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

行政补充：《妈妈咪呀》：预防和减少围产期抑郁症状的基于互联网的计划的多中心随机对照试验

• 批准号: 10382034
• 负责人: Patricia Anne Kinser
• 金额: $ 25.17万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10382034
• 关键词: Address; Administrative Supplement; Affect; Anxiety; Behavioral; Birth; Blood Pressure; COVID-19; COVID-19 pandemic; Cessation of life; Clinical; Common Data Element; Communities; Country; Discrimination; Domestic Violence; Economics; Education; Employment; Enrollment; Ethnic Origin; Food; Future; Goals; Health; Housing; Internet; Knowledge; Maternal Health; Maternal Mortality; Maternal and Child Health; Measures; Mediator of activation protein; Mental Health; Minority Groups; Moods; Morbidity - disease rate; Outcome; Outcome Study; Parents; Participant; Perinatal; PhenX Toolkit; Postpartum Women; Pregnancy; Pregnancy Complications; Pregnant Women; Premature Birth; Race; Randomized Controlled Trials; Registries; Research; Risk; Risk Factors; SARS-CoV-2 infection; Site; Stress; Structural Racism; Structure; Symptoms; Time; TimeLine; Trauma; Underrepresented Minority; Woman; base; coping; data harmonization; depressive symptoms; design; intersectionality; intervention effect; maternal morbidity; mental function; mortality; pandemic disease; perinatal depressive symptom; perinatal health; perinatal mental health; prevent; programs; recruit; resilience; response; social culture; social exclusion; sociodemographic factors; study population; treatment as usual; underserved minority

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.

项目摘要 - 用于Mamma Mia研究的行政补充（1R01HD100395-01; PI： Kinser） 此要求对行政补充的要求是对NOT-OD-21-071的响应。父母研究摘要： 家长研究（1R01HD100395-01）或“妈妈MIA研究”是一个大规模的多站点随机分组 对照试验（RCT）评估Internet和基于移动的方法（Mamma MIA）的影响 防止和干预n = 1950 Divers妇女的围产期抑郁症状和相关症状 这个国家。特别是，这种纵向多站点三组RCT的目的是比较效果， 并探索这些效果的调解人和主持人，分为三个组：妈妈米娅（自指导的互联网/ 基于移动的程序）； Mamma Mia Plus（基于互联网/移动的程序以及指导临床 支持）;而且，通常的照顾。家长研究成功地符合研究时间表。我们已经注册n = 523 1年级的参与者预计将在行政期间注册n = 600名参与者 补充。行政补充摘要：该补充剂将探讨几个问题 解决NOT-OD-21-071中定义的三个目标，以解决在 19009大流行：（1）SARS-COV-2感染如何影响心理健康和功能 妈妈Mia研究人群？ （2）COVID-19的大流行的影响是否增加了风险 孕妇和产后妇女的抑郁症状，这种感知的影响确实可以作为 随着时间的流逝，干预效果的主持人？ （3）结构种族主义和 在Covid-19的背景下，研究人群的孕产妇健康结果的歧视？具体来说， 社会人口统计学因素，边缘化和交叉性如何（例如种族/种族，教育地位， 就业类型），情境化压力（使用专门为代表性不足设计的措施 少数民族妇女）和感知的歧视与怀孕和 产后妇女，这些对这些干预的影响是否随着时间的推移而现代？这些因素如何 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 研究人群中的孕产妇血压，围产期情绪和焦虑）？ （4）弹性和风险如何 在COVID-19大流行的背景下 不安全感，伴侣的死亡，家庭暴力）在这项研究人群中影响围产期健康结果？到 回答这些问题，我们将为研究团队提供SRD和围产期心理健康的专家； 创伤和韧性专家；以及两个顾问/社区合作伙伴来增强社区 - 参与并解决研究中招聘，保留和结构性偏见的关键问题 服务不足的少数族裔人口。我们将使用常见的数据元素（例如DR2，苯克斯工具包） 数据协调，以促进有关行为，社会文化和结构性因素的知识 在大流行的背景下，这会影响与妊娠有关的发病率/死亡率和母子健康。