Guiding Good Choices for Health — GGC4H  

Adolescent Substance Use Clinical Trial

Official title: A Pragmatic Trial of Parent-focused Prevention in Pediatric Primary Care

Status Recruiting

Clinical Trial Summary

This study evaluates the feasibility and effectiveness of implementing Guiding Good Choices (GGC), an anticipatory guidance curriculum for parents of early adolescents, in three large, integrated healthcare systems. By "parents," the study team is referring here and throughout this protocol to those adults who are the primary caregivers of children, irrespective of their biological relationship to the child. In prior community trials, GGC has been shown to prevent adolescent substance use (alcohol, tobacco, and marijuana), depressive symptoms, and delinquent behavior. This study offers an opportunity to test GGC effectiveness with respect to improving adolescent behavioral health outcomes when implemented at scale in pediatric primary care within a pragmatic trial.

Clinical Trial Description

Fifty percent of all adolescents will use some form of illicit drugs before the end of high school, 20-25% will meet criteria for depression, and many others will engage in health compromising behaviors like delinquency and violence-with consequences for their long-term health. Evidence-based parenting interventions shown to prevent these behavioral health concerns could improve adolescent health trajectories if implemented widely in pediatric primary care. The American Academy of Pediatrics' Bright Futures recommends that pediatricians offer developmentally tailored anticipatory guidance to all parents to support their children's healthy development, but programs providing guidance are not offered universally. This study tests the feasibility and effectiveness of implementing Guiding Good Choices, a universal, evidence-based anticipatory guidance curriculum for parents of early adolescents, in three large, integrated healthcare systems serving socioeconomically diverse families. This intervention reduced adolescent alcohol, tobacco and marijuana use, depression, and delinquent behavior in two previous randomized controlled trials. It also strengthened parenting practices and parent-adolescent relationship quality, both broadly protective against behavioral health concerns. Guiding Good Choices has the capacity to achieve population-level impact on adolescent health if made widely available through pediatric primary care. Parents trust pediatricians' advice regarding their children's well-being, and current research with socioeconomically diverse groups suggests that they are eager to participate in family-focused programs offered in primary care clinics. Building on this body of research, the investigative team, in close cooperation with the NIH Healthcare Systems Research Collaboratory and healthcare systems partners, will conduct a cluster-randomized trial of Guiding Good Choices in 72 pediatric primary care practices, across three heterogeneous health care systems (HCS). Half of the pediatricians will be randomly assigned to the intervention arm, and half will serve as usual care controls. Using a workflow that is easy to adopt, implement and maintain, at each adolescent's 12-year-old well visit, primary care pediatricians will recommend that parents enroll in the intervention. Over 3,600 families are expected to be recruited into the trial prior to beginning intervention with them. Half will be recruited in year 2 and half in year 3. The team will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance, or RE-AIM, framework to test implementation outcomes and effectiveness, including hypothesized reductions in the study's primary outcome of substance use initiation, several secondary behavioral health problems (e.g., substance use frequency, mood symptoms and diagnoses, delinquency) and some exploratory outcomes (e.g., emergency department and inpatient service utilization) among adolescents in the intervention arm compared to those in the control arm. Data from an Adolescent Behavioral Health Survey and electronic healthcare records will be used to monitor outcomes up to 3 years post intervention. The feasibility and sustainability of implementing the intervention in each HCS, including health economic evaluation to understand costs in relation to value gained, will also be assessed. ;

Related Conditions & MeSH terms

• Adolescent Substance Use
• Substance-Related Disorders

• NCT number: NCT04040153
• Study type: Interventional
• Source: University of Washington
• Contact: Diane Christiansen
• Phone: 206-685-9068
• Email: dianech@uw.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: September 30, 2019
• Completion date: May 31, 2023