Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2027-09-29

Brief Summary

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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.

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Detailed Description

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Early exposure to Adverse Childhood Experiences (ACEs), such as parental substance use, increases the likelihood of future substance use and drug overdose, resulting in an intergenerational cycle of substance-related ACEs that can continue indefinitely if left uninterrupted. Community-level interventions may moderate the relationship between ACEs and substance use by providing an array of family support services and treatments to reduce disparities and improve reach and service linkages in the community. Although research suggests that effectively decreasing the prevalence and impact of ACEs and substance use requires addressing both family- and community-level factors in tandem, there is a critical gap within the evidence base pertaining to interventions that effectively integrate the two factors to prevent substance use and ACEs. RTI International and its partners, the New Jersey Prevention Network and RWJBarnabas Health, will evaluate an intervention integrating New Jersey's established, evidence-based Strengthening Families Program (SFP) with clinically trained, trauma-informed Family Advocates (FAs) who will assist families (i.e., parents/caregivers and youth between the ages of 12 and17) in accessing community resources. Specifically, this study will use a Hybrid Type 1 effectiveness-implementation design across 36 New Jersey communities experiencing a disproportionate burden of substance use and ACEs.

Conditions

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Substance-Related Disorders Adverse Childhood Experiences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Strengthening Families Program + Family Advocate

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 Type EXPERIMENTAL

Strengthening Families Program + Family Advocate

Intervention Type BEHAVIORAL

This intervention will integrate clinically trained, trauma-informed Family Advocates (FA) into the established, evidence-based Strengthening Families Program (SFP). Families will participate in the SFP7-17 curriculum, which consists of 11 sessions over 10-14 weeks. FAs will assist families in accessing community resources for substance use and Adverse Childhood Experiences (ACE) prevention and treatment.

Strengthening Families Program-Only

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.

Group Type ACTIVE_COMPARATOR

Strengthening Families Program

Intervention Type BEHAVIORAL

This intervention consists of the SFP7-17 Group Class Curriculum. Families will participate in the SFP7-17 curriculum, which consists of 11 sessions over 10-14 weeks.

Interventions

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Strengthening Families Program + Family Advocate

This intervention will integrate clinically trained, trauma-informed Family Advocates (FA) into the established, evidence-based Strengthening Families Program (SFP). Families will participate in the SFP7-17 curriculum, which consists of 11 sessions over 10-14 weeks. FAs will assist families in accessing community resources for substance use and Adverse Childhood Experiences (ACE) prevention and treatment.

Intervention Type BEHAVIORAL

Strengthening Families Program

This intervention consists of the SFP7-17 Group Class Curriculum. Families will participate in the SFP7-17 curriculum, which consists of 11 sessions over 10-14 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Either reside in, or attend SFP meetings, within one of the 36 New Jersey communities with disproportionate levels of ACEs and substance use disorder (SUD) issues that are assigned to either the treatment or control conditions via the study's cluster randomized controlled trial design
* Meet family eligibility requirements:

* One or more adult caregivers
* One or more adolescents, ages 7 to 17
* Caregiver provision of signed and dated informed consent form
* For children, informed assent and parental permission via the informed consent to participate in the study
* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
* Willingness to adhere to the regimens of the SFP and FA interventions
* Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart phone, internet access)

Exclusion Criteria

* Caregiver has previously completed SFP with one or more children, ages 7 to 17
* Intellectual disabilities (i.e., cognitive impairments that would prohibit the completion of the SFP curriculum or data collection instruments)
* Language difficulties (caregivers and children must read and understand spoken English)

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes