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

Recruiting now · Not applicable

Conditions studied: Adolescent Alcohol Use

In brief

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.

Key facts

Study ID

NCT07059078

Run by

Johns Hopkins University

People needed

1500

Starts

2025-09-03

Expected to finish

2030-09-30

Last updated by the study team

2025-09-16

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Harriet Lane Clinic — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins University Center for Adolescent and Young Adult Health — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins Community Physicians, Canton Crossing — Baltimore, Maryland, United States
• Johns Hopkins Community Physicians, Water's Edge — Belcamp, Maryland, United States
• Johns Hopkins Community Physicians, Bowie — Bowie, Maryland, United States
• Johns Hopkins Community Physicians, Howard County Pediatrics — Columbia, Maryland, United States
• Johns Hopkins Community Physicians, Glen Burnie — Glen Burnie, Maryland, United States
• Johns Hopkins Community Physicians, Hagerstown — Hagerstown, Maryland, United States
• Johns Hopkins Community Physicians, White Marsh Pediatrics — Nottingham, Maryland, United States
• Johns Hopkins Community Physicians, Odenton Medical — Odenton, Maryland, United States
• Johns Hopkins Community Physicians, Remington — Baltimore, Maryland, United States
• Johns Hopkins Community Physicians, Rockville Pediatrics — Rockville, Maryland, United States
• Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56) — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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