Recruiting

BMAI & MT

Sponsor:

Johns Hopkins University

Code:

NCT07059078

Conditions

Adolescent Alcohol Use

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Brief Motivational Interviewing-based Alcohol Intervention

Smartphone App-delivered Mindfulness Training

Study Details

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.

Conditions

Adolescent Alcohol Use

Study ID

NCT07059078

Start date

Sep 3, 2025

Status verified date

Sep, 2025

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Feb 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Brief Motivational interviewing-based Alcohol Intervention (BMAI)

Participants randomized to this arm will receive a brief motivational interviewing-based alcohol intervention (BMAI) delivered in person by a pediatric clinician in the pediatric primary care (PPC) office setting.

BMAI is adapted from the Provider Guide: Adolescent SBIRT Using the S2BI-CRAFFT Screening Tool and incorporates motivational interviewing (MI) principles. It includes clinician-delivered feedback, advice, and goal setting to help adolescents recognize links between alcohol/drug use and negative health outcomes, and to develop personalized change plans.

BMAI is delivered across one or more visits, with the initial session typically lasting 10-30 minutes and follow-ups lasting 5-15 minutes. Clinicians delivering BMAI include pediatricians, nurses, and social workers who provide primary care to 12-17-year-olds at participating JHMI sites and who have completed SBIRT/BMAI training and monitoring as part of the trial.

active comparator: BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT)

Participants randomized to this arm will receive the BMAI intervention described above plus 8 weeks of adjunctive smartphone-delivered mindfulness training (MT) via the Healthy Minds Program (HMP) app.

The HMP app offers self-guided, self-paced mindfulness and meditation training, with core modules on Awareness, Insight, Connection, and Purpose. This study focuses on the Awareness and Insight modules, which teach breath and body awareness, noting of emotions, and the application of mindfulness in daily life.

After randomization, participants will meet with study staff to download the app, receive instruction, and be asked to use it 5-30 minutes daily, following a pathway of 4 weeks of Awareness content, then 4 weeks of Insight content.

After the 8-week MT period, participants will have open access to all HMP modules and be encouraged to explore the remaining content as desired during the follow-up period.

Interventions

Brief Motivational Interviewing-based Alcohol Intervention

Participants in both arms (BMAI and BMAI + MT) will receive a brief motivational interviewing-based alcohol intervention (BMAI) delivered by a pediatric clinician in the primary care setting.

BMAI is adapted from the Provider Guide: Adolescent SBIRT Using the S2BI-CRAFFT Screening Tool, grounded in the stages of change model and motivational interviewing (MI). It consists of one or more brief sessions involving structured feedback, advice, and goal setting to help adolescents recognize links between substance use and health outcomes and develop personalized change plans. The intervention is face-to-face, delivered during routine or follow-up visits, and modeled after the brief negotiated interview. The first session lasts 10-30 minutes and includes six MI-based steps. This is followed by one or more additional brief MI sessions lasting 5-15 minutes where the patient's goals are reviewed, gains or barriers are addressed, and ongoing support is provided.

Smartphone App-delivered Mindfulness Training

In addition to BMAI, participants in the BMAI + MT arm will receive 8 weeks of smartphone-delivered mindfulness training using the Healthy Minds Program (HMP) app.

The HMP app provides self-guided, self-paced mindfulness and meditation training designed to improve psychological well-being, reduce stress/anxiety, and enhance self-regulation. It includes podcast-style teachings and guided meditations. The app features four modules-Awareness, Insight, Connection, and Purpose-based on neuroscience research. Each module offers 27 practices (5-30 minutes each). This study focuses on the Awareness and Insight modules, which teach breath and body awareness and emotion noting to support mindfulness in daily life. Participants will be asked to use the app 5-30 minutes per day, following 4 weeks of Awareness content, then 4 weeks of Insight. After 8 weeks, they will have open access to all modules and be encouraged to explore additional practices as they find helpful during follow-up.

Primary outcome measure

  • Alcohol Use (total standard drinks) in the past 30 days [ Time Frame: Baseline, 1, 3, 6, and 12 months ]
  • Acceptability of intervention (adolescent report) assessed by the Client Satisfaction Questionnaire-Patient Report [ Time Frame: Month 2 ]
  • Acceptability of intervention (caregiver report) assessed by the Client Satisfaction Questionnaire-Caregiver Report [ Time Frame: Month 2 ]
  • Acceptability of intervention (provider report) assessed by the Provider Satisfaction Questionnaire [ Time Frame: month 3, and month 12 ]
  • Intervention experiences, perspectives, and preferences (adolescent report) assessed by qualitative interview [ Time Frame: Month 2 ]
  • Intervention experiences, perspectives, and preferences (caregiver report) assessed by qualitative interview [ Time Frame: Month 2 ]
  • Intervention experiences, perspectives, and preferences (provider report) assessed by qualitative interview [ Time Frame: month 3, and month 12 ]
  • Implementation barriers and facilitators for SBIRT and BMAI (provider report) [ Time Frame: Baseline, month 3, and month 12 ]
  • Percentage of providers reporting barriers and facilitators (provider report) [ Time Frame: Baseline, month 3, and month 12 ]

Central Contacts and Locations

Central contacts

Christopher J Hammond, MD, PhD

(410) 550-0144chammo20@jhmi.edu

Gabrielle Newton, MPH

gnewton3@jh.edu

Locations

Harriet Lane Clinic

Recruiting

Baltimore, Maryland, United States, 21287

Johns Hopkins University Center for Adolescent and Young Adult Health

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Keywords

  • Alcohol use
  • Alcohol-related problems
  • Drug use
  • Adolescent
  • Motivational interviewing
  • Mindfulness
  • Mindfulness training
  • brief alcohol intervention
  • digital therapeutic intervention
  • SBIRT
  • PCORI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-09-16.