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 |
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Learning Disorders, Specific Developmental Disability | Behavioral: BMT-i |
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:
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 |
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
|
Ages Eligible for Study: | 5 Years to 13 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
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 |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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. |
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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:
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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 |
|
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Intervention | Behavioral: BMT-i
Passing the BMT-i test
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
229 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Centre Hospitalier Intercommunal Creteil | ||||
Study Sponsor | Centre Hospitalier Intercommunal Creteil | ||||
Collaborators |
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Investigators | Not Provided | ||||
PRS Account | Centre Hospitalier Intercommunal Creteil | ||||
Verification Date | May 2021 |