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Completed

NCT Number: NCT02660775

Social Cognitive Assessment in Autism and Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Professeur FRANCK Nicolas

Bron, Auvergne-Rhône-Alpes, 69678, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

schizophrenia

Behavioral

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

Behavioral

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

Behavioral

only social cognitive measures

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: (ClaCoS)

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 21, 2016
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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