- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439276
Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery (COGSO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hélène Morel
- Phone Number: +33 0171196346
- Email: helene.morel@aphp.fr
Study Contact Backup
- Name: Dorothée Leunen
- Phone Number: 0171196346
- Email: dorothee.leunen@aphp.fr
Study Locations
-
-
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Paris, France, 75015
- Recruiting
- Hôpital Necker-Enfants Malades
-
Contact:
- Dorothée Leunen
- Email: dorothee.leunen@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Autism Spectrum Disorder
Diagnosis of Autism Spectrum Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5. 40 children and teenagers. |
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:
Standard supplementary tasks assessing social cognition and executive functions, as well as parent questionnaires, will be administered :
|
|
Experimental: Attention Deficit Hyperactivity Disorder
Diagnosis of Attention Deficit Hyperactivity Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5. 40 children and teenagers. |
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:
Standard supplementary tasks assessing social cognition and executive functions, as well as parent questionnaires, will be administered :
|
|
Experimental: Multiple complex developmental disorder
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. |
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:
Standard supplementary tasks assessing social cognition and executive functions, as well as parent questionnaires, will be administered :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 1
|
|
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.
|
Day 1
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dorothée Leunen, Assistance Publique - Hôpitaux de Paris
- Study Director: Lisa Ouss, M.D., Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Beauchamp MH. Neuropsychology's social landscape: Common ground with social neuroscience. Neuropsychology. 2017 Nov;31(8):981-1002. doi: 10.1037/neu0000395.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Child Development Disorders, Pervasive
- Attention Deficit and Disruptive Behavior Disorders
- Autism Spectrum Disorder
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- APHP250777
- 2025-A01031-48 (Other Identifier: ID-RCB Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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