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Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care
NCT07059078 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- BEHAVIORAL Brief Motivational Interviewing-based Alcohol Intervention
- BEHAVIORAL Smartphone App-delivered Mindfulness Training
Study Locations (13)
Maryland
- Johns Hopkins Community Physicians, Remington — Baltimore
- Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56) — Baltimore
- Johns Hopkins Community Physicians, Canton Crossing — Baltimore
- Harriet Lane Clinic — Baltimore
- Johns Hopkins University Center for Adolescent and Young Adult Health — Baltimore
- Johns Hopkins Community Physicians, Water's Edge — Belcamp
- Johns Hopkins Community Physicians, Bowie — Bowie
- Johns Hopkins Community Physicians, Howard County Pediatrics — Columbia
- Johns Hopkins Community Physicians, Glen Burnie — Glen Burnie
- Johns Hopkins Community Physicians, Hagerstown — Hagerstown
- Johns Hopkins Community Physicians, White Marsh Pediatrics — Nottingham
- Johns Hopkins Community Physicians, Odenton Medical — Odenton
- Johns Hopkins Community Physicians, Rockville Pediatrics — Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2025-09-03 |
| Est. Completion | 2030-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07059078
The ClinicalTrials.gov registry entry for NCT07059078 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Adolescent Alcohol Use appearing as the primary indexed condition, and to 2 interventions — of which Brief Motivational Interviewing-based Alcohol Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07059078 reports 13 study locations spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07059078 about?
NCT07059078 is a clinical study titled "Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care". 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 superior...
What is the current status of trial NCT07059078?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,500 participants. The study started on 2025-09-03. Estimated completion is 2030-09-30.
What conditions does trial NCT07059078 study?
This clinical trial studies the following conditions: Adolescent Alcohol Use. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07059078?
The interventions under investigation include: Brief Motivational Interviewing-based Alcohol Intervention (BEHAVIORAL), Smartphone App-delivered Mindfulness Training (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07059078?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07059078 being conducted?
This trial has 13 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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