent/permission to participate. Exclusion Criteria: * Severe medical or psychiatric condition (e.g., behavioral dysregulation, psychopathology, or cognitive impairment that in the judgement of study or PPC provider may make participation hazardous \[e.g., psychosis, homicidality, active suicidality, mania\]) * Intellectual Disability (self-, caregiver-, or PPC-reported, or PPC-documented) * Current or recent specialty substance use disorder treatment in the past 6 months * Demonstrated current physiological alcohol withdrawal requiring urgent inpatient referral in the judgement of study or PPC physician * Reported regular opioid, benzodiazepine, or cocaine use (\> weekly) or history of opioid, benzodiazepine, or cocaine overdose in the past 6 months * Previous experience with a mindfulness-based intervention in the past 12 months * Current regular meditation practice (\> 30 min/day for \> 5 days avg. over 30 days prior to screening).
About the study
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.
What is being tested
- Brief Motivational Interviewing-based Alcohol Intervention (behavioral)
- Smartphone App-delivered Mindfulness Training (behavioral)
Sponsor: Johns Hopkins University · Participants: 1,500 · Started: Sep 3, 2025
Contact the study team
- Christopher J Hammond, MD, PhD · Phone: (410) 550-0144
Official record on ClinicalTrials.gov — NCT07059078
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.