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

NCT06236100 | Recruiting

• 1 other identifier: 0218779
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• 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

• System linkages

  Baseline and 6-month post-intervention follow-up

• Average start-up cost

  Pre-implementation

Other Outcomes (4)

• Service utilization

  Baseline and 6-month post-intervention follow-up

• Treatment/service adherence

  Baseline and 6-month post-intervention follow-up

• Lessons learned (process evaluation)

  Pre-implementation to intervention completion (ranging from 10 to 14 weeks)

Study Arms (2)

Strengthening Families Program + Family Advocate

EXPERIMENTAL

Families in the treatment group will be connected to clinically trained, trauma-informed FAs that will assess and refer families to community services. The intervention will provide wraparound supports to prevent ACEs and substance use and, critically, enable providers and community-based partners to align their services in a way that addresses the social determinants of health and other community-level factors that impact substance use and the relationship between social connection and ACEs. The FA component of the intervention will run concurrent to the Strengthening Families Program 7-17 sessions, with the FAs interacting weekly with families over the 10- to 14-week intervention period. On a weekly basis, FAs will conduct 1-hour, post-session check-ins with each family. This 1-hour period will consist of a 20-minute phone call with families to discuss their needs, with the remaining 40 minutes used to debrief, make service referrals, and complete documentation.

Behavioral: Strengthening Families Program + Family Advocate

Strengthening Families Program-Only

ACTIVE COMPARATOR

Families in the control group will participate in the Strengthening Families Program 7-17 (SFP7-17) Group Class Curriculum for families with children ages 7-17. Parents and children participate in SFP7-17, both separately and together, as the curriculum has lessons for parents, teens, and children plus a joint Family Practice class. SFP7-17 meetings are 2 hours in length and are typically held in person (but families can participate remotely, during extenuating circumstances) with participating families completing 11 sessions over a 10- to 14-week period.

Behavioral: Strengthening Families Program

Interventions

Strengthening Families Program + Family Advocate BEHAVIORAL

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 + Family Advocate

Strengthening Families Program BEHAVIORAL

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.

Strengthening Families Program-Only

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• RWJBarnabas Health Institute for Prevention and Recovery: collaborator
• RTI International: lead
• New Jersey Prevention Network: collaborator

Study Sites (1)

New Jersey Prevention Network

Tinton Falls, New Jersey, 07724, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Phillip W. Graham, DrPH

  RTI International

  PRINCIPAL INVESTIGATOR

• Dallas J Elgin, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea L. Zapcic, BA

CONTACT

908-433-2064; Andrea@njpn.org

Brittany Simon, MA

CONTACT

201-218-5551; Brittany.Simon@rwjbh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Public Health Analyst

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: February 1, 2024
• Study Start: November 29, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): September 29, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)