Family Support Programs for Preventing Substance Use Disorders

Recruiting in Palo Alto (17 mi)

Overseen by Dallas J Elgin, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: RTI International

Disqualifiers: Intellectual disabilities, Language difficulties, others

No Placebo Group

Trial Summary

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.

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}

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.

Trial 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 (Behavioral Intervention)
• Strengthening Families Program + Family Advocate (Behavioral Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

New Jersey Prevention Network Tinton Falls, NJ

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Patients Recruited

942,000+

RWJBarnabas Health Institute for Prevention and Recovery

Collaborator

Trials

1

Patients Recruited

360+

New Jersey Prevention Network

Collaborator

Trials

1

Patients Recruited

360+

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] The Strengthening Families Programme 10-14 (SFP10-14) is a USA-developed universal group-based intervention aiming to prevent substance misuse by strengthening protective factors within the family. This study evaluated a proportionate universal implementation of the adapted UK version (SFP10-14UK) which brought together families identified as likely/not likely to experience/present challenges within a group setting.

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

Cultural adaptation process for international dissemination of the strengthening families program. [2022] The Strengthening Families Program (SFP) is an evidence-based family skills training intervention developed and found efficacious for substance abuse prevention by U.S researchers in the 1980s. In the 1990s, a cultural adaptation process was developed to transport SFP for effectiveness trials with diverse populations (African, Hispanic, Asian, Pacific Islander, and Native American). Since 2003, SFP has been culturally adapted for use in 17 countries. This article reviews the SFP theory and research and a recommended cultural adaptation process. Challenges in international dissemination of evidence-based programs (EBPs) are discussed based on the results of U.N. and U.S. governmental initiatives to transport EBP family interventions to developing countries. The technology transfer and quality assurance system are described, including the language translation and cultural adaptation process for materials development, staff training, and on-site and online Web-based supervision and technical assistance and evaluation services to assure quality implementation and process evaluation feedback for improvements.

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

Family-based interventions for substance use and misuse prevention. [2022] Because "substance abuse" is a "family disease" of lifestyle, including both genetic and family environmental causes, effective family strengthening prevention programs should be included in all comprehensive substance abuse prevention activities. This article presents reviews of causal models of substance use and evidence-based practices. National searches by the authors suggest that there is sufficient research evidence to support broad dissemination of five highly effective family strengthening approaches (e.g., behavioral parent training, family skills training, in-home family support, brief family therapy, and family education). Additionally, family approaches have average effect sizes two to nine time larger than child-only prevention approaches. Comprehensive prevention programs combining both approaches produced much larger effect sizes. The Strengthening Families Program (SFP) is the only one of these programs that has been replicated with positive results by independent researchers with different cultural groups and with different ages of children. Few research-based programs have been adopted by practitioners, partly because of technology transfer issues. Overall, research on ways to improve dissemination, marketing, training, and funding is needed to improve adoption of effective prevention programs.

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

[Strengthening Families Program: key points for the French adaptation]. [2018] The Strengthening Families Program (SFP) is an American evidence-based family skills training intervention, developed in 35 countries around the world.The aim of this study was to identify potential key-points to ensure successful implantation of SFP in France.

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] The Strengthening Families Program (SFP) is an evidence-based parent training and youth life skills and drug prevention program traditionally delivered in group settings. Families attend parent and youth classes conducted by trained facilitators. Recently, a 2-disk home-use DVD series was created with the same SFP skills as the group classes for parents and the youth to watch together at home. Additional lesson material was added that included healthy brain development, school success, anger management, dangers of alcohol and drugs, and mindfulness. The SFP DVD reduces SFP delivery costs for agencies and logistic burdens to families. Creative applications of the DVD include holding SFP DVD family discussion groups of multiple families and using SFP DVD video clips as part of a shorter 10-week group class version for parents and the youth.

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] Prevention of alcohol, drug and tobacco misuse by young people is a key public health priority. There is a need to develop the evidence base through rigorous evaluations of innovative approaches to substance misuse prevention. The Strengthening Families Programme 10-14 is a universal family-based alcohol, drugs and tobacco prevention programme, which has achieved promising results in US trials, and which now requires cross-cultural assessment. This paper therefore describes the protocol for a randomised controlled trial of the UK version of the Strengthening Families Programme 10-14 (SFP 10-14 UK).

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] In 2013, Brazil's Ministry of Health adopted the Strengthening Families Program (SFP 10-14), developed internationally for preventing drug abuse by enhancing family bonds. The social validity of the objectives, procedures, and perceived impacts of the program were investigated for participants and facilitators in northeastern Brazil. Focus groups with parents/guardians (N = 199), adolescents (N = 111), and facilitators (N = 100) were implemented. Content analysis revealed that the program's objectives were considered socially relevant and that there was a positive short-term perceived impact on family cohesion, authoritative parenting style, adolescent life skills, and the facilitators' professional capacity. The parents/guardians and adolescents presented a positive perception of the appropriateness of the program's methodology, while facilitators indicated the need to adapt it to vulnerable families and improve its implementation conditions. Future studies may benefit from these findings when developing similarly viable and scalable interventions in low-resource settings. Brazilian Trial Register RBR-7q9xh5. Registered 5 August 2017, http://www.ensaiosclinicos.gov.br/rg/RBR-7q9xh5/.

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

Formative Evaluation to Build an Online Parenting Skills and Youth Drug Prevention Program: Mixed Methods Study. [2020] Family-based drug prevention programs that use group-based formats with trained facilitators, such as the Strengthening Families Program (SFP), are effective in preventing underage drinking and youth drug use. However, these programs are resource-intensive and have high costs and logistical demands. Tailoring them for Web-based delivery is more cost-effective and makes it easier to scale these programs for widespread dissemination. This requires the active involvement of all key stakeholders to determine content and delivery format.