Slow Language ImpairmentSLI:COGGENNCT03660995
Better Understanding Slow Language Impairment
A study of Slow Language Impairment, run by CHU de Reims at 1 site in France.
Trial summary
This study was designed to examine the development of children aged 6 to 10 with slow language impairment (SLI). The aim was threefold: (1) to investigate language skills of children with SLI at different levels - formal, semantic, pragmatic- in comparison with those of control children; (2) to test a procedural… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Slow Language Impairment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2019to 29 May 2023
- Phase
- Interventional
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For SLI group, the inclusion criteria are:
- To present a slow language impairment
- To speak French
- For control group, the inclusion criteria are:
- Being at elementary French school
- Speak French
Who cannot join
- Child with a neuro-motrice pathology or psychopathology
- Child with a neurological medication
- Child who have a score inferior to percentile 20 on the "Coloured Progressive Matrices" (Raven, 1998)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Christine RAYNAUD, craynaud@chu-reims.fr
About this study
Official title: Better Understanding Slow Language Impairment: Cognitive and Genetic Mechanisms
This study was designed to examine the development of children aged 6 to 10 with slow language impairment (SLI). The aim was threefold: (1) to investigate language skills of children with SLI at different levels - formal, semantic, pragmatic- in comparison with those of control children; (2) to test a procedural deficit hypothesis: abnormal development in the procedural memory system could account for some language deficits; (3) to make genotype-phenotype comparisons, focusing on the different levels of language development and on procedural skills. The main hypothesis is that genetic mutations, contingently epistatique, will lead to procedural learning deficit, which will have a negative impact on language skills at the formal level and consequently on semantic and pragmatic levels.
Read the detailed description
To test the main hypothesis, 60 SLI children and 100 controls children will be included on the protocol. Due to the lack of specific standardized tests, the diagnostic of specific language-impaired French children is a challenge. Thus, both a battery of standardized and non-standardized language tests (assessing the different levels: formal, semantic and pragmatic) will be administered to children to establish a profile of weaknesses for each child with SLI and to examine the relationships between SLI and procedural learning. DNA sampling will be conducted on each child, SLI and control, to allow subsequently the molecular analyses in order to run the association comparisons between behavioral data and genetic profiles.
The protocol includes as verbal standardized tests: the Echelle "Vocabulaire en Images Peabody" (EVIP;), the "Epreuve de COmpre´hension Syntaxico-SEmantique" (ECOSSE), two specific subtests (lexicon and grammar) of the "Evaluation du Langage Oral" (ELO;), and as non-standardized tests: a semantic inference task (drawing the meaning of new words from the context, and the meaning of predicative metaphors), and a pragmatic inference task (understanding of indirect requests, on speakers' intention meaning and on irony). The procedural learning skills will be assessed thanks to a serial reaction task, specifically adapted for children).
The complete sequencing of FoXP2 gene, as well as the genotyping of the 44 single nucleotide polymorphisms (SNPs), located in the risk haplotypes identified in ATP2C2, CMIP, CNTNAP2 genes and in the KIAA0319/TTRAP/THEM2 locus, will be conducted.
- Conditions
- Slow Language Impairment
- Being tested
- Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling.
- Keywords
- Slow language impairment, semantic, pragmatic, procedural learning, genotype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling.Behavioural
Behavioral evaluation of language skills at the formal, semantic and pragmatic levels and of procedural learning for each child with SLI and each control child.
DNA sampling for each child.
| Study group | Role | What they receive |
|---|---|---|
| SLI children | Experimental | Not described Receives: Behavioral: Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling. |
| Control children | Active comparator | Not described Receives: Behavioral: Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language development
Assessment using :
- For each of the following tasks, the number of correct answers of children at the questions is collected. These scores can be aggregated (addition).Echelle "Vocabulaire en Images Peabody" (EVIP; Dunn, The´riault-Whalen, \& Dunn, 1993). Scale range: 0-170.
- the "Epreuve de COmpréhension Syntaxico-SEmantique" (ECOSSE; Lecocq, 1996) task. Scale range: 0-92. ,
- two specific subtests (lexicon and grammar) of the "Evaluation du Langage Oral" (ELO; Khomsi, 2001). Scale range: 0-57, respectively 32 (Lexicon subtest) and 25 'grammar subtest)
- non-standardized tests: a semantic inference task (drawing the meaning of new words from the context, and the meaning of predicative metaphors), and a pragmatic inference task (understanding of indirect requests, on speakers' intention meaning and on irony). Scale range: 0-55.
Measured: Day 0
Procedural learning
Assessment thanks to an experimental serial reaction task, specifically adapted for children (Gabriel et al., 2011). This is a computerized task in which are collected reaction times of children according to the spatial input occurrences on the screen, which follow a fixed procedure that is to be implicit learned (procedural learning).
