Neurodevelopmental DisordersCOGSONCT07439276
Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery
A study testing Test and Questionnaires in people with Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Test and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Having an active neurological disorder (e.g., active epilepsy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Dorothée Leunen, dorothee.leunen@aphp.fr
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.
Read the 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.
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Atypical Neurodevelopmental Disorder
- Being tested
- Test, Questionnaires
- Keywords
- Neurodevelopmental disorders, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Atypical neurodevelopmental disorder, Social cognition, Children and teenagers
- Medical subject headings
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestOther
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
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Experimental | Diagnosis of Autism Spectrum Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5.
40 children and teenagers. Receives: 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. Receives: 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. Receives: Other: Test; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
Influence of socio-demographic factors on social cognition performance
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.
Measured: Day 1
Influence of cognitive factors on social cognition
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start8 Apr 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Dorothée Leunen, Principal investigator, Assistance Publique - Hôpitaux de ParisLisa Ouss, M.D., Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439276
- Sponsor's protocol ID
- APHP250777
- Other IDs
- 2025-A01031-48
- Acronym
- COGSO
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33061748Pinkham 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.
PubMed 23728248Parke 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.
PubMed 30541372Isaksson 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.
PubMed 30972652Cassel 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.
PubMed 27899036Beauchamp MH. Neuropsychology's social landscape: Common ground with social neuroscience. Neuropsychology. 2017 Nov;31(8):981-1002. doi: 10.1037/neu0000395.
PubMed 29376673Beauchamp 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.
PubMed 23789866
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery
- ClinicalTrials.gov ID
- NCT07439276
- Acronym / sponsor ID
- COGSO / APHP250777
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | Experimental | Other: Test, Other: QuestionnairesDiagnosis of Autism Spectrum Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5. 40 children and teenagers. |
| Attention Deficit Hyperactivity Disorder | Experimental | Other: Test, Other: QuestionnairesDiagnosis of Attention Deficit Hyperactivity Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5. 40 children and teenagers. |
| Multiple complex developmental disorder | Experimental | Other: Test, Other: QuestionnairesSymptoms 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Having an active neurological disorder (e.g., active epilepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestSocial 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 | Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Multiple complex developmental disorder |
| QuestionnairesStandard 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 | Other | Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Multiple complex developmental disorder |
Primary outcome
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.
2 secondary outcomes
Influence of socio-demographic factors on social cognition performance
Time frame: Day 1
Influence of cognitive factors on social cognition
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 33061748Posar 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.
- Background: PubMed 23728248Pinkham 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.
- Background: PubMed 30541372Parke 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.
- Background: PubMed 30972652Isaksson 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.
- Background: PubMed 27899036Cassel 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.
- Background: PubMed 29376673Beauchamp MH. Neuropsychology's social landscape: Common ground with social neuroscience. Neuropsychology. 2017 Nov;31(8):981-1002. doi: 10.1037/neu0000395.
- Background: PubMed 23789866Beauchamp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorothée Leunen principal investigator
Assistance Publique - Hôpitaux de Paris
Lisa Ouss, M.D. study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test and Questionnaires in people with Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorothée Leunen (0171196346, dorothee.leunen@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall social cognition score and scores per dimension, obtained on the multidimensional social cognition battery (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07439276, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.