Guiding Good Choices for Adolescent Substance Abuse

(GGC4H Trial)

Not currently recruiting at 2 trial locations

Overseen By Diane Christiansen

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Intellectual impairment, Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a program called Guiding Good Choices (GGC) in pediatric clinics for preventing substance use, depression, and delinquent behavior in young teens. GGC is a curriculum designed to help parents support their children through early adolescence. The trial compares outcomes for families using this program with those who do not. Families with children aged 12, about to enter the program and part of certain healthcare systems, might be eligible to join. As an unphased trial, this study offers families the opportunity to contribute to valuable research that could enhance support for young teens.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Guiding Good Choices program is safe for adolescents?

Research has shown that the Guiding Good Choices (GGC) program is safe for parents of young teenagers. This program is not a drug or medical treatment; it is a training program for parents. Studies have found that GGC can help reduce drug use and bad behavior in teenagers and improve family communication. As GGC is a program and not a medicine, no health risks have been reported. Families who have used GGC have experienced positive results without harm or negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for adolescent substance abuse, which often involve counseling or medication after issues have already developed, Guiding Good Choices is a proactive prevention program. This intervention is unique because it targets substance use before it starts by empowering parents with strategies to guide their children toward making healthier choices. Researchers are excited about this approach because it shifts the focus from treatment to prevention, potentially reducing the incidence of substance abuse in adolescents by addressing risk factors early on.

What evidence suggests that Guiding Good Choices is effective for adolescent substance abuse?

Research has shown that the Guiding Good Choices (GGC) program helps prevent teenagers from using substances like alcohol, tobacco, and marijuana. In this trial, some participants will enroll in the GGC program, which studies have demonstrated reduces symptoms of depression and bad behavior in teens. The program teaches parents how to communicate and interact better with their children, lowering the chances of early substance use. By focusing on family skills, GGC aims to create a healthier environment for teenagers, leading to better mental and behavioral health. These findings suggest that GGC can be a useful tool for improving teen well-being in healthcare settings. ^{1 5 6 7 8}

Who Is on the Research Team?

Margaret R Kuklinski, PhD

Principal Investigator

University of Washington

Richard F Catalano, PhD

Principal Investigator

University of Washington

Stacy A Sterling, DrPh

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for early adolescents aged 12, who are patients at certain clinics within Kaiser Permanente Northern California, Kaiser Permanente Colorado, or Henry Ford Health System. It's aimed at those without cognitive impairments that would hinder participation and whose parents speak English.

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)

I am 12 years old, or will be during the study period.

Exclusion Criteria

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

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. Exclusions will be operationalized by specific ICD-9/ICD-10 diagnostic codes documented in the EHR for adolescents and identified at the discretion of the pediatrician or study team members for parents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment

Recruitment of over 3,600 families into the trial prior to beginning intervention

2 years

Intervention

Implementation of Guiding Good Choices, a parenting intervention to prevent adolescent substance use and improve behavioral health outcomes

Ongoing during the trial

Follow-up

Participants are monitored for outcomes such as substance use initiation and behavioral health problems

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Guiding Good Choices

Trial Overview

The study tests the 'Guiding Good Choices' program's ability to prevent substance abuse and improve behavioral health in adolescents when implemented on a large scale in pediatric primary care settings.

How Is the Trial Designed?

Group I: Guiding Good Choices Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

An estimated 158,520 children and adolescents visit emergency departments annually due to adverse drug events (ADEs), with nearly half of these cases occurring in children aged 1 to 4 years.

Unintentional overdoses are the most common cause of these ADEs, highlighting the need for targeted interventions to prevent such incidents, especially for medications frequently prescribed to young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. Cohen, AL., Budnitz, DS., Weidenbach, KN., et al.[2018]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

The study focuses on creating a Consumer Guide to help parents choose effective treatment programs for adolescent substance abuse, addressing the lack of resources available for informed decision-making.

The guide is based on evaluating the quality of treatment programs by the number and frequency of evidence-based practices (EBPs) they implement, which are crucial for their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Adolescent Substance Abuse Programs with Updated Quality Indicators: The Development of a Consumer Guide for Adolescent Treatment. Cacciola, JS., Meyers, K., Bates, SE., et al.[2023]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., et al.[2022]

Adolescent substance use can lead to serious long-term issues such as dependence, criminal behavior, and mental health disorders, highlighting the need for effective family-based interventions.

The article reviews various evidence-based family treatments for adolescent substance use, including multisystemic therapy and functional family therapy, emphasizing their outcomes and implementation factors to help clinicians choose the best approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Treatments for Adolescent Substance Use. Horigian, VE., Anderson, AR., Szapocznik, J.[2020]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04040153

NCT04040153 | Guiding Good Choices for Health

In prior community trials, GGC has been shown to prevent adolescent substance use (alcohol, tobacco, and marijuana), depressive symptoms, and delinquent ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8802622/

Parent-focused Prevention of Adolescent Health Risk Behavior

The study team hypothesizes that adolescents whose parents are randomized into the GGC intervention arm will show reductions in substance use initiation, the ...

3.

blueprintsprograms.org

blueprintsprograms.org/programs/39999999/guiding-good-choices/print/

Guiding Good Choices

The Substance Abuse Prevention and Treatment Block Grant can fund a variety of substance abuse ... data to determine the growth in adolescent substance use and ...

4.

crimesolutions.ojp.gov

crimesolutions.ojp.gov/ratedprograms/guiding-good-choices

Program Profile: Guiding Good Choices - CrimeSolutions.gov

This is a family-competency training program to promote healthy parent-child interactions and address children's risk for early substance use.

5.

rethinkingclinicaltrials.org

rethinkingclinicaltrials.org/demonstration-projects/ug3-project-pragmatic-trial-of-parent-focused-prevention-in-pediatric-primary-care-implementation-and-adolescent-health-outcomes-in-three-health-systems-ggc4h-guiding-good-choices-for-health/

UH3 Project: Guiding Good Choices for Health (GGC4H)

In prior community trials, GGC has been shown to prevent adolescent substance use (alcohol, tobacco, and marijuana), depressive symptoms, and delinquent ...

6.

dcricollab.dcri.duke.edu

dcricollab.dcri.duke.edu/sites/NIHKR/KR/GGC%20ICEPS_June%202023.pdf

The Guiding Good Choices Program

• Adolescents: Lower substance use and antisocial behavior, fewer symptoms of depression for 4-6 years. • Families: Better communication ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2916744/

Evidence-Based Interventions for Preventing Substance Use ...

This article reviews the epidemiology, etiologic risk and protective factors, and evidence-based approaches that have been found to be most effective in ...

8.

communitiesthatcare.net

communitiesthatcare.net/programs/ggc/

Guiding Good Choices | The Center for ...

Guiding Good Choices gives families information and tools that work to protect preteens and teens from the inevitable risks they encounter as they become more ...