Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation
IMPACT
Can an Evidence-Based Mental Health Intervention be Implemented Into Preexisting Home Visiting Programs Using Implementation Facilitation?
4 other identifiers
interventional
1,750
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2024
CompletedFirst Posted
Study publicly available on registry
August 28, 2024
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
April 20, 2026
April 1, 2026
2.9 years
August 22, 2024
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adoption
Percent of home visitors who deliver Mothers and Babies intervention to program recipients
From date of recruitment assessed up to 12 months (3 months postpartum)
Fidelity
Percent of home visitors who deliver all 9 sessions of Mothers and Babies to program recipients
From date of recruitment assessed up to 12 months (3 months postpartum)
Secondary Outcomes (1)
Depressive Symptoms
From date of recruitment assessed up to 12 months (3 months postpartum)
Study Arms (3)
HV Supervisor Refused
NO INTERVENTIONHome visitors outside the trial will receive no implementation support from their supervisors with respect to the Mothers and Babies intervention.
Standard Implementation
ACTIVE COMPARATORControl arm home visitors will receive standard Mothers and Babies implementation support from their supervisors.
Adapted Facilitation
EXPERIMENTALHome 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.
Interventions
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 Mothers and Babies training includes ongoing implementation support from the Mothers and Babies training team
Eligibility Criteria
You may qualify if:
- Affiliated as staff or volunteer with a home visiting program in Iowa or Indiana at the time of enrollment
- Aged 18 years or older
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Indiana Department of Health
Indianapolis, Indiana, 46204, United States
Department of Health and Human Services
Des Moines, Iowa, 50319, United States
Related Publications (1)
Faro EZ, Jones D, Adeagbo M, Cho H, Swartzendruber G, Tabb KM, Tandon SD, Ryckman K. Can an evidence-based mental health intervention be implemented into preexisting home visiting programs using implementation facilitation? Study protocol for a three variable implementation effectiveness context hybrid trial. Implement Sci. 2024 Nov 11;19(1):76. doi: 10.1186/s13012-024-01402-7.
PMID: 39529089DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Elissa Z Faro, PhD
Hackensack Meridian Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2024
First Posted
August 28, 2024
Study Start
April 1, 2026
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
February 28, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ANALYTIC CODE
- Time Frame
- As approved by the NDA
- Access Criteria
- Data will only be accessible to researchers who submit a Data Use Certification (DUC) and who meet the NDA's criteria to request access.
Coded interview/focus group transcript data will be both preserved and shared through relevant publications or other dissemination (e.g., conference presentations). Interview/focus group/observation transcript data will be deposited with NIMH Data Archive (NDA), located within a broad-use permission group where data will only be accessible to researchers who submit a Data Use Certification (DUC) and who meet the NDA's criteria to request access. The DUC includes terms that prohibit the attempt of reidentification. Survey responses will be both preserved and shared. Aggregate data and codebooks will be shared with relevant publications or by the end of the project period. Aggregate data is a dataset comprised of the consolidation of data relating to multiple survey participants, and therefore cannot be traced back to a specific participant. Respondent identifiers will not be shared. De-identified survey data will also be deposited with NDA.