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

Johns Hopkins University

Status: Enrolling

Conditions: Adolescent Alcohol Use

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07059078

IRB00452272

Details and patient eligibility

About

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.

Full description

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?

Enrollment: 1,500 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,500 participants in 2 patient groups

Brief Motivational interviewing-based Alcohol Intervention (BMAI)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Brief Motivational Interviewing-based Alcohol Intervention

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

Active Comparator group

Description:

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.

Treatment:

Behavioral: Brief Motivational Interviewing-based Alcohol Intervention

Behavioral: Smartphone App-delivered Mindfulness Training