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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
360
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.
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.
New Jersey Prevention Network
Tinton Falls, New Jersey, United States
RECRUITINGSubstance use prevalence
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.
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Substance use perceptions of harm
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.
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Referrals to clinical services
Measure of rate of referrals to clinical services among participating families using the study's Weekly Clinical and Non-Clinical Services Referral Log
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Referrals to non-clinical services
Measure of rate of referrals to non-clinical services among participating families using the study's Weekly Clinical and Non-Clinical Services Referral Log
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
ACEs prevalence
Measure of ACEs prevalence among parents/caregivers and youth in participating families using 3 questions from the study's pre-test and 6-month post-test ACEs/Social Needs Screener. These 3 questions focus on the prevalence of the three main ACEs categories of abuse, neglect, and household challenges.
Time frame: Baseline and 6-month post-intervention follow-up
Social needs prevalence
Measure of social needs prevalence among parents/caregivers and youth in participating families using 18 questions from the study's pre-test and 6-month post-test ACEs/Social Needs Screener. These 18 questions correspond to 5 social determinants of health domains (including house, food security, transportation, finances, and personal safety) from the American Academy of Family Physicians' social determinants of health screening tool.
Time frame: Baseline and 6-month post-intervention follow-up
Substance use risk
Measure of substance use risk 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 ease of access to different types of substances that may increase risk of substance use.
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
System linkages
Measures of change in clinical and non-clinical referral networks (such as changes in network size, edges, density, centrality, reciprocity, triadic closure, and assortativity) using questions included on the study's pre-test and 6-month post-test community service provider survey
Time frame: Baseline and 6-month post-intervention follow-up
Average start-up cost
Measure of average cost per agency of starting up a program to deliver the intervention or active comparator using data from the study's Costing Instrument and Interview and administrative data from the New Jersey Prevention Network
Time frame: Pre-implementation
Intervention cost
Measure of intervention cost at the participant level of delivering the intervention or active comparator using data from the study's Costing Instrument and Interview, 4 questions from the Intervention Cost Survey for SFP Facilitators, and 2 questions from the Intervention Cost Survey for Family Advocates
Time frame: Intervention start to intervention completion (ranging from 10 to 14 weeks)
Cost per service referral
Measure of cost per service referral at the participant level using data from outcomes 6, 7, and 12, comparing cost per service referral for treatment and active comparator
Time frame: Intervention start to intervention completion (ranging from 10 to 14 weeks)
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