Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03919357
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
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
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919357


Contacts
Layout table for location contacts
Contact: Camille JUNG 0157022268 ext +33 camille.jung@chicreteil.fr

Locations
Layout table for location information
France
Cabinet du Dr Vurpillat-Almanza Recruiting
Besançon, France
Contact: VURPILLAT-ALMANZA Pascale         
Cabinet du Dr Piollet Recruiting
Chamalieres, France
Contact: PIOLLET Anne         
Cabinet du Dr Gelbert Recruiting
Chambéry, France, 73000
Contact: GELBERT Nathalie         
CH Versailles - André Mignot Recruiting
Le Chesnay, France
Contact: SPERENZA Mario         
Centre Médical Pédiatrique Flammarion Recruiting
Marseille, France
Contact: BERNARD Valérie         
Hôpital Saint Eloi - Montpellier Recruiting
Montpellier, France
Contact: DELTEIL Florence         
Cabinet du Dr Kochert Recruiting
Orléans, France, 45000
Contact: KOCHERT Fabienne         
Centre Paris Santé Réussite Recruiting
Paris, France, 75020
Contact: BILLARD Catherine         
Sub-Investigator: Frédérique BARBE         
Cabinet du Dr Cahn-Sellem Recruiting
Puteaux, France, 92800
Contact: CAHN SELLEM Fabienne         
CHU de Rouen Recruiting
Rouen, France
Contact: RADI Sophie         
Cabinet du Dr Reynaud Recruiting
Saint-Denis, France
Contact: REYNAUD Benoit         
Cabinet du Dr Willig Recruiting
Toulouse, France
Contact: WILLIG Thiébaut-Noël         
Cabinet du Dr Pineau Recruiting
Trélazé, France
Contact: PINEAU Pascal         
Cabinet du Dr Lubelski Recruiting
Verrières-le-Buisson, France
Contact: LUBELSKI Patricia         
Cabinet du Dr Werner Recruiting
Villeneuve les Avignon, France
Contact: WERNER Andreas         
Martinique
Cabinet du Dr Dulorme Recruiting
Le Lamentin, Martinique, 97129
Contact: DULORME Frédérique         
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

Layout table for additonal information
Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03919357     History of Changes
Other Study ID Numbers: ValidBMTI2018
2018-A01870-55 ( Other Identifier: ID-RCB )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Learning Disorders
Developmental Disabilities
Specific Learning Disorder
Neurodevelopmental Disorders
Mental Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms