Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age

Schizophrenia Clinical Trial

— DYS FUTURS UHR  

Official title:

Childhood Learning and Executive Function Disorders and Risk of Psychosis in the Adulthood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280367
• Other study ID #: APHP191093
• Secondary ID: 2019-A02663-54
• Status: Completed
• Start date: January 28, 2020
• Est. completion date: May 29, 2020

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 executive function disorders, and patients with anxiety).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Executive Function Disorders
• Learning Disabilities
• Learning Disorders
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Diagnostic Test:
• Standardised semi-structured talk
Comprehensive assessment of at-risk mental states (CAARMS) will be used.
• Autistic spectre disorder screening
Autism-spectrum quotient (AQ) auto-questionnaire will be used.
• Anxiety measuring
An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.

Locations

Country	Name	City	State
France	Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline
Secondary	Autistic screening	Autism-spectrum quotient (AQ) auto-questionnaire will be used to evaluate difficulty in social interaction.	At baseline
Secondary	Anxiety measuring	An inventory for measuring clinical anxiety: Beck Anxiety Inventory	At baseline
Secondary	Social interaction difficulty evaluation	Liebowitz Social Anxiety Scale as questionnaire	At baseline