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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Hôpital le Vinatier
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT02660775
First received: December 16, 2015
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Schizophrenia Behavioral: schizophrenia Behavioral: Autism Behavioral: Healthy controls

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Social Cognitive Assessment in Psychiatry - Validation of a New Battery: ClaCoS

Resource links provided by NLM:


Further study details as provided by Hôpital le Vinatier:

Primary Outcome Measures:
  • Change from Baseline in social cognition measures [ Time Frame: Week 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:
  • Change from Baseline in symptoms measure [ Time Frame: Week 12 ]
    Positive and negative symptoms scale, global score, positive sub scale score and negative sub scale score (PANSS)

  • Change from Baseline in Neurocognitive functioning measures [ Time Frame: Week 12 ]
    Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.


Estimated Enrollment: 440
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02660775

Contacts
Contact: FRANCK NICOLAS, PUPH +33(0)426738531 nicolas.franck@ch-le-vinatier.fr
Contact: PEYROUX ELODIE, DR +33(0)426738531 elodie.peyroux@ch-le-vinatier.fr

Locations
France
Professeur FRANCK Nicolas Recruiting
Bron, Rhone-alpes, France, 69678
Contact: FRANCK NICOLAS, PUPH    +33(0)426738531    nicolas.franck@ch-le-vinatier.fr   
Contact: PEYROUX ELODIE, DR       elodie.peyroux@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Principal Investigator: FRANCK NICOLAS, PUPH Service Universitaire de Réhabilitation - Le Vinatier Hospital
  More Information

Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02660775     History of Changes
Other Study ID Numbers: 2015-A00580-49
Study First Received: December 16, 2015
Last Updated: August 3, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hôpital le Vinatier:
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 22, 2017