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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
schizophrenia
Autism
Healthy controls
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Schizophrenia focused on measuring schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Professeur FRANCK Nicolas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

schizophrenia

autism

healthy controls

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

Change from Baseline in symptoms measure
Positive and negative symptoms scale, global score, positive sub scale score and negative sub scale score (PANSS)
Change from Baseline in Neurocognitive functioning measures
Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.

Full Information

First Posted
December 16, 2015
Last Updated
January 26, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT02660775
Brief Title
Social Cognitive Assessment in Autism and Schizophrenia
Acronym
(ClaCoS)
Official Title
Social Cognitive Assessment in Psychiatry - Validation of a New Battery: ClaCoS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2015 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
schizophrenia
Arm Type
Experimental
Arm 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.
Arm Title
autism
Arm Type
Experimental
Arm 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.
Arm Title
healthy controls
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
schizophrenia
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Autism
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Healthy controls
Intervention Description
only social cognitive measures
Primary Outcome Measure Information:
Title
Change from Baseline in social cognition measures
Description
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 )
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in symptoms measure
Description
Positive and negative symptoms scale, global score, positive sub scale score and negative sub scale score (PANSS)
Time Frame
Week 12
Title
Change from Baseline in Neurocognitive functioning measures
Description
Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCK NICOLAS, PUPH
Organizational Affiliation
Service Universitaire de Réhabilitation - Le Vinatier Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professeur FRANCK Nicolas
City
Bron
State/Province
Rhone-alpes
ZIP/Postal Code
69678
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Social Cognitive Assessment in Autism and Schizophrenia

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