Computer-facilitated Screening and Brief Intervention in Pediatric Primary Care to Reduce Underage Drinking: Protocol and Analysis Plan for the ASPIRE Multi-site Cluster Randomized Trial (Preprint)

Abstract

Alcohol and other substance use disorders usually begin with substance use in adolescence. Pediatric primary care offices, where most adolescents receive health care, are a promising venue for early identification of alcohol and other drug use and for brief intervention to prevent associated problems and the development of substance use disorder.

This study is testing the effectiveness of a computer-facilitated screening and brief intervention system (cSBI; the “CRAFFT Interactive System” or CRAFFT-IS) on heavy episodic drinking, riding with a substance-impaired driver, or driving while substance-impaired among 14- to 17-year-olds presenting for a well visit at pediatric primary care practices.

We are conducting a cluster-randomized controlled trial of the CRAFFT-IS versus Usual Care (UC). We are recruiting up to 40 primary care clinicians (MD, DO, NP, PA) at up to 20 pediatric primary care practices within the American Academy of Pediatrics Pediatric Research in Office Settings (AAP PROS) network. Clinicians are randomized 1:1 within practice to implement CRAFFT-IS or UC with a target sample size of 1,300 adolescent patients aged 14 to 17 years. Prior to the start of enrollment in the practice, intervention clinicians complete self-paced online learning modules, trainer-led live sessions, and mock sessions to establish baseline competency with intervention counseling. Adolescent patients and their parents/guardians receive mailed recruitment materials that invite adolescents to complete an eligibility survey. Eligible and interested adolescents provide informed assent (parental permission requirement has been waived). Prior to their well visit, enrolled adolescents seeing intervention clinicians complete a self-administered online CRAFFT screening questionnaire and view brief psychoeducational content illustrating substance use-associated health risks. During the visit, intervention clinicians access a computerized summary of the patient’s screening results and a tailored counseling script to deliver a motivational interviewing-based brief intervention. All participants complete study assessments pre-visit, immediately post-visit, and monthly for 12 months follow-up. Primary outcomes include past-90-day heavy episodic drinking and riding with a substance-impaired driver at 3-, 6-, 9-, and 12-months follow-up. Multiple logistic regression modeling with generalized estimating equations and mixed-effects modeling will be used in outcomes analyses. Exploratory aims include examining other substance use outcomes (e.g., cannabis, nicotine vaping), potential mediators of intervention effect (e.g., self-efficacy not to drink), and effect moderation by baseline risk level and sociodemographic characteristics.

The first practice and clinicians were enrolled in August 2022. Recruitment is expected to continue until late 2024 and data collection will be completed in 2025.

Findings from this study will inform screening and brief intervention efforts in pediatric primary care and have implications for the reduction of alcohol-related morbidity and mortality in adolescents.

This trial is registered at clinicaltrials.gov (NCT04450966).