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

April 10, 2024 updated by: Centre Hospitalier Universitaire de Nice

Comparison of a Speech-Language Pathology Assessment Tool for Pragmatic and Discourse Skills for Patients With Schizophrenic Spectrum Disorders and Other Psychotic Disorders

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 .

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nice, France, 06003
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diagnostic
all patients have the study test
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess of pragmatic skills
Time Frame: day 0
The patients is evaluated by means of a semi-directed interview
day 0
assess discourse skills
Time Frame: day 0
he patient is evaluated through two image description tasks
day 0
assess narrative skills
Time Frame: day 0
the patients is evaluated through the oral restitution of two heard texts.
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benoit Michel, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Actual)

March 6, 2023

Study Completion (Actual)

February 13, 2024

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 22-AOI-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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