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临床试验/NCT06162689
NCT06162689Enrolling By Invitation不适用

Do Risk Factors for Postpartum Psychosis Alter Offspring Outcomes in Middle Childhood

King's College London1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
201
试验地点
1
主要终点
Child Salivary Cortisol

研究概览

简要总结

The goal of this observational study is to examine the relationship between severe perinatal maternal mental illness and stress reactivity and general development of children aged 6 to 8 years. Mothers were previously recruited and assessed during pregnancy and their babies were assessed at 6 days, 8 weeks and 12 months post delivery. This follow-up will assess the occurrence of any psychiatric episodes (e.g., depression, mania, psychosis) in the intervening period. Assessments of the children will include evaluation of their response to a mildly stressful procedure, as well as their physical, cognitive and social-emotional development, and their mental health. Possible factors that may moderate the relationship between the mother's perinatal mental health and the child's stress reactivity and development, including the home environment, adversity, parent-child interaction and maternal and paternal (or co-parent) mental health will also be assessed.

详细描述

The principle research question is "does maternal stress system in pregnant women at risk of postpartum psychosis modify stress reactivity in children aged 6 to 8"?.

The "stress system" the investigators are studying is the endocrine system known as the hypothalamic-pituitary-adrenal (HPA) axis. The investigators measured levels of hormones from this system in blood and saliva in a sample of women at risk and not at risk of postpartum psychosis during pregnancy and measured cortisol in the saliva of their babies, before and after a stressful experience at 6 days, 8 weeks and 12 months of age.

The investigators found that infants born to women at risk of postpartum psychosis (PP) who relapsed in the first 4 weeks post-delivery had altered HPA axis activity at 6 days post-birth, compared with infants born to women at risk who remained well in the postpartum period.

The investigators now plan to examine whether levels of mothers' stress hormones associated with risk of postpartum psychosis during pregnancy are also associated with longer-lasting children's cortisol stress reactivity and diurnal rhythm of cortisol during middle childhood (ages 6 to 8).

Genetic material will be extracted from the child's specimens to look at genes, epigenetics (DNA methylation) and changes in gene expression, specifically, changes in genes which might be relevant to the development of stress. Assessments of maternal endocrine and maternal and paternal / co-parent mood measures will be undertaken. Children's cortisol response to stress and cortisol diurnal rhythm will be carried out at ages 6 to 8 years, together with assessments of their growth, cognitive development, social-emotional functioning and mental health. The father or co-parent mental health, their relationship with the mother and their interaction/relationship with the child will also be measured to investigate whether these moderate any effects of maternal perinatal mental health on child development.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women who participated in the previous study (Risk factors of perinatal mental disorders: Stress, electrophysiological, and neuroimaging markers), who gave consent to be contacted again, together with their offspring, and the child's father/co-parent.

排除标准

  • Women who participated in the previous study who refused consent to be contacted again.

结局指标

主要结局

Child Salivary Cortisol

时间窗: 6-8 years

Child stress response - salivary cortisol: saliva samples will be collected before and after a mild stress test: MacArthur Story Stem battery (MSSB) to asses stress reactivity

次要结局

  • The Security Scale(6-8 years)
  • Traumatic Events Screening Inventory (TESI)(6-8 years)
  • Dimensional Change Card Sort Test (DCCS)(6-8 years)
  • State-Trait Anxiety Inventory for Children (STAIC)(6-8 years)
  • Juvenile Victimization Questionnaire (JVQ)(6-8 years)
  • Wechsler Individual Achievement Test Second UK Edition (WIAT-II UK)(6-8 years)
  • Child Rearing Practices Report (CRPR)(6-8 years)
  • Wechsler Intelligence Scale for Children (4th Edition) (WISC-IV)(6-8 years)
  • Strengths and Difficulties Questionnaire (SDQ)(6-8 years)
  • Anthropometric Measures(6-8 years)
  • Depression Self-Rating Scale (DSRS)(6-8 years)
  • Development and Well-Being Assessment (DAWBA).(6-8 years)
  • Etch-a-Sketch Task(6-8 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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