Abstract / Summary
Perinatal mental health conditions are among the most common and consequential complications of pregnancy, associated with maternal mortality rates and health disparities, particularly among Black, Indigenous, and People of Color (BIPOC) populations. Home visiting programs (HVPs) are a widely available but underutilized platform for delivering evidence-based perinatal mental health services. Mothers and Babies is a cognitive-behavioral intervention with a strong evidence base for reducing perinatal depressive symptoms, yet uptake across the heterogeneous landscape of HVPs remains limited by contextual, structural, and workforce-related barriers. This paper describes a community- and partner-driven formative evaluation used to adapt an implementation facilitation strategy across diverse HVP contexts as part of a hybrid implementation-effectiveness-context cluster randomized controlled trial (cRCT). We conducted a multi-component formative evaluation using implementation mapping as a structured, participatory framework, including semi-structured interviews with BIPOC birthing people (n=9), a landscape analysis identifying 509 HVPs across both states, and a survey completed by 72 HVPs. We convened two in-person Community Coalition meetings with home visitors, supervisors, program directors, mental health providers, and state Department of Health representatives, and three virtual meetings with an Iowa HVP Parent Expert Panel, including one in Spanish. Nominal Group Technique structured determinant prioritization, informing co-development of performance objectives and a matrix of change. Participants identified determinants spanning workforce capacity, system integration, training needs, and client trust. Priorities differed by state: Indiana participants emphasized overcoming logistical barriers such as workload and procedural integration, while Iowa participants prioritized leveraging training infrastructure, communication systems, and mental health consultation. Parent Expert Panels highlighted trust, stigma reduction, flexible scheduling, and personalized support. Triangulation produced a matrix of change organized around four performance outcomes: Professional Development and Staff Growth; Integration into Current System of Implementation; Staff Understand the Importance of Mental Health; and Building Client Trust and Rapport — informing the IMPACT Implementation Support Package. A community- and partner-engaged, multi-method formative evaluation can identify context-specific implementation determinants and translate them into actionable tools for scaling evidence-based mental health services within existing health systems — offering a structured approach for service planners and researchers working across heterogeneous community health settings. NCT06575894, registered 29 August 2024 at ClinicalTrials.gov ( https://clinicaltrials.gov/study/NCT06575894 ). This formative evaluation was conducted as the first phase of a trial registered at ClinicalTrials.gov (NCT06575894; registered 29 August 2024).