Psychotic DisordersVEOSNCT05742893
Comparison of a Speech-Language Assessment Tool for Pragmatic and Discourse Skills in Schizophrenia Spectrum Disorders
A study testing Measurement of pragmatic and discourse test scores in the two scales. in people with Psychotic Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Measurement of pragmatic and discourse test scores in the two scales.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2023to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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 .
Read the 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.
- Conditions
- Psychotic Disorders
- Being tested
- Measurement of pragmatic and discourse test scores in the two scales.
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of pragmatic and discourse test scores in the two scales.Diagnostic 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 .
| Study group | Role | What they receive |
|---|---|---|
| diagnostic | Experimental | all patients have the study test Receives: Diagnostic Test: Measurement of pragmatic and discourse test scores in the two scales. |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess of pragmatic skills
The patients is evaluated by means of a semi-directed interview
Measured: day 0
assess discourse skills
he patient is evaluated through two image description tasks
Measured: day 0
assess narrative skills
the patients is evaluated through the oral restitution of two heard texts.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start6 Mar 2023
- Primary completion6 Mar 2023
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Michel, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742893
- Sponsor's protocol ID
- 22-AOI-04
- Acronym
- VEOS
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05742893
- Acronym / sponsor ID
- VEOS / 22-AOI-04
- Conditions
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic | Experimental | Diagnostic Test: Measurement of pragmatic and discourse test scores in the two scales.all patients have the study test |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of pragmatic and discourse test scores in the two scales.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 . | Diagnostic test | diagnostic |
Primary outcome
assess of pragmatic skills
Time frame: day 0
The patients is evaluated by means of a semi-directed interview
assess discourse skills
Time frame: day 0
he patient is evaluated through two image description tasks
assess narrative skills
Time frame: day 0
the patients is evaluated through the oral restitution of two heard texts.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Michel principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of pragmatic and discourse test scores in the two scales. in people with Psychotic Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess of pragmatic skills (time frame: day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.