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

PCORI Comparative Effectiveness Study: Comparative Effectiveness of Brief Motivational Interviewing +/- Adjunctive Smartphone App-delivered Mindfulness Training for Reducing Alcohol Use in Adolescents in Pediatric Primary Care Settings

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.

Alcohol use is prevalent in U.S. adolescents and contributes to adverse health outcomes in this population. Over the past decade, screening, brief intervention, and referral to treatment (SBIRT) has become the primary model for addressing alcohol problems in US adolescents in pediatric healthcare settings. However, uptake and fidelity of SBIRT vary widely in real world settings and barriers to implementing effective brief interventions are common. Standard brief alcohol interventions (BAIs) have predominantly applied motivational interviewing (MI) and feedback techniques to target alcohol and other drug use in adolescents. There is a need to expand BAI options for youth who do not respond to these standard approaches. One intervention approach with growing societal interest and emerging evidence for efficacy in adolescent alcohol and other drug use is mindfulness training (MT). This project will compare two types of evidenced-based care for alcohol use in adolescents recruited from 13 pediatric primary care clinics in a regional health system. The interventions will be a patient-centered brief motivational interviewing-based alcohol intervention (BMAI) delivered by PPC clinicians as part of routine care, and BMAI in combination with smartphone app-delivered mindfulness training (BMAI+ MT).

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?

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).