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 - 妈妈咪呀研究的行政补充（1R01HD100395-01；PI： 金泽） 此行政补充请求是对 NOT-OD-21-071 的回应。家长研究总结： 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）的效果 预防和干预全国 1950 名不同女性的围产期抑郁及相关症状 国家。特别是，这项纵向多中心三组随机对照试验的目的是比较效果， 并探索三组这些影响的中介者和调节者：妈妈咪呀（自助互联网/ 基于移动设备的程序）； Mamma Mia Plus（自助式互联网/移动程序以及指导临床 支持）;还有，平时的护理。家长研究已成功满足研究时间表；我们已注册 n=523 第一年的参与者，预计在行政管理期间招收 n=600 名参与者 补充。行政补充摘要：该补充文件将探讨几个问题 实现 NOT-OD-21-071 中定义的三个目标，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机体功能 妈妈咪呀研究人群？ (2) COVID-19 大流行的感知影响是否会增加风险 孕妇和产后妇女的抑郁症状，这种感知的影响是否可以作为一种 随着时间的推移干预效果的调节者？ （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受到歧视？具体来说， 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）、情境压力（使用专门为代表性不足的人设计的措施 少数族裔妇女），并且感知到的歧视与怀孕和怀孕期间出现抑郁症状的风险有关。 产后妇女，随着时间的推移，这些会缓和干预的效果吗？这些因素如何 与出生结局、妊娠并发症和/或围产期健康（例如早产、妊娠升高 研究人群中的母亲血压、围产期情绪和焦虑）？ (4) 韧性和风险如何 COVID-19 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）会影响本研究人群的围产期健康结果吗？到 回答这些问题后，我们将为研究团队增添一位SRD和围产期心理健康方面的专家；一个 创伤和复原力专家；和两名顾问/社区合作伙伴，以增强社区- 参与并解决研究中招募、保留和结构性偏见的关键问题 服务不足的少数民族人口。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 影响大流行背景下与怀孕相关的发病率/死亡率和母婴健康。