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Search / Trial NCT07059078

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

Launched by JOHNS HOPKINS UNIVERSITY · Jul 1, 2025

Trial Information

Current as of August 22, 2025

Not yet recruiting

Keywords

Alcohol Use Alcohol Related Problems Drug Use Adolescent Motivational Interviewing Mindfulness Mindfulness Training Brief Alcohol Intervention Digital Therapeutic Intervention Sbirt Pcori

ClinConnect Summary

This clinical trial is studying ways to help teens who use alcohol by testing two different approaches in pediatric primary care settings. One group will receive a brief counseling session called motivational interviewing, which is designed to encourage positive behavior change. The other group will get the same counseling plus mindfulness training delivered through a smartphone app. Mindfulness involves simple exercises that help people focus and manage stress. The study will compare how well these approaches reduce alcohol use and related problems over one year.

Teens between 12 and 17 years old who receive care through Johns Hopkins pediatric clinics and who have used alcohol at least once in the past year may be eligible to participate. They need to be able to speak and understand English or Spanish and have parental permission to join. The study will not include teens with serious medical or mental health conditions, those currently in specialized addiction treatment, or those already practicing mindfulness regularly. Participants will be randomly assigned to one of the two groups and will be followed for a year to see how the treatments work. This study aims to find effective, easy-to-use ways to support teens in reducing risky alcohol use.

Gender

ALL

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 Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Belcamp, Maryland, United States

Bowie, Maryland, United States

Columbia, Maryland, United States

Glen Burnie, Maryland, United States

Hagerstown, Maryland, United States

Nottingham, Maryland, United States

Odenton, Maryland, United States

Rockville, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Christopher J Hammond, MD, PhD

Principal Investigator

Johns Hopkins University

Hoover Adger, MD, MPH, MBA

Study Director

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported