NCT07059078 Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care
| NCT ID | NCT07059078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Adolescent Alcohol Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2025-09-03 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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).
Contact & Investigator
Christopher J Hammond, MD, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07059078 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Adolescent Alcohol Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059078 currently recruiting?
Yes, NCT07059078 is actively recruiting participants. Contact the research team at chammo20@jhmi.edu for enrollment information.
Where is the NCT07059078 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States, Baltimore, United States, Baltimore, United States and 9 additional locations.
Who is sponsoring the NCT07059078 clinical trial?
NCT07059078 is sponsored by Johns Hopkins University. The principal investigator is Christopher J Hammond, MD, PhD at Johns Hopkins University. The trial plans to enroll 1,500 participants.