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

BackgroundPerinatal 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. Significant disparities persist in the diagnosis and treatment of perinatal depression and anxiety and these inequities are often intersectional. Preliminary research with stakeholders including community advisory boards, underrepresented and minority birthing people, and state departments of health, demonstrates the importance of social support as a mechanism for reducing disparities in 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. Our project aims to explore the impact of context on the implementation of a mental health intervention, focusing on the lived experiences of diverse populations served by HVPs to reduce disparities in adverse maternal outcomes.MethodsUsing implementation facilitation, our study will engage multilevel stakeholders (e.g., policymakers, front-line implementers, and intervention recipients) to adapt facilitation to integrate a maternal mental health intervention (i.e., Mothers and Babies) 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.DiscussionThe immediate impact of this research will be to show whether adapted facilitation can improve the uptake and fidelity of Mothers and Babies across multiple HVP models and thus positively affect depressive symptoms and perceived stress of recipients. Our implementation protocol may be used by researchers, practitioners, and policy makers to better integrate evidence-based interventions into diverse contexts, leading to more equitable implementation and improved health outcomes.Trial registrationClinicalTrials.gov Identifier: NCT06575894, registered on August 29, 2024 https://clinicaltrials.gov/study/NCT06575894?id=NCT06575894&rank=1.