About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Brief Motivational Interviewing-based Alcohol Intervention
- Smartphone App-delivered Mindfulness Training
Treatment groups
Sponsors and collaborators
Johns Hopkins University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator