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Comparison of a Speech-Language Assessment Tool for Pragmatic and Discourse Skills in Schizophrenia Spectrum Disorders (VEOS)

Primary Purpose

Psychotic Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Measurement of pragmatic and discourse test scores in the two scales.
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psychotic Disorders

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female between the ages of 18 and 60 Patient with a diagnosis of schizophrenic spectrum disorder and other psychotic disorders meeting DSM V criteria Patient who has been clinically and treatment stable for at least three months Patient who can read and write French Patient who is a beneficiary of a social security plan or similar Patient with ability to sign free and informed consent Exclusion Criteria: - Patient hospitalized under restraint Patient under guardianship Patient who has stopped taking his or her treatment Patient who had a change in treatment in the period of less than three months prior to the pass Patient with a worsening of the disease in the three months prior to the inclusion visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    diagnostic

    Arm Description

    all patients have the study test

    Outcomes

    Primary Outcome Measures

    assess of pragmatic skills
    The patients is evaluated by means of a semi-directed interview
    assess discourse skills
    he patient is evaluated through two image description tasks
    assess narrative skills
    the patients is evaluated through the oral restitution of two heard texts.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2023
    Last Updated
    February 14, 2023
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05742893
    Brief Title
    Comparison of a Speech-Language Assessment Tool for Pragmatic and Discourse Skills in Schizophrenia Spectrum Disorders
    Acronym
    VEOS
    Official Title
    Comparison of a Speech-Language Pathology Assessment Tool for Pragmatic and Discourse Skills for Patients With Schizophrenic Spectrum Disorders and Other Psychotic Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    October 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The scientific literature has largely objectified language disorders in schizophrenia. And more precisely, the impairment of pragmatic and discursive language skills. Currently, there is no standardized language assessment tool specific to these patients. The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia .
    Detailed Description
    The scientific literature has largely objectified language disorders in schizophrenia. And more precisely, the impairment of pragmatic and discursive language skills. Currently, there is no standardized language assessment tool specific to these patients. The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia. To do so, patients will have to pass six tests: three tests of the new tool and three corresponding gold standard tests. The first two tests will assess pragmatic skills by means of a semi-directed interview. The next two tests will assess discourse skills through two image description tasks. Finally, the last two tests will evaluate narrative skills through the oral restitution of two heard texts. The main objective is to compare the performance of schizophrenic patients detected in the pathological zone with the scales of the new tool versus the gold standard scales. The secondary objective is to determine which skills are most affected by comparing patients' scores in pragmatic skills versus those in discourse skills. This tool would allow to precisely objectify language disorders and to optimize the multidisciplinary diagnosis and care of patients suffering from schizophrenia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychotic Disorders

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    diagnostic
    Arm Type
    Experimental
    Arm Description
    all patients have the study test
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Measurement of pragmatic and discourse test scores in the two scales.
    Intervention Description
    The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia .
    Primary Outcome Measure Information:
    Title
    assess of pragmatic skills
    Description
    The patients is evaluated by means of a semi-directed interview
    Time Frame
    day 0
    Title
    assess discourse skills
    Description
    he patient is evaluated through two image description tasks
    Time Frame
    day 0
    Title
    assess narrative skills
    Description
    the patients is evaluated through the oral restitution of two heard texts.
    Time Frame
    day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female between the ages of 18 and 60 Patient with a diagnosis of schizophrenic spectrum disorder and other psychotic disorders meeting DSM V criteria Patient who has been clinically and treatment stable for at least three months Patient who can read and write French Patient who is a beneficiary of a social security plan or similar Patient with ability to sign free and informed consent Exclusion Criteria: - Patient hospitalized under restraint Patient under guardianship Patient who has stopped taking his or her treatment Patient who had a change in treatment in the period of less than three months prior to the pass Patient with a worsening of the disease in the three months prior to the inclusion visit
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    CAUSERET Marion
    Phone
    0492034702
    Email
    causeret.m@chu-nice.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Benoit Michel
    Organizational Affiliation
    Centre Hospitalier Universitaire de Nice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of a Speech-Language Assessment Tool for Pragmatic and Discourse Skills in Schizophrenia Spectrum Disorders

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