Brief Motivational Interviewing +/- Mindfulness Training for Adolescent Alcohol Use in Pediatric Primary Care

NCT07059078 | Recruiting DMC

• 1 other identifier: IRB00452272
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 13

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Alcohol Use (total standard drinks) in the past 30 days

  Alcohol use (total standard drinks) in the past 30 days, measured via Timeline Follow Back (TLFB) calendar method at five time points (baseline and 1, 3, 6, and 12 months) over a one year follow-up period, compared between BMAI and BMAI + MT groups.

  Baseline, 1, 3, 6, and 12 months

• Acceptability of intervention (adolescent report) assessed by the Client Satisfaction Questionnaire-Patient Report

  Adolescent reported acceptability of BMAI and MT intervention components will be assessed via the Client Satisfaction Questionnaire-Patient Report (CSQ-Patient Report) collected at month 2. CSQ Patient Report scale ranges from 0 to 32 with higher scores indicating greater satisfaction with the intervention.

  Month 2

• Acceptability of intervention (caregiver report) assessed by the Client Satisfaction Questionnaire-Caregiver Report

  Caregiver reported acceptability of BMAI and MT components will be assessed via the Client Satisfaction Questionnaire-Caregiver Report (CSQ-Caregiver Report) at month 2. CSQ Caregiver Report scale ranges from 0 to 32 with higher scores indicating greater satisfaction with the intervention.

  Month 2

• Acceptability of intervention (provider report) assessed by the Provider Satisfaction Questionnaire

  Provider reported acceptability of BMAI and MT components will be assessed via the Provider Satisfaction Questionnaire (PSQ), an adapted form of the Client Satisfaction Questionnaire at month 3 and month 12. PSQ scale ranges from 0 to 32 with higher scores indicating greater satisfaction with the intervention.

  month 3, and month 12

• Intervention experiences, perspectives, and preferences (adolescent report) assessed by qualitative interview

  Adolescent reported personal experiences, perspectives, and preferences related to BMAI and MT components, assessed via qualitative semi-structured interviews obtained from adolescent participants at 2 months. Themes and sub-themes using a grounded theory, inductive approach will be used to identify patient experience with the study arms and interventions.

  Month 2

• Intervention experiences, perspectives, and preferences (caregiver report) assessed by qualitative interview

  Caregiver reported personal experiences, perspectives, and preferences related to BMAI and MT components, assessed via qualitative semi-structured interviews obtained from caregiver's of adolescent participants at 2 months. Themes and sub-themes using a grounded theory, inductive approach will be used to identify patient experience with the study arms and interventions.

  Month 2

• Intervention experiences, perspectives, and preferences (provider report) assessed by qualitative interview

  Provider reported personal experiences, perspectives, and preferences related to BMAI and MT components, assessed via qualitative semi-structured interviews obtained from pediatric primary care (PPC) providers obtained at months 3 and 12. Themes and sub-themes using a grounded theory, inductive approach will be used to identify patient experience with the study arms and interventions.

  month 3, and month 12

• Implementation barriers and facilitators for SBIRT and BMAI (provider report)

  Provider reported barriers and facilitators related to implementation of BMAI intervention and screening brief intervention and referral to treatment (SBIRT) framework, assessed using items about perceived barriers and facilitators from the SBIRT provider questionnaire obtained from PPC clinicians at baseline, month 3, and month 12. The SBIRT provider questionnaire includes questions on substance use screening, brief intervention, and SBIRT practices and perceived barriers and facilitators to screening, providing brief interventions, and implementing SBIRT in their PPC office setting. Number of barriers, number of facilitators, and percentage of providers reporting specific types of barriers and facilitators will be serve as the implementation outcome.

  Baseline, month 3, and month 12

• Percentage of providers reporting barriers and facilitators (provider report)

  Percentage of providers reporting specific types of barriers and facilitators will serve as the implementation outcome.

