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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007095
Other study ID # PO16068*
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2017
Est. completion date August 31, 2023

Study information

Verified date October 2023
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date August 31, 2023
Est. primary completion date July 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Evaluation of the children's social cognitive development
standardized neuropsychological tests

Locations

Country Name City State
France Chu Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Social cognition / Theory of mind small stories involving the thoughts and feelings of characters Day 0
Primary working memory Executives functions Day 0
Primary shifting Executives functions Day 0
Primary Trait Anxiety Inventory Parent's psychological features Day 0
Primary Beck Depression Inventory Parent's psychological features Day 0
Primary Social Support Questionnaire Parent's psychological features Day 0
Primary Trauma Parent's psychological features Day 0
Primary Parental Stress Index Parent's psychological features Day 0
See also
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