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

NCT07439276 | Recruiting

• 2 other identifiers: APHP2507772025-A01031-48
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders; Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Atypical Neurodevelopmental Disorder

Keywords

Neurodevelopmental disorders; Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Atypical neurodevelopmental disorder; Social cognition; Children and teenagers

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 1

Secondary Outcomes (2)

• Influence of socio-demographic factors on social cognition performance

  Day 1

• Influence of cognitive factors on social cognition

  Day 1

Study Arms (3)

Autism Spectrum Disorder

EXPERIMENTAL

Diagnosis of Autism Spectrum Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5. 40 children and teenagers.

Other: Test; Other: Questionnaires

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.

Other: Test; Other: Questionnaires

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.

Other: Test; Other: Questionnaires

Interventions

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: 1. Dynamic emotion recognition task 2. Contextual emotion recognition task 3. Combined theory of mind and social perception task 4. Attributional style

Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder; Multiple complex developmental disorder

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

Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder; Multiple complex developmental disorder

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Beauchamp MH. Neuropsychology's social landscape: Common ground with social neuroscience. Neuropsychology. 2017 Nov;31(8):981-1002. doi: 10.1037/neu0000395.

  PMID: 29376673 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders; Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive; Attention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dorothée Leunen

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Lisa Ouss, M.D.

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Dorothée Leunen

CONTACT

0171196346; dorothee.leunen@aphp.fr

Hélène Morel

CONTACT

0171196346; helene.morel@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 27, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)