Clinical trial Recruiting at 1 site Interventional Ages 7 and up

Program to prevent substance use and support families affected by childhood trauma

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

Run by RTI International · NCT06236100 · Data updated 2026-11-12

This study is testing whether a program that combines family support with community resources can help reduce substance use and the effects of childhood trauma in families across New Jersey.

Quick facts

Study typeInterventional
Ages7 Years and up
SexAll
Enrollment360 (estimated)
SponsorRTI International
Academic / other
Locations1 site (Tinton Falls, New Jersey)
StatusRecruiting
StartedNovember 29, 2023
Main results expectedOctober 31, 2026
Study endsSeptember 29, 2027
Registry record updatedMay 5, 2026
Trial IDNCT06236100 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include families with adolescents aged 7 to 17 living in New Jersey communities with high levels of ACEs and substance use issues.

Probably not a fit

Patients who do not reside in the targeted New Jersey communities or do not have adolescents in the specified age range may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention evaluates the effectiveness of the Strengthening Families Program (SFP) combined with Family Advocates (FA) in reducing substance use and adverse childhood experiences (ACEs) across 36 communities in New Jersey. The study employs a cluster randomized controlled trial design, comparing outcomes in communities receiving the combined intervention against those receiving SFP alone. Additionally, it includes a process evaluation to identify implementation barriers and a cost evaluation to assess the economic feasibility of the interventions. The goal is to provide insights into effective community-level strategies for mitigating the impact of ACEs and substance use disorders.

Why it matters

Potential benefit: If successful, this program could significantly reduce substance use and improve family support for those affected by adverse childhood experiences.

How similar studies have gone: Previous studies have shown promise in community-level interventions targeting ACEs and substance use, but this specific integration of family advocacy with established programs is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • New Jersey Prevention Network
    Tinton Falls, New Jersey, United States
    Recruiting

Study contacts

  • Principal investigator: Phillip W. Graham, DrPH — RTI International
  • Study coordinator: Andrea L. Zapcic, BA
  • Email: Andrea@njpn.org
  • Phone: 908-433-2064

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.