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Behavioral Intervention

Family Support Programs for Preventing Substance Use Disorders

N/A

Recruiting

Led By Phillip W. Graham, DrPH

Research Sponsored by RTI International

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Intellectual disabilities that would prohibit the completion of the SFP curriculum or data collection instruments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-implementation to intervention completion (ranging from 10 to 14 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to evaluate an intervention program designed to prevent the negative effects of adverse childhood experiences (ACEs) and reduce substance use and overdoses in communities facing higher rates of these issues. The study

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves social interventions rather than medical treatments, traditional side effects associated with medications are not applicable. However, there could be unintended consequences or emotional impacts related to participating in such programs.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can complete the SFP curriculum and all required forms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Referrals to clinical services

Referrals to non-clinical services

Substance use perceptions of harm

+1 more

Secondary study objectives

ACEs prevalence

Average start-up cost

Cost per service referral

+4 more

Other study objectives

Lessons learned (process evaluation)

Service utilization

Social connectedness across systems (process evaluation)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Strengthening Families Program + Family AdvocateExperimental Treatment1 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-OnlyActive Control1 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.

0 / 1Eligibility criteria met