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NCT Number: NCT07439276

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

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location status: Recruiting

Location contact

Dorothée Leunen

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Test

Other

Social cognition battery developed by the Child and Adolescent Psychiatry Department of Necker-Enfants Malades Hospital:

4 tasks allow exploration of the components of social cognition:

  • Dynamic emotion recognition task
  • Contextual emotion recognition task
  • Combined theory of mind and social perception task
  • Attributional style

questionnaires

Other

Standard supplementary tasks assessing social cognition and executive functions, as well as parent questionnaires, will be administered :

  • Conners 3
  • Child Behavior Checklist
  • SOCODEV : Social Skills Assessment Questionnaire
  • Behavior Rating Inventory of Executive Function
  • Revised Children's Anxiety and Depression Scale
  • Autism Diagnostic Interviex-Revised
  • Intention Attribution Test for Children

Primary outcomes

  1. 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

  1. Influence of socio-demographic factors on social cognition performance

    Time frame: Day 1

    Study of the influence of socio-demographic factors: analyze the impact of factors such as age, sex, socio-economic level and family characteristics on social cognition performance obtained on the multidimensional social cognition battery, in order to better understand individual and contextual variations.

  2. Influence of cognitive factors on social cognition

    Time frame: Day 1

    Study of the influence of cognitive factors on social cognition: examine the influence of overall cognitive efficiency (IQ) and executive functions (EF) on social cognition abilities, assessed by the multidimensional social cognition battery, in order to identify the interactions between cognitive and sociocognitive dimensions.

Study contacts

Contact information is provided by the study sponsor or research team.

Dorothée Leunen

CONTACT

[email protected]

0171196346

Hélène Morel

CONTACT

[email protected]

0171196346 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: COGSO

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
Apr 16, 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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