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Social Cognitive Assessment in Autism and Schizophrenia

Not Applicable
Completed
Conditions
Schizophrenia
Interventions
Behavioral: Healthy controls
Behavioral: schizophrenia
Behavioral: Autism
Registration Number
NCT02660775
Lead Sponsor
Hôpital le Vinatier
Brief Summary

In people with schizophrenia or people with autism, impairments of social cognition are a core feature of the disease and, according to researchers who represent valuable references on this subject for the international community, three to five processes of social cognition are usually altered in those diseases: (1) emotional processing which is the ability to identify emotions through facial expressions, gestures, and tone of voice, (2) theory of mind (ToM), which is defined as "the ability to attribute mental states (beliefs, intents, desires, ...) to oneself and others, and to understand that others have beliefs, intentions, and desires that are different from one's own", (3) attributional style which refers to how people explain the causes of positive and negative events, and corresponding, in schizophrenia, to self-serving and personalizing bias that means a tendency to blame others for negative life events rather than sharing the responsibilities between different sources; and (4 and 5) social perception and knowledge, which can be defined as decoding and interpreting social cues from others, taking the social context into account, and knowing social rules, roles, and goals. Components of social cognition appear to be related to both symptomatology and functioning in everyday life. The present study aims to assess a new social cognitive battery developed by several teams in France: ClaCoS.

Detailed Description

The project's objectives are: (1) to assess relevance of ClaCoS in schizophrenia and autism compared to healthy controls, and to analyze links between social cognition and both neurocognition and symptoms, (2) to collect data in a large sample of healthy controls in order to establish appropriate standards for tools composing ClaCoS battery.

For the first objective, three kind of evaluation will be proposed: clinical, neurocognitive and social cognitive (ClaCoS). Three populations of 80 participants will be compared: healthy controls, patients with schizophrenia or schizoaffective disorders, and patients with autism spectrum disorders. These three groups will be matched on sex, age and level of education.

For the second objective a systematic collection of data will be carried out in a large sample of healthy controls. In this part of the study, only social cognitive measures will be recorded. Subjects will be ranked according to three criteria: three classes for age (18-25 years old, 26-35 and 36-45), five classes for socio-professional status according to the INSEE classification, and two classes for sex (men/women).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
440
Inclusion Criteria
  • Aged 18-45 years old
  • No psychiatric or neurologic conditions or comorbidity
  • No relatives with people with people with history of neuropsychiatric disease
  • French native language or education in a French school since the first year of primary school
  • Consent to participate to the study
Exclusion Criteria
  • Aged 18-45 years old
  • Patients with schizophrenia: diagnosis assessed with DSM5 criteria
  • No modification of psychotropic treatment during the month before inclusion
  • French native language or education in a French school since the first year of primary school
  • Consent to participate to the study and agreement of the legal guardian

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
healthy controlsHealthy controlsthis project is to assess relevance of ClaCoS in autism compared to healthy controls, and to analyze links between social cognition and both neurocognition and symptoms, (2) to collect data in a large sample of healthy controls in order to establish appropriate standards for tools composing ClaCoS battery.
schizophreniaschizophreniathis project is to assess relevance of ClaCoS in schizophrenia compared to healthy controls, and to analyze links between social cognition and both neurocognition and symptoms, (2) to collect data in a large sample of healthy controls in order to establish appropriate standards for tools composing ClaCoS battery.
autismAutismthis project is to assess relevance of ClaCoS in autism compared to healthy controls, and to analyze links between social cognition and both neurocognition and symptoms, (2) to collect data in a large sample of healthy controls in order to establish appropriate standards for tools composing ClaCoS battery.
Primary Outcome Measures
NameTimeMethod
Change from Baseline in social cognition measuresWeek 12

The battery (ClaCoS ) is composed by 6 tests and several scores will be recorded for each:

* for emotion perception : total score, score per emotion, detection levels (TREF)

* for theory of mind : total score, error type (MASC)

* for attributional bias : hostility score, attribution score, aggression score (AIHQ )

* for social perception and knowledge : interpretation score - with and without index, comprehension score (PerSo)

* for empathy : Empathy quotient (EQ) for people with autism / Questionnaire of cognitive and affective empathy (QCAE )for people with schizophrenia (total score and sub scores)

* for self assessment : total score and scores per processes( ACSo )

Secondary Outcome Measures
NameTimeMethod
Change from Baseline in symptoms measureWeek 12

Positive and negative symptoms scale, global score, positive sub scale score and negative sub scale score (PANSS)

Change from Baseline in Neurocognitive functioning measuresWeek 12

Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.

Trial Locations

Locations (1)

Professeur FRANCK Nicolas

🇫🇷

Bron, Rhone-alpes, France

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