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CompletedNCT03919357ValidBMTIUpdated May 20, 2021

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

An observational study in Learning Disorders, Specific and Developmental Disability, sponsored by Centre Hospitalier Intercommunal Creteil. Completed at 16 sites in 2 countries. Open to participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2021-05-20.

Sponsored by Centre Hospitalier Intercommunal Creteil · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
229
Ages
5 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Learning Disorders, Specific
  • Developmental Disability
03

In context

Specific Learning Disorder

24 studies on the registry are indexed under Specific Learning Disorder; 4 are open to participants now.

Browse Specific Learning Disorder studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 13 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Diagnosis of intellectual development disorder of autism spectrum disorder and suspect or confirm
  • Refusal to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
229 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralBMT-i

    Passing the BMT-i test

06

What researchers measure

Primary outcomes

  1. Sensitivity of BMT-i (modular computerized test battery)

    Calculation of the sensitivity of the BMT-i compared to the reference balance sheets

    Time frame: 3 months

  2. Specificity of BMT-i

    Calculation of the specificity of the BMT-i compared to the reference balance sheets

    Time frame: 3 months

Secondary outcomes

  1. Sensitivity and specificity of the BMT-i by type of complaint

    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)

    Time frame: 3 months

  2. Kappa de Cohen test between BMTi assessments and the reference assessments

    Assessment of the concordance between the BMTi assessments and the baseline assessments

    Time frame: 3 months

  3. Concordance between investigators evaluations and reviewers evaluations

    Evaluation of the concordance between the BMTi evaluations rated by the investigators and the reviewers

    Time frame: 3 months

  4. Curves ROC (Receiver operating characteristic)

    Receiver operating characteristic (ROC) curves to validate selected BMT-i diagnostic thresholds

    Time frame: 3 months

07

Study locations

16 sites
  • Cabinet du Dr Vurpillat-Almanza
    Besançon, France
  • Cabinet du Dr Piollet
    Chamalieres, France
  • Cabinet du Dr Gelbert
    Chambéry, 73000, France
  • CH Versailles - André Mignot
    Le Chesnay, France
  • Centre Médical Pédiatrique Flammarion
    Marseille, France
  • Hôpital Saint Eloi - Montpellier
    Montpellier, France
  • Cabinet du Dr Kochert
    Orléans, 45000, France
  • Centre Paris Santé Réussite
    Paris, 75020, France
  • Cabinet du Dr Cahn-Sellem
    Puteaux, 92800, France
  • 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
  • Cabinet du Dr Dulorme
    Le Lamentin, 97129, Martinique
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03919357
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
Responsible party
Sponsor
First posted
Apr 18, 2019
Start date
Mar 7, 2019
Primary completion
Mar 1, 2021
Completion
Apr 1, 2021
Last update
May 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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