Back to resultsAmbulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). (TDys)
Primary Purpose
Specific Developmental Disorders of Speech and Language, Specific Learning Disorder, Dyslexia, Developmental
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic of specific learning disabilities or of Developmental Coordination Disorder
Sponsored by
About this trial
This is an interventional screening trial for Specific Developmental Disorders of Speech and Language focused on measuring Specific Learning Disorder, Developmental Coordination Disorder, Specific Developmental Disorders of Speech and Language, Dyslexia, Developmental, Dyspraxia
Eligibility Criteria
Inclusion Criteria:
The population studied is composed of children:
- from 8 to 12 years old
- seen for any reason for consultation in general practice
- Schooled in an ordinary environment since the Preparatory Course in France
- Francophone parents
- One of whose parents has signed the consent
- Consent of the child
- Social Insured
Exclusion Criteria:
The background and living conditions that may promote secondary learning disabilities, for example:
- Child with a known intellectual disability (Wisc)
- Child in IME (Institut Médico Educatif)
- Child followed in SESSAD (Specialised education service at home)
- Child not knowing how to answer the questions asked
- Child with a known etiology causing learning disabilities (epilepsy, autism spectrum disorder, hearing impairment, visual impairment (deafness, blindness, low vision))
- Child on treatment (antiepileptic, neuroleptic, antidepressant, anxiolytic)
- Child under the care of a psychiatrist,
- Child followed by the CMP (Centre médico-psychologique)
- Child living in an institution,
- Adopted child
- A child whose mother has experienced known depression during the child's early childhood (0-18 months) because it causes attachment disorders, which can impact the child's development, including learning
- Child of a family that has lived through more than two family recompositions
- Child known to be a victim of abuse.
- Out of school child.
To determine the presence of an HV-Labile
- Child with a known visual correction greater than + or- 2 diopters
- Known amblyopic child
- Known strabic child
- Child with no known binocular vision.
Sites / Locations
- Office-based general practionerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Presence of HV-Labile
Absence of HV-Labile
Arm Description
Presence of vertical heterophoria labile with proprioceptive Maddox
Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox
Outcomes
Primary Outcome Measures
Sensitivity of the HV-Labile to SLD or DCD
Estimated and provided with its 95% confidence interval.
Secondary Outcome Measures
Specificity of the HV-Labile to SLD or DCD
Estimated and provided with its 95% confidence interval.
Positive and negative likelihood ratios
Estimated and provided with its 95% confidence interval.
Prevalence of children with HV-Labile
Estimated and provided with its 95% confidence interval.
Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile
Estimated and provided with its 95% confidence interval.
Positive predictive values
Estimated and provided with its 95% confidence interval.
Negative predictive values
Estimated and provided with its 95% confidence interval.
Full Information
NCT ID
NCT04122820
First Posted
October 5, 2019
Last Updated
October 17, 2019
Sponsor
CNGE IRMG Association
Collaborators
Scalab CNRS 9193
1. Study Identification
Unique Protocol Identification Number
NCT04122820
Brief Title
Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD).
Acronym
TDys
Official Title
Sensitivity of the Search for a Heterophory-Vertical-Labile (HV-Labile) for Ambulatory Screening for Specific Learning Disabilities (SLD) or Developmental Coordination Disorder (DCD).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CNGE IRMG Association
Collaborators
Scalab CNRS 9193
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate, in primary care, the sensitivity of Heterophory-Vertical-Labile (HV-Labile) in ambulatory screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). in children aged 8 to 12 years.
Detailed Description
General practitioners during a day of professional training on learning disabilities will be trained to perform the proprioceptive Maddox, to search for a HVLabile.
Each trained practitioner will then test at least six children aged 8 to 12 years old in his or her practice, seen at random
250 to 300 physicians will be trained as part of this research
EXPERIMENTAL DESIGN
Cross-sectional study with prospective recruitment.
Search for a Vertical Labile Heterophory (HV-Labile).
Prescription of a standardized speech and language screening assessment for HV-Labile, and in the same number of children without HV-Labile by secondary coupling.
Delivery of symptomatic questionnaire.
In case of learning disabilities, the attending physician should look for a possible etiology.
Adapted speech therapy care for more than six months.
Speech and language therapy check-up at more than six months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Developmental Disorders of Speech and Language, Specific Learning Disorder, Dyslexia, Developmental, Developmental Coordination Disorder, Dyspraxia
Keywords
Specific Learning Disorder, Developmental Coordination Disorder, Specific Developmental Disorders of Speech and Language, Dyslexia, Developmental, Dyspraxia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of the presence of a specific learning disability, or a Developmental Coordination Disorder, in the case of the presence or absence of referential instability of central origin.
