RecruitingNot ApplicableNCT06236100

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

Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial

Sponsor

RTI International

Enrollment

360 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 7 Years

Inclusion Criteria9

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 Criteria3

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)

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Interventions

BEHAVIORALStrengthening 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.

BEHAVIORALStrengthening 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.