Preterm Birth and Social Cognition (TERM-COG)
|Preterm Children||Behavioral: Evaluation of the children's social cognitive development|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes|
- Social cognition / Theory of mind [ Time Frame: Day 0 ]small stories involving the thoughts and feelings of characters
- working memory [ Time Frame: Day 0 ]Executives functions
- shifting [ Time Frame: Day 0 ]Executives functions
- Trait Anxiety Inventory [ Time Frame: Day 0 ]Parent's psychological features
- Beck Depression Inventory [ Time Frame: Day 0 ]Parent's psychological features
- Social Support Questionnaire [ Time Frame: Day 0 ]Parent's psychological features
- Trauma [ Time Frame: Day 0 ]Parent's psychological features
- Parental Stress Index [ Time Frame: Day 0 ]Parent's psychological features
|Study Start Date:||January 2017|
|Estimated Study Completion Date:||June 2020|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
|Experimental: preterm children||Behavioral: Evaluation of the children's social cognitive development|
|Active Comparator: term children||Behavioral: Evaluation of the children's social cognitive development|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03007095
|Contact: Rolland Anne-Catherine||3 26 78 85 58 ext firstname.lastname@example.org|
|France, Reims, France, 51092|