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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: schizophrenia; Behavioral: Autism; Behavioral: Healthy controls

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).

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhone-alpes
    • Bron, Rhone-alpes, France, 69678
      • Professeur FRANCK Nicolas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: schizophrenia; 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.	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)
Experimental: autism; 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.	Behavioral: 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
Placebo Comparator: healthy controls; 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.	Behavioral: Healthy controls; only social cognitive measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from Baseline in Neurocognitive functioning measures	Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.	Week 12

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: FRANCK NICOLAS, PUPH, Service Universitaire de Réhabilitation - Le Vinatier Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2015
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: January 18, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 2015-A00580-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No