Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care
NCT04450966 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 406
Last updated 2025-07-25
Summary
Our goal is to conduct a large multi-site randomized controlled trial (RCT) of a promising computer-facilitated Screening and clinician Brief Intervention (cSBI) system designed for delivery by pediatric primary care clinicians and aimed at reducing unhealthy alcohol use and related riding/driving safety risk among adolescent patients. Our setting will be the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care research network, with \>600 U.S. primary care practices having participated in recent studies. This trial addresses the evidence gap identified in the latest U.S. Preventive Services Task Force review of alcohol screening and brief counseling interventions among adolescents, and, if shown effective, the cSBI system could be widely disseminated via AAP's existing education, teaching, and advocacy platforms to its 67,000 pediatrician members, thereby greatly increasing the potential for population-level impact of alcohol screening and brief intervention for U.S. adolescents.
Conditions
- Heavy Drinking
- Driving Under the Influence
- Riding With Driver Under the Influence
Interventions
- BEHAVIORAL
-
Computer-facilitated Screening and Brief Intervention
cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, immediately followed by 2) computer-delivered brief psychoeducation on the health risks of substance use to prime patients for the clinician encounter, and 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling during the visit.
Sponsors & Collaborators
-
American Academy of Pediatrics
collaborator OTHER -
Children's Hospital of Philadelphia
collaborator OTHER -
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH - lead OTHER
Principal Investigators
-
Sion K Harris, PhD · Boston Children's Hospital
-
Lydia A Shrier, MD, MPH · Boston Children's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-03-10
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- United States
Study Locations
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