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

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Completed

CT.gov ID

NCT03919357

Collaborator

Association pour la recherche des troubles de l'apprentissage (Other), Orthoédition (Other), Association Française de Pédiatrie Ambulatoire- AFPA (Other), Association pour l'Etude du Développement de l'Enfant (Other)

229

Enrollment

Locations

24.8

Actual Duration (Months)

14.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Learning Disorders, Specific Developmental Disability	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. .

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 Design

Study Type:

Observational

Actual Enrollment :

229 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 7, 2019

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Sensitivity of BMT-i (modular computerized test battery) [3 months]
Calculation of the sensitivity of the BMT-i compared to the reference balance sheets
Specificity of BMT-i [3 months]
Calculation of the specificity of the BMT-i compared to the reference balance sheets

Secondary Outcome Measures

Sensitivity and specificity of the BMT-i by type of complaint [3 months]
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)
Kappa de Cohen test between BMTi assessments and the reference assessments [3 months]
Assessment of the concordance between the BMTi assessments and the baseline assessments
Concordance between investigators evaluations and reviewers evaluations [3 months]
Evaluation of the concordance between the BMTi evaluations rated by the investigators and the reviewers
Curves ROC (Receiver operating characteristic) [3 months]
Receiver operating characteristic (ROC) curves to validate selected BMT-i diagnostic thresholds

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cabinet du Dr Vurpillat-Almanza	Besançon	France
2	Cabinet du Dr Piollet	Chamalieres	France
3	Cabinet du Dr Gelbert	Chambéry	France	73000
4	CH Versailles - André Mignot	Le Chesnay	France
5	Centre Médical Pédiatrique Flammarion	Marseille	France
6	Hôpital Saint Eloi - Montpellier	Montpellier	France
7	Cabinet du Dr Kochert	Orléans	France	45000
8	Centre Paris Santé Réussite	Paris	France	75020
9	Cabinet du Dr Cahn-Sellem	Puteaux	France	92800
10	CHU de Rouen	Rouen	France
11	Cabinet du Dr Reynaud	Saint-Denis	France
12	Cabinet du Dr Willig	Toulouse	France
13	Cabinet du Dr Pineau	Trélazé	France
14	Cabinet du Dr Lubelski	Verrières-le-Buisson	France
15	Cabinet du Dr Werner	Villeneuve les Avignon	France
16	Cabinet du Dr Dulorme	Le Lamentin	Martinique	97129

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil
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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT03919357

Other Study ID Numbers:

ValidBMTI2018
2018-A01870-55

First Posted:

Apr 18, 2019

Last Update Posted:

May 20, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Learning Disabilities

Developmental Disabilities

Specific Learning Disorder

Study Results

No Results Posted as of May 20, 2021