Recruiting

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

Sponsor:

RTI International

Code:

NCT06236100

Conditions

Substance-Related Disorders

Adverse Childhood Experiences

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Accepted

Interventions

Strengthening Families Program + Family Advocate

Strengthening Families Program

Study Details

Brief 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.

Conditions

Substance-Related Disorders

Adverse Childhood Experiences

Study ID

NCT06236100

Start date

Nov 29, 2023

Status verified date

Apr, 2026

Completion date

Sep 29, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Strengthening Families Program + Family Advocate

Families in the treatment group will be connected to clinically trained, trauma-informed FAs that will assess and refer families to community services. The intervention will provide wraparound supports to prevent ACEs and substance use and, critically, enable providers and community-based partners to align their services in a way that addresses the social determinants of health and other community-level factors that impact substance use and the relationship between social connection and ACEs. The FA component of the intervention will run concurrent to the Strengthening Families Program 7-17 sessions, with the FAs interacting weekly with families over the 10- to 14-week intervention period. On a weekly basis, FAs will conduct 1-hour, post-session check-ins with each family. This 1-hour period will consist of a 20-minute phone call with families to discuss their needs, with the remaining 40 minutes used to debrief, make service referrals, and complete documentation.

active comparator: Strengthening Families Program-Only

Families in the control group will participate in the Strengthening Families Program 7-17 (SFP7-17) Group Class Curriculum for families with children ages 7-17. Parents and children participate in SFP7-17, both separately and together, as the curriculum has lessons for parents, teens, and children plus a joint Family Practice class. SFP7-17 meetings are 2 hours in length and are typically held in person (but families can participate remotely, during extenuating circumstances) with participating families completing 11 sessions over a 10- to 14-week period.

Interventions

Strengthening Families Program + Family Advocate

This intervention will integrate clinically trained, trauma-informed Family Advocates (FA) into the established, evidence-based Strengthening Families Program (SFP). Families will participate in the SFP7-17 curriculum, which consists of 11 sessions over 10-14 weeks. FAs will assist families in accessing community resources for substance use and Adverse Childhood Experiences (ACE) prevention and treatment.

Strengthening Families Program

This intervention consists of the SFP7-17 Group Class Curriculum. Families will participate in the SFP7-17 curriculum, which consists of 11 sessions over 10-14 weeks.

Primary outcome measure

Substance use prevalence [ Time Frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up ]
Substance use perceptions of harm [ Time Frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up ]
Referrals to clinical services [ Time Frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up ]
Referrals to non-clinical services [ Time Frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up ]

Central Contacts and Locations

Central contacts

Andrea L. Zapcic, BA

908-433-2064 Andrea@njpn.org

Brittany Simon, MA

201-218-5551 Brittany.Simon@rwjbh.org

Locations

New Jersey Prevention Network

Recruiting

Tinton Falls, New Jersey, United States, 07724

Contacts

Andrea Zapcic

Andrea@njpn.org

Brittany Simon

Brittany.Simon@rwjbh.org

Principal Investigator:

Andrea Zapcic

More Information

Sponsor

RTI International

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

Adverse Childhood Experiences
Strengthening Families Program
Family Advocate
Community-level interventions
Hybrid Type 1 Design
Mixed-Method Evaluation
Effectiveness Trial
Cluster Randomized Controlled Trial
Process Evaluation
Cost Evaluation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RTI International on 2026-05-05.