Social Cognitive Assessment in Autism and Schizophrenia

Schizophrenia Clinical Trial

— (ClaCoS)  

Official title:

Social Cognitive Assessment in Psychiatry - Validation of a New Battery: ClaCoS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660775
• Other study ID #: 2015-A00580-49
• Status: Completed
• Phase: N/A
• Start date: December 4, 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2022
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: June 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• schizophrenia
The battery (ClaCoS) is composed by 6 tests and several scores will be recorded for each: for emotion perception : Facial emotions recognition task (TREF) for theory of mind : Movie for the assessment of social cognition ( MASC-VF) for attributional bias : Ambiguous Intentions Hostility Questionnaire ( AIHQ) for social perception and knowledge : interpretation score - with and without index, comprehension score ( PerSo ) for empathy :Questionnaire of cognitive and affective empathy ( QCAE) for people with schizophrenia for self assessment : Self - assessment of social cognition (ACSo)
• Autism
The battery (ClaCoS ) is composed by 6 tests and several scores will be recorded for each: for emotion perception : Facial emotions recognition task(TREF ): total score, score per emotion, detection levels for theory of mind : Movie for the assessment of social cognition (MASC ) :total score, error type for attributional bias : Ambiguous Intentions Hostility Questionnaire (AIHQ) :hostility score, attribution score, aggression score for social perception and knowledge : interpretation score - with and without index, comprehension score ( PerSo ) for empathy : Empathy quotient (EQ) for self assessment : Self - assessment of social cognition ( ACSo ): total score and scores per processes
• Healthy controls
only social cognitive measures

Locations

Country	Name	City	State
France	Professeur FRANCK Nicolas	Bron	Rhone-alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in social cognition measures	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 )	Week 12
Secondary	Change from Baseline in symptoms measure	Positive and negative symptoms scale, global score, positive sub scale score and negative sub scale score (PANSS)	Week 12
Secondary	Change from Baseline in Neurocognitive functioning measures	Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.	Week 12