The Mood, Mother and Child Study: Protocol for a Prospective Longitudinal Study and Randomized Controlled Trial.
The Mood, Mother and Child Study: Protocol for a Prospective Longitudinal Study and Randomized Controlled Trial.
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DOI：
10.2196/51132
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发表时间：
2023-10-26
影响因子：
1.7
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中科院分区：
文献类型：
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围产期抑郁症每年在美国影响超过400，000对母子，并且与许多不利的母婴发育结果相关。先前的研究表明，催产素和下丘脑-垂体-肾上腺（HPA）轴在母亲和儿童中的功能失调是介导或调节与母亲抑郁症相关的风险传递的潜在机制。“情绪、母亲和儿童”研究将审查受母亲抑郁症影响的母子二人组的风险和复原力的心理生物学来源。本手稿描述了（1）研究原理和目的，（2）研究设计和程序以及如何改变它们以应对COVID-19大流行病，以及（3）测试研究假设的数据分析计划。这是一项前瞻性纵向研究，包括一项嵌入式随机对照试验，旨在检查（1）产后抑郁和焦虑症状、母婴催产素和HPA轴功能以及儿童发育结局之间的相关性，以及（2）外源性催产素和HPA反应性之间的因果关系。这项研究是由国家儿童健康和人类发展研究所资助的，并得到了机构审查委员会的批准。招募和数据收集工作已经开始，预期结果将于2024年公布。分析提出了检验所提出的假设。前瞻性纵向研究设计与嵌入式随机对照试验的独特组合将使情绪，母亲和儿童研究应用发展透镜研究从出生到童年中期的母亲抑郁和焦虑症状，以及促进母亲和儿童结局风险和弹性的心理生物学机制。这将是第一项同时评估（1）使用多种方法的催产素的作用，（2）外源性催产素与具有不同程度抑郁和焦虑症状的母亲的HPA轴功能之间的因果关系，以及（3）育儿行为和母亲和儿童心理生物学特征的多重中介和调节作用的研究。这些目标的目的是提供深入了解催产素对女性的心理生物学影响，并为未来治疗围产期情绪障碍的临床试验提供信息。ClinicalTrials.gov NCT 03593473; https://classic.clinicaltrials.gov/ct2/show/NCT03593473 DERR 1 -10.2196/51132
Perinatal depression affects >400,000 mother-child dyads in the United States every year and is associated with numerous adverse maternal and child developmental outcomes. Previous research implicates the dysregulation of oxytocin and the hypothalamic-pituitary-adrenal (HPA) axis functioning in mothers and children as potential mechanisms mediating or moderating the transmission of risk associated with maternal depression. The Mood, Mother and Child study will examine the psychobiological sources of risk and resilience within mother-child dyads affected by maternal depression. This manuscript describes (1) the study rationale and aims, (2) the research design and procedures and how they were altered in response to the COVID-19 pandemic, and (3) the data analysis plan to test the study hypotheses. This is a prospective longitudinal study with an embedded randomized controlled trial that examines (1) correlations among postpartum depression and anxiety symptoms, maternal and child oxytocin and HPA axis functioning, and child developmental outcomes and (2) the causal relationship between exogenous oxytocin and HPA reactivity. This study is funded by the National Institute of Child Health and Human Development with institutional review board approval. Recruitment and data collection have commenced, and the expected results will be available in 2024. Analyses are presented for testing the proposed hypotheses. The unique combination of a prospective longitudinal research design with an embedded randomized controlled trial will allow the Mood, Mother and Child study to apply a developmental lens to the study of maternal depression and anxiety symptoms from birth to middle childhood and the psychobiological mechanisms promoting risk and resiliency for both mother and child outcomes. This will be the first study that simultaneously evaluates (1) the role of oxytocin using multiple methodologies, (2) the causal relationships between exogenous oxytocin and HPA axis functioning among mothers with differing levels of depression and anxiety symptoms, and (3) the multiple mediating and moderating roles of parenting behaviors and maternal and child psychobiological characteristics. The goals of these aims are to provide insights into the psychobiological effects of oxytocin in women and inform future clinical trials to treat perinatal mood disorders. ClinicalTrials.gov NCT03593473; https://classic.clinicaltrials.gov/ct2/show/NCT03593473 DERR1-10.2196/51132