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Recruiting NCT07439276

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

No phase Interventional Neurodevelopmental Disorders Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Atypical Neurodevelopmental Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Test, Questionnaires.
Who it may be relevant to
Registry conditions: Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Atypical Neurodevelopmental Disorder. Basic parameters: 8 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Test
    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: 1. Dynamic emotion recognition task 2. Contextual emotion recognition task 3. Combined theory of mind and social perception task 4. Attributional style
  • Other Questionnaires
    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 outcome measures

  • Overall social cognition score and scores per dimension, obtained on the multidimensional social cognition battery [Time frame: Day 1]
Secondary outcome measures (2)
  • Influence of socio-demographic factors on social cognition performance [Time frame: Day 1]
  • Influence of cognitive factors on social cognition [Time frame: Day 1]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Hôpital Necker-Enfants Malades — Paris

Publications

  • Posar A, Visconti P. Whatever happened to multiple complex developmental disorder? Turk Pediatri Ars. 2020 Sep 23;55(3):222-228. doi: 10.14744/TurkPediatriArs.2020.65693. eCollection 2020. PMID 33061748
  • Pinkham AE, Penn DL, Green MF, Buck B, Healey K, Harvey PD. The social cognition psychometric evaluation study: results of the expert survey and RAND panel. Schizophr Bull. 2014 Jul;40(4):813-23. doi: 10.1093/schbul/sbt081. Epub 2013 May 31. PMID 23728248
  • Parke EM, Becker ML, Graves SJ, Baily AR, Paul MG, Freeman AJ, Allen DN. Social Cognition in Children With ADHD. J Atten Disord. 2021 Feb;25(4):519-529. doi: 10.1177/1087054718816157. Epub 2018 Dec 13. PMID 30541372
  • Isaksson J, Van't Westeinde A, Cauvet E, Kuja-Halkola R, Lundin K, Neufeld J, Willfors C, Bolte S. Social Cognition in Autism and Other Neurodevelopmental Disorders: A Co-twin Control Study. J Autism Dev Disord. 2019 Jul;49(7):2838-2848. doi: 10.1007/s10803-019-04001-4. PMID 30972652
  • Cassel A, McDonald S, Kelly M, Togher L. Learning from the minds of others: A review of social cognition treatments and their relevance to traumatic brain injury. Neuropsychol Rehabil. 2019 Jan;29(1):22-55. doi: 10.1080/09602011.2016.1257435. Epub 2016 Nov 30. PMID 27899036
  • Beauchamp MH. Neuropsychology's social landscape: Common ground with social neuroscience. Neuropsychology. 2017 Nov;31(8):981-1002. doi: 10.1037/neu0000395. PMID 29376673
  • Beauchamp MH, Dooley JJ, Anderson V. A preliminary investigation of moral reasoning and empathy after traumatic brain injury in adolescents. Brain Inj. 2013;27(7-8):896-902. doi: 10.3109/02699052.2013.775486. Epub 2013 Apr 5. PMID 23789866

Identifiers

NCT: NCT07439276 · APHP250777 · 2025-A01031-48

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