- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280367
Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age (DYS FUTURS UHR)
Childhood Learning and Executive Function Disorders and Risk of Psychosis in the Adulthood
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Garches, France, 92380
- Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Comparator group
Specific learning disorders group
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Comprehensive assessment of at-risk mental states (CAARMS) will be used.
Autism-spectrum quotient (AQ) auto-questionnaire will be used.
An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.
|
|
neuro-developmental complexed group
Group of neuro-developmental complexe of learning
|
Comprehensive assessment of at-risk mental states (CAARMS) will be used.
Autism-spectrum quotient (AQ) auto-questionnaire will be used.
An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.
|
|
Complexed with anxiety
Disorders in learning with anxiety
|
Comprehensive assessment of at-risk mental states (CAARMS) will be used.
Autism-spectrum quotient (AQ) auto-questionnaire will be used.
An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autistic screening
Time Frame: At baseline
|
Autism-spectrum quotient (AQ) auto-questionnaire will be used to evaluate difficulty in social interaction.
|
At baseline
|
|
Anxiety measuring
Time Frame: At baseline
|
An inventory for measuring clinical anxiety: Beck Anxiety Inventory
|
At baseline
|
|
Social interaction difficulty evaluation
Time Frame: At baseline
|
Liebowitz Social Anxiety Scale as questionnaire
|
At baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emilie SCHLUMBERGER, MD, Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP
- Study Director: Albane Mansoux, Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP191093
- 2019-A02663-54 (Registry Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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