Clinical trial NCT04040153: Guiding Good Choices for Health
Official title: A Pragmatic Trial of Parent-focused Prevention in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adolescent Substance Use
Keywords: Substance
Alcohol
Tobacco
E-cigarette
Marijuana
Adolescent
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: Henry Ford Health System
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-07-31
Enrollment: 3636
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster-randomized, pragmatic trial, with randomization at the pediatrician level and observation of intervention effects at the adolescent patient level. Using a constrained randomization approach, the study team will randomize 72 pediatricians, 24 in each healthcare system (36 intervention, 36 control), to either Intervention (GGC) or Control arms. Constraints (pediatrician panel size, pediatrician gender, and a pediatrician panel-level indicator of socioeconomic status) will ensure balance across intervention and control arms after randomization, reduce potential variability in effect sizes among pediatricians, and increase power. Patients and families are not aware of their pediatrician's assignment. Adolescents born between 6.1.2007 and 5.31.2009 and empaneled with the 72 pediatricians will participate in the study if their parent/legal guardian consents. GGC will be recommended to all parents/legal guardians of adolescents in the intervention arm.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Adolescent is empaneled with an intervention or control arm pediatrician in a participating clinic in one of the three healthcare systems (Kaiser Permanente Northern California, Kaiser Permanente Colorado, Henry Ford Health System)
* Adolescent is 12.00 - 12.99 years during intervention period (born between 6.1.2007 and 5.31.2009), which means that some adolescents may be 11 at baseline assessment

Exclusion Criteria:

* An intellectual, developmental or cognitive impairment that would prevent parent or adolescent from understanding the purpose of the study and measures, or, for those in the intervention arm, the Guiding Good Choices curriculum. For adolescents, exclusions will be operationalized by specific ICD-9/ICD-10 diagnostic codes documented in the EHR. For parents, impairment will be identified at the discretion of the pediatrician referring GGC or by study team members making study recruitment and intervention enrollment calls to parents.
* Parent's primary language is not English, as documented in the EHR or identified at study recruitment call

Primary outcomes:
measure: Incidence of adolescent substance use initiation (alcohol, cigarettes, e-cigarettes, and/or marijuana) through last follow-up
timeFrame: Final follow-up in year 5 of study
Secondary outcomes:
measure: Prevalence of any past-year substance use (alcohol, cigarettes, e-cigarettes, marijuana) by adolescents at final follow-up
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Prevalence of any past-30-day substance use (alcohol, cigarettes, e-cigarettes, marijuana) by adolescents at final follow-up
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Incidence of antisocial behavior among adolescents through final follow-up
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Mean adolescent depression symptom score at final follow-up
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Mean adolescent anxiety symptom score at final follow-up
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Prevalence of past-year antisocial behavior among adolescents at final follow-up
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
Other outcomes:
measure: Prevalence of substance use disorders among adolescents through final extraction
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Prevalence of any psychiatric disorder (depression, anxiety, or conduct disorder) among adolescents through final extraction
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Prevalence of specialty substance use treatment services utilization by adolescents through final extraction
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Prevalence of specialty mental health services utilization by adolescents through final extraction
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Prevalence of emergency department utilization by adolescents through final extraction
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
measure: Prevalence of inpatient hospitalization utilization by adolescents through final extraction
timeFrame: 3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Aurora
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: University of Washington
name: Margaret R Kuklinski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Richard F Catalano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Stacy A Sterling, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheuer H, Kuklinski MR, Sterling SA, Catalano RF, Beck A, Braciszewski J, Boggs J, Hawkins JD, Loree AM, Weisner C, Carey S, Elsiss F, Morse E, Negusse R, Jessen A, Kline-Simon A, Oesterle S, Quesenberry C, Sofrygin O, Yoon T. Parent-focused prevention of adolescent health risk behavior: Study protocol for a multisite cluster-randomized trial implemented in pediatric primary care. Contemp Clin Trials. 2022 Jan;112:106621. doi: 10.1016/j.cct.2021.106621. Epub 2021 Nov 14.