Family-Based Substance Use Prevention for Youth at Risk

Overseen By Jocelyn Antonio, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Acute family crisis, Cognitive limitation, others

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

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Risk for substance use disorder (SUD) begins early in the life course. Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority, there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting. The investigators propose a three-year plan to collect critical pilot data to pilot test and optimize a dyadic intervention that aims to increase family resilience, strengthen coping skills, help families plan for the future, and prevent youth SUD. The 'prototype' for the intervention approach is Family Talk, an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home. The investigators have made preliminary adaptations to the model in preparation for testing. To prepare for a subsequent efficacy study, a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted. The feasibility of the intervention will be evaluated. In addition, empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on family-based interventions rather than medication changes.

What data supports the effectiveness of the treatment Modified Family Talk Intervention for preventing substance use in youth at risk?

Research shows that family-based programs, like the Strengthening Families Program, can help prevent substance use in young people by focusing on building family strengths and skills. These programs are more effective when they involve both parents and children, and they have been shown to work in various settings, including healthcare. ^{1 2 3 4 5}

Is the Family-Based Substance Use Prevention for Youth at Risk treatment safe for humans?

The research on family-based substance use prevention programs, including those similar to the Family Talk Intervention, generally focuses on their effectiveness rather than safety. However, these programs are typically designed to be safe as they involve family education and support rather than medical or pharmaceutical interventions. ^{1 3 4 6 7}

How is the Modified Family Talk Intervention different from other treatments for preventing substance use in youth?

The Modified Family Talk Intervention is unique because it involves both youth and their families, focusing on improving family communication and relationships to prevent substance use, unlike many other programs that primarily target parents. This approach emphasizes the role of family dynamics in building resilience against substance use. ^{1 3 5 8 9}

Research Team

Caroline J Kistin, MD MSc

Principal Investigator

Brown University School of Public Health

Eligibility Criteria

This trial is for youth aged 12-18 without substance use disorders, who are comfortable in English or Spanish. Their parents must be over 18, receiving treatment for SUD and getting primary care at Boston Medical Center Health System.

Inclusion Criteria

You receive your main medical care at Boston Medical Center (BMC) Health System.

I am comfortable speaking English or Spanish.

I am between 12 and 18 years old and do not have a substance use disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

20 parent-youth dyads will receive the Modified Family Talk intervention to optimize the intervention model

12 months

Regular sessions throughout the study

Parameter Estimation

20 parent-youth dyads will receive current best practice care to estimate study parameters for future trials

12 months

Regular sessions throughout the study

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3-12 months

Treatment Details

Interventions

• Modified Family Talk Intervention
• Parameter Estimation

Trial Overview The study tests a 'Modified Family Talk' intervention against a control to prevent youth substance use. It's a pilot randomized controlled trial with parent-youth pairs to optimize the model and plan for larger future trials.

Participant Groups

Group I: Parameter estimation arm Experimental Treatment 1 Intervention

20 parent-youth dyads randomized to this control-like arm will receive current best practice care in the patient-centered medical home

Group II: Intervention refinement arm Experimental Treatment 1 Intervention

20 parent-youth \[12-18 years old\] dyads will be randomized to this arm and receive the Modified Family Talk intervention.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Drug Abuse

Collaborator

Trials

11

Recruited

12,500+

Findings from Research

Family-based interventions for preventing substance use disorders in children and adolescents are effective when they focus on enhancing developmental competencies and family resources, rather than just addressing substance use directly.

Evidence-based family treatment programs like Multisystemic Therapy and Functional Family Therapy show small-to-medium effects, but there is a need for more research on their effective components and how to implement these programs effectively in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current State of Family-Based Prevention and Therapy of Substance-Use Disorders in Children and Adolescents: A Review]. Arnaud, N., Sack, PM., Thomasius, R.[2019]

Family interventions are increasingly recognized as one of the most effective strategies for preventing and treating alcohol-related issues.

