NCT02609542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

9.2 years

First QC Date

August 4, 2015

Last Update Submit

November 26, 2025

Conditions

Keywords

oral languageSTOLmemoryeye tracking

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in the score associated to speech-language outcome measured by a scale grouping results of different questionnaires

    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 Outcomes (6)

  • Changes from baseline in the Raven's Progressive Matrices (RPM) test

    0,12, 24 months

  • Changes from baseline in the Peabody Picture Vocabulary Test

    0,12, 24 months

  • Changes from baseline in the number repetition test

    0,12, 24 months

  • Changes from baseline in the sentences repetition test

    0,12, 24 months

  • Changes from baseline in the non-words repetition test

    0,12, 24 months

  • +1 more secondary outcomes

Study Arms (2)

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

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

Interventions

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

Also known as: visual world paradigm
Control groupSTOL group

Eligibility Criteria

Age45 Months - 95 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital St Vincent-de-Paul (GHICL)

Lille, Hauts-de-France, 59000, France

Location

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Delphine Fleurion, Psychologist

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2015

First Posted

November 20, 2015

Study Start

March 1, 2014

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

December 4, 2025

Record last verified: 2025-11

Locations