跳至主要内容
临床试验/NCT07439276
NCT07439276招募中不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Overall social cognition score and scores per dimension, obtained on the multidimensional social cognition battery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Autism Spectrum Disorder

Experimental

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

40 children and teenagers.

干预措施: Test (Other)

Autism Spectrum Disorder

Experimental

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

40 children and teenagers.

干预措施: Questionnaires (Other)

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.

干预措施: Test (Other)

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.

干预措施: Questionnaires (Other)

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.

干预措施: Test (Other)

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.

干预措施: Questionnaires (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Influence of socio-demographic factors on social cognition performance(Day 1)
  • Influence of cognitive factors on social cognition(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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