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NCT Number: NCT06236100

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

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.

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Key information

Conditions

Substance-related Disorders Adverse Childhood Experiences Chemically-Induced Disorders Mental Disorders

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Jersey Prevention Network

Tinton Falls, New Jersey, 07724, United States

Location status: Recruiting

Location contact

Andrea Zapcic

CONTACT

[email protected]

Andrea Zapcic

PRINCIPAL_INVESTIGATOR

Brittany Simon

CONTACT

[email protected]

Brittany Simon

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

Primary outcomes

  1. Substance use prevalence

    Time frame: 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.

  2. Substance use perceptions of harm

    Time frame: 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.

  3. Referrals to clinical services

    Time frame: 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

  4. Referrals to non-clinical services

    Time frame: 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

Secondary outcomes

  1. ACEs prevalence

    Time frame: Baseline and 6-month post-intervention follow-up

    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.

  2. Social needs prevalence

    Time frame: Baseline and 6-month post-intervention follow-up

    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.

  3. Substance use risk

    Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up

    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.

  4. System linkages

    Time frame: Baseline and 6-month post-intervention follow-up

    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

  5. Average start-up cost

    Time frame: Pre-implementation

    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

  6. Intervention cost

    Time frame: Intervention start to intervention completion (ranging from 10 to 14 weeks)

    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

  7. Cost per service referral

    Time frame: Intervention start to intervention completion (ranging from 10 to 14 weeks)

    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

Other outcomes

  1. Service utilization

    Time frame: Baseline and 6-month post-intervention follow-up

    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

  2. Treatment/service adherence

    Time frame: Baseline and 6-month post-intervention follow-up

    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

  3. Lessons learned (process evaluation)

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

    Lessons learned related to implementing the intervention using data from the Post-Trial Focus Groups and Prevention Agency Program Lead Interviews

  4. Social connectedness across systems (process evaluation)

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea L. Zapcic, BA

CONTACT

[email protected]

908-433-2064

Brittany Simon, MA

CONTACT

[email protected]

201-218-5551

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • New Jersey Prevention Network
  • RWJBarnabas Health Institute for Prevention and Recovery

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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