search
Back to results

Preterm Birth and Social Cognition (TERM-COG)

Primary Purpose

Preterm Children

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of the children's social cognitive development
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Preterm Children

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Reims

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

preterm children

term children

Arm Description

Outcomes

Primary Outcome Measures

Social cognition / Theory of mind
small stories involving the thoughts and feelings of characters
working memory
Executives functions
shifting
Executives functions
Trait Anxiety Inventory
Parent's psychological features
Beck Depression Inventory
Parent's psychological features
Social Support Questionnaire
Parent's psychological features
Trauma
Parent's psychological features
Parental Stress Index
Parent's psychological features

Secondary Outcome Measures

Full Information

First Posted
December 27, 2016
Last Updated
October 6, 2023
Sponsor
CHU de Reims
search

1. Study Identification

Unique Protocol Identification Number
NCT03007095
Brief Title
Preterm Birth and Social Cognition
Acronym
TERM-COG
Official Title
Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
July 19, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Children

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preterm children
Arm Type
Experimental
Arm Title
term children
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of the children's social cognitive development
Intervention Description
standardized neuropsychological tests
Primary Outcome Measure Information:
Title
Social cognition / Theory of mind
Description
small stories involving the thoughts and feelings of characters
Time Frame
Day 0
Title
working memory
Description
Executives functions
Time Frame
Day 0
Title
shifting
Description
Executives functions
Time Frame
Day 0
Title
Trait Anxiety Inventory
Description
Parent's psychological features
Time Frame
Day 0
Title
Beck Depression Inventory
Description
Parent's psychological features
Time Frame
Day 0
Title
Social Support Questionnaire
Description
Parent's psychological features
Time Frame
Day 0
Title
Trauma
Description
Parent's psychological features
Time Frame
Day 0
Title
Parental Stress Index
Description
Parent's psychological features
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34566706
Citation
Eutrope J, Novo A, Barbe C, Loron G, Rolland AC, Caillies S. Impact of Executive Functions and Parental Anxiety on the Development of Social Cognition in Premature Children: A Cross-Sectional Case-Control Protocol. Front Psychiatry. 2021 Sep 9;12:484571. doi: 10.3389/fpsyt.2021.484571. eCollection 2021.
Results Reference
derived

Learn more about this trial

Preterm Birth and Social Cognition

We'll reach out to this number within 24 hrs