Recent evidence presented at a UK conference highlights the importance of these interventions, suggesting they should be prioritized in alcohol education and treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family interventions for alcohol problems. Hodgson, R.[2019]

Family-based preventive interventions are becoming an important approach to reduce substance use and antisocial behavior, focusing on high-risk and adolescent populations.

Key recommendations for improving these interventions include customizing strategies for individual families, collaborating with various social systems, and combining insights from both prevention and treatment fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based preventive intervention: an approach to preventing substance use and antisocial behavior. Hogue, A., Liddle, HA.[2022]

The study involved 494 ethnically diverse families with 11-year-old children, examining the implementation of two family-based substance use prevention programs in healthcare settings, highlighting the importance of understanding the healthcare environment for effective program delivery.

Allowing families to choose between the Strengthening Families Program and Family Matters led to higher engagement, with families who chose their program completing it faster and participating more actively, suggesting that program choice enhances family involvement in prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of adolescent family-based substance use prevention programs in health care settings: Comparisons across conditions and programs. Aalborg, AE., Miller, BA., Husson, G., 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]

The Connecting program, adapted for foster families, showed high satisfaction rates with 100% of parents recommending it, and 62% of families completed all tasks, indicating good usability and feasibility.

Participation in the program led to improved family communication about sex and substance use, reduced family conflict, and increased family rules regarding monitoring and media use, suggesting it effectively enhances family management and reduces antisocial behavior in teens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Connecting, a Substance-Abuse Prevention Program for Foster Teens and their Caregivers. Haggerty, KP., Barkan, SE., Skinner, M., et al.[2020]

A study involving 545 parents of youth with substance use disorders showed that participation in a clinician-led group based on the CRAFT model improved parents' feelings of empowerment in coping with their child's issues, despite overall stress levels remaining unchanged.

The low retention rate, with only 12% of parents completing all 8 weeks, suggests a need for adaptations to the program to enhance engagement and support for parents in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Naturalistic Evaluation of a Group Intervention for Parents of Youth with Substance Use Disorders. Ameral, V., Yule, A., McKowen, J., et al.[2021]

Substance misuse poses significant risks to youth in low- and middle-income countries, similar to those in high-income countries, highlighting the need for targeted preventive programs.

Family-based interventions are promising strategies for preventing substance misuse among young people, as they can be adapted to address specific family-related risk factors identified in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based prevention in youth's substance misuse in low- and middle-income countries: A review from Turkey and cultural adaptation of family based interventions. Callak, Y., Onat, MB., Yilmaz, G., et al.[2022]

In a randomized clinical trial involving 80 urban, low-income adolescents aged 11 to 15, family-based therapy (MDFT) was found to be significantly more effective than peer group therapy in reducing substance use and improving various protective factors across individual, family, peer, and school domains.

The study supports the clinical effectiveness and potential for wider use of MDFT, highlighting its ability to address multiple risk factors and promote positive outcomes in adolescents with substance abuse and behavioral problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intervention for adolescent substance abuse: pretreatment to posttreatment outcomes of a randomized clinical trial comparing multidimensional family therapy and peer group treatment. Liddle, HA., Rowe, CL., Dakof, GA., et al.[2007]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Current State of Family-Based Prevention and Therapy of Substance-Use Disorders in Children and Adolescents: A Review]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Family interventions for alcohol problems. [2019]

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

Family-based preventive intervention: an approach to preventing substance use and antisocial behavior. [2022]

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

Implementation of adolescent family-based substance use prevention programs in health care settings: Comparisons across conditions and programs. [2022]

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

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

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

Feasibility of Connecting, a Substance-Abuse Prevention Program for Foster Teens and their Caregivers. [2020]

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

A Naturalistic Evaluation of a Group Intervention for Parents of Youth with Substance Use Disorders. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Family-based prevention in youth's substance misuse in low- and middle-income countries: A review from Turkey and cultural adaptation of family based interventions. [2022]

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

Early intervention for adolescent substance abuse: pretreatment to posttreatment outcomes of a randomized clinical trial comparing multidimensional family therapy and peer group treatment. [2007]