Using a New Calibrated Tool in Specific Language and Learning Disorders : the BMTi (ValidBMTI)

Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (BMTi)

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.

Study Overview

• Status: Completed
• Conditions: Developmental Disability; Learning Disorders, Specific
• Intervention / Treatment: Behavioral: BMT-i

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.

• Study Type: Observational
• Enrollment (Actual): 229

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Cabinet du Dr Vurpillat-Almanza
  • Chamalieres, France
    • Cabinet du Dr Piollet
  • Chambéry, France, 73000
    • Cabinet du Dr Gelbert
  • Le Chesnay, France
    • CH Versailles - André Mignot
  • Marseille, France
    • Centre Médical Pédiatrique Flammarion
  • Montpellier, France
    • Hôpital Saint Eloi - Montpellier
  • Orléans, France, 45000
    • Cabinet du Dr Kochert
  • Paris, France, 75020
    • Centre Paris Santé Réussite
  • Puteaux, France, 92800
    • Cabinet du Dr Cahn-Sellem
  • Rouen, France
    • CHU de Rouen
  • Saint-Denis, France
    • Cabinet du Dr Reynaud
  • Toulouse, France
    • Cabinet du Dr Willig
  • Trélazé, France
    • Cabinet du Dr Pineau
  • Verrières-le-Buisson, France
    • Cabinet du Dr Lubelski
  • Villeneuve les Avignon, France
    • Cabinet du Dr Werner
• Martinique
  • Le Lamentin, Martinique, 97129
    • Cabinet du Dr Dulorme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children between 5 and 13 years old with a complex developmental and learning disorder

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Verbal; Passing of a specialized questionnaire on verbal disorders	Behavioral: BMT-i; Passing the BMT-i test
Non-verbal; Passing of a specialized questionnaire on non verbal disorders	Behavioral: BMT-i; Passing the BMT-i test
Attention; Passing of a specialized questionnaire on attention disorders	Behavioral: BMT-i; Passing the BMT-i test
Complaint about learning; Passing of a specialized questionnaire on learning disorders	Behavioral: BMT-i; Passing the BMT-i test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of BMT-i (modular computerized test battery)	Calculation of the sensitivity of the BMT-i compared to the reference balance sheets	3 months
Specificity of BMT-i	Calculation of the specificity of the BMT-i compared to the reference balance sheets	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Concordance between investigators evaluations and reviewers evaluations	Evaluation of the concordance between the BMTi evaluations rated by the investigators and the reviewers	3 months
Curves ROC (Receiver operating characteristic)	Receiver operating characteristic (ROC) curves to validate selected BMT-i diagnostic thresholds	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Association pour la recherche des troubles de l'apprentissage; Orthoédition; Association Française de Pédiatrie Ambulatoire- AFPA; Association pour l'Etude du Développement de l'Enfant

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Developmental Disabilities; Learning Disabilities; Specific Learning Disorder
• Other Study ID Numbers: ValidBMTI2018; 2018-A01870-55 (Other Identifier: ID-RCB)

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