Family Support Programs for Preventing Substance Use Disorders

Overseen By Brittany Simon, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: RTI International

Disqualifiers: Intellectual disabilities, Language difficulties, others

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

Compensation: Varies

Number of Visits: 1

360 Participants Needed

Trial Summary

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 Strengthening Families Program treatment for preventing substance use disorders?

Research shows that the Strengthening Families Program (SFP) is effective in preventing substance misuse by strengthening family protective factors. It has been successfully adapted and implemented in various countries, demonstrating positive results across different cultural groups and age ranges. ^{1 2 3 4 5}

Is the Strengthening Families Program safe for humans?

The Strengthening Families Program (SFP) has been implemented in various countries and settings, showing positive impacts on family cohesion and parenting without reported safety concerns. It is generally considered safe for families to participate in this program. ^{1 3 5 6 7}

How is the Strengthening Families Program treatment different from other treatments for preventing substance use disorders?

The Strengthening Families Program is unique because it focuses on strengthening family relationships and skills to prevent substance use, rather than directly targeting the individual. It can be delivered in group settings or through a home-use DVD, making it flexible and accessible for families. Additionally, it has been culturally adapted for diverse populations, ensuring its effectiveness across different cultural groups. ^{1 2 3 5 8}

What is the purpose of this trial?

Primary Objective: Conduct a rigorous evaluation of a prevention-based intervention designed to mitigate the harms of adverse childhood experiences (ACEs) exposure and prevent future ACEs, substance use, and overdose within 36 communities experiencing a disproportionate burden of substance use and ACEs. The study has three aims: (1) use a cluster randomized controlled trial to test effectiveness of the Strengthening Families Program (SFP) + Family Advocate (FA) intervention on substance use, overdose, and ACEs in 18 communities compared with SFP-only in 18 communities; (2) conduct a robust process evaluation informed by the Consolidated Framework for Implementation Research (CFIR) to explore implementation barriers and facilitators; and (3) conduct a cost evaluation to accurately estimate the costs required to implement SFP and SFP+FA and assess the cost-effectiveness of SFP+FA relative to SFP alone. Findings will provide a roadmap about the best ways to help disproportionately affected communities prevent substance use, overdose, and ACEs.

Research Team

Phillip W. Graham, DrPH

Principal Investigator

RTI International

Dallas J Elgin, PhD

Principal Investigator

RTI International

Eligibility Criteria

This trial is for communities heavily impacted by substance use and adverse childhood experiences (ACEs). It aims to evaluate a program designed to prevent substance misuse and reduce the harms of ACEs. Specific eligibility criteria are not provided, suggesting that it may be open to various participants within these communities.

Inclusion Criteria

Caregiver provision of signed and dated informed consent form

I am willing to follow the guidelines of the SFP and FA treatments.

Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access)

Exclusion Criteria

I have completed the SFP program with my child aged 7 to 17.

Language difficulties (caregivers and children must read and understand spoken English)

I can complete the SFP curriculum and all required forms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Families participate in the Strengthening Families Program with or without Family Advocate support over a 10- to 14-week period

10-14 weeks

Weekly sessions with 1-hour post-session check-ins

Follow-up

Participants are monitored for substance use, ACEs, and service utilization through surveys and assessments

6 months

Treatment Details

Interventions

• Strengthening Families Program
• Strengthening Families Program + Family Advocate

Trial Overview The study compares two approaches: one group receives the Strengthening Families Program (SFP) with additional support from a Family Advocate, while another group gets only SFP. The effectiveness in preventing substance use and reducing ACEs will be measured across 36 communities.

Participant Groups

Group I: Strengthening Families Program + Family Advocate Experimental Treatment 1 Intervention

Families in the treatment group will be connected to clinically trained, trauma-informed FAs that will assess and refer families to community services. The intervention will provide wraparound supports to prevent ACEs and substance use and, critically, enable providers and community-based partners to align their services in a way that addresses the social determinants of health and other community-level factors that impact substance use and the relationship between social connection and ACEs. The FA component of the intervention will run concurrent to the Strengthening Families Program 7-17 sessions, with the FAs interacting weekly with families over the 10- to 14-week intervention period. On a weekly basis, FAs will conduct 1-hour, post-session check-ins with each family. This 1-hour period will consist of a 20-minute phone call with families to discuss their needs, with the remaining 40 minutes used to debrief, make service referrals, and complete documentation.

Group II: Strengthening Families Program-Only Active Control 1 Intervention

Families in the control group will participate in the Strengthening Families Program 7-17 (SFP7-17) Group Class Curriculum for families with children ages 7-17. Parents and children participate in SFP7-17, both separately and together, as the curriculum has lessons for parents, teens, and children plus a joint Family Practice class. SFP7-17 meetings are 2 hours in length and are typically held in person (but families can participate remotely, during extenuating circumstances) with participating families completing 11 sessions over a 10- to 14-week period.

