Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
NCT07059078

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

Led by Johns Hopkins University · Updated on 2025-09-16

1500

Participants Needed

13

Research Sites

264 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 12 and 17 years
  • Receiving pediatric primary care through the Johns Hopkins Medical Institute healthcare network
  • Positive screening for moderate or high alcohol use risk with any monthly alcohol use in the past 12 months
  • Able to speak, understand, and read English or Spanish
  • Able to provide assent and have parental consent/permission to participate
Not Eligible

You will not qualify if you...

  • Severe medical or psychiatric conditions that may make participation hazardous (e.g., psychosis, homicidality, active suicidality, mania)
  • Intellectual disability reported or documented by self, caregiver, or provider
  • Current or recent specialty substance use disorder treatment in the past 6 months
  • Current physiological alcohol withdrawal requiring urgent inpatient referral
  • Regular opioid, benzodiazepine, or cocaine use more than weekly or overdose in past 6 months
  • Previous mindfulness-based intervention experience in the past 12 months
  • Regular meditation practice over 30 minutes per day for more than 5 days per week in the 30 days before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 13 locations

1

Johns Hopkins Community Physicians, Remington

Baltimore, Maryland, United States, 21211

Not Yet Recruiting

2

Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56)

Baltimore, Maryland, United States, 21224

Not Yet Recruiting

3

Johns Hopkins Community Physicians, Canton Crossing

Baltimore, Maryland, United States, 21224

Not Yet Recruiting

4

Harriet Lane Clinic

Baltimore, Maryland, United States, 21287

Actively Recruiting

5

Johns Hopkins University Center for Adolescent and Young Adult Health

Baltimore, Maryland, United States, 21287

Actively Recruiting

6

Johns Hopkins Community Physicians, Water's Edge

Belcamp, Maryland, United States, 21017

Not Yet Recruiting

7

Johns Hopkins Community Physicians, Bowie

Bowie, Maryland, United States, 20715

Not Yet Recruiting

8

Johns Hopkins Community Physicians, Howard County Pediatrics

Columbia, Maryland, United States, 21046

Not Yet Recruiting

9

Johns Hopkins Community Physicians, Glen Burnie

Glen Burnie, Maryland, United States, 20161

Not Yet Recruiting

10

Johns Hopkins Community Physicians, Hagerstown

Hagerstown, Maryland, United States, 21742

Not Yet Recruiting

11

Johns Hopkins Community Physicians, White Marsh Pediatrics

Nottingham, Maryland, United States, 21236

Not Yet Recruiting

12

Johns Hopkins Community Physicians, Odenton Medical

Odenton, Maryland, United States, 21113

Not Yet Recruiting

13

Johns Hopkins Community Physicians, Rockville Pediatrics

Rockville, Maryland, United States, 20854

Not Yet Recruiting

Loading map...

Research Team

C

Christopher J Hammond, MD, PhD

CONTACT

G

Gabrielle Newton, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here