Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Substance use prevalence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Substance use prevalence
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- System linkages(Baseline and 6-month post-intervention follow-up)
- Cost per service referral(Intervention start to intervention completion (ranging from 10 to 14 weeks))
- ACEs prevalence(Baseline and 6-month post-intervention follow-up)
- Social needs prevalence(Baseline and 6-month post-intervention follow-up)
- Substance use risk(Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up)
- Average start-up cost(Pre-implementation)
- Intervention cost(Intervention start to intervention completion (ranging from 10 to 14 weeks))