Protocol for a randomized controlled trial of the Mommy&Me study: A multi-modal approach to address social determinants of health and mental health among low-income Black perinatal populations.

Background: Mental health disorders, including stress, anxiety, and depression, are the most common complications during pregnancy, with significant racial disparities in prevalence and access to care. Low-income Black/African American/of African descent (Black) individuals are at greater risk for perinatal mental health issues and face more obstacles to care due to a variety of barriers, including poor implementation of screening protocols, stigma, adverse experiences of social determinants of health, and distrust of healthcare systems. These disparities are particularly striking in Washington, DC, and worsened during the COVID-19 pandemic. Methods: This study has two aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) prevention and treatment intervention for low-income Black pregnant women; and (2) to determine the effectiveness of multiple interventions: patient navigation, culturally adapted CBT, and/or peer support groups versus usual care for pregnant individuals at subthreshold and threshold risk for prenatal stress, depression and/or anxiety in a two-arm prospective longitudinal randomized controlled study. Outcomes will be tracked from pregnancy through 12 months postpartum, assessing maternal mental health, engagement with the intervention, healthcare experiences and utilization, and infant outcomes. Conclusions: If found to be efficacious, results will help develop scalable, culturally relevant interventions aimed at reducing racial disparities in maternal mental health care and improving health outcomes for both mothers and infants. Trial registration: ClinicalTrials.gov ID NCT05345834.