ACTIVE_NOT_RECRUITING

Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Computer-facilitated Screening and Brief Intervention (cSBI) in Pediatric Primary Care to Reduce Underage Drinking: a Large, Multi-site Randomized Trial

Quick Facts

Study Start:2023-03-10
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04450966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Ages 14-17
  2. * Presenting for well-visit with participating clinician
  3. * Reports any lifetime alcohol use
  4. * If no lifetime alcohol use, reports riding with a driver under the influence in the past 12 months
  5. * Has own cell phone and is willing to share cell phone number before their scheduled visit
  6. * Completes required pre-visit activity/activities before well visit
  1. * Youth in foster care
  2. * Unable to read and communicate in English
  3. * Unable to complete follow-ups
  4. * Currently receiving treatment from specialty clinician(s) for a substance use concern
  5. * Deemed by their clinician to be inappropriate for study participation due to neurodevelopmental delays or medical/emotional concerns

Contacts and Locations

Principal Investigator

Sion K Harris, PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Lydia A Shrier, MD, MPH
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

American Academy of Pediatrics
Itasca, Illinois, 60143
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Sion K Harris, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital
  • Lydia A Shrier, MD, MPH, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-10
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-03-10
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

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