Brief motivational counseling with or without a smartphone mindfulness app for teens who drink alcohol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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, 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
• Johns Hopkins Community Physicians, Water's Edge
  Belcamp, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.