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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450966 on ClinicalTrials.gov