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

RTI International · with New Jersey Prevention Network, RWJBarnabas Health Institute for Prevention and Recovery · NCT06236100

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 7+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
360
US sites recruiting
1
Study start
November 29, 2023
Record last updated
May 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Strengthening Families Program + Family Advocate; Strengthening Families Program

Conditions: Substance-Related Disorders; Adverse Childhood Experiences

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 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: 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 the completion of the SFP curriculum or data collection instruments)
  • Language difficulties (caregivers and children must read and understand spoken English)

Recruiting US locations

  • New Jersey Prevention Network

    Tinton Falls, NJ 07724

    Site contact: Andrea Zapcic · Andrea@njpn.org

Study contacts (from the official record)

  • Andrea L. Zapcic, BA · 908-433-2064 · Andrea@njpn.org
  • Brittany Simon, MA · 201-218-5551 · Brittany.Simon@rwjbh.org
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