Clinical trial NCT03919357: Using a New Calibrated Tool in Specific Language and Learning Disorders : the BMTi
Official title: Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (BMTi)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Learning Disorders, Specific
Developmental Disability
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association pour la recherche des troubles de l'apprentissage
name: Orthoédition
name: Association Française de Pédiatrie Ambulatoire- AFPA
name: Association pour l'Etude du Développement de l'Enfant
First posted: 2019-04-18
Enrollment: 229
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 5 and 13 years old with a complex developmental and learning disorder

Brief summary: The group of experts at HAS has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications International Classification of Diseases (CIM) CIM 11 and Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation.

This orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned.

The BMTi, a battery of third-generation tests (after the Rapid battery of evaluation of the cognitive functions (BREV) and then the Evaluation of cognitive functions and learning of the child (EDA)) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. .

The research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.

Detailed description: The group of experts at High Authority of Health (HAS) has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications CIM 11 and DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation.

This orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned.

The BMTi, a battery of third-generation tests (after the BREV and then the EDA) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. .

The research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.

This research project finds its place in a more global approach for a complete application of the recommendations of the group of experts of the High Authority of Health with:

* the systematic evaluation of educational prevention strategies by intensive training in small groups of children with similar needs, in schools,
* the evaluation of the role of the primary care physician in the prescription of the initial investigation report in the face of a simple reading, writing or numeracy disorder (research project with letter of intent filed in the framework of the call for tenders 38/5000 general direction of the offer of care (DGOS) PREPS 2018),
* the current project to validate referral tools to second-level appraisals,
* an evaluation project of the financing modalities filed under the regional health agency "Occitanie" in the framework of the call for tenders of article 51,
* the introduction of training courses for the first and second-line tools for ambulatory doctors.

Eligibility criteria: Inclusion Criteria:

* Child aged 5 to 13
* Complex complaint affecting one of the different areas of development and learning
* Affiliation to a social security scheme

Exclusion Criteria:

* Diagnosis of intellectual development disorder of autism spectrum disorder and suspect or confirm
* Refusal to participate

Primary outcomes:
measure: Sensitivity of BMT-i (modular computerized test battery)
timeFrame: 3 months
measure: Specificity of BMT-i
timeFrame: 3 months
Secondary outcomes:
measure: Sensitivity and specificity of the BMT-i by type of complaint
timeFrame: 3 months
measure: Kappa de Cohen test between BMTi assessments and the reference assessments
timeFrame: 3 months
measure: Concordance between investigators evaluations and reviewers evaluations
timeFrame: 3 months
measure: Curves ROC (Receiver operating characteristic)
timeFrame: 3 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Cabinet du Dr Vurpillat-Almanza
city: Chamalieres
country: France
facility: Cabinet du Dr Piollet
city: Chambéry
country: France
facility: Cabinet du Dr Gelbert
city: Le Chesnay
country: France
facility: CH Versailles - André Mignot
city: Marseille
country: France
facility: Centre Médical Pédiatrique Flammarion
city: Montpellier
country: France
facility: Hôpital Saint Eloi - Montpellier
city: Orléans
country: France
facility: Cabinet du Dr Kochert
city: Paris
country: France
facility: Centre Paris Santé Réussite
city: Puteaux
country: France
facility: Cabinet du Dr Cahn-Sellem
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Denis
country: France
facility: Cabinet du Dr Reynaud
city: Toulouse
country: France
facility: Cabinet du Dr Willig
city: Trélazé
country: France
facility: Cabinet du Dr Pineau
city: Verrières-le-Buisson
country: France
facility: Cabinet du Dr Lubelski
city: Villeneuve les Avignon
country: France
facility: Cabinet du Dr Werner
city: Le Lamentin
country: Martinique
facility: Cabinet du Dr Dulorme
Study officials:
References: