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Completed

NCT Number: NCT03919357

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

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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Key information

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet du Dr Vurpillat-Almanza, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMT-i

Behavioral

Passing the BMT-i test

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

  • Association Française de Pédiatrie Ambulatoire- AFPA
  • Association pour l'Etude du Développement de l'Enfant
  • Association pour la recherche des troubles de l'apprentissage
  • Orthoédition

Registry information

Official study title

Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (BMTi)

Acronym: ValidBMTI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2019
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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