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Memorisation of Phonologic Information Among Children With Oral Language Developement Disorder (MEMENTO)

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ClinicalTrials.gov Identifier: NCT02609542
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:

The disorder of oral language development is defined by the delay in language acquisition in children who possess efficient auditory acuity and normal non verbal intellect.

The diversity of language developement disorders depends either in the expressive level or in the receptive level leading to divers syndromes and symptoms. These syndromes and symptoms are regrouped under the name of STOL (Specific Troubles of Oral Language).

In the current project the visual exploitation and learning capability of children presenting a STOL condition will be compared to patients with a normal development. The investigator's hypothesis is as follows: STOL patients for whom the STOL disorder is reduced between 4 and 7 years of age will present a better performance at verbal memorisation, compared to patients with a persistent STOL condition after the age of 6.


Condition or disease Intervention/treatment
Language Development Disorders Other: Eye Tracking

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Study Type : Observational
Estimated Enrollment : 264 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Coding and Memorisation of Phonologic Information Among Preschool and School Children With Oral Language Developement Disorder.
Study Start Date : March 2014
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Group/Cohort Intervention/treatment
STOL group

STOL children will be recruited in the neuropediatric unit at the GHICL in Lille. Children will be followed and we will determine if capacities of verbal memory of the children presenting STOL diagnosed at an early stage of their development (before 6 years) are predictive of the evolution of the disorder according to their cognitive profile and more specifically, their language profile as well as their tests performances. The participants' eye movements ( visual world paradigm or eye tracking) will be recorded in order to determine the interplay between linguistic and visual information processing.

Patients with a persistent STOL will be identified at the end of the follow up.

Other: Eye Tracking
Eye tracker will allows the recording of various information concerning eye fixation (number, duration, location) and saccadic eye movement (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during tests performance
Other Name: visual world paradigm

Control group
Children with no language development disorder willing to participate in the study will be recruited at school. The participants' eye movements ( visual world paradigm or eye tracking) will be recorded in order to determine the interplay between linguistic and visual information processing.
Other: Eye Tracking
Eye tracker will allows the recording of various information concerning eye fixation (number, duration, location) and saccadic eye movement (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during tests performance
Other Name: visual world paradigm




Primary Outcome Measures :
  1. Changes from baseline in the score associated to speech-language outcome measured by a scale grouping results of different questionnaires [ Time Frame: 0,12, 24 months ]
    We will determine if capacities of verbal memory of the children presenting STOL diagnosed at an early stage of their development (before 6 years) are predictive of the evolution of the disorder according to their cognitive profile and more specifically, their language profile as well as their tests performances. To measure the speech language outcome is necessary to take in consideration the score of more than one test performance.


Secondary Outcome Measures :
  1. Changes from baseline in the Raven's Progressive Matrices (RPM) test [ Time Frame: 0,12, 24 months ]
    Raven's Progressive Matrices (RPM) is a test often used in educational settings that is comprised of 60 multiple choice questions. This is a nonverbal test in that the questions are comprised of visual patterns. RPM measures the ability to think clearly about complex ideas and the ability to store and recall information.

  2. Changes from baseline in the Peabody Picture Vocabulary Test [ Time Frame: 0,12, 24 months ]
    The Peabody Picture Vocabulary Test measures an individual's receptive (hearing) vocabulary and provides, at the same time, a quick estimate of verbal ability or scholastic aptitude.

  3. Changes from baseline in the number repetition test [ Time Frame: 0,12, 24 months ]
  4. Changes from baseline in the sentences repetition test [ Time Frame: 0,12, 24 months ]
  5. Changes from baseline in the non-words repetition test [ Time Frame: 0,12, 24 months ]
  6. Changes from baseline in the children's eye tracking [ Time Frame: 0,12, 24 months ]

    It is done in order to determine if their is a relation between the evolution of processes involved in verbal memorisation (cognitive mechanisms in charge of data processing).

    Eye tracker will allow the recording of information regarding eye fixation (number, duration, location) and saccadic eye movements (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during test performances.




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Ages Eligible for Study:   45 Months to 95 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
STOL children between 45 and 95 months of age at inclusion recruited at the neuropediatric consultation and control children of the same age recruited at schools
Criteria

Inclusion Criteria for STOL patients:

  • Child aged between 45 and 95 months at inclusion
  • A score > or equal to 5 percentile on the non verbal intelligence test (PM47)
  • Patient diagnosed with STOL by the neuropediatric medical team
  • Coverage of the social insurance
  • Consent form signed by the parents or the legal representative of the child
  • Normal or corrected sight
  • Normal hearing

Inclusion Criteria for control patients:

  • Child aged between 45 and 95 months on the day of inclusion
  • A score > or equal to 5 percentile on the non verbal intelligence test (PM47)
  • Child who did not receive any speech therapy
  • Coverage of the social insurance
  • Consent form signed by the parents or the legal representative of the child
  • Normal or corrected sight
  • Normal hearing

Exclusion Criteria for STOL patients:

  • Mother language other than French
  • Score < to 5 percentile on the non verbal intelligence test (PM47)
  • Child with pervasive developmental disorder

Exclusion Criteria for control patients:

  • Mother language other than French
  • Score < to 5 percentile on the non verbal intelligence test (PM47)
  • Child who received speech therapy

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): NCT02609542


Contacts
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Contact: Amélie Lansiaux, MD, PhD lansiaux.amelie@ghicl.net
Contact: Mélanie Hamez, Med Monitor hamez.melanie@ghicl.net

Locations
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France
Hôpital St Vincent-de-Paul (GHICL) Recruiting
Lille, Nord-Pas-de-Calais, France, 59000
Contact: Delphine Fleurion, MD    +0033320874223 ext +0033623531011    delphine.fleurion@gmail.com   
Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: Delphine Fleurion, Psychologist Groupement des Hôpitaux de l'Institut Catholique de Lille

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02609542    
Other Study ID Numbers: RC-P0029
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Keywords provided by Lille Catholic University:
oral language
STOL
memory
eye tracking
Additional relevant MeSH terms:
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Language Development Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms