Social Cognitive Assessment in Autism and Schizophrenia

NCT02660775 | Completed DMC

• 1 other identifier: 2015-A00580-49
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline in symptoms measure

  Week 12

• Change from Baseline in Neurocognitive functioning measures

  Week 12

Study Arms (3)

schizophrenia

EXPERIMENTAL

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

autism

EXPERIMENTAL

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

healthy controls

PLACEBO COMPARATOR

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

Interventions

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)

schizophrenia

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

autism

Healthy controls BEHAVIORAL

only social cognitive measures

healthy controls

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Aged 18-45 years old
• Patients with schizophrenia: diagnosis assessed with DSM5 criteria
• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Professeur FRANCK Nicolas

Bron, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• FRANCK NICOLAS, PUPH

  Service Universitaire de Réhabilitation - Le Vinatier Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: January 21, 2016
• Study Start: December 4, 2015
• Primary Completion: March 31, 2021
• Study Completion: June 30, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)