跳至主要内容
临床试验/NCT03007095
NCT03007095已完成不适用

Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes

CHU de Reims2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
56
试验地点
2
主要终点
working memory

研究概览

简要总结

The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. The literature regarding development of term born children indicates that executive functions are linked to the emergence of social cognition. Then, the investigators asked if children born prematurely, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Additionally, as it has been shown that parental anxiety is a key factor of preterm children development, the investigators assumed that it should play a role in social cognition outcomes.

详细描述

The present study examines the social cognition development of very preterm children at 7 to 10 years old. In the literature, there has yet to be any research on social cognition of children born prematurely while preterm children are usually described as having difficulties in social relations. The main hypothesis is that preterm children would present a deficit or a delay in the social cognition development in comparison with that of matched term children, and that this deficit or delay should be explained by executive dysfunctions and parental anxiety.

Social cognition can be defined as the ability to understand the mind of other people and more specifically to perceive emotion, to have empathy, to attribute false-belief, to understand intended meaning, among others. In this study, the investigators will mainly focus on the ability of 80 very preterm children to understand the mind of others, well known as theory of mind in the literature, thanks to small stories involving the thinking and feelings of characters.

The executive functioning, which refers to multiple processes underlying human higher order abilities, will be assessed thanks to standardized neuropsychological tests. In this study, the investigators will focus on the three main well known executive functions: inhibition, working memory and shifting. They expect, consistently with the literature, that preterm children will have executive dysfunctions, and that these will be linked to children theory of mind abilities.

Finally, given that parental anxiety affects child development, the investigators plan to assess some psychological features of children's parents in our study, such the level of parental anxiety. They assume that this level will also be linked to theory of mind abilities of children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm children:
  • Girls or boys born before 37 weeks of gestational age.
  • Aged between 7 to 10 years-old
  • At school
  • Term children:
  • Girls or boys born after 37 weeks of gestational age.
  • Aged between 6 and 10 years-old: 6 year-olds were included for the mental age matching with preterm children.
  • At school

排除标准

  • Children :
  • Child with a intrauterine growth failure
  • Child from multiple births
  • Child with organic malformation
  • Child with a genetic anomaly
  • Child with a neuromoteur pathology
  • Child with a global developmental delay (Intellectual quotient inferior to 80).
  • Parents :
  • Minor parent (less than 18 year old)
  • Parent with an intellectual disability
  • Parent with a psychotic syndrome
  • Parent who does not understand French

结局指标

主要结局

working memory

时间窗: Day 0

Executives functions

shifting

时间窗: Day 0

Executives functions

Parental Stress Index

时间窗: Day 0

Parent's psychological features

Social cognition / Theory of mind

时间窗: Day 0

small stories involving the thoughts and feelings of characters

Trait Anxiety Inventory

时间窗: Day 0

Parent's psychological features

Social Support Questionnaire

时间窗: Day 0

Parent's psychological features

Beck Depression Inventory

时间窗: Day 0

Parent's psychological features

Trauma

时间窗: Day 0

Parent's psychological features

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Preterm Birth and Social Cognition | 临床试验