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

June 21, 2023 updated by: Lille Catholic University

Coding and Memorisation of Phonologic Information Among Preschool and School Children With Oral Language Developement Disorder.

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Nord-Pas-de-Calais
      • Lille, Nord-Pas-de-Calais, France, 59000
        • Recruiting
        • Hôpital St Vincent-de-Paul (GHICL)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

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 Names:
  • 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.
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 Names:
  • visual world paradigm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0,12, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0,12, 24 months
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.
0,12, 24 months
Changes from baseline in the number repetition test
Time Frame: 0,12, 24 months
0,12, 24 months
Changes from baseline in the sentences repetition test
Time Frame: 0,12, 24 months
0,12, 24 months
Changes from baseline in the non-words repetition test
Time Frame: 0,12, 24 months
0,12, 24 months
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.

0,12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Delphine Fleurion, Psychologist, Groupement des Hôpitaux de l'institut Catholique de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimated)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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