Guiding Good Choices for Adolescent Substance Abuse

(GGC4H Trial)

Recruiting at 2 trial locations

Overseen By Diane Christiansen

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

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

Compensation: Varies

Number of Visits: Unknown

3636 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Guiding Good Choices for adolescent substance abuse?

Family-based treatments, which include approaches like Guiding Good Choices, have shown positive outcomes in reducing adolescent substance use and related problems. These treatments often involve family therapy, which has been found to be effective in improving substance use outcomes and reducing school and legal issues. ^{1 2 3 4 5}

Is the Guiding Good Choices program safe for participants?

In a study of psychosocial treatments for substance abuse, including programs like Guiding Good Choices, no serious adverse events were found to be related to the study, suggesting these types of programs are generally safe for participants. ^{6 7 8 9 10}

How is the Guiding Good Choices treatment different from other treatments for adolescent substance abuse?

Guiding Good Choices is unique because it focuses on involving family therapy as a key component, which has shown encouraging results in treating adolescent substance abuse. This approach emphasizes the role of family dynamics and support in preventing and addressing substance use, setting it apart from treatments that focus solely on individual therapy. ^{1 3 11 12 13}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adolescent substance abuse: a simplified approach to drug testing. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Adolescent treatment. Implications for assessment, practice guidelines, and outcome management. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Assessing Adolescent Substance Abuse Programs with Updated Quality Indicators: The Development of a Consumer Guide for Adolescent Treatment. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Evidence base on outpatient behavioral treatments for adolescent substance use: updates and recommendations 2007-2013. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Family-Based Treatments for Adolescent Substance Use. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events from cough and cold medications in children. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Integration of the Screening, Brief Intervention, and Referral to Treatment Screening Instrument Into School Nurse Practice. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Screening adolescents for substance use: The role of NPs in school settings. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Adolescent drug and alcohol use. Strategies for assessment, intervention, and prevention. [2019]