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

{ "Brief Motivational Interviewing and Mindfulness for Adolescent Alcohol Use", "This study is looking at ways to help adolescents (teenagers) who use alcohol. It compares two approaches: a brief motivational interviewing-based alcohol intervention (BMAI) delivered by a doctor or nurse, and BMAI combined with smartphone-delivered mindfulness training. The goal is to see which approach is more effective at reducing alcohol use. You might be able to join if you are 12-17 years old, receive care at Johns Hopkins Medical Institute, and have screened positive for moderate or high alcohol use risk. Researchers will measure how much alcohol is used over 12 months and how acceptable the interventions are to both adolescents and their caregivers.", "design": "This is a randomized study comparing two interventions in 1500 participants. It is observer-blinded, meaning some people involved in the study won't know which treatment you receive.", "commitments": "You would receive an intervention from a pediatric clinician, and potentially use a smartphone app for 8 weeks. Your alcohol use will be measured at the start, and then at 1, 3, 6, and 12 months.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for 12 months after starting the intervention to track alcohol use.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07059078

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

Recruiting
NAAges 12–17InterventionalTreatment
Johns Hopkins University
~1,500 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:Brief Motivational Interviewing-based Alcohol InterventionSmartphone App-delivered Mindfulness Training

At a glance

Recruiting sites
2 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Alcohol Use (total standard drinks) in the past 30 days
Measured over Baseline, 1, 3, 6, and 12 months
+8 more outcomes measured
Adolescent Alcohol Use
13 sites across 1 states
Maryland13
  • Christopher J Hammond, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
  • Hoover Adger, MD, MPH, MBA · STUDY_DIRECTOR · Johns Hopkins University

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Eligibility criteria

Inclusion

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

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).
  • Alcohol Use (total standard drinks) in the past 30 daysBaseline, 1, 3, 6, and 12 months

    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.

  • Acceptability of intervention (adolescent report) assessed by the Client Satisfaction Questionnaire-Patient ReportMonth 2

    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.

  • Acceptability of intervention (caregiver report) assessed by the Client Satisfaction Questionnaire-Caregiver ReportMonth 2

    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.

  • Acceptability of intervention (provider report) assessed by the Provider Satisfaction Questionnairemonth 3, and month 12

    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.

  • Intervention experiences, perspectives, and preferences (adolescent report) assessed by qualitative interviewMonth 2

    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.

  • Intervention experiences, perspectives, and preferences (caregiver report) assessed by qualitative interviewMonth 2

    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.

  • Intervention experiences, perspectives, and preferences (provider report) assessed by qualitative interviewmonth 3, and month 12

    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.

  • Implementation barriers and facilitators for SBIRT and BMAI (provider report)Baseline, month 3, and month 12

    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.

  • Percentage of providers reporting barriers and facilitators (provider report)Baseline, month 3, and month 12

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