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

Not Applicable

Not yet recruiting

• Conditions: Mental Health Disorder

• Registration Number: NCT06575894
• Lead Sponsor: University of Iowa

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.

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-08
• Study Start: 2025-07-01
• Primary Completion: 2028-05-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1750

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fidelity	From date of recruitment assessed up to 12 months (3 months postpartum)	Percent of home visitors who deliver all 9 sessions of Mothers and Babies to program recipients
Adoption	From date of recruitment assessed up to 12 months (3 months postpartum)	Percent of home visitors who deliver Mothers and Babies intervention to program recipients

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms	From date of recruitment assessed up to 12 months (3 months postpartum)	Program recipient scores on the Edinburgh Postnatal Depression Scale (Scores range from 0-30; a score of more than 10 suggests minor or major depression may be present.)