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

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ClinicalTrials.gov Identifier: NCT04122820
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Scalab CNRS 9193
Information provided by (Responsible Party):
Luc Virlet, Scalab CNRS 9193

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.

Condition or disease Intervention/treatment Phase
Specific Developmental Disorders of Speech and Language Specific Learning Disorder Dyslexia, Developmental Developmental Coordination Disorder Dyspraxia Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (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.
Primary Purpose: Screening
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).
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Sensitivity of the HV-Labile to SLD or DCD [ Time Frame: through study completion, an average of 3 year ]
    Estimated and provided with its 95% confidence interval.


Secondary Outcome Measures :
  1. Specificity of the HV-Labile to SLD or DCD [ Time Frame: through study completion, an average of 3 year ]
    Estimated and provided with its 95% confidence interval.

  2. Positive and negative likelihood ratios [ Time Frame: through study completion, an average of 3 year ]
    Estimated and provided with its 95% confidence interval.

  3. Prevalence of children with HV-Labile [ Time Frame: through study completion, an average of 3 year ]
    Estimated and provided with its 95% confidence interval.

  4. Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile [ Time Frame: through study completion, an average of 3 year ]
    Estimated and provided with its 95% confidence interval.

  5. Positive predictive values [ Time Frame: through study completion, an average of 3 year ]
    Estimated and provided with its 95% confidence interval.

  6. Negative predictive values [ Time Frame: through study completion, an average of 3 year ]
    Estimated and provided with its 95% confidence interval.


Other Outcome Measures:
  1. 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 [ Time Frame: through study completion, an average of 3 year ]
    Estimated and provided with its 95% confidence interval.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122820


Contacts
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Contact: Luc Virlet +33678296310 virlet.luc@laposte.net
Contact: Joel Cogneau +33674787920 j.cogneau@irmg.fr

Locations
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France
Office-based general practioner Recruiting
Strasbourg, Alsace, France, 67000
Contact: Luc Virlet    +33678296310    virlet.luc@laposte.net   
Sponsors and Collaborators
CNGE IRMG Association
Scalab CNRS 9193
Investigators
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Principal Investigator: Luc Virlet SCalab CNRS 9193, Lille University

Additional Information:
Publications of Results:
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Responsible Party: Luc Virlet, Principal Investigator, Scalab CNRS 9193
ClinicalTrials.gov Identifier: NCT04122820     History of Changes
Other Study ID Numbers: CNGEIRMG 0310
2019-A00416-51 ( Registry Identifier: ID-RCB )
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luc Virlet, Scalab CNRS 9193:
Specific Learning Disorder
Developmental Coordination Disorder
Specific Developmental Disorders of Speech and Language
Dyslexia, Developmental
Dyspraxia
Additional relevant MeSH terms:
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Dyslexia
Learning Disorders
Apraxias
Speech Disorders
Disease
Developmental Disabilities
Motor Skills Disorders
Specific Learning Disorder
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Psychomotor Disorders