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

NCT ID: NCT06575894

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-15
• Study Completion Date: 2029-05-01

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.

Detailed Description

Perinatal mental health conditions are the most common complication of pregnancy and childbirth (1 in 8 women). When left untreated, perinatal depression and anxiety adversely affects the entire family with pregnancy complications and negative outcomes including preterm birth, impaired mother-infant bonding, impaired lactation, substance abuse, divorce, suicide, and infanticide. Despite this, significant gaps persist in the diagnosis and treatment of perinatal depression and anxiety. Preliminary research with stakeholders including community advisory boards, underrepresented groups, and state departments of health, demonstrates the importance of social support as a mechanism for improving perinatal depression, particularly in rural geographies. Home visiting programs (HVPs) can provide the social support needed to improve mental health outcomes in pregnant and postpartum women.

Using the strategy of implementation facilitation, our proposed study will engage multilevel stakeholders (e.g., policymakers, front-line implementers, and intervention recipients) to adapt facilitation to integrate a maternal mental health intervention across two midwestern, rural states (Iowa and Indiana) with multiple HVP models. Given the complexity and heterogeneity of the contexts in which Mothers and Babies will be integrated, a three variable hybrid implementation-effectiveness-context trial will test the adapted facilitation strategy compared with implementation as usual (i.e., standard education) and will assess contextual factors related to the outcomes. Using an evidence-based implementation strategy that tailors implementation delivery to the needs of the specific populations and context may improve fidelity and adoption, particularly in rural states where residents have limited access to care.

The immediate impact of this research will be to show whether adapted facilitation can improve the uptake and fidelity of a maternal mental health intervention like Mothers and Babies across multiple HVP models and thus positively affect depressive symptoms and perceived stress of recipients. Further, our implementation protocol can be used by other states to better integrate other evidence-based interventions into public health programs, leading to further improvements in maternal mental health, better access, and further reductions in adverse outcomes for mothers, children, and families.

Conditions

Mental Health Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

HV Supervisor Refused

Home visitors outside the trial will receive no implementation support from their supervisors with respect to the Mothers and Babies intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard Implementation

Control arm home visitors will receive standard Mothers and Babies implementation support from their supervisors.

Group Type: ACTIVE_COMPARATOR

Standard Implementation

Intervention Type: BEHAVIORAL

Standard Mothers and Babies training includes ongoing implementation support from the Mothers and Babies training team

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.

Group Type: EXPERIMENTAL

Adapted Facilitation

Intervention Type: 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.

Interventions

Adapted Facilitation

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.

Intervention Type: BEHAVIORAL

Standard Implementation

Standard Mothers and Babies training includes ongoing implementation support from the Mothers and Babies training team

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Affiliated as staff or volunteer with a home visiting program in Iowa or Indiana at the time of enrollment
• Aged 18 years or older

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elissa Z Faro, PhD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Central Contacts

Elissa Z Faro, PhD

Role: CONTACT

elissa.faro@hmh-cdi.org

201-880-3100

Kelli Ryckman, PhD

Role: CONTACT

kryckman@iu.edu

References

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.

Reference Type: DERIVED

PMID: 39529089 (View on PubMed)

Other Identifiers

1R01MH134474-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2025-0522

Identifier Type: OTHER

Identifier Source: secondary_id

28141

Identifier Type: OTHER

Identifier Source: secondary_id

202312148

Identifier Type: -

Identifier Source: org_study_id