Guiding Good Choices for Health

NCT04040153 | Active Not Recruiting DMC

• 2 other identifiers: SITE000000374UH3AT009838
• Study Type: interventional
• Target: 3,636
• Locations: 1 country
• Sites: 3

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.

Conditions

Adolescent Substance Use

Keywords

Substance; Alcohol; Tobacco; E-cigarette; Marijuana; Adolescent

Outcome Measures

Primary Outcomes (1)

• Incidence of adolescent substance use initiation (alcohol, cigarettes, e-cigarettes, and/or marijuana) through last follow-up

  Substance use initiation by the study's endpoint will be operationalized by a dichotomous indicator of ever use (yes/no) of alcohol, cigarettes, e-cigarettes, or marijuana formed from adolescent prospective self-reports about their lifetime use of these substances in each data collection wave. Substances will be assessed by separate items, e.g., "Have you ever used marijuana (by used we mean smoked, vaped, eaten, etc.)," "Have you ever used an e-cigarette or vaped ("Juul," "e-hookah," etc.)?" Lifetime use by last follow-up will be indicated by reported use of any of the substances in any wave. Lack of use will be indicated by no reported use of any of the substances in all waves.

  Final follow-up in year 5 of study

Secondary Outcomes (6)

• Prevalence of any past-year substance use (alcohol, cigarettes, e-cigarettes, marijuana) by adolescents at final follow-up

  3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments

• Prevalence of any past-30-day substance use (alcohol, cigarettes, e-cigarettes, marijuana) by adolescents at final follow-up

  3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments

• Incidence of antisocial behavior among adolescents through final follow-up

  3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments

• Mean adolescent depression symptom score at final follow-up

  3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments

• Mean adolescent anxiety symptom score at final follow-up

  3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments

Other Outcomes (6)

• Prevalence of substance use disorders among adolescents through final extraction

  3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments

• Prevalence of any psychiatric disorder (depression, anxiety, or conduct disorder) among adolescents through final extraction

  3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments

• Prevalence of specialty substance use treatment services utilization by adolescents through final extraction

  3-year follow-up (cohort 1), 2-year follow-up (cohort 2) assessments

Study Arms (2)

Guiding Good Choices

EXPERIMENTAL

Enrollment in the intervention, Guiding Good Choices, a substance use initiation prevention program, will be recommended by the pediatrician to parents of those adolescents empaneled with an intervention arm pediatrician

Behavioral: Guiding Good Choices

Control

NO INTERVENTION

Parents of adolescents empaneled with a control arm pediatrician will not be offered Guiding Good Choices

Interventions

Guiding Good Choices BEHAVIORAL

Guiding Good Choices is a 5-session group-based prevention program for parents of early adolescents. Weekly 2.5 hour sessions will be held at participants' primary care clinics and led by two trained interventionists. Through didactic material, video segments, interactive activities, and home practice, the curriculum teaches parents to understand the progression from individual and environmental risk and protective factors to substance use and problem behavior, enhances parenting behaviors and skills, teaches effective family management skills, strengthens parent-adolescent interactions and bonding, broadens opportunities for family involvement, teaches conflict reduction and anger management skills, and teaches adolescents skills to resist peer influences to engage in risky behavior. Parents who opt not to attend groups will be offered a self-guided intervention manual containing the same core content and video access, plus supportive coaching to motivate use and address questions.

Also known as: Preparing for the Drug-Free Years

Guiding Good Choices

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Parent's primary language is not English, as documented in the EHR or identified at study recruitment call

Sponsors & Collaborators

• University of Washington: lead
• Kaiser Permanente: collaborator
• Henry Ford Health System: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (3)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Kaiser Permanente Colorado

Aurora, Colorado, 80014, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 34785305 DERIVED

MeSH Terms

Conditions

Vaping; Marijuana Abuse

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Margaret R Kuklinski, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Richard F Catalano, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Stacy A Sterling, DrPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: July 31, 2019
• Study Start: September 30, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

US (3)