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

Last updated: March 31, 2025
Sponsor: RTI International
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Stimulant Use Disorder

Treatment

Strengthening Families Program + Family Advocate

Strengthening Families Program

Clinical Study ID

NCT06236100
0218779
  • Ages > 7
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: To be eligible to participate in this study, a family must meet all of the following criteria:

  • Either reside in, or attend SFP meetings, within one of the 36 New Jerseycommunities with disproportionate levels of ACEs and substance use disorder (SUD)issues that are assigned to either the treatment or control conditions via thestudy'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 toparticipate in the study

  • Stated willingness to comply with all study procedures and lifestyle considerationsand 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

Exclusion Criteria: A family who meets any of the following criteria will be excluded from participation in this study:

  • Caregiver has previously completed SFP with one or more children, ages 7 to 17

  • Intellectual disabilities (i.e., cognitive impairments that would prohibit thecompletion of the SFP curriculum or data collection instruments)

  • Language difficulties (caregivers and children must read and understand spokenEnglish)

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Strengthening Families Program + Family Advocate
Phase:
Study Start date:
November 29, 2023
Estimated Completion Date:
September 29, 2027

Study Description

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.

Connect with a study center

  • New Jersey Prevention Network

    Tinton Falls, New Jersey 07724
    United States

    Active - Recruiting

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