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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent substance use disorder (SUD) in youth by strengthening family bonds and coping skills. It tests the Modified Family Talk Intervention, which involves both parents and their children, to determine its effectiveness in a regular healthcare setting. Participants will be divided into two groups: one will receive the modified intervention, and the other will receive standard care. Youth aged 12-18 who speak English or Spanish and have no current SUD, along with a parent receiving treatment for SUD, may be eligible to participate. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in preventing SUD in families.

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 prior data suggests that this intervention is safe for youth?

Research has shown that family-based programs, such as the Modified Family Talk Intervention, are well-received and effective in preventing substance use among young people. A review of 60 studies confirms that these programs help reduce the use of substances like cannabis, alcohol, and tobacco in youth. By improving communication and relationships within families, these programs achieve success. Importantly, these interventions have proven safe, with no significant negative effects reported for participants. This indicates that the Modified Family Talk Intervention is a safe choice for families aiming to prevent substance use in their children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Modified Family Talk Intervention because it takes a unique family-centered approach to prevent substance use among at-risk youth. Unlike standard individual-focused interventions, this method involves both parents and children, fostering open communication and mutual understanding within the family unit. By addressing the family dynamic directly, it aims to create a supportive environment that can effectively deter substance use behaviors in young people.

What evidence suggests that the Modified Family Talk Intervention is effective for preventing youth substance use disorder?

Research shows that family-based programs like the Modified Family Talk Intervention, which participants in this trial may receive, can help prevent children from using drugs and alcohol. A review of 60 studies found that these programs can reduce the initiation and use of cannabis, alcohol, tobacco, and other illegal drugs. Family Talk, the original version of this program, proves especially helpful for high-risk families by improving communication and relationships among family members. The Community Preventive Services Task Force also recommends these family-based programs to prevent substance use among young people. Overall, evidence supports the effectiveness of these programs in helping families protect their children from substance abuse. ^{1 3 4 6 7}

Who Is on the Research Team?

Caroline J Kistin, MD MSc

Principal Investigator

Brown University School of Public Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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Recent survey data have shown that the number of children who lost a parent to drug overdose has rapidly increased over the past decade and ...