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.
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
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
Parallel
Brief Motivational Interviewing-based Alcohol Intervention
BehavioralParticipants 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
BehavioralIn 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.
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.
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.
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.
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.
Heavy episodic drinking (HED) days in the past 30 days
Heavy episodic drinking days in the past 30 days (defined as number of days in the past 30 days where participant consumed \> 5 drinks for male and \> 4 drinks for female participants in single session), measured via 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.
Cannabis use days in the past 30 days
Cannabis/ tetrahydrocannabinol (THC) product use days in the past 30 days, measured via 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.
Tobacco/nicotine use days in the past 30 days
Tobacco/nicotine product use days in the past 30 days, measured via 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.
Other drug use days in the past 30 days
Other drug use days in the past 30 days (defined as number of days in the past 30 days where drugs other than alcohol, cannabis, tobacco/nicotine were used), measured via 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.
Drinking to Cope (DTC) with negative emotions assessed by the 5 item Coping Subscale
Drinking to Cope (DTC) with negative emotions assessed with the 5-item Coping Subscale of the Drinking Motives Questionnaire-Revised (DMQ-R) 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. The DTC subscale ranges from 5 to 25 with higher scores indicating greater coping motives for alcohol use.
Alcohol Cravings assessed by the 5 item Penn Alcohol Craving scale
Alcohol cravings assessed with the 5-Item Penn Alcohol Craving Scale (PACS) 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. The PACS scale ranges from 0 to 30 with higher scores indicating greater cravings for alcohol use in the past week.
Dispositional Mindfulness assessed by the10 item Child and Adolescent Mindfulness Measure
Dispositional Mindfulness assessed with the 10-Item Child and Adolescent Mindfulness Measure (CAAM), 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. The CAAM scale ranges from 0 to 40 with higher scores indicating greater levels of dispositional mindfulness. Dispositional mindfulness at baseline and change in dispositional mindfulness during/following treatment will be examined as potential moderators and mediators of BMAI vs. BMAI + MT intervention effects on alcohol outcomes, respectively.
Mindfulness Practice assessed by Applied Mindfulness Process Scale
Mindfulness practice (defined as use of mindfulness skills in day-to-day life) assessed with the Applied Mindfulness Process Scale (AMPS), 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. The AMPS scale ranges from 0 to 60 with higher scores indicating greater application of mindfulness skills in daily life coinciding with mindfulness practice. Mindfulness practice will be examined as a potential mediator of BMAI vs. BMAI + MT intervention effects on alcohol outcomes.
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Johns Hopkins University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
