Substance-Related Disorders Clinical Trial
Official title:
Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial
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.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | September 29, 2027 |
Est. primary completion date | October 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years and older |
Eligibility | 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, smartphone, 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) |
Country | Name | City | State |
---|---|---|---|
United States | New Jersey Prevention Network | Tinton Falls | New Jersey |
Lead Sponsor | Collaborator |
---|---|
RTI International | New Jersey Prevention Network, RWJBarnabas Health Institute for Prevention and Recovery |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Service utilization | Referred service utilization rates among participating families in the treatment and active comparator using data from the SFP adult and SFP youth post-test, and 6-month follow-up surveys | Baseline and 6-month post-intervention follow-up | |
Other | Treatment/service adherence | Referred treatment/service adherence rates among participating families in the treatment and active comparator using data from the SFP adult and SFP youth post-test, and 6-month follow-up surveys | Baseline and 6-month post-intervention follow-up | |
Other | Lessons learned (process evaluation) | Lessons learned related to implementing the intervention using data from the Post-Trial Focus Groups and Prevention Agency Program Lead Interviews | Pre-implementation to intervention completion (ranging from 10 to 14 weeks) | |
Other | Social connectedness across systems (process evaluation) | Extent that implementation of the intervention facilitates increased cross-system coordination and communication among the agencies that support families using data from the Post-Trial Focus Groups and Prevention Agency Program Lead Interviews | Pre-implementation to intervention completion (ranging from 10 to 14 weeks) | |
Primary | Substance 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. | Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up | |
Primary | 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. | Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up | |
Primary | 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 | Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up | |
Primary | 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 | Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up | |
Secondary | 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. | Baseline and 6-month post-intervention follow-up | |
Secondary | 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. | Baseline and 6-month post-intervention follow-up | |
Secondary | 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. | Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up | |
Secondary | 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 | Baseline and 6-month post-intervention follow-up | |
Secondary | 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 | Pre-implementation | |
Secondary | 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 | Intervention start to intervention completion (ranging from 10 to 14 weeks) | |
Secondary | 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 | Intervention start to intervention completion (ranging from 10 to 14 weeks) |
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