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

RWJBarnabas Health Institute for Prevention and Recovery

Collaborator

Trials

1

Recruited

360+

New Jersey Prevention Network

Collaborator

Trials

1

Recruited

360+

Findings from Research

The Strengthening Families Programme 10-14 (SFP10-14UK) did not show significant effectiveness in reducing alcohol consumption or drunkenness among young people two years after the intervention, based on a study involving 715 families in Wales.

Despite previous evidence supporting the program's effectiveness, this study emphasizes the need for careful evaluation of interventions when they are adapted for different settings, as the expected benefits were not observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Strengthening Families Programme in the UK at preventing substance misuse in 10-14 year-olds: a pragmatic randomised controlled trial. Segrott, J., Gillespie, D., Lau, M., et al.[2023]

The Strengthening Families Program (SFP) is an effective family skills training intervention for preventing substance abuse, originally developed in the 1980s and adapted for diverse cultural contexts since the 1990s.

SFP has been successfully implemented in 17 countries, with a comprehensive cultural adaptation process that includes language translation, staff training, and ongoing support to ensure quality and effectiveness in various populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural adaptation process for international dissemination of the strengthening families program. Kumpfer, KL., Pinyuchon, M., Teixeira de Melo, A., et al.[2022]

Family strengthening prevention programs are crucial in addressing substance abuse, as they tackle both genetic and environmental factors, and five effective approaches have been identified through national research.

The Strengthening Families Program (SFP) stands out as the only program with positive results replicated across diverse cultural groups and age ranges, highlighting its effectiveness in substance abuse prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based interventions for substance use and misuse prevention. Kumpfer, KL., Alvarado, R., Whiteside, HO.[2022]

The Strengthening Families Program (SFP) was successfully implemented in three cities in France, showing positive results in family retention rates and immediate efficacy among four groups of families.

Cultural adaptations, including local partnerships and training, were essential for the successful implementation of SFP, indicating that standardized programs can be effectively tailored for different contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Strengthening Families Program: key points for the French adaptation]. Roehrig, C., Pradier, C.[2018]

The home-use DVD version of the Strengthening Families Program (SFP) demonstrated a significant improvement in program outcomes, outperforming traditional group norms in 13 out of 15 comparisons, with an average effect size increase of 28%.

This study suggests that delivering family-based interventions through affordable technology like DVDs can be as effective as traditional group classes, highlighting a potential cost-effective alternative for families and agencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Parenting Behavior Intervention (the Strengthening Families Program) for Families: Noninferiority Trial of Different Program Delivery Methods. Kumpfer, KL., Brown, JL.[2020]

The Strengthening Families Programme 10-14 (SFP 10-14 UK) is being evaluated in a randomized controlled trial involving families to assess its effectiveness in preventing alcohol, drug, and tobacco misuse among young people, with a follow-up period of 2 years.

The trial aims to measure key outcomes such as the frequency of alcohol consumption and instances of drunkenness in the past 30 days, comparing families receiving the SFP 10-14 UK intervention to those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10-14 UK (SFP 10-14 UK). Segrott, J., Gillespie, D., Holliday, J., et al.[2023]

The Strengthening Families Program (SFP 10-14) was found to be socially relevant and positively impacted family cohesion and adolescent life skills among participants in northeastern Brazil, based on focus groups with 199 parents, 111 adolescents, and 100 facilitators.

Facilitators noted the need for adaptations to better serve vulnerable families, suggesting that while the program is effective, improvements in implementation could enhance its reach and effectiveness in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Validity of the Strengthening Families Program in Northeastern Brazil: the Voices of Parents, Adolescents, and Facilitators. Murta, SG., de Almeida Nobre-Sandoval, L., Rocha, VPS., et al.[2022]

The study involved 85 adults in focus groups and 20 stakeholder interviews to gather input on designing a Web-based version of the Strengthening Families Program (SFP), highlighting the importance of lesson content, delivery logistics, and multimedia interactivity for effective youth drug prevention.

User-centered feedback indicated that parents who engaged with more SFP lessons were more likely to support the online program, emphasizing the need for interactivity and addressing concerns about technology use to enhance program effectiveness and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative Evaluation to Build an Online Parenting Skills and Youth Drug Prevention Program: Mixed Methods Study. Scheier, LM., Kumpfer, KL., Brown, JL., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the Strengthening Families Programme in the UK at preventing substance misuse in 10-14 year-olds: a pragmatic randomised controlled trial. [2023]

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

Cultural adaptation process for international dissemination of the strengthening families program. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Family-based interventions for substance use and misuse prevention. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Strengthening Families Program: key points for the French adaptation]. [2018]

5. Canada pubmed.ncbi.nlm.nih.gov

A Parenting Behavior Intervention (the Strengthening Families Program) for Families: Noninferiority Trial of Different Program Delivery Methods. [2020]

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

Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10-14 UK (SFP 10-14 UK). [2023]

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

Social Validity of the Strengthening Families Program in Northeastern Brazil: the Voices of Parents, Adolescents, and Facilitators. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Formative Evaluation to Build an Online Parenting Skills and Youth Drug Prevention Program: Mixed Methods Study. [2020]