ClinicalTrials.gg
RecruitingNCT07439276COGSOUpdated Apr 16, 2026

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

An interventional study of Test and Questionnaires in Neurodevelopmental Disorders, Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
8 Years to 16 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 50 studies in Neurodevelopmental Disorders with a site in France — 31 open to participants now, 33 under way, 5 of them phase 3. Neurodevelopmental Disorders · France.

Planned enrollment
15th of 25
100 · median 132
Started
2026
with 11 others
No phase
17 of 50
13 open now
Primary completion
2029-04
later than 25 of 32 live
Registered
45th of 50
by date
Lead sponsor
6 of 50
Assistance Publique - Hôpitaux de Paris

Among the 50 studies in Neurodevelopmental Disorders with a site in France, this one is the 15th largest by planned enrollment of the 25 interventional ones, is one of 12 that started in 2026, is one of 17 with no phase, reaches primary completion later than 25 of the 32 other live ones, and was the 45th registered.

By phase

50 studies; the count open now beside each. This study's row is marked.

Observational25 · 13 open
No phasethis study17 · 13 open
Phase 35 · 3 open
Phase 22 · 2 open
Phase 41 · 0 open

By the year they started

First in 2006; this study’s year is marked. 12 started in 2026.

Size and results

Median enrollment 132 across the 25 interventional studies, 200 across the 25 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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.

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
8 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 )
  • 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

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Autism Spectrum Disorder

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

    Other: Test · Other: Questionnaires

  • 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.

    Other: Test · Other: Questionnaires

  • 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.

    Other: Test · Other: Questionnaires

Interventions

  • OtherTest

    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

  • OtherQuestionnaires

    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

06

What researchers measure

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.

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 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. PubMed 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. PubMed 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. PubMed 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. PubMed 27899036 ↗
  • Beauchamp MH. Neuropsychology's social landscape: Common ground with social neuroscience. Neuropsychology. 2017 Nov;31(8):981-1002. doi: 10.1037/neu0000395. PubMed 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. PubMed 23789866 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Apr 2029, 36 months after the start.

Of 142 non-industry interventional studies with no phase under Neurodevelopmental Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 36 months is above that.

Counting every sponsor, half of 148 studies reached it within 30 months; a quarter within 15 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2026
First posted
Feb 27, 2026
StartActual
Apr 8, 2026
Primary completionEst.
Apr 2029
CompletionEst.
Apr 2029
Last update
Apr 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07439276
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Apr 8, 2026
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Apr 16, 2026

Study contacts

Dorothée Leunen
Contact
dorothee.leunen@aphp.fr
0171196346
Hélène Morel
Contact
helene.morel@aphp.fr
0171196346 ext. +33
Dorothée Leunen
principal investigator · Assistance Publique - Hôpitaux de Paris
Lisa Ouss, M.D.
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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