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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03919357
Other study ID # ValidBMTI2018
Secondary ID 2018-A01870-55
Status Completed
Phase
First received
Last updated
Start date March 7, 2019
Est. completion date April 1, 2021

Study information

Verified date May 2021
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 229
Est. completion date April 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years to 13 Years
Eligibility 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

Study Design


Intervention

Behavioral:
BMT-i
Passing the BMT-i test

Locations

Country Name City State
France Cabinet du Dr Vurpillat-Almanza Besançon
France Cabinet du Dr Piollet Chamalieres
France Cabinet du Dr Gelbert Chambéry
France CH Versailles - André Mignot Le Chesnay
France Centre Médical Pédiatrique Flammarion Marseille
France Hôpital Saint Eloi - Montpellier Montpellier
France Cabinet du Dr Kochert Orléans
France Centre Paris Santé Réussite Paris
France Cabinet du Dr Cahn-Sellem Puteaux
France CHU de Rouen Rouen
France Cabinet du Dr Reynaud Saint-Denis
France Cabinet du Dr Willig Toulouse
France Cabinet du Dr Pineau Trélazé
France Cabinet du Dr Lubelski Verrières-le-Buisson
France Cabinet du Dr Werner Villeneuve les Avignon
Martinique Cabinet du Dr Dulorme Le Lamentin

Sponsors (5)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil Association Française de Pédiatrie Ambulatoire- AFPA, Association pour l'Etude du Développement de l'Enfant, Association pour la recherche des troubles de l'apprentissage, Orthoédition

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of BMT-i (modular computerized test battery) Calculation of the sensitivity of the BMT-i compared to the reference balance sheets 3 months
Primary Specificity of BMT-i Calculation of the specificity of the BMT-i compared to the reference balance sheets 3 months
Secondary Sensitivity and specificity of the BMT-i by type of complaint Calculation of the sensitivity and specificity of the BMT-i compared to the reference balance in each type of complaint (oral language, learning, graphics and attention) 3 months
Secondary Kappa de Cohen test between BMTi assessments and the reference assessments Assessment of the concordance between the BMTi assessments and the baseline assessments 3 months
Secondary Concordance between investigators evaluations and reviewers evaluations Evaluation of the concordance between the BMTi evaluations rated by the investigators and the reviewers 3 months
Secondary Curves ROC (Receiver operating characteristic) Receiver operating characteristic (ROC) curves to validate selected BMT-i diagnostic thresholds 3 months
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