Learning Disorders, SpecificValidBMTINCT03919357
Using a New Calibrated Tool in Specific Language and Learning Disorders : the BMTi
An observational study of Learning Disorders, Specific and Developmental Disability, run by Centre Hospitalier Intercommunal Creteil at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Learning Disorders, Specific, Developmental Disability
- What is being tested?
- BMT-i
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 229 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 7 Mar 2019to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between 5 and 13 years old with a complex developmental and learning disorder
Who may be able to join
- Child aged 5 to 13
- Complex complaint affecting one of the different areas of development and learning
- Affiliation to a social security scheme
Who cannot join
- Diagnosis of intellectual development disorder of autism spectrum disorder and suspect or confirm
- Refusal to participate
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
France15 sites
Cabinet du Dr Vurpillat-Almanza
Besançon
Cabinet du Dr Piollet
Chamalières
Cabinet du Dr Gelbert
Chambéry, 73000
CH Versailles - André Mignot
Le Chesnay
Centre Médical Pédiatrique Flammarion
Marseille
Hôpital Saint Eloi - Montpellier
Montpellier
Cabinet du Dr Kochert
Orléans, 45000
Centre Paris Santé Réussite
Paris, 75020
Cabinet du Dr Cahn-Sellem
Puteaux, 92800
CHU de Rouen
Rouen
Cabinet du Dr Reynaud
Saint-Denis
Cabinet du Dr Willig
Toulouse
Cabinet du Dr Pineau
Trélazé
Cabinet du Dr Lubelski
Verrières-le-Buisson
Cabinet du Dr Werner
Villeneuve-lès-Avignon
About this study
Official title: Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (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.
Read more
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.
- Being tested
- BMT-i
- Medical subject headings
- Specific Learning Disorder, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT-iBehavioural
Passing the BMT-i test
| Study group | Role | What they receive |
|---|---|---|
| Verbal | Passing of a specialized questionnaire on verbal disorders Receives: Behavioral: BMT-i | |
| Non-verbal | Passing of a specialized questionnaire on non verbal disorders Receives: Behavioral: BMT-i | |
| Attention | Passing of a specialized questionnaire on attention disorders Receives: Behavioral: BMT-i | |
| Complaint about learning | Passing of a specialized questionnaire on learning disorders Receives: Behavioral: BMT-i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of BMT-i (modular computerized test battery)
Calculation of the sensitivity of the BMT-i compared to the reference balance sheets
Measured: 3 months
Specificity of BMT-i
Calculation of the specificity of the BMT-i compared to the reference balance sheets
Measured: 3 months
Secondary outcomes (4)
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)
Measured: 3 months
Kappa de Cohen test between BMTi assessments and the reference assessments
Assessment of the concordance between the BMTi assessments and the baseline assessments
Measured: 3 months
Concordance between investigators evaluations and reviewers evaluations
Evaluation of the concordance between the BMTi evaluations rated by the investigators and the reviewers
Measured: 3 months
Curves ROC (Receiver operating characteristic)
Receiver operating characteristic (ROC) curves to validate selected BMT-i diagnostic thresholds
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start7 Mar 2019
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning Disorders, SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919357
- Sponsor's protocol ID
- ValidBMTI2018
- Other IDs
- 2018-A01870-55
- Acronym
- ValidBMTI
- Status last verified
- May 2021
- First submitted
- 4 Apr 2019
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (BMTi)
- ClinicalTrials.gov ID
- NCT03919357
- Acronym / sponsor ID
- ValidBMTI / ValidBMTI2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- 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
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Verbal | – | Behavioral: BMT-iPassing of a specialized questionnaire on verbal disorders |
| Non-verbal | – | Behavioral: BMT-iPassing of a specialized questionnaire on non verbal disorders |
| Attention | – | Behavioral: BMT-iPassing of a specialized questionnaire on attention disorders |
| Complaint about learning | – | Behavioral: BMT-iPassing of a specialized questionnaire on learning disorders |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between 5 and 13 years old with a complex developmental and learning disorder
Key inclusion criteria (3 listed)
- Child aged 5 to 13
- Complex complaint affecting one of the different areas of development and learning
- Affiliation to a social security scheme
Key exclusion criteria (2 listed)
- Diagnosis of intellectual development disorder of autism spectrum disorder and suspect or confirm
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMT-iPassing the BMT-i test | Behavioural | Attention, Complaint about learning, Non-verbal, Verbal |
Primary outcome
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
Specificity of BMT-i
Time frame: 3 months
Calculation of the specificity of the BMT-i compared to the reference balance sheets
4 secondary outcomes
Sensitivity and specificity of the BMT-i by type of complaint
Time frame: 3 months
Kappa de Cohen test between BMTi assessments and the reference assessments
Time frame: 3 months
Concordance between investigators evaluations and reviewers evaluations
Time frame: 3 months
Curves ROC (Receiver operating characteristic)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Learning Disorders, Specific and Developmental Disability, run by Centre Hospitalier Intercommunal Creteil at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of BMT-i (modular computerized test battery) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.