Masking
Outcomes Assessor
Masking Description
An adjudication committee to determine the presence or absence of a specific learning disability will be set up, regardless of the presence of a central reference instability.
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Presence of HV-Labile
Arm Type
Other
Arm Description
Presence of vertical heterophoria labile with proprioceptive Maddox
Arm Title
Absence of HV-Labile
Arm Type
Other
Arm Description
Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic of specific learning disabilities or of Developmental Coordination Disorder
Intervention Description
Speech therapy assessment, or occupational therapy. In case of pathological disorder, search for a sensory disorder, and therapeutic management. If the pathological disorder persists for more than six months, elimination of a secondary etiology.
Primary Outcome Measure Information:
Title
Sensitivity of the HV-Labile to SLD or DCD
Description
Estimated and provided with its 95% confidence interval.
Time Frame
through study completion, an average of 3 year
Secondary Outcome Measure Information:
Title
Specificity of the HV-Labile to SLD or DCD
Description
Estimated and provided with its 95% confidence interval.
Time Frame
through study completion, an average of 3 year
Title
Positive and negative likelihood ratios
Description
Estimated and provided with its 95% confidence interval.
Time Frame
through study completion, an average of 3 year
Title
Prevalence of children with HV-Labile
Description
Estimated and provided with its 95% confidence interval.
Time Frame
through study completion, an average of 3 year
Title
Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile
Description
Estimated and provided with its 95% confidence interval.
Time Frame
through study completion, an average of 3 year
Title
Positive predictive values
Description
Estimated and provided with its 95% confidence interval.
Time Frame
through study completion, an average of 3 year
Title
Negative predictive values
Description
Estimated and provided with its 95% confidence interval.
Time Frame
through study completion, an average of 3 year
Other Pre-specified Outcome Measures:
Title
Calculation of results based on a Cut Off at -1.5 standard deviation, or -2 standard deviation, to determine the presence of a SLD or a DCD
Description
Estimated and provided with its 95% confidence interval.
Time Frame
through study completion, an average of 3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The population studied is composed of children:
from 8 to 12 years old
seen for any reason for consultation in general practice
Schooled in an ordinary environment since the Preparatory Course in France
Francophone parents
One of whose parents has signed the consent
Consent of the child
Social Insured
Exclusion Criteria:
The background and living conditions that may promote secondary learning disabilities, for example:
Child with a known intellectual disability (Wisc)
Child in IME (Institut Médico Educatif)
Child followed in SESSAD (Specialised education service at home)
Child not knowing how to answer the questions asked
Child with a known etiology causing learning disabilities (epilepsy, autism spectrum disorder, hearing impairment, visual impairment (deafness, blindness, low vision))
Child on treatment (antiepileptic, neuroleptic, antidepressant, anxiolytic)
Child under the care of a psychiatrist,
Child followed by the CMP (Centre médico-psychologique)
Child living in an institution,
Adopted child
A child whose mother has experienced known depression during the child's early childhood (0-18 months) because it causes attachment disorders, which can impact the child's development, including learning
Child of a family that has lived through more than two family recompositions
Child known to be a victim of abuse.
Out of school child.
To determine the presence of an HV-Labile
Child with a known visual correction greater than + or- 2 diopters
Known amblyopic child
Known strabic child
Child with no known binocular vision.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc Virlet
Phone
+33678296310
Email
virlet.luc@laposte.net
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Cogneau
Phone
+33674787920
Email
j.cogneau@irmg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Virlet
Organizational Affiliation
SCalab CNRS 9193, Lille University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Office-based general practioner
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Virlet
Phone
+33678296310
Email
virlet.luc@laposte.net
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers.
Citations:
PubMed Identifier
26445526
Citation
Quercia P, Quercia M, Feiss LJ, Allaert F. The distinctive vertical heterophoria of dyslexics. Clin Ophthalmol. 2015 Sep 25;9:1785-97. doi: 10.2147/OPTH.S88497. eCollection 2015.
Results Reference
result
Links:
URL
http://www.softal.fr/IMG/pdf/softa-poster-7_avril_14_-virlet-.pdf
Description
The study undertaken with 100 all-view children shows a strong correlation between the presence of SDP-HV-labile and the presence of specific learning disorders. She encourages us not to neglect the proprioceptive approach in the study of the SLD.
Learn more about this trial
Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD).
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