Actively Recruiting
Comparative Effectiveness of Brief Motivational Interviewing With or Without Smartphone App Mindfulness Training for Reducing Alcohol Use in Adolescents in Pediatric Primary Care
Led by Johns Hopkins University · Updated on 2025-09-16
1500
Participants Needed
13
Research Sites
86 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 common among U.S. adolescents and contributes to negative health effects. This research compares two approaches to help reduce alcohol use in adolescents receiving care in pediatric primary care clinics. It evaluates a brief motivational interviewing-based alcohol intervention (BMAI) alone versus the same intervention combined with smartphone app-delivered mindfulness training (MT). The study aims to assess effectiveness, implementation factors, and how different patient characteristics influence results over one year. Participants receive either BMAI delivered in person by trained pediatric clinicians during routine visits or BMAI plus 8 weeks of mindfulness training using the Healthy Minds Program app. BMAI involves feedback, advice, and goal setting to support behavior change, with sessions lasting 10-30 minutes initially and shorter follow-ups. The mindfulness app provides self-guided training focusing on breath and body awareness, emotion noting, and daily mindfulness practice, with suggested use of 5-30 minutes daily. During the study, participants complete assessments of alcohol use, related problems, and intervention satisfaction at multiple time points up to 12 months. Researchers collect reports from adolescents, caregivers, and providers about experiences and barriers. Outcome measures include alcohol use frequency, heavy drinking days, cannabis and tobacco use, alcohol-related consequences, quality of life, and emergency health service use. The study monitors implementation and participant engagement to understand which components work best for different youth.
CONDITIONS
Brief Title
Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 to 17 years
- Receiving pediatric primary care through Johns Hopkins Medical Institute healthcare network
- Screening positive for moderate or high alcohol use risk with monthly alcohol use in the past year
- Able to speak, understand, and read English or Spanish
- Able to provide assent and have parental consent/permission to participate
You will not qualify if you...
- Severe medical or psychiatric condition that could make participation unsafe (e.g., psychosis, active suicidality, mania)
- Intellectual disability reported or documented
- Current or recent specialty substance use disorder treatment within past 6 months
- Physiological alcohol withdrawal requiring urgent inpatient referral
- Regular opioid, benzodiazepine, or cocaine use more than weekly or history of overdose in past 6 months
- Previous mindfulness-based intervention experience in past 12 months
- Current regular meditation practice over 30 minutes per day for more than 5 days per week in past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks for mindfulness training; BMAI sessions occur over multiple visits during this period
Participants receive a brief motivational interviewing-based alcohol intervention (BMAI) delivered by pediatric clinicians during routine or follow-up visits. Some participants also receive 8 weeks of adjunctive smartphone app-delivered mindfulness training using the Healthy Minds Program app.
One or more in-person visits for BMAI; app use 5-30 minutes daily for 8 weeks for mindfulness training
Duration - Up to 12 months
Participants are followed for up to 12 months after treatment to assess alcohol use and other outcomes.
Assessments at 1, 3, 6, and 12 months post-baseline
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
Research Team
C
Christopher J Hammond, MD, PhD
G
Gabrielle Newton, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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