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出境医 / 临床实验 / Using a New Calibrated Tool in Specific Language and Learning Disorders : the BMTi (ValidBMTI)

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

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
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. .

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 Design
Layout table for study information
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 : March 7, 2019
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : April 1, 2021
Arms 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

Outcome Measures
Primary Outcome Measures :
  1. Sensitivity of BMT-i (modular computerized test battery) [ Time Frame: 3 months ]
    Calculation of the sensitivity of the BMT-i compared to the reference balance sheets

  2. Specificity of BMT-i [ Time Frame: 3 months ]
    Calculation of the specificity of the BMT-i compared to the reference balance sheets


Secondary Outcome Measures :
  1. Sensitivity and specificity of the BMT-i by type of complaint [ Time Frame: 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)

  2. Kappa de Cohen test between BMTi assessments and the reference assessments [ Time Frame: 3 months ]
    Assessment of the concordance between the BMTi assessments and the baseline assessments

  3. Concordance between investigators evaluations and reviewers evaluations [ Time Frame: 3 months ]
    Evaluation of the concordance between the BMTi evaluations rated by the investigators and the reviewers

  4. Curves ROC (Receiver operating characteristic) [ Time Frame: 3 months ]
    Receiver operating characteristic (ROC) curves to validate selected BMT-i diagnostic thresholds


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children between 5 and 13 years old with a complex developmental and learning disorder
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
Contacts and Locations

Locations
Layout table for location information
France
Cabinet du Dr Vurpillat-Almanza
Besançon, France
Cabinet du Dr Piollet
Chamalieres, France
Cabinet du Dr Gelbert
Chambéry, France, 73000
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, 45000
Centre Paris Santé Réussite
Paris, France, 75020
Cabinet du Dr Cahn-Sellem
Puteaux, France, 92800
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, France
Martinique
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
Tracking Information
First Submitted Date April 4, 2019
First Posted Date April 18, 2019
Last Update Posted Date May 20, 2021
Actual Study Start Date March 7, 2019
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2019)
  • Sensitivity of BMT-i (modular computerized test battery) [ Time Frame: 3 months ]
    Calculation of the sensitivity of the BMT-i compared to the reference balance sheets
  • Specificity of BMT-i [ Time Frame: 3 months ]
    Calculation of the specificity of the BMT-i compared to the reference balance sheets
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 15, 2019)
  • Sensitivity and specificity of the BMT-i by type of complaint [ Time Frame: 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 [ Time Frame: 3 months ]
    Assessment of the concordance between the BMTi assessments and the baseline assessments
  • Concordance between investigators evaluations and reviewers evaluations [ Time Frame: 3 months ]
    Evaluation of the concordance between the BMTi evaluations rated by the investigators and the reviewers
  • Curves ROC (Receiver operating characteristic) [ Time Frame: 3 months ]
    Receiver operating characteristic (ROC) curves to validate selected BMT-i diagnostic thresholds
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children between 5 and 13 years old with a complex developmental and learning disorder
Condition
  • Learning Disorders, Specific
  • Developmental Disability
Intervention Behavioral: BMT-i
Passing the BMT-i test
Study Groups/Cohorts
  • Verbal
    Passing of a specialized questionnaire on verbal disorders
    Intervention: Behavioral: BMT-i
  • Non-verbal
    Passing of a specialized questionnaire on non verbal disorders
    Intervention: Behavioral: BMT-i
  • Attention
    Passing of a specialized questionnaire on attention disorders
    Intervention: Behavioral: BMT-i
  • Complaint about learning
    Passing of a specialized questionnaire on learning disorders
    Intervention: Behavioral: BMT-i
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2021)
229
Original Estimated Enrollment
 (submitted: April 15, 2019)
200
Actual Study Completion Date April 1, 2021
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 13 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Martinique
Removed Location Countries  
 
Administrative Information
NCT Number NCT03919357
Other Study ID Numbers ValidBMTI2018
2018-A01870-55 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Intercommunal Creteil
Study 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
Investigators Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date May 2021