Social Cognitive Assessment in Autism and Schizophrenia ((ClaCoS))

Hôpital le Vinatier

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: Healthy controls; Behavioral: Autism; Behavioral: schizophrenia

Study type: Interventional

Funder types: Other

Identifiers

NCT02660775

2015-A00580-49

Details and patient eligibility

About

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.

Full 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).

Enrollment: 440 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 3 patient groups, including a placebo group

schizophrenia

Experimental group

Description:

this 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.

Treatment:

Behavioral: schizophrenia

autism

Experimental group

Description:

this 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.

Treatment:

Behavioral: Autism

healthy controls

Placebo Comparator group

Description:

this 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.

Treatment:

Behavioral: Healthy controls