Comparing the Effects of Prenatal Depression and its Treatment on Developmental Outcomes of the Offspring

比较产前抑郁症及其治疗对后代发育结果的影响

基本信息

批准号：
10120323
负责人：
Lyndsay Ammon Avalos
金额：
$ 67.6万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-25 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10120323
关键词：
5 year old 8 year old Address Age Animal Model Area Attention deficit hyperactivity disorder Behavior Disorders Behavioral Birth Brain Brain imaging California Categories Child Childhood Clinical Code Cognition Disorders Cognitive Cohort Studies Communication Communication impairment DSM-V Depression screen Development Developmental Delay Disorders Diagnosis Diagnostic and Statistical Manual of Mental Disorders Early Intervention Electronic Health Record Epidemiology Fathers Fetal Development Fetus Health High Prevalence Hospitals Human Impairment Infant Intellectual functioning disability Interview Knowledge Link Literature Long-Term Effects Measures Medical Records Mental Depression Methodology Monitor Mothers Motor Neurodevelopmental Disorder Neurodevelopmental Impairment Outcome Parents Patients Persons Pharmacological Treatment Population Postpartum Depression Postpartum Period Pregnancy Pregnant Women Prenatal care Prevalence Problem Solving Process Psychotherapy Public Health Questionnaires Recording of previous events Research Risk Risk Factors Sampling Selective Serotonin Reuptake Inhibitor Services Severities Structure Testing Time Woman antepartum depression autism spectrum disorder base boys clinical Diagnosis cohort design emotional behavior epidemiology study fetal girls imaging study instrument motor disorder motor impairment offspring peripartum depression prenatal prenatal testing primary outcome psychologic public health relevance recruit screening screening program secondary analysis sex skills social treatment effect

项目摘要

ABSTRACT The risk associated with both untreated depression and selective serotonin reuptake inhibitors (SSRIs) treatment has presented a significant dilemma to the 20% of pregnant women suffering from prenatal depression and their clinicians. Both prenatal depression and SSRIs have been found to adversely impact fetal brain development. However, the limited epidemiologic research on neurodevelopmental outcomes of the offspring suffers severe methodological limitations and thus, the literature is inconclusive. The proposed study addresses these methodological limitations and leverages Kaiser Permanente Northern California’s (KPNC’s) unique universal perinatal depression screening program to assemble a longitudinal birth cohort of >320,000 children from 0 to 8 years of age born between 2013-2020. As part of standard prenatal care, women are screened for depression twice during pregnancy (at the first prenatal visit and 26-28 weeks) providing a large cohort of women with depression and its severity measures throughout pregnancy. In addition, KPNC’s universal childhood developmental screening program provides systematic screening for neurodevelopmental disorders. The primary outcomes will be six neurodevelopmental disorder diagnoses defined in the DSM 5: intellectual disability, global developmental delay, motor disorders, communication disorder, autism spectrum disorder, and attention-deficit/hyperactivity disorder (ADHD); corresponding diagnosis codes will be ascertained from KPNC’s electronic health records (EHR) and supplemented through linkage to California’s Department of Developmental Services. We will use KPNC EHRs to ascertain information on important confounders and link to the father’s medical records to ascertain information on psychiatric history. We will test the hypothesis that the underlying prenatal depression and SSRIs are independent risk factors for adverse neurodevelopmental outcomes and may differ by infant sex. We will evaluate the effect of untreated prenatal depression, compared to no prenatal depression on the six neurodevelopmental outcomes of the offspring, after adjusting for confounders. We will also assess the effects of treatment with SSRIs during pregnancy on neurodevelopmental outcomes of the offspring compared to both untreated prenatal depression and treatment with psychotherapy only, while taking into account depression severity and other confounders. Finally, to examine their impact on less severe neurodevelopmental outcomes we will recruit a subsample of 2,000 5- year old children (500 randomly chosen from each of four exposure categories: no prenatal depression, untreated prenatal depression, treatment with SSRIs, treatment with psychotherapy only) to ascertain information through parent interview on neurodevelopmental outcomes that may not meet the criteria of a clinical diagnosis, but may suggest a need to monitor and/or provide early interventions. Findings from this study will have significant public health and clinical implications by providing information that can be immediately used by pregnant women and clinicians making treatment decisions.

抽象的与未经治疗的抑郁症和选择性血清素再摄取抑制剂 (SSRI) 相关的风险治疗给 20% 患有产前疾病的孕妇带来了严重的困境研究发现产前抑郁症和 SSRIs 都会对胎儿产生不利影响。然而，关于神经发育结果的流行病学研究有限。后代受到严重的方法学限制，因此该文献尚无定论。解决这些方法上的局限性并利用北加州凯撒医疗机构 (KPNC) 独特的通用围产期抑郁症筛查计划，汇集超过 320,000 名纵向出生队列 2013 年至 2020 年期间出生的 0 至 8 岁儿童作为标准产前护理的一部分，女性怀孕期间进行了两次抑郁症筛查（第一次产前检查和 26-28 周），提供了大量此外，KPNC 还对患有抑郁症的女性进行了队列研究，并对其严重程度进行了测量。全民儿童发育筛查计划为神经发育障碍提供系统筛查主要结果是 DSM 5 中定义的六种神经发育障碍诊断：智力障碍、全面性发育迟缓、运动障碍、沟通障碍、自闭症谱系障碍，以及注意力缺陷/多动障碍（ADHD）相应的诊断代码；从 KPNC 的电子健康记录 (EHR) 中确定，并通过与加州的链接进行补充我们将使用 KPNC EHR 来确定重要信息。我们将测试混淆因素并链接到父亲的病历以确定精神病史信息。假设潜在的产前抑郁症和 SSRIs 是不良反应的独立危险因素神经发育结果可能因婴儿性别而异。我们将评估未经治疗的产前治疗的影响。与没有产前抑郁症的后代的六种神经发育结果相比，抑郁症，调整混杂因素后，我们还将评估妊娠期间 SSRI 治疗对患者的影响。与未经治疗的产前抑郁症和治疗后的后代的神经发育结果相比仅进行心理治疗，同时考虑抑郁症的严重程度和其他混杂因素。为了检查它们对不太严重的神经发育结果的影响，我们将招募 2,000 名 5- 岁儿童（从四个暴露类别中随机选择 500 名：无产前抑郁症、未经治疗的产前抑郁症、用 SSRI 治疗、仅用心理治疗治疗）以确定通过家长访谈获得的有关可能不符合标准的神经发育结果的信息临床诊断，但可能表明需要监测和/或提供早期干预措施。研究将通过提供可用于以下方面的信息来产生重大的公共卫生和临床影响：孕妇立即使用并有利于做出治疗决定。