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Behavioral Intervention

Strengthening Families Program + Family Advocate for Adverse Childhood Experiences

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-implementation to intervention completion (ranging from 10 to 14 weeks)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Referrals to clinical services
Referrals to non-clinical services
Substance use perceptions of harm
+1 more
Secondary outcome measures
ACEs prevalence
Average start-up cost
Cost per service referral
+4 more
Other outcome measures
Lessons learned (process evaluation)
Service utilization
Social connectedness across systems (process evaluation)
+1 more

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.

Find a Location

Who is running the clinical trial?

RTI InternationalLead Sponsor
189 Previous Clinical Trials
875,754 Total Patients Enrolled
RWJBarnabas Health Institute for Prevention and RecoveryUNKNOWN
New Jersey Prevention NetworkUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently eligible to participate in this ongoing medical study?

"Indeed, according to the information available on clinicaltrials.gov, this trial is currently seeking eligible participants. The study was initially posted for recruitment on November 29th, 2023 and underwent its most recent update on January 23rd, 2024."

Answered by AI

What is the upper limit for the total number of participants allowed to participate in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is currently seeking individuals to participate. The trial was initially posted on November 29th, 2023 and was most recently updated on January 23rd, 2024. A total of 360 participants are being sought for this study at a single site."

Answered by AI
~240 spots leftby Oct 2026