SchizophreniaDYS FUTURS UHRNCT04280367
Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age
An observational study of Schizophrenia and Learning Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study aims to study transition toward schizophrenia in patients with learning disorders, and to compare the risk between patients with specific learning disorders, and patients with complexed learning disorders (by two types: patients with other neuro-developmental disorders including… Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Schizophrenia, Learning Disorders, Executive Function Disorders
- What is being tested?
- Standardised semi-structured talk, Autistic spectre disorder screening and Anxiety measuring
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2020to 29 May 2020
- Phase
- Observational
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients between 15 and 30 years, suffering learning disorders complicated with two orders: with other neuro-developmental, or with anxiety (vs specific: comparator group).
Who may be able to join
- Patients born between 1990 and 2005, have been cared by Dr Schlumberger in 2014 in the center of language and learning disorders at Raymond Poincaré hospital;
- With severe learning disorders: deficiency in school work, need at least one medical appointment and long-term rehabilitation in the center of language and learning disorders at Raymond Poincaré hospital;
- Affiliated to a social protection schema;
- Written informed consent signed.
Who cannot join
- Absence of learning disorder;
- Intellectual deficiency;
- Epilepsia;
- Patients who will performed follow-up at Chartres city;
- Patients under guardianship or curatorship;
- Foreign patients under AME schema, a medical help from the state in France.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré
Garches, 92380
About this study
Official title: Childhood Learning and Executive Function Disorders and Risk of Psychosis in the Adulthood
The primary objective of the study aims to study transition toward schizophrenia in patients with learning disorders, and to compare the risk between patients with specific learning disorders, and patients with complexed learning disorders (by two types: patients with other neuro-developmental disorders including executive function disorders, and patients with anxiety).
Read the detailed description
As secondary objectives, the study aims to:
- argue the clinical predicted markers (neuropsychological) transition toward psychosis.
- test the feasibility and the acceptability of a early diagnosis for a potential applicable guidance for different referent centers of learning in French territory.
- have a better classification of patients with learning disorders in order to target a prospective primary prevention of risk of psychosis via the questionnaires (AQ of Baron-Cohen: Autism-spectrum quotient auto-questionnaire; Inventory of Beck Anxiety Inventory, auto-questionnaire for panic disorder and general anxiety; Liebowitz Social Anxiety Scale).
- improve identification of the early signs and the early emerging psychological diseases intervention management (schizophrenia).
- Psychic disability: prevent and reduce non-seeking care and accompaniment situations, and risk of rupture of care.
- permitting better care of psychosocial rehabilitation with cognitive evaluation.
This study will be conducted in Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP, in France.
- Being tested
- Standardised semi-structured talk, Autistic spectre disorder screening, Anxiety measuring
- Keywords
- learning disorders, executive function disorders, psychosis, children, adult-age
- Medical subject headings
- Schizophrenia, Learning Disabilities, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised semi-structured talkDiagnostic test
Comprehensive assessment of at-risk mental states (CAARMS) will be used.
Autistic spectre disorder screeningDiagnostic test
Autism-spectrum quotient (AQ) auto-questionnaire will be used.
Anxiety measuringDiagnostic test
An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.
| Study group | Role | What they receive |
|---|---|---|
| Comparator group | Specific learning disorders group Receives: Diagnostic Test: Standardised semi-structured talk; Diagnostic Test: Autistic spectre disorder screening; Diagnostic Test: Anxiety measuring | |
| neuro-developmental complexed group | Group of neuro-developmental complexe of learning Receives: Diagnostic Test: Standardised semi-structured talk; Diagnostic Test: Autistic spectre disorder screening; Diagnostic Test: Anxiety measuring | |
| Complexed with anxiety | Disorders in learning with anxiety Receives: Diagnostic Test: Standardised semi-structured talk; Diagnostic Test: Autistic spectre disorder screening; Diagnostic Test: Anxiety measuring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interview
Assessement with Comprehensive Assessment of At-Risk Mental States (CAARMS) during 6 to 90 minutes at the center of Raymond Poincaré hospital.
The unique collection during the interview, quotation of each patient will be given from the assessement.
There will be 4 groups by the results: CAARMS negative subjects, vulnerable subjects, attenuated psychosis subjects and subjects with brief and limited intermittent psychotic syndrome. The further statistic comparison will be done between the 3 last groups classified with results of CAARMS.
Measured: At baseline
Secondary outcomes (3)
Autistic screening
Autism-spectrum quotient (AQ) auto-questionnaire will be used to evaluate difficulty in social interaction.
