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

Conditions

• Adverse Childhood Experiences
• Substance-Related Disorders

Eligibility Criteria

Sex

ALL

Age

7 Years - N/A

Healthy Volunteers

Accepted

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 — 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.

Study Details

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.

Key Dates

Start date

Nov 29, 2023

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Sep 29, 2027

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Strengthening Families Program + Family Advocate
  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.
• Active Comparator: Strengthening Families Program-Only
  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.

Primary Outcome Measure

Substance use prevalence [ Time Frame: Baseline, intervention completion (ranging from 10 to 14 weeks), and 6-month post-intervention follow-up ]

Central Contacts

• Andrea L. Zapcic, BA
  908-433-2064
  [email protected]
• Brittany Simon, MA
  201-218-5551
  [email protected]

Locations (1)

Find similar trials in Tinton Falls, NJ

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