Language Development DisordersMEMENTONCT02609542
Memorisation of Phonologic Information Among Children With Oral Language Developement Disorder
An observational study of Language Development Disorders, run by Lille Catholic University at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 95 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development Disorders
- What is being tested?
- Eye Tracking
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 95 months
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Show all 14Show fewer
- Normal hearing
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Language Development Disorders
- Being tested
- Eye Tracking
- Keywords
- oral language, STOL, memory, eye tracking
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye TrackingOther
Also called visual world paradigm
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Eye Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0,12, 24 months
Secondary outcomes (6)
Changes from baseline in the Raven's Progressive Matrices (RPM) test
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.
Measured: 0,12, 24 months
Changes from baseline in the Peabody Picture Vocabulary Test
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.
Measured: 0,12, 24 months
Changes from baseline in the number repetition test
Measured: 0,12, 24 months
Changes from baseline in the sentences repetition test
Measured: 0,12, 24 months
Changes from baseline in the non-words repetition test
Measured: 0,12, 24 months
Changes from baseline in the children's eye tracking
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.
Measured: 0,12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMar 2014
- Primary completionMay 2023
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine Fleurion, Psychologist, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609542
- Sponsor's protocol ID
- RC-P0029
- Acronym
- MEMENTO
- Status last verified
- Nov 2025
- First submitted
- 4 Aug 2015
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coding and Memorisation of Phonologic Information Among Preschool and School Children With Oral Language Developement Disorder.
- ClinicalTrials.gov ID
- NCT02609542
- Acronym / sponsor ID
- MEMENTO / RC-P0029
- Conditions
- Language Development Disorders
- Keywords
- oral language, STOL, memory, eye tracking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2023 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STOL group | – | Other: Eye TrackingSTOL 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. |
| Control group | – | Other: Eye TrackingChildren 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. |
Who may qualify
- Ages
- 45 to 95 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye TrackingAlso: visual world paradigmEye 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 | Control group, STOL group |
Primary outcome
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.
6 secondary outcomes
Changes from baseline in the Raven's Progressive Matrices (RPM) test
Time frame: 0,12, 24 months
Changes from baseline in the Peabody Picture Vocabulary Test
Time frame: 0,12, 24 months
Changes from baseline in the number repetition test
Time frame: 0,12, 24 months
Changes from baseline in the sentences repetition test
Time frame: 0,12, 24 months
Changes from baseline in the non-words repetition test
Time frame: 0,12, 24 months
Changes from baseline in the children's eye tracking
Time frame: 0,12, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine Fleurion, Psychologist principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Language Development Disorders, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.