Clinical trial NCT02609542: Memorisation of Phonologic Information Among Children With Oral Language Developement Disorder
Official title: Coding and Memorisation of Phonologic Information Among Preschool and School Children With Oral Language Developement Disorder.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Language Development Disorders
Keywords: oral language
STOL
memory
eye tracking
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 264
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Changes from baseline in the score associated to speech-language outcome measured by a scale grouping results of different questionnaires
timeFrame: 0,12, 24 months
Secondary outcomes:
measure: Changes from baseline in the Raven's Progressive Matrices (RPM) test
timeFrame: 0,12, 24 months
measure: Changes from baseline in the Peabody Picture Vocabulary Test
timeFrame: 0,12, 24 months
measure: Changes from baseline in the number repetition test
timeFrame: 0,12, 24 months
measure: Changes from baseline in the sentences repetition test
timeFrame: 0,12, 24 months
measure: Changes from baseline in the non-words repetition test
timeFrame: 0,12, 24 months
measure: Changes from baseline in the children's eye tracking
timeFrame: 0,12, 24 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital St Vincent-de-Paul (GHICL)
state: Nord-Pas-de-Calais
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Delphine Fleurion, Psychologist
role: PRINCIPAL_INVESTIGATOR
References: