Substance-Related DisordersNCT06236100
Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program
A study testing Strengthening Families Program + Family Advocate and Strengthening Families Program in people with Substance-Related Disorders and Adverse Childhood Experiences, run by RTI International at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders, Adverse Childhood Experiences
- What is being tested?
- Strengthening Families Program + Family Advocate and Strengthening Families Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 29 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New Jersey Prevention Network
Tinton Falls, New Jersey, 07724
Andrea Zapcic, Andrea@njpn.org
Brittany Simon, Brittany.Simon@rwjbh.org
About this study
Official title: Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation 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.
Read the detailed 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.
- Being tested
- Strengthening Families Program + Family Advocate, Strengthening Families Program
- 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
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening Families Program + Family AdvocateBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Strengthening Families Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
Secondary outcomes (7)
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.
Measured: Baseline and 6-month post-intervention follow-up
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.
Measured: Baseline and 6-month post-intervention follow-up
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.
Measured: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
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
Measured: Baseline and 6-month post-intervention follow-up
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
Measured: Pre-implementation
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
Measured: Intervention start to intervention completion (ranging from 10 to 14 weeks)
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
Measured: Intervention start to intervention completion (ranging from 10 to 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start29 Nov 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Prevention Network, RWJBarnabas Health Institute for Prevention and Recovery
- Responsible party
- Principal investigator, Dallas Elgin, RTI International
- Investigators
- Phillip W. Graham, DrPH, Principal investigator, RTI InternationalDallas J Elgin, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236100
- Sponsor's protocol ID
- 0218779
- Status last verified
- Apr 2026
- First submitted
- 26 Dec 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elgin D, Graham PW, Johnson K, Khan S, Mills M, Wondimagegnehu F, Gibbons B, Williams J, Jiang X, Zapcic A, Simon B. Evaluating the Combined Effects of an Adverse Childhood Experiences-Focused Family Advocate Model and the Strengthening Families Program: Study Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial in 36 New Jersey Communities. JMIR Res Protoc. 2026 Apr 9;15:e85151. doi: 10.2196/85151.
PubMed 41955537
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT06236100
- Acronym / sponsor ID
- 0218779
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- New Jersey Prevention Network, RWJBarnabas Health Institute for Prevention and Recovery
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening Families Program + Family Advocate | Experimental | Behavioral: Strengthening Families Program + Family AdvocateFamilies 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. |
| Strengthening Families Program-Only | Active comparator | Behavioral: Strengthening Families ProgramFamilies 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening Families Program + Family AdvocateThis 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. | Behavioural | Strengthening Families Program + Family Advocate |
| Strengthening Families ProgramThis 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. | Behavioural | Strengthening Families Program-Only |
Primary outcome
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.
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.
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
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
7 secondary outcomes
ACEs prevalence
Time frame: Baseline and 6-month post-intervention follow-up
Social needs prevalence
Time frame: Baseline and 6-month post-intervention follow-up
Substance use risk
Time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up
System linkages
Time frame: Baseline and 6-month post-intervention follow-up
Average start-up cost
Time frame: Pre-implementation
Intervention cost
Time frame: Intervention start to intervention completion (ranging from 10 to 14 weeks)
Cost per service referral
Time frame: Intervention start to intervention completion (ranging from 10 to 14 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 41955537Elgin D, Graham PW, Johnson K, Khan S, Mills M, Wondimagegnehu F, Gibbons B, Williams J, Jiang X, Zapcic A, Simon B. Evaluating the Combined Effects of an Adverse Childhood Experiences-Focused Family Advocate Model and the Strengthening Families Program: Study Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial in 36 New Jersey Communities. JMIR Res Protoc. 2026 Apr 9;15:e85151. doi: 10.2196/85151.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phillip W. Graham, DrPH principal investigator
RTI International
Dallas J Elgin, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening Families Program + Family Advocate and Strengthening Families Program in people with Substance-Related Disorders and Adverse Childhood Experiences, run by RTI International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea L. Zapcic, BA (908-433-2064, Andrea@njpn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use prevalence (time frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.