Measured: At baseline
Anxiety measuring
An inventory for measuring clinical anxiety: Beck Anxiety Inventory
Measured: At baseline
Social interaction difficulty evaluation
Liebowitz Social Anxiety Scale as questionnaire
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start28 Jan 2020
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie SCHLUMBERGER, MD, Principal investigator, Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHPAlbane Mansoux, Study director, Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280367
- Sponsor's protocol ID
- APHP191093
- Other IDs
- 2019-A02663-54
- Acronym
- DYS FUTURS UHR
- Status last verified
- Aug 2023
- First submitted
- 20 Feb 2020
- Last updated
- 22 Aug 2023
- 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Learning and Executive Function Disorders and Risk of Psychosis in the Adulthood
- ClinicalTrials.gov ID
- NCT04280367
- Acronym / sponsor ID
- DYS FUTURS UHR / APHP191093
- Keywords
- learning disorders, executive function disorders, psychosis, children, adult-age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 21 Feb 2020 (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 primary objective of the study aims to study transition toward schizophrenia in patients with learning disorders, and to compare the risk between patients with specific learning disorders, and patients with complexed learning disorders (by two types: patients with other neuro-developmental disorders including executive function disorders, and patients with anxiety).
Detailed description
As secondary objectives, the study aims to:
- argue the clinical predicted markers (neuropsychological) transition toward psychosis.
- test the feasibility and the acceptability of a early diagnosis for a potential applicable guidance for different referent centers of learning in French territory.
- have a better classification of patients with learning disorders in order to target a prospective primary prevention of risk of psychosis via the questionnaires (AQ of Baron-Cohen: Autism-spectrum quotient auto-questionnaire; Inventory of Beck Anxiety Inventory, auto-questionnaire for panic disorder and general anxiety; Liebowitz Social Anxiety Scale).
- improve identification of the early signs and the early emerging psychological diseases intervention management (schizophrenia).
- Psychic disability: prevent and reduce non-seeking care and accompaniment situations, and risk of rupture of care.
- permitting better care of psychosocial rehabilitation with cognitive evaluation.
This study will be conducted in Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP, in France.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comparator group | – | Diagnostic Test: Standardised semi-structured talk, Diagnostic Test: Autistic spectre disorder screening, Diagnostic Test: Anxiety measuringSpecific learning disorders group |
| neuro-developmental complexed group | – | Diagnostic Test: Standardised semi-structured talk, Diagnostic Test: Autistic spectre disorder screening, Diagnostic Test: Anxiety measuringGroup of neuro-developmental complexe of learning |
| Complexed with anxiety | – | Diagnostic Test: Standardised semi-structured talk, Diagnostic Test: Autistic spectre disorder screening, Diagnostic Test: Anxiety measuringDisorders in learning with anxiety |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients between 15 and 30 years, suffering learning disorders complicated with two orders: with other neuro-developmental, or with anxiety (vs specific: comparator group).
Key inclusion criteria (4 listed)
- Patients born between 1990 and 2005, have been cared by Dr Schlumberger in 2014 in the center of language and learning disorders at Raymond Poincaré hospital;
- With severe learning disorders: deficiency in school work, need at least one medical appointment and long-term rehabilitation in the center of language and learning disorders at Raymond Poincaré hospital;
- Affiliated to a social protection schema;
- Written informed consent signed.
Key exclusion criteria (6 listed)
- Absence of learning disorder;
- Intellectual deficiency;
- Epilepsia;
- Patients who will performed follow-up at Chartres city;
- Patients under guardianship or curatorship;
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 |
|---|---|---|
| Standardised semi-structured talkComprehensive assessment of at-risk mental states (CAARMS) will be used. | Diagnostic test | Comparator group, Complexed with anxiety, neuro-developmental complexed group |
| Autistic spectre disorder screeningAutism-spectrum quotient (AQ) auto-questionnaire will be used. | Diagnostic test | Comparator group, Complexed with anxiety, neuro-developmental complexed group |
| Anxiety measuringAn inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale. | Diagnostic test | Comparator group, Complexed with anxiety, neuro-developmental complexed group |
Primary outcome
Semi-structured interview
Time frame: At baseline
Assessement with Comprehensive Assessment of At-Risk Mental States (CAARMS) during 6 to 90 minutes at the center of Raymond Poincaré hospital. The unique collection during the interview, quotation of each patient will be given from the assessement. There will be 4 groups by the results: CAARMS negative subjects, vulnerable subjects, attenuated psychosis subjects and subjects with brief and limited intermittent psychotic syndrome. The further statistic comparison will be done between the 3 last groups classified with results of CAARMS.
3 secondary outcomes
Autistic screening
Time frame: At baseline
Anxiety measuring
Time frame: At baseline
Social interaction difficulty evaluation
Time frame: At baseline
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 22 Aug 2023.
- 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.
Emilie SCHLUMBERGER, MD principal investigator
Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP
Albane Mansoux study director
Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Learning Disorders, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 6 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 22 Aug 2023. 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?
Semi-structured interview (time frame: At baseline). 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 22 Aug 2023.