Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age (DYS FUTURS UHR)

August 21, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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).

Study Overview

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

Observational

Enrollment (Actual)

20

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

      • Garches, France, 92380
        • Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré

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

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Comparator group
Specific learning disorders group
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

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

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

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)

January 28, 2020

Primary Completion (Actual)

May 29, 2020

Study Completion (Actual)

May 29, 2020

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

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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