  Baseline, month 3, and month 12

Secondary Outcomes (9)

• Heavy episodic drinking (HED) days in the past 30 days

  Baseline, 1, 3, 6, and 12 months

• Cannabis use days in the past 30 days

  Baseline, 1, 3, 6, and 12 months

• Tobacco/nicotine use days in the past 30 days

  Baseline, 1, 3, 6, and 12 months

• Other drug use days in the past 30 days

  Baseline, 1, 3, 6, and 12 months

• Alcohol-related problem severity assessed by the Alcohol Use Disorders Identification Test

  Baseline, 1, 3, 6, and 12 months

Other Outcomes (12)

• Drinking to Cope (DTC) with negative emotions assessed by the 5 item Coping Subscale

  Baseline, 1, 3, 6, and 12 months

• Alcohol Cravings assessed by the 5 item Penn Alcohol Craving scale

  Baseline, 1, 3, 6, and 12 months

• Dispositional Mindfulness assessed by the10 item Child and Adolescent Mindfulness Measure

  Baseline, 1, 3, 6, and 12 months

Study Arms (2)

Brief Motivational interviewing-based Alcohol Intervention (BMAI)

ACTIVE COMPARATOR

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.

Behavioral: Brief Motivational Interviewing-based Alcohol Intervention

BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT)

ACTIVE COMPARATOR

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.

Behavioral: Brief Motivational Interviewing-based Alcohol Intervention; Behavioral: Smartphone App-delivered Mindfulness Training

Interventions

Brief Motivational Interviewing-based Alcohol Intervention BEHAVIORAL

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); Brief Motivational interviewing-based Alcohol Intervention (BMAI)

Smartphone App-delivered Mindfulness Training BEHAVIORAL

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.

BMAI + Smartphone app-delivered Mindfulness Training (BMAI + MT)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (13)

Johns Hopkins Community Physicians, Remington

Baltimore, Maryland, 21211, United States

NOT YET RECRUITING

Johns Hopkins Bayview Pediatrics (Baltimore Medical System, Yard 56)

Baltimore, Maryland, 21224, United States

NOT YET RECRUITING

Johns Hopkins Community Physicians, Canton Crossing

Baltimore, Maryland, 21224, United States

NOT YET RECRUITING

Harriet Lane Clinic

Baltimore, Maryland, 21287, United States

RECRUITING

Johns Hopkins University Center for Adolescent and Young Adult Health

Baltimore, Maryland, 21287, United States

RECRUITING

Johns Hopkins Community Physicians, Water's Edge

Belcamp, Maryland, 21017, United States

NOT YET RECRUITING

Johns Hopkins Community Physicians, Bowie

Bowie, Maryland, 20715, United States

NOT YET RECRUITING

Johns Hopkins Community Physicians, Howard County Pediatrics

Columbia, Maryland, 21046, United States

NOT YET RECRUITING

Johns Hopkins Community Physicians, Glen Burnie

Glen Burnie, Maryland, 20161, United States

NOT YET RECRUITING

Johns Hopkins Community Physicians, Hagerstown

Hagerstown, Maryland, 21742, United States

NOT YET RECRUITING

Johns Hopkins Community Physicians, White Marsh Pediatrics

Nottingham, Maryland, 21236, United States

NOT YET RECRUITING

Johns Hopkins Community Physicians, Odenton Medical

Odenton, Maryland, 21113, United States

NOT YET RECRUITING

Johns Hopkins Community Physicians, Rockville Pediatrics

Rockville, Maryland, 20854, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Underage Drinking; Alcohol Drinking

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

Adolescent Behavior; Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Study Officials

• Christopher J Hammond, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Hoover Adger, MD, MPH, MBA

  Johns Hopkins University

  STUDY DIRECTOR

Central Study Contacts

Christopher J Hammond, MD, PhD

CONTACT

(410) 550-0144; chammo20@jhmi.edu

Gabrielle Newton, MPH

CONTACT

gnewton3@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Research Assistant who is collecting patient data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)