Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care

NCT04450966 | Active Not Recruiting DMC

• 1 other identifier: NIAAA_1R01AA027253-01A1
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Any heavy episodic drinking day during past 3 months

  Defined using the NIAAA Youth Guide age/gender-specific number of drinks.

  3 months follow-up

• Any heavy episodic drinking day during past 3 months

  Defined using the NIAAA Youth Guide age/gender-specific number of drinks.

  6 months follow-up

• Any heavy episodic drinking day during past 3 months

  Defined using the NIAAA Youth Guide age/gender-specific number of drinks.

  9 months follow-up

• Any heavy episodic drinking day during past 3 months

  Defined using the NIAAA Youth Guide age/gender-specific number of drinks.

  12 months follow-up

• Time to first day of heavy episodic drinking during 12 month follow-up period

  Defined using the NIAAA Youth Guide age/gender- specific number of drinks.

  1-12 months follow-up

Secondary Outcomes (4)

• Any riding/driving risk

  3 months follow-up

• Any riding/driving risk

  6 months follow-up

• Any riding/driving risk

  9 months follow-up

• Any riding/driving risk

  12 months follow-up

Other Outcomes (16)

• Alcohol-related problems or negative consequences experienced since post-visit survey

  6 months follow-up

• Alcohol-related problems or negative consequences experienced since post-visit survey

  12 months follow-up

• Past 3 months alcohol use days

  3 months follow-up

Study Arms (2)

Usual Care

NO INTERVENTION

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

Computer-facilitated screening and brief intervention

EXPERIMENTAL

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

Behavioral: Computer-facilitated Screening and Brief Intervention

Interventions

Computer-facilitated Screening and Brief Intervention 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.

Also known as: cSBI

Computer-facilitated screening and brief intervention

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• American Academy of Pediatrics: collaborator
• Children's Hospital of Philadelphia: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (3)

American Academy of Pediatrics

Itasca, Illinois, 60143, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 38530346 DERIVED

MeSH Terms

Conditions

Driving Under the Influence

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior; Dangerous Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sion K Harris, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Lydia A Shrier, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Multi-site cluster-randomized parallel groups trial. \>30 pediatric primary care clinicians will be recruited from \~10 practices and will be allocated 1:1 to either deliver usual care or the cSBI intervention to their participating patients ages 14-17 years-old.

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: March 10, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 12 months of study completion.
• Access Criteria: We will share the dataset with external investigators when a data use agreement (DUA) is executed between Boston Children's Hospital and the institution of the person making the request. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project and schedule for data destruction.

Locations

US (3)