Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Hackensack Meridian Health
Study ID
NCT06575894
Status
Enrolling By Invitation

Conditions

  • Mental Health Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adapted Facilitation — BEHAVIORAL
    Home visiting supervisor trained in adapted facilitation will employ interactive problem-solving focused on supporting the home visitors to implement Mothers and Babies - working with pregnant people, challenges with resources, additional training needs, etc. - based on understanding the individual communities, contexts, and recipients' and home visitors' needs over the course of the project.
  • Standard Implementation — BEHAVIORAL
    Standard Mothers and Babies training includes ongoing implementation support from the Mothers and Babies training team

Study Details

Depression and anxiety during and after pregnancy are common medical complications contributing to a rising maternal mortality rate. Home visiting programs can offer evidence-based interventions to improve mental health outcomes for a vulnerable pregnant population; however, barriers remain to achieving the full potential of these interventions. Our work will explore the impact of context on the implementation of a mental health intervention to provide action-based and impactful data that focuses on the lived experiences of the diverse populations served by home visiting programs in Iowa and Indiana.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
1,750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: HV Supervisor Refused
    Home visitors outside the trial will receive no implementation support from their supervisors with respect to the Mothers and Babies intervention.
  • Active Comparator: Standard Implementation
    Control arm home visitors will receive standard Mothers and Babies implementation support from their supervisors.
  • Experimental: Adapted Facilitation
    Home visitors in the adapted facilitation group will receive standard Mothers and Babies support plus adapted facilitation delivered by home visiting supervisors trained in adapted implementation facilitation.

Primary Outcome Measure

Adoption [ Time Frame: From date of recruitment assessed up to 12 months (3 months postpartum) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana Department of HealthIndianapolisIndiana46204-
Department of Health and Human ServicesDes MoinesIowa50319-

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