Mills-Koonce W Roger, Grewen Karen, O'Shea Nisha Gottredson, Pearson Brenda, Strange Chelsea Grace, Meltzer-Brody Samantha E, Guintivano Jerry Dolph, Stuebe Alison M
School of Education, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
JMIR Res Protoc. 2023 Oct 26;12:e51132. doi: 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.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51132.
在美国，围产期抑郁症每年影响超过40万对母婴，并且与众多不良的母婴发育结局相关。先前的研究表明，母亲和儿童体内催产素失调以及下丘脑-垂体-肾上腺（HPA）轴功能异常是介导或调节与母亲抑郁相关风险传递的潜在机制。
“情绪、母亲和儿童”研究将探讨受母亲抑郁影响的母婴二元组中风险和恢复力的心理生物学来源。本手稿描述了（1）研究的基本原理和目标，（2）研究设计和程序以及它们如何因应对2019冠状病毒病大流行而改变，以及（3）检验研究假设的数据分析计划。
这是一项前瞻性纵向研究，其中包含一项嵌入式随机对照试验，该试验将研究（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）外源性催产素与HPA反应性之间的因果关系。本研究由美国国立儿童健康与人类发展研究所资助，并获得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。文中展示了用于检验所提出假设的分析。
前瞻性纵向研究设计与嵌入式随机对照试验的独特结合，将使“情绪、母亲和儿童”研究能够从发育的角度研究从出生到童年中期母亲的抑郁和焦虑症状，以及促进母婴结局风险和恢复力的心理生物学机制。这将是第一项同时评估（1）使用多种方法研究催产素的作用，（2）不同抑郁和焦虑症状水平母亲中外源性催产素与HPA轴功能之间的因果关系，以及（3）养育行为以及母婴心理生物学特征的多种中介和调节作用的研究。这些目标的目的是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 NCT03593473；https://classic.clinicaltrials.gov/ct2/show/NCT03593473。
国际注册报告识别码（IRRID）：DERR1-10.2196/51132。
