Program to prevent substance use and support families affected by childhood trauma
Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial
NA · RTI International · NCT06236100
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | RTI International (other) |
| Locations | 1 site (Tinton Falls, New Jersey) |
| Trial ID | NCT06236100 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tinton Falls, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Substance-Related Disorders, Adverse Childhood Experiences, Strengthening Families Program, Family Advocate, Community-level interventions, Hybrid Type 1 Design, Mixed-Method Evaluation, Effectiveness Trial