Clinical trial NCT04122820: Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD).
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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: CNGE IRMG Association
Sponsor class: OTHER
Collaborators: name: Scalab CNRS 9193
First posted: 2019-10-10
Enrollment: 1800
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Sensitivity of the HV-Labile to SLD or DCD
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: Specificity of the HV-Labile to SLD or DCD
timeFrame: through study completion, an average of 3 year
measure: Positive and negative likelihood ratios
timeFrame: through study completion, an average of 3 year
measure: Prevalence of children with HV-Labile
timeFrame: through study completion, an average of 3 year
measure: Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile
timeFrame: through study completion, an average of 3 year
measure: Positive predictive values
timeFrame: through study completion, an average of 3 year
measure: Negative predictive values
timeFrame: through study completion, an average of 3 year
Other outcomes:
measure: 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
timeFrame: through study completion, an average of 3 year
Locations:
city: Strasbourg
country: France
facility: Office-based general practioner
state: Alsace
Study officials:
affiliation: SCalab CNRS 9193, Lille University
name: Luc Virlet
role: PRINCIPAL_INVESTIGATOR
References:
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.