Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Early exposure to Adverse Childhood Experiences (ACEs), such as parental substance use, increases the likelihood of future substance use and drug overdose, resulting in an intergenerational cycle of substance-related ACEs that can continue indefinitely if left uninterrupted. Community-level interventions may moderate the relationship between ACEs and substance use by providing an array of family support services and treatments to reduce disparities and improve reach and service linkages in the community. Although research suggests that effectively decreasing the prevalence and impact of ACEs and substance use requires addressing both family- and community-level factors in tandem, there is a critical gap within the evidence base pertaining to interventions that effectively integrate the two factors to prevent substance use and ACEs. RTI International and its partners, the New Jersey Prevention Network and RWJBarnabas Health, will evaluate an intervention integrating New Jersey's established, evidence-based Strengthening Families Program (SFP) with clinically trained, trauma-informed Family Advocates (FAs) who will assist families (i.e., parents/caregivers and youth between the ages of 12 and17) in accessing community resources. Specifically, this study will use a Hybrid Type 1 effectiveness-implementation design across 36 New Jersey communities experiencing a disproportionate burden of substance use and ACEs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06236100
Study type Interventional
Source RTI International
Contact Andrea L. Zapcic, BA
Phone 908-433-2064
Email Andrea@njpn.org
Status Recruiting
Phase N/A
Start date November 29, 2023
Completion date September 29, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT05054738 - CRP and S&A for Inpatient Veterans N/A
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Completed NCT02233738 - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services N/A
Enrolling by invitation NCT06084221 - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems N/A
Completed NCT02907944 - Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation N/A
Completed NCT02570360 - Exercise and Treatment-as-usual in Substance Use Treatment Outcomes N/A
Completed NCT02829970 - Helping College Students With ADHD Lead Healthier Lifestyles N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT02125539 - Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment Phase 2
Completed NCT02388243 - The Computer-based Drug and Alcohol Training Assessment in Kenya N/A
Completed NCT02715557 - Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers N/A
Completed NCT02218970 - The Effect of Muscular Strength Training in Patients With Drug Addiction N/A
Completed NCT01633138 - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy N/A
Completed NCT01591239 - Home-Based Program to Help Parents of Drug Abusing Adolescents N/A
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Withdrawn NCT01224002 - A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine N/A
Withdrawn NCT00891631 - Primary Care iSBIRT to Reduce Serious Teen Health Risks Phase 1/Phase 2
Completed NCT01365247 - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00970372 - Dual-Diagnosis and Compulsory Treatment N/A
Completed NCT00419029 - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment N/A