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Clinical Trials/NCT07439276
NCT07439276
Recruiting
Not Applicable

Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery

Assistance Publique - Hôpitaux de Paris1 site in 1 country100 target enrollmentStarted: April 8, 2026Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
Overall social cognition score and scores per dimension, obtained on the multidimensional social cognition battery

Overview

Brief Summary

In France, more than one in ten school-aged children suffers from a mental health disorder, and half of these disorders appear before the age of 14. Yet, only half of affected children receive appropriate support. At the cognitive level, it is now widely accepted by the scientific community that strong socio-cognitive skills protect against the emergence of certain disorders. Social cognition skills, crucial for development and social integration, are often underestimated in clinical neuropsychology, particularly due to the lack of validated assessment tools for children.

The challenges related to the clinical assessment of social cognition in children and adolescents are therefore significant, especially since specific deficits are likely to be associated with numerous developmental pathologies and psychiatric disorders (neurodevelopmental disorders, mood disorders, anxiety disorders, psychotic disorders). However, these disorders are insufficiently assessed. A more precise characterization would allow for the identification of therapeutic targets specific to each neurodevelopmental disorder.

Therefore, this research aims to address this lack of tools by using a multidimensional assessment battery of social cognition in children and adolescents aged 8 to 16, evaluating four fundamental domains of social cognition: emotion processing, social perception, theory of mind, and attributional style. This multidimensional assessment battery of social cognition is developed by the Child and Adolescent Psychiatry Department of Necker-Enfants Malades Hospital.

Detailed Description

In France, more than one in ten school-aged children suffers from a mental health disorder, and half of these disorders appear before the age of 14. Yet, only half of affected children receive appropriate support. At the cognitive level, it is now widely accepted by the scientific community that strong socio-cognitive skills protect against the emergence of certain disorders. Social cognition skills, crucial for development and social integration, are often underestimated in clinical neuropsychology, particularly due to the lack of validated assessment tools for children.

The challenges related to the clinical assessment of social cognition in children and adolescents are therefore significant, especially since specific deficits are likely to be associated with numerous developmental pathologies and psychiatric disorders (neurodevelopmental disorders, mood disorders, anxiety disorders, psychotic disorders). However, these disorders are insufficiently assessed. A more precise characterization would allow for the identification of therapeutic targets specific to each neurodevelopmental disorder.

Therefore, this research aims to address this lack of tools by using a multidimensional assessment battery of social cognition in children and adolescents aged 8 to 16, evaluating four fundamental domains of social cognition: emotion processing, social perception, theory of mind, and attributional style. This multidimensional assessment battery of social cognition is developed by the Child and Adolescent Psychiatry Department of Necker-Enfants Malades Hospital.

Patients will be recruited from the child psychiatry department of Necker-Enfants Malades Hospital as part of a diagnostic or follow-up process. A consultation will be offered to participate in the research, during which participants will complete the COGSO battery as well as additional tasks assessing social cognition and executive functions, and parent questionnaires.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
8 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Children and adolescents aged 8 to 16 years
  • Proficiency in French (native language)
  • Information and consent obtained from those holding parental authority, and agreement from the child or adolescent
  • No recently modified (\<6 weeks) psychotropic medication from the following categories: antidepressants, anxiolytics, antipsychotics, psychostimulants, mood stabilizers.
  • IQ above 70 (WISC-V)
  • Criteria for Neurodevelopmental Disorders: Diagnosis of Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder (according to DSM-5)
  • Multiple complex developmental disorder : Symptoms characteristic of a neurodevelopmental disorder without meeting all the criteria for a specific disorder and presence of multiple complex developmental disorder criteria with at least 5 elements from the specified categories.

Exclusion Criteria

  • \- Having an active neurological disorder (e.g., active epilepsy)

Arms & Interventions

Autism Spectrum Disorder

Experimental

Diagnosis of Autism Spectrum Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5.

40 children and teenagers.

Intervention: Test (Other)

Autism Spectrum Disorder

Experimental

Diagnosis of Autism Spectrum Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5.

40 children and teenagers.

Intervention: Questionnaires (Other)

Attention Deficit Hyperactivity Disorder

Experimental

Diagnosis of Attention Deficit Hyperactivity Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5.

40 children and teenagers.

Intervention: Test (Other)

Attention Deficit Hyperactivity Disorder

Experimental

Diagnosis of Attention Deficit Hyperactivity Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5.

40 children and teenagers.

Intervention: Questionnaires (Other)

Multiple complex developmental disorder

Experimental

Symptoms characteristic of a neurodevelopmental disorder without meeting the full criteria for a specific disorder and presence of criteria for a multiple complex developmental disorder with at least 5 elements from the specified categories.

20 children and teenagers.

Intervention: Test (Other)

Multiple complex developmental disorder

Experimental

Symptoms characteristic of a neurodevelopmental disorder without meeting the full criteria for a specific disorder and presence of criteria for a multiple complex developmental disorder with at least 5 elements from the specified categories.

20 children and teenagers.

Intervention: Questionnaires (Other)

Outcomes

Primary Outcomes

Overall social cognition score and scores per dimension, obtained on the multidimensional social cognition battery

Time Frame: Day 1

The overall social cognition score, as well as the scores for each dimension, obtained on the multidimensional social cognition battery, will be compared between groups of children and adolescents with ASD, ADHD, and MCDD. The sensitivity and specificity of the multidimensional social cognition battery will be assessed by evaluating the ability of the tests to highlight socio-cognitive difficulties in clinical children, without claiming to be used for independent diagnosis.

Secondary Outcomes

  • Influence of socio-demographic factors on social cognition performance(Day 1)
  • Influence of cognitive factors on social cognition(Day 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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