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

项目总结-《妈妈咪呀》研究的行政补充（1R01HD100395 - 01; PI： Kinser） 本行政补充申请是对NOT-OD-21 - 071的回应。母研究总结： 母研究（1R01HD100395 - 01）或"妈妈咪呀研究"是一项大规模多中心随机化研究， 对照试验（RCT），评估基于互联网和移动设备的方法（妈妈咪呀）对 预防和干预围产期抑郁和相关症状，n = 1950名不同妇女， 全国特别是，本纵向多中心三组RCT的目的是比较效果， 并探讨这些影响的中介和主持人，三组：妈妈咪呀（自我指导的互联网/ 基于移动的程序）;妈妈咪呀Plus（自我引导的互联网/基于移动的程序PLUS引导的临床 （三）日常护理。母研究已成功满足研究时间表;我们已入组n = 523 第1年的参与者，预计在管理期间招募n = 600名参与者 补充.行政补充摘要：补充将探讨几个问题， 实现NOT-OD-21 - 071中确定的三个目标，在以下背景下解决孕产妇死亡率和发病率问题： COVID-19大流行：（1）SARS-CoV-2感染如何影响心理健康和 妈妈咪呀研究人群？(2)2019冠状病毒病大流行的影响是否会增加 孕妇和产后妇女的抑郁症状，这种感知的影响是否作为一种 随着时间的推移，干预的效果的调节剂？(3)结构性种族主义的影响是什么， 在COVID-19背景下，研究人群的孕产妇健康结果是否存在歧视？具体地说， 社会人口因素、边缘化和交叉性（例如，种族/民族，教育状况， 就业类型）、背景压力（使用专门针对任职人数偏低的 少数民族妇女），和感知的歧视与抑郁症状的风险， 产后妇女，这些是否会随着时间的推移缓和干预的影响？这些因素是如何 与出生结果、妊娠并发症和/或围产期健康有关（例如，早产，升高 产妇血压，围产期情绪和焦虑）的研究人群？(4)弹性和风险如何 COVID-19大流行背景下的因素（例如，感知应对、经济压力、食物/住房 不安全感、伴侣死亡、家庭暴力）是否影响围产期健康结局？到 为了回答这些问题，我们将在研究小组中增加一名SRD和围产期心理健康专家; 创伤和复原力专家;以及两名顾问/社区伙伴，以加强社区- 参与和解决招聘，保留和研究中的结构性偏见的关键问题， 服务不足的少数民族我们将使用常见的数据元素（例如，DR2，PhenX toolkit） 数据协调，以促进对行为，社会文化和结构因素的了解 在这一大流行病的背景下，影响到与怀孕有关的发病率/死亡率和母婴健康。

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.