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--《妈妈咪呀研究》行政副刊(1R01HD100395-01；PI： Kinser) 这一行政补充请求是对NOT-OD-21-071号文件的回应。家长研究总结： 母体研究(1R01HD100395-01)，或“妈妈咪呀研究”，是一项大规模的多点随机研究 对照试验(RCT)评估基于互联网和移动的方法(Mamma Mia)对 1950名不同类型妇女围产期抑郁及相关症状的预防和干预 这个国家。特别是，这种纵向多点三组RCT的目的是比较效果， 并探索这些影响的中介者和调节者，分为三组：妈妈咪呀(自我引导的互联网/ 基于移动的计划)；Mamma Mia Plus(自我引导的互联网/基于移动的计划加上指导临床 支持)；以及，通常的护理。母研究已成功满足研究时间表；我们已招收n=523人 第一年的参与者，预计在行政期间招收n=600名参与者 副刊。行政副刊综述：副刊将探讨以下几个问题 处理NOT-OD-21-071中定义的三个目标，在以下情况下处理孕产妇死亡率和发病率 新冠肺炎大流行：(1)感染SARS-CoV-2如何影响心理健康和心理健康 母婴传播研究人群？(2)新冠肺炎大流行的感知影响是否增加了 孕妇和产后妇女的抑郁症状，以及这种感知的影响是否作为一种 随着时间的推移，干预的效果是什么？(3)结构性种族主义和 新冠肺炎背景下研究人群对孕产妇健康结果的歧视？具体来说， 社会人口因素、边缘化和交叉性(例如，种族/族裔、教育状况、 就业类型)、背景压力(使用专门为任职人数不足而设计的措施 少数族裔妇女)，以及感觉到的歧视与孕妇和 产后妇女，随着时间的推移，这些是否会缓和干预的效果？这些因素是如何 与出生结局、妊娠并发症和/或围产期健康有关(例如，早产、高危 母体血压、围产期情绪和焦虑)在研究人群中？(4)弹性和风险如何 新冠肺炎大流行背景下的因素(例如，感知的应对方式、经济压力、食物/住房 不安全感、伴侣死亡、家庭暴力)会影响该研究人群的围产期健康结果吗？至 回答这些问题，我们将为研究团队增加一名SRD和围产期心理健康方面的专家；以及 创伤和复原力专家；以及两名顾问/社区合作伙伴，以加强社区- 参与并解决研究中的招聘、保留和结构性偏差等关键问题 服务不足的少数族裔人口。我们将在未来使用通用数据元素(例如DR2、PhenX工具包 数据协调，以促进有关行为、社会文化和结构因素的知识 在大流行的背景下影响与怀孕有关的发病率/死亡率和母婴健康的疾病。

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.