Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236100
• Other study ID #: 0218779
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: September 29, 2027

Study information

• Verified date: January 2024
• Source: RTI International
• Contact: Andrea L. Zapcic, BA
• Phone: 908-433-2064
• Email: Andrea[@]njpn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Substance-Related Disorders

Intervention

Behavioral:
• Strengthening Families Program + Family Advocate
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.
• Strengthening Families Program
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.

Locations

Country	Name	City	State
United States	New Jersey Prevention Network	Tinton Falls	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
RTI International	New Jersey Prevention Network, RWJBarnabas Health Institute for Prevention and Recovery

Country where clinical trial is conducted

United States, 

Outcome

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)