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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates programs that help families prevent substance use and minimize the impact of adverse childhood experiences (ACEs). It compares two approaches: the Strengthening Families Program alone and the same program with added support from a Family Advocate who connects families to community services. Families living in or attending meetings in certain New Jersey communities, with at least one caregiver and one child aged 7 to 17, may be eligible to participate. The goal is to identify the most effective way to support communities facing high levels of substance use and ACEs. As an unphased trial, this study allows families to contribute to innovative community support strategies.

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 these family support programs are safe for preventing substance use disorders?

Research has shown that the Strengthening Families Program (SFP) is generally safe and well-tolerated. This program has been used with both families facing challenges and the general public to improve family relationships and reduce the risk of future substance use. Studies have found that SFP helps prevent drug use among children whose parents have substance use issues. These studies have reported no major safety concerns.

The Family Advocate (FA) part of the program enhances SFP by offering extra support and connecting families to community services. Although specific safety data on the FA component is lacking, support services typically aim to assist families without introducing safety risks.

Overall, based on the available evidence for SFP and the supportive nature of the FA component, the treatment appears safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Strengthening Families Program and the addition of Family Advocates because these strategies offer a fresh approach to preventing substance use disorders. Unlike traditional treatments that often focus solely on individuals after issues arise, this program aims to prevent problems by enhancing family dynamics and providing comprehensive support. The inclusion of clinically trained Family Advocates is a unique feature, as they work closely with families to address social determinants of health and connect them to community services, potentially reducing adverse childhood experiences and strengthening social connections. This proactive and inclusive method stands out because it targets the root causes of substance use, offering a holistic solution that goes beyond conventional treatment methods.

What evidence suggests that this trial's programs could be effective for preventing substance use disorders?

Research has shown that the Strengthening Families Program (SFP), a treatment option in this trial, helps prevent substance use by improving family interactions and reducing risks. One study found that families participating in the three-part SFP saw better outcomes for children aged 6-12, particularly in areas related to future drug use. In this trial, another treatment arm adds a Family Advocate (FA) to the program, providing extra support by connecting families with community services and addressing social issues affecting substance use. This combined approach of SFP + FA aims to enhance the program's effectiveness by better meeting families' needs. Overall, SFP boosts resilience and lowers risks associated with substance use. ^{2 3 4 6 7}

Who Is on the Research Team?

Dallas J Elgin, PhD

Principal Investigator

RTI International

Phillip W. Graham, DrPH

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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 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 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 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 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]

Citations

1. strengtheningfamiliesprogram.org strengtheningfamiliesprogram.org/research/study-design-and-outcomes/

Study Design and Outcomes This study found the 3-component program (SFP) was more effective in improving predictor variables for later drug use in 6-12 yr. old children of drug abusers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8206301/

Beyond effectiveness of the Strengthening Families ... The results disclosed that effectiveness, implementation, and maintenance at the individual-level were the most evaluated aspects, while reach, maintenance at ...

3. preventchildabusenc.org preventchildabusenc.org/wp-content/uploads/2020/06/NC-Strenghthening-Families-Program-Year-10-Evaluation-Report.pdf

Strengthening Families Program Year 10 Report A meta-analysis conducted at Oxford University comparing family approaches to substance abuse prevention to child-only approaches found effect sizes averaged ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04214327

NCT04214327 | Strengthening Families Program Online This study tests a new web-based online parenting skills training and youth drug prevention program based on the evidence-based Strengthening Families Program.

5. strengtheningfamiliesprogram.org strengtheningfamiliesprogram.org/about/detailed-info/

About SFP - Programs The Strengthening Families Program (SFP) is a science-based family skills training program designed to increase resilience and reduce risk factors.

6. strengtheningfamiliesprogram.org strengtheningfamiliesprogram.org/

Strengthening Families Program The Strengthening Families Program (SFP) is an evidence-based family skills training program for high-risk and general population families.

7. cebc4cw.org cebc4cw.org/program/strengthening-families-program-sfp/detailed

Strengthening Families Program Sfp › Program › Detailed The Strengthening Families Program (SFP) is a 10- to 14-week parenting and family skills training program for high-risk and general population families.