NCT07059078 · Johns Hopkins University
Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care
(PCORIMINDSET)
What this study 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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Baltimore, Maryland
- Belcamp, Maryland
- Bowie, Maryland
- Columbia, Maryland
- Glen Burnie, Maryland
- Hagerstown, Maryland
- Nottingham, Maryland
- Odenton, Maryland
- Rockville, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2025 · Source of record for eligibility and locations