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

NCT03919357 | Completed

• 2 other identifiers: ValidBMTI20182018-A01870-55
• Study Type: observational
• Target: 229
• Locations: 2 countries
• Sites: 16

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.

Conditions

Learning Disorders, Specific; Developmental Disability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Sensitivity and specificity of the BMT-i by type of complaint

  3 months

• Kappa de Cohen test between BMTi assessments and the reference assessments

  3 months

• Concordance between investigators evaluations and reviewers evaluations

  3 months

• Curves ROC (Receiver operating characteristic)

  3 months

Study Arms (4)

Verbal

Passing of a specialized questionnaire on verbal disorders

Behavioral: BMT-i

Non-verbal

Passing of a specialized questionnaire on non verbal disorders

Behavioral: BMT-i

Attention

Passing of a specialized questionnaire on attention disorders

Behavioral: BMT-i

Complaint about learning

Passing of a specialized questionnaire on learning disorders

Behavioral: BMT-i

Interventions

BMT-i BEHAVIORAL

Passing the BMT-i test

Attention; Complaint about learning; Non-verbal; Verbal

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Child aged 5 to 13
• Complex complaint affecting one of the different areas of development and learning
• Affiliation to a social security scheme

You may not qualify if:

• Diagnosis of intellectual development disorder of autism spectrum disorder and suspect or confirm
• Refusal to participate

Sponsors & Collaborators

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

Study Sites (16)

Cabinet du Dr Vurpillat-Almanza

Besançon, France

Location

Cabinet du Dr Piollet

Chamalières, France

Location

Cabinet du Dr Gelbert

Chambéry, 73000, France

Location

CH Versailles - André Mignot

Le Chesnay, France

Location

Centre Médical Pédiatrique Flammarion

Marseille, France

Location

Hôpital Saint Eloi - Montpellier

Montpellier, France

Location

Cabinet du Dr Kochert

Orléans, 45000, France

Location

Centre Paris Santé Réussite

Paris, 75020, France

Location

Cabinet du Dr Cahn-Sellem

Puteaux, 92800, France

Location

CHU de Rouen

Rouen, France

Location

Cabinet du Dr Reynaud

Saint-Denis, France

Location

Cabinet du Dr Willig

Toulouse, France

Location

Cabinet du Dr Pineau

Trélazé, France

Location

Cabinet du Dr Lubelski

Verrières-le-Buisson, France

Location

Cabinet du Dr Werner

Villeneuve-lès-Avignon, France

Location

Cabinet du Dr Dulorme

Le Lamentin, 97129, Martinique

Location

MeSH Terms

Conditions

Specific Learning Disorder; Developmental Disabilities

Condition Hierarchy (Ancestors)

Learning Disabilities; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 18, 2019
• Study Start: March 7, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15); MA (1)