NCT06236100 · RTI International
Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program
What this 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Substance use prevalence
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Measure of substance use prevalence among parents/caregivers and youth derived from 4 questions included on the SFP adult and SFP youth pre-test, post-test, and 6-month follow-up surveys. These 4 questions focus on whether various substances were ever used, used in the past 30 days, on how many day substances were used (if any), and which substances were used.
Substance use perceptions of harm
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Measure of substance use perceptions of harm among parents/caregivers and youth derived from 3 questions included on the SFP adult and SFP youth pre-test, post-test, and 6-month follow-up surveys. These 3 questions focus on perceptions of harm associated with alcoholic beverages, marijuana, and prescription drugs.
Referrals to clinical services
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Measure of rate of referrals to clinical services among participating families using the study's Weekly Clinical and Non-Clinical Services Referral Log
Referrals to non-clinical services
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Measure of rate of referrals to non-clinical services among participating families using the study's Weekly Clinical and Non-Clinical Services Referral Log
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Tinton Falls, New Jersey
Collaborators
New Jersey Prevention Network, RWJBarnabas Health Institute for Prevention and Recovery
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations