Administrative Supplement: “Mamma Mia”: A multisite randomized controlled trial of an internet-based program for preventing and reducing perinatal depressive symptoms

项目摘要-妈妈咪啊研究行政补充(1R01HD100395-01; PI：

Project Summary - for Administrative Supplement to the Mamma Mia Study (1R01HD100395-01; PI: Kinser) This request for an administrative supplement is in response to NOT-OD-21-071. Summary of Parent Study: The parent study (1R01HD100395-01), or the “Mamma Mia Study”, is a large-scale multi-site randomized controlled trial (RCT) evaluating the effects of an internet and mobile-based approach (Mamma Mia) for preventing and intervening with perinatal depressive and related symptoms in n=1950 diverse women across the country. In particular, the purpose of this longitudinal multisite three-group RCT is to compare the effects, and explore mediators and moderators of these effects, of three groups: Mamma Mia (self-guided internet/ mobile-based program); Mamma Mia Plus (self-guided internet/mobile-based program PLUS guided clinical support); and, usual care. The parent study has successfully met study timelines; we have enrolled n=523 participants in Year 1 and anticipate enrolling n=600 participants during the period of the administrative supplement. Summary of Administrative Supplement: The supplement will explore several questions to address three goals defined in NOT-OD-21-071, addressing maternal mortality and morbidity in the context of the COVID-19 pandemic: (1) How does SARS-CoV-2 infection affect mental health and functioning of the Mamma Mia study population? (2) Does the perceived impact of the COVID-19 pandemic increase risk for depressive symptoms in pregnant and postpartum women, and does this perceived impact serve as a moderator of the effects of the intervention over time? (3) What is the impact of structural racism and discrimination on maternal health outcomes of the study population in the context of COVID-19? Specifically, how do sociodemographic factors, marginalization and intersectionality (e.g., race/ethnicity, education status, type of employment), contextualized stress (using measures designed specifically for underrepresented minority women), and perceived discrimination relate to risk of depressive symptoms in pregnant and postpartum women, and do these moderate the effects of the intervention over time? How do these factors relate to birth outcomes, pregnancy complications, and/or perinatal health (e.g., preterm birth, elevated maternal blood pressure, perinatal mood and anxiety) in the study population? (4) How do resilience and risk factors in the context of the COVID-19 pandemic (e.g., perceived coping, economic stress, food/housing insecurity, death of partner, domestic violence) affect perinatal health outcomes in this study population? To answer these questions, we will add to the research team an expert in SRD and perinatal mental health; an expert in trauma and resilience; and two Consultants/ Community Partners to enhance community- engagement and address key issues of recruitment, retention, and structural bias in research with underserved, minority populations. We will use common data elements (e.g., DR2, PhenX toolkit) for future data harmonization, in order to contribute to knowledge about behavioral, sociocultural, and structural factors that affect pregnancy-related morbidity/mortality and maternal-child health in the context of the pandemic.