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

Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial

Who can join

Ages 7 and older · All sexes · Healthy volunteers welcome

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)

About the study

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.

What is being tested

• Strengthening Families Program + Family Advocate (behavioral)
• Strengthening Families Program (behavioral)

Sponsor: RTI International · Participants: 360 · Started: Nov 29, 2023

Contact the study team

• Andrea L. Zapcic, BA · Phone: 908-433-2064
• Brittany Simon, MA · Phone: 201-218-5551

Official record on ClinicalTrials.gov — NCT06236100

Locations in the U.S.

Conditions

• Drug Use and Addiction

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.