Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). (TDys)

Sensitivity of the Search for a Heterophory-Vertical-Labile (HV-Labile) for Ambulatory Screening for Specific Learning Disabilities (SLD) or Developmental Coordination Disorder (DCD).

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.

Study Overview

• Status: Unknown
• Conditions: Specific Learning Disorder; Developmental Coordination Disorder; Specific Developmental Disorders of Speech and Language; Dyslexia, Developmental; Dyspraxia
• Intervention / Treatment: Diagnostic test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luc Virlet; Phone Number: +33678296310; Email: virlet.luc@laposte.net
• Study Contact Backup: Name: Joel Cogneau; Phone Number: +33674787920; Email: j.cogneau@irmg.fr

Study Locations

• France
  • Alsace
    • Strasbourg, Alsace, France, 67000
      • Recruiting
      • Office-based general practioner
      • Contact: Luc Virlet; Phone Number: +33678296310; Email: virlet.luc@laposte.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Presence of HV-Labile; Presence of vertical heterophoria labile with proprioceptive Maddox	Diagnostic test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder; 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.
Other: Absence of HV-Labile; Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox	Diagnostic test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the HV-Labile to SLD or DCD	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of the HV-Labile to SLD or DCD	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Positive and negative likelihood ratios	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Prevalence of children with HV-Labile	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Positive predictive values	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Negative predictive values	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year

Collaborators and Investigators

• Sponsor: CNGE IRMG Association
• Collaborators: Scalab CNRS 9193
• Investigators: Principal Investigator: Luc Virlet, Scalab CNRS 9193, Lille University

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: October 5, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Specific Learning Disorder; Developmental Coordination Disorder; Specific Developmental Disorders of Speech and Language; Dyslexia, Developmental; Dyspraxia
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Psychomotor Disorders; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Disease; Dyslexia; Developmental Disabilities; Apraxias; Learning Disabilities; Specific Learning Disorder; Motor Skills Disorders
• Other Study ID Numbers: CNGEIRMG 0310; 2019-A00416-51 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No