Clinical trial NCT06575894: Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation
Official title: Can an Evidence-Based Mental Health Intervention be Implemented Into Preexisting Home Visiting Programs Using Implementation Facilitation?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Disorder
Keywords: perinatal
home visiting
context
ethnography
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-08-28
Enrollment: 1750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Exclusion criteria:

- No exclusion criteria.

Primary outcomes:
measure: Adoption
timeFrame: From date of recruitment assessed up to 12 months (3 months postpartum)
measure: Fidelity
timeFrame: From date of recruitment assessed up to 12 months (3 months postpartum)
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: From date of recruitment assessed up to 12 months (3 months postpartum)
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Elissa Z Faro, PhD
role: PRINCIPAL_INVESTIGATOR
References: