Clinical trial NCT06236100: Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program
Official title: Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance-Related Disorders
Adverse Childhood Experiences
Keywords: Adverse Childhood Experiences
Strengthening Families Program
Family Advocate
Community-level interventions
Hybrid Type 1 Design
Mixed-Method Evaluation
Effectiveness Trial
Cluster Randomized Controlled Trial
Process Evaluation
Cost Evaluation
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: New Jersey Prevention Network
name: RWJBarnabas Health Institute for Prevention and Recovery
First posted: 2024-02-01
Enrollment: 360
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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, smart phone, 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)

Primary outcomes:
measure: Substance use prevalence
timeFrame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
measure: Substance use perceptions of harm
timeFrame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
measure: Referrals to clinical services
timeFrame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
measure: Referrals to non-clinical services
timeFrame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Secondary outcomes:
measure: ACEs prevalence
timeFrame: Baseline and 6-month post-intervention follow-up
measure: Social needs prevalence
timeFrame: Baseline and 6-month post-intervention follow-up
measure: Substance use risk
timeFrame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
measure: System linkages
timeFrame: Baseline and 6-month post-intervention follow-up
measure: Average start-up cost
timeFrame: Pre-implementation
measure: Intervention cost
timeFrame: Intervention start to intervention completion (ranging from 10 to 14 weeks)
measure: Cost per service referral
timeFrame: Intervention start to intervention completion (ranging from 10 to 14 weeks)
Other outcomes:
measure: Service utilization
timeFrame: Baseline and 6-month post-intervention follow-up
measure: Treatment/service adherence
timeFrame: Baseline and 6-month post-intervention follow-up
measure: Lessons learned (process evaluation)
timeFrame: Pre-implementation to intervention completion (ranging from 10 to 14 weeks)
measure: Social connectedness across systems (process evaluation)
timeFrame: Pre-implementation to intervention completion (ranging from 10 to 14 weeks)
Locations:
city: Tinton Falls
country: United States
facility: New Jersey Prevention Network
state: New Jersey
Study officials:
affiliation: RTI International
name: Phillip W. Graham, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Dallas J Elgin, PhD
role: PRINCIPAL_INVESTIGATOR
References: