<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03007095</url>
  </required_header>
  <id_info>
    <org_study_id>PO16068*</org_study_id>
    <nct_id>NCT03007095</nct_id>
  </id_info>
  <brief_title>Preterm Birth and Social Cognition</brief_title>
  <acronym>TERM-COG</acronym>
  <official_title>Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims at investigating social cognition outcomes of children born prematurely.&#xD;
      Social cognition can be briefly defined as a process which underlines people's social and&#xD;
      emotional behaviors. There are behavioral and cognitive evidences indicating that preterm&#xD;
      children have executive dysfunctions. Executive functions refer to multiple cognitive&#xD;
      processes that contribute to human higher order abilities, such as purposeful and&#xD;
      future-orientated behavior. The literature regarding development of term born children&#xD;
      indicates that executive functions are linked to the emergence of social cognition. Then, the&#xD;
      investigators asked if children born prematurely, as they commonly present executive&#xD;
      dysfunctions, would show an atypical development of social cognition. Additionally, as it has&#xD;
      been shown that parental anxiety is a key factor of preterm children development, the&#xD;
      investigators assumed that it should play a role in social cognition outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study examines the social cognition development of very preterm children at 7 to&#xD;
      10 years old. In the literature, there has yet to be any research on social cognition of&#xD;
      children born prematurely while preterm children are usually described as having difficulties&#xD;
      in social relations. The main hypothesis is that preterm children would present a deficit or&#xD;
      a delay in the social cognition development in comparison with that of matched term children,&#xD;
      and that this deficit or delay should be explained by executive dysfunctions and parental&#xD;
      anxiety.&#xD;
&#xD;
      Social cognition can be defined as the ability to understand the mind of other people and&#xD;
      more specifically to perceive emotion, to have empathy, to attribute false-belief, to&#xD;
      understand intended meaning, among others. In this study, the investigators will mainly focus&#xD;
      on the ability of 80 very preterm children to understand the mind of others, well known as&#xD;
      theory of mind in the literature, thanks to small stories involving the thinking and feelings&#xD;
      of characters.&#xD;
&#xD;
      The executive functioning, which refers to multiple processes underlying human higher order&#xD;
      abilities, will be assessed thanks to standardized neuropsychological tests. In this study,&#xD;
      the investigators will focus on the three main well known executive functions: inhibition,&#xD;
      working memory and shifting. They expect, consistently with the literature, that preterm&#xD;
      children will have executive dysfunctions, and that these will be linked to children theory&#xD;
      of mind abilities.&#xD;
&#xD;
      Finally, given that parental anxiety affects child development, the investigators plan to&#xD;
      assess some psychological features of children's parents in our study, such the level of&#xD;
      parental anxiety. They assume that this level will also be linked to theory of mind abilities&#xD;
      of children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Social cognition / Theory of mind</measure>
    <time_frame>Day 0</time_frame>
    <description>small stories involving the thoughts and feelings of characters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>working memory</measure>
    <time_frame>Day 0</time_frame>
    <description>Executives functions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>shifting</measure>
    <time_frame>Day 0</time_frame>
    <description>Executives functions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trait Anxiety Inventory</measure>
    <time_frame>Day 0</time_frame>
    <description>Parent's psychological features</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>Day 0</time_frame>
    <description>Parent's psychological features</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Support Questionnaire</measure>
    <time_frame>Day 0</time_frame>
    <description>Parent's psychological features</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trauma</measure>
    <time_frame>Day 0</time_frame>
    <description>Parent's psychological features</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental Stress Index</measure>
    <time_frame>Day 0</time_frame>
    <description>Parent's psychological features</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Preterm Children</condition>
  <arm_group>
    <arm_group_label>preterm children</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>term children</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Evaluation of the children's social cognitive development</intervention_name>
    <description>standardized neuropsychological tests</description>
    <arm_group_label>preterm children</arm_group_label>
    <arm_group_label>term children</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Preterm children:&#xD;
&#xD;
          -  Girls or boys born before 37 weeks of gestational age.&#xD;
&#xD;
          -  Aged between 7 to 10 years-old&#xD;
&#xD;
          -  At school&#xD;
&#xD;
        Term children:&#xD;
&#xD;
          -  Girls or boys born after 37 weeks of gestational age.&#xD;
&#xD;
          -  Aged between 6 and 10 years-old: 6 year-olds were included for the mental age matching&#xD;
             with preterm children.&#xD;
&#xD;
          -  At school&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children :&#xD;
&#xD;
               -  Child with a intrauterine growth failure&#xD;
&#xD;
               -  Child from multiple births&#xD;
&#xD;
               -  Child with organic malformation&#xD;
&#xD;
               -  Child with a genetic anomaly&#xD;
&#xD;
               -  Child with a neuromoteur pathology&#xD;
&#xD;
               -  Child with a global developmental delay (Intellectual quotient inferior to 80).&#xD;
&#xD;
          -  Parents :&#xD;
&#xD;
               -  Minor parent (less than 18 year old)&#xD;
&#xD;
               -  Parent with an intellectual disability&#xD;
&#xD;
               -  Parent with a psychotic syndrome&#xD;
&#xD;
               -  Parent who does not understand French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rolland Anne-Catherine</last_name>
    <phone>3 26 78 85 58</phone>
    <phone_ext>0033</phone_ext>
    <email>acrolland@chu-reims.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Damien JOLLY</last_name>
      <phone>326788472</phone>
      <phone_ext>33</phone_ext>
      <email>djolly@chu-reims.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03007095
org study id: PO16068*
nct id: NCT03007095
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Social cognition / Theory of mind
time frame: Day 0
description: small stories involving the thoughts and feelings of characters
measure: working memory
time frame: Day 0
description: Executives functions
measure: shifting
time frame: Day 0
description: Executives functions
measure: Trait Anxiety Inventory
time frame: Day 0
description: Parent's psychological features
measure: Beck Depression Inventory
time frame: Day 0
description: Parent's psychological features
measure: Social Support Questionnaire
time frame: Day 0
description: Parent's psychological features
measure: Trauma
time frame: Day 0
description: Parent's psychological features
measure: Parental Stress Index
time frame: Day 0
description: Parent's psychological features
arm group label: preterm children
arm group type: Experimental
arm group label: term children
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Evaluation of the children's social cognitive development
description: standardized neuropsychological tests
arm group label: preterm children
arm group label: term children
criteria: 
gender: All
minimum age: 6 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rolland Anne-Catherine
phone: 3 26 78 85 58
phone ext: 0033
email: acrolland@chu-reims.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Premature Birth