Evaluating the Combined Effects of an ACEs-Focused Family Advocate Model and the Strengthening Families Program: Study Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial in 36 New Jersey Communities (Preprint)

<sec> <title>BACKGROUND</title> Early exposure to adverse childhood experiences (ACEs), such as parental substance use, elevates the risk of future substance use and drug overdose and in the absence of intervention could perpetuate a cycle of substance-related ACEs across generations. Although research suggests that effectively decreasing the prevalence and impact of ACEs and substance use can benefit from addressing both family- and community-level factors in tandem, there is a critical gap in the evidence base pertaining to interventions that effectively integrate these two factors to prevent substance use and ACEs. </sec> <sec> <title>OBJECTIVE</title> This study aims to conduct a rigorous evaluation of a novel intervention that integrates the established, evidence-based Strengthening Families Program with clinically trained, trauma-informed Family Advocates who will assist families in accessing resources related to ACEs and social determinants of health. </sec> <sec> <title>METHODS</title> This study uses a hybrid type 1 effectiveness-implementation trial design, which is used to test a clinical intervention while gathering information on its delivery during the effectiveness trial and on the potential for implementation in real-world settings. Our hybrid type 1 design consists of three components. A cluster-randomized controlled trial will be used to test the effectiveness of the intervention on substance use, overdose, and ACEs in 36 New Jersey communities. A robust process evaluation informed by the Consolidated Framework for Implementation Research will be used to explore implementation barriers and facilitators. A cost evaluation will be conducted to accurately estimate the costs required to implement the intervention components and assess the cost-effectiveness of the intervention. </sec> <sec> <title>RESULTS</title> Funding was awarded in 2022 and institutional review board approval in November 2023. Intervention and evaluation development lasted approximately 1 year, with study partners engaged in the co-design process to ensure alignment with the principles of community-placed behavioral health research. Study recruitment began in November 2023 and is anticipated to continue until September 2026. Final data collection is anticipated by March 2027, followed by data analysis. </sec> <sec> <title>CONCLUSIONS</title> This study evaluates a novel intervention that integrates New Jersey’s established, evidence-based Strengthening Families Program with clinically trained, trauma-informed Family Advocates who will assist families in accessing community resources. By evaluating both family- and community-level outcomes through a hybrid type 1 design, the study bridges a key gap in the evidence base and provides a framework for combining multilevel interventions to reduce the long-term impacts of ACEs and substance use on youth and families. Future findings will provide critical insight related to intervention effectiveness, implementation barriers and facilitators, and the intervention’s associated costs and cost-effectiveness. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov registration number: NCT06236100 (Date of registration: 02/01/2024) </sec>