Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7+
SponsorRTI International
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
One or more adult caregivers
One or more adolescents, ages 7 to 17
Caregiver provision of signed and dated informed consent form
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Strengthening Families Program + Family Advocate
BehavioralThis 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
BehavioralThis 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Strengthening Families Program + Family AdvocateExperimental treatment 1 intervention
Group B: Strengthening Families Program-OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up2
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.
Time frame
Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up3
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
Time frame
Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up4
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
Time frame
Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-upSecondary outcomes
1
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.
Time frame
Baseline and 6-month post-intervention follow-up2
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.
Time frame
Baseline and 6-month post-intervention follow-up3
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.
Time frame
Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up4
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
Time frame
Baseline and 6-month post-intervention follow-upOther outcomes
1
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
Time frame
Baseline and 6-month post-intervention follow-up2
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
Time frame
Baseline and 6-month post-intervention follow-up3
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
Time frame
Pre-implementation to intervention completion (ranging from 10 to 14 weeks)4
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
Time frame
Pre-implementation to intervention completion (ranging from 10 to 14 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
RTI International
Lead sponsor
New Jersey Prevention Network
Collaborator
RWJBarnabas Health Institute for Prevention and Recovery
Collaborator
Source ClinicalTrials.gov