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Preterm Birth and Social Cognition

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03007095
Acronym
TERM-COG
Enrollment
56
Registered
2017-01-02
Start date
2017-07-20
Completion date
2023-08-31
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Children

Brief 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.

Detailed 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.

Interventions

BEHAVIORALEvaluation of the children's social cognitive development

standardized neuropsychological tests

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Social cognition / Theory of mindDay 0small stories involving the thoughts and feelings of characters
working memoryDay 0Executives functions
shiftingDay 0Executives functions
Trait Anxiety InventoryDay 0Parent's psychological features
Beck Depression InventoryDay 0Parent's psychological features
Social Support QuestionnaireDay 0Parent's psychological features
TraumaDay 0Parent's psychological features
Parental Stress IndexDay 0Parent's psychological features

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026