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Completed

NCT Number: NCT03007095

Preterm Birth and Social Cognition

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.

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Key information

Conditions

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of the children's social cognitive development

Behavioral

standardized neuropsychological tests

Primary outcomes

  1. Social cognition / Theory of mind

    Time frame: Day 0

    small stories involving the thoughts and feelings of characters

  2. working memory

    Time frame: Day 0

    Executives functions

  3. shifting

    Time frame: Day 0

    Executives functions

  4. Trait Anxiety Inventory

    Time frame: Day 0

    Parent's psychological features

  5. Beck Depression Inventory

    Time frame: Day 0

    Parent's psychological features

  6. Social Support Questionnaire

    Time frame: Day 0

    Parent's psychological features

  7. Trauma

    Time frame: Day 0

    Parent's psychological features

  8. Parental Stress Index

    Time frame: Day 0

    Parent's psychological features

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: TERM-COG

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2017
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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