Study protocol for a patient-centered hybrid type 1 effectiveness-implementation randomized controlled trial evaluating caregiver involvement in primary care-based brief interventions for adolescents with mild alcohol use disorder

INTRODUCTION: Primary care is a useful setting for identifying and delivering brief interventions to adolescents with mild alcohol use disorders (AUD). High-quality evidence suggests brief interventions that incorporate motivational interviewing (MI) and basic cognitive behavioral therapy (CBT) skills help adolescents reduce substance use. Caregiver involvement in interventions for mild AUD may improve outcomes. However, when and how to involve caregivers in primary care-based interventions for adolescents with mild AUD remains unclear. METHODS: In this patient-centered hybrid type 1 effectiveness-implementation randomized controlled trial, adolescents with mild AUD receiving an individual skill-building intervention (Teen Intervene, TI) in primary care will be randomized to one of three conditions: 1) no caregiver involvement; 2) a single, live caregiver session; and 3) an online, self-paced caregiver program. The primary aim is to compare the effectiveness of TI conditions (i.e., no caregiver involvement vs. caregiver session vs. online caregiver component) in reducing alcohol use in adolescents. The second study aim is to identify youth and family factors associated with intervention response vs. non-response in each treatment condition, such as baseline substance use intensity, youth and caregiver perceptions of alcohol/substance use risk, youth personality factors, and caregiving practices. CONCLUSION: Findings from this study will help support decisions and eventual cost-benefit analyses about which programs to offer to different patients. When interventions are matched appropriately to patient needs at scale, possible long-term benefits include improved outcomes among the approximately 750,000 U.S. adolescents with mild AUD.