Brief motivational counseling with or without a smartphone mindfulness app for teens who drink alcohol
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
This study will test whether adding a smartphone mindfulness program to brief motivational counseling helps 12–17-year-olds who drink alcohol cut down and avoid alcohol-related problems over one year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 13 sites (Baltimore, Maryland and 12 other locations) |
| Trial ID | NCT07059078 on ClinicalTrials.gov |
What this trial studies
Researchers will randomize adolescents identified in pediatric primary care to receive a brief motivational interviewing–based alcohol intervention (BMAI) alone or the same BMAI plus smartphone app–delivered mindfulness training (BMAI+MT). The trial uses a pragmatic, two-arm, superiority, observer-blinded design across multiple clinics in a regional health network. Primary effectiveness outcomes are alcohol use and alcohol-related problems measured over a 12-month follow-up, and the study also examines implementation outcomes and factors that influence response. Interventions are delivered as part of routine pediatric primary care to enhance real-world applicability.
Who should consider this trial
Good fit: Ideal candidates are 12–17-year-olds who receive pediatric primary care within the Johns Hopkins network, screen positive for monthly alcohol use on the S2BI, can read English or Spanish, and can provide assent with parental permission.
Not a fit: Patients with severe medical or psychiatric instability (for example, active psychosis or suicidality), intellectual disability, recent specialty substance use treatment, or current physiological alcohol withdrawal are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding an app-delivered mindfulness program to brief motivational counseling could reduce teen drinking and alcohol-related harms and be scaled in pediatric primary care.
How similar studies have performed: Standard brief interventions using motivational interviewing have some evidence in adolescents, mindfulness training shows emerging evidence, and combining BMAI with app-delivered mindfulness is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Baltimore, Maryland and 12 other locations
- Johns Hopkins Community Physicians, Remington — Baltimore, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56) — Baltimore, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Community Physicians, Canton Crossing — Baltimore, Maryland, United States (Not_yet_recruiting)
- Harriet Lane Clinic — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins University Center for Adolescent and Young Adult Health — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins Community Physicians, Water's Edge — Belcamp, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Community Physicians, Bowie — Bowie, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Community Physicians, Howard County Pediatrics — Columbia, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Community Physicians, Glen Burnie — Glen Burnie, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Community Physicians, Hagerstown — Hagerstown, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Community Physicians, White Marsh Pediatrics — Nottingham, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Community Physicians, Odenton Medical — Odenton, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins Community Physicians, Rockville Pediatrics — Rockville, Maryland, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Christopher J Hammond, MD, PhD — Johns Hopkins University
- Study coordinator: Christopher J Hammond, MD, PhD
- Email: chammo20@jhmi.edu
- Phone: (410) 550-0144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.