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临床试验/NCT03919357
NCT03919357已完成不适用

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

Centre Hospitalier Intercommunal Creteil16 个研究点 分布在 2 个国家目标入组 229 人开始时间: 2019年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
229
试验地点
16
主要终点
Sensitivity of BMT-i (modular computerized test battery)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Sensitivity of BMT-i (modular computerized test battery)

时间窗: 3 months

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

Specificity of BMT-i

时间窗: 3 months

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

次要结局

  • Kappa de Cohen test between BMTi assessments and the reference assessments(3 months)
  • Sensitivity and specificity of the BMT-i by type of complaint(3 months)
  • Concordance between investigators evaluations and reviewers evaluations(3 months)
  • Curves ROC (Receiver operating characteristic)(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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