Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care
NCT ID: NCT07059078
Last Updated: 2025-09-16
Study Results
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Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2025-09-03
2030-09-30
Brief Summary
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Detailed Description
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The project is a pragmatic effectiveness and implementation study that employs a superiority, two-arm, randomized, prospective, observer-blinded, controlled trial design to compare the effectiveness of BMAI alone vs. BMAI augmented with adjunctive smartphone app-delivered MT on alcohol outcomes over a one-year follow-up period. The investigators will use the well-established standard BMAI adapted from the Provider Guide: Adolescent SBIRT Using the Screening to Brief Intervention Car, Relax, Alone, Forget, Friends, Trouble (S2BI-CRAFFT) Screening Tool, an evidence-based brief intervention for alcohol use in youth, and the widely disseminated Healthy Minds Program (HMP) smartphone meditation/mindfulness app which is freely available, science-based, and has shown feasibility and efficacy for reducing stress in youth populations. These interventions which combine elements of face-to-face +/- digital delivery and MI +/- MT will be tested in PPC clinics throughout the Johns Hopkins Medical Institute (JHMI) healthcare network which primarily serves racially/ethnically diverse population of urban and suburban youth in the greater Baltimore/Washington region that has a high proportion of minoritized youth.
The project seeks to answer the following three research questions:
Comparative effectiveness outcomes: What is the relative effectiveness of face-to-face clinician-administered BMAI with vs. without adjunctive app-delivered MT with the HMP app for alcohol using youth in PPC settings? Does supplementing clinician-administered BMAI with app-delivered MT result in superior outcomes in the form of reduced alcohol use and problems for this population or subgroups of the population?
Implementation outcomes: What are the patient and stakeholder perspectives, experiences, and preferences related to delivering BAI with these different components? What are the barriers and facilitators to delivering these BAI in PPC settings and for the diverse patient population served?
Heterogeneity of treatment effect (HTE) outcomes: How do baseline factors such as clinical severity, comorbid psychiatric symptoms and conditions, Socio-economic status (SES), sex, race, ethnicity, caregiver involvement, treatment preference, organization and clinical site readiness, and level of SBIRT integration at PPC clinic sites moderate outcomes across comparator interventions? How do changes in factors that may be mechanism of behavioral change (MOBC) for the different interventions (e.g. 'intrinsic' motivation to quit/reduce drinking, self-efficacy, and goal commitment for MI and mindfulness, anxiety, depression, impulsivity, and self-regulation for MT) and degree of engagement with intervention components (e.g., no. of sessions attended, time spent and no. of MT exercises completed, application of mindfulness in real-life settings) mediate outcomes across comparator interventions? Which patient subgroups benefit the most from which specific mindfulness and motivational BAI components?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
12 Years
17 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Christopher J Hammond, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Hoover Adger, MD, MPH, MBA
Role: STUDY_DIRECTOR
Johns Hopkins University
Locations
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Johns Hopkins Community Physicians, Remington
Baltimore, Maryland, United States
Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56)
Baltimore, Maryland, United States
Johns Hopkins Community Physicians, Canton Crossing
Baltimore, Maryland, United States
Harriet Lane Clinic
Baltimore, Maryland, United States
Johns Hopkins University Center for Adolescent and Young Adult Health
Baltimore, Maryland, United States
Johns Hopkins Community Physicians, Water's Edge
Belcamp, Maryland, United States
Johns Hopkins Community Physicians, Bowie
Bowie, Maryland, United States
Johns Hopkins Community Physicians, Howard County Pediatrics
Columbia, Maryland, United States
Johns Hopkins Community Physicians, Glen Burnie
Glen Burnie, Maryland, United States
Johns Hopkins Community Physicians, Hagerstown
Hagerstown, Maryland, United States
Johns Hopkins Community Physicians, White Marsh Pediatrics
Nottingham, Maryland, United States
Johns Hopkins Community Physicians, Odenton Medical
Odenton, Maryland, United States
Johns Hopkins Community Physicians, Rockville Pediatrics
Rockville, Maryland, United States
Countries
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Central Contacts
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Other Identifiers
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IRB00452272
Identifier Type: -
Identifier Source: org_study_id
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