Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care

NCT ID: NCT04450966

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2026-03-31

Brief 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.

Detailed Description

Alcohol use disorders frequently have a pediatric origin. Pediatric primary care offices, where the majority of adolescents receive health care, are a promising venue for early identification and intervention through universal screening and brief counseling. However, while the U.S. Preventive Services Task Force recommends primary care-based alcohol screening and brief intervention for adults, it found insufficient evidence to recommend it for adolescents.

The goal of the proposed study is to address this evidence gap by testing the effectiveness of a promising computer-facilitated Screening and Brief Intervention (cSBI) system for delivery by pediatric primary care clinicians to adolescents at well-visits. This cluster-randomized controlled trial will be conducted in the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care practice-based research network. PROS has demonstrated success in >30 years of practice-based research, with >600 practices participating in recent studies. Drawing on more than 15 years of our prior research on adolescent alcohol screening and brief counseling in primary care offices, the cSBI system was developed to provide a time-efficient and feasible way for pediatric practices to improve both the frequency and quality of alcohol screening and counseling. cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, 2) 10 interactive psychoeducational pages for the adolescent on substance use health risks, 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling, and 4) clinician training materials and protocol.

In a New England-based pilot study, we found that, compared to usual care (UC), the cSBI approach: 1) increased patient receipt of alcohol-related counseling during well-visits; 2) improved patients' ratings of the quality of their clinician encounter; and 3) among those who reported past-year use at baseline (n=192), was associated with a 34% lower risk of a heavy episodic drinking episode during 12 months follow-up. cSBI also reduced risk of riding with an impaired driver, a major safety risk associated with alcohol, by 42% among those with prior riding risk.

A larger RCT of this approach, which employs an adequately-powered sample and tests generalizability of effects beyond New England, is needed. We will randomize >30 pediatric primary care clinicians in ~10 practices nationwide to deliver UC or cSBI (1:1) to their eligible and assenting 14- to 17-year-old patients arriving for well-visits. Our aims are to test cSBI's effect on adolescent patients' heavy episodic drinking, and on riding with an impaired driver/driving while impaired, during 12 months follow-up. We hypothesize that, compared to adolescent patients receiving usual care, those receiving cSBI will have lower rates of reporting heavy episodic drinking and riding with an impaired driver/driving while impaired during the study follow-up period.

Conditions

Heavy Drinking; Driving Under the Influence; Riding With Driver Under the Influence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Computer-facilitated screening and brief intervention

Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention.

Group Type: EXPERIMENTAL

Computer-facilitated Screening and Brief Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

cSBI

Eligibility Criteria

Inclusion Criteria

• Ages 14-17
• Presenting for well-visit with participating clinician
• Reports any lifetime alcohol use
• If no lifetime alcohol use, reports riding with a driver under the influence in the past 12 months
• Has own cell phone and is willing to share cell phone number before their scheduled visit
• Completes required pre-visit activity/activities before well visit

Exclusion Criteria

• Youth in foster care
• Unable to read and communicate in English
• Unable to complete follow-ups
• Currently receiving treatment from specialty clinician(s) for a substance use concern
• Deemed by their clinician to be inappropriate for study participation due to neurodevelopmental delays or medical/emotional concerns

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Academy of Pediatrics

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sion Kim Harris

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sion K Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Lydia A Shrier, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

American Academy of Pediatrics

Itasca, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

Shrier LA, O'Connell MM, Torres A, Shone LP, Fiks AG, Plumb JA, Maturo JL, McCaskill NH, Harris D, Burke PJ, Felt T, Murphy ML, Sherritt L, Harris SK. Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 26;13:e55039. doi: 10.2196/55039.

Reference Type: DERIVED

PMID: 38530346 (View on PubMed)

Other Identifiers

NIAAA_1R01AA027253-01A1

Identifier Type: -

Identifier Source: org_study_id