Measured: Day 0
Secondary outcomes (1)
DNA sampling
The complete sequencing of FoXP2 gene, as well as the genotyping of the 44 single nucleotide polymorphisms (SNPs), located in the risk haplotypes identified in ATP2C2 (Newbury et al., 2009), CMIP (Newbury et al., 2009), CNTNAP2 (Vernes et al. 2008) genes and in the KIAA0319/TTRAP/THEM2 locus (Pinel et al., 2012), will be conducted.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start29 Jun 2019
- Primary completion29 May 2022 (estimated)
- Study completion29 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slow Language ImpairmentStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660995
- Sponsor's protocol ID
- PO18001
- Acronym
- SLI:COGGEN
- Status last verified
- Jun 2020
- First submitted
- 4 Jan 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Understanding Slow Language Impairment: Cognitive and Genetic Mechanisms
- ClinicalTrials.gov ID
- NCT03660995
- Acronym / sponsor ID
- SLI:COGGEN / PO18001
- Conditions
- Slow Language Impairment
- Keywords
- Slow language impairment, semantic, pragmatic, procedural learning, genotype
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 29 Jun 2019 (actual)
- Primary completion
- 29 May 2022 (estimated)
- Study completion
- 29 May 2023 (estimated)
- First posted
- 7 Sep 2018 (actual)
- 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.
This study was designed to examine the development of children aged 6 to 10 with slow language impairment (SLI). The aim was threefold: (1) to investigate language skills of children with SLI at different levels - formal, semantic, pragmatic- in comparison with those of control children; (2) to test a procedural deficit hypothesis: abnormal development in the procedural memory system could account for some language deficits; (3) to make genotype-phenotype comparisons, focusing on the different levels of language development and on procedural skills. The main hypothesis is that genetic mutations, contingently epistatique, will lead to procedural learning deficit, which will have a negative impact on language skills at the formal level and consequently on semantic and pragmatic levels.
Detailed description
To test the main hypothesis, 60 SLI children and 100 controls children will be included on the protocol. Due to the lack of specific standardized tests, the diagnostic of specific language-impaired French children is a challenge. Thus, both a battery of standardized and non-standardized language tests (assessing the different levels: formal, semantic and pragmatic) will be administered to children to establish a profile of weaknesses for each child with SLI and to examine the relationships between SLI and procedural learning. DNA sampling will be conducted on each child, SLI and control, to allow subsequently the molecular analyses in order to run the association comparisons between behavioral data and genetic profiles.
The protocol includes as verbal standardized tests: the Echelle "Vocabulaire en Images Peabody" (EVIP;), the "Epreuve de COmpre´hension Syntaxico-SEmantique" (ECOSSE), two specific subtests (lexicon and grammar) of the "Evaluation du Langage Oral" (ELO;), and as non-standardized tests: a semantic inference task (drawing the meaning of new words from the context, and the meaning of predicative metaphors), and a pragmatic inference task (understanding of indirect requests, on speakers' intention meaning and on irony). The procedural learning skills will be assessed thanks to a serial reaction task, specifically adapted for children).
The complete sequencing of FoXP2 gene, as well as the genotyping of the 44 single nucleotide polymorphisms (SNPs), located in the risk haplotypes identified in ATP2C2, CMIP, CNTNAP2 genes and in the KIAA0319/TTRAP/THEM2 locus, will be conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLI children | Experimental | Behavioral: Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling. |
| Control children | Active comparator | Behavioral: Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- To present a slow language impairment
- To speak French
- Being at elementary French school
- Speak French
Key exclusion criteria (3 listed)
- Child with a neuro-motrice pathology or psychopathology
- Child with a neurological medication
- Child who have a score inferior to percentile 20 on the "Coloured Progressive Matrices" (Raven, 1998)
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 |
|---|---|---|
| Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling.Behavioral evaluation of language skills at the formal, semantic and pragmatic levels and of procedural learning for each child with SLI and each control child. DNA sampling for each child. | Behavioural | Control children, SLI children |
Primary outcome
Language development
Time frame: Day 0
Assessment using : * For each of the following tasks, the number of correct answers of children at the questions is collected. These scores can be aggregated (addition).Echelle "Vocabulaire en Images Peabody" (EVIP; Dunn, The´riault-Whalen, \& Dunn, 1993). Scale range: 0-170. * the "Epreuve de COmpréhension Syntaxico-SEmantique" (ECOSSE; Lecocq, 1996) task. Scale range: 0-92. , * two specific subtests (lexicon and grammar) of the "Evaluation du Langage Oral" (ELO; Khomsi, 2001). Scale range: 0-57, respectively 32 (Lexicon subtest) and 25 'grammar subtest) * non-standardized tests: a semantic inference task (drawing the meaning of new words from the context, and the meaning of predicative metaphors), and a pragmatic inference task (understanding of indirect requests, on speakers' intention meaning and on irony). Scale range: 0-55.
Procedural learning
Time frame: Day 0
Assessment thanks to an experimental serial reaction task, specifically adapted for children (Gabriel et al., 2011). This is a computerized task in which are collected reaction times of children according to the spatial input occurrences on the screen, which follow a fixed procedure that is to be implicit learned (procedural learning).
1 secondary outcome
DNA sampling
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Slow Language Impairment, run by CHU de Reims 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine RAYNAUD (0326784649 ext. +33, craynaud@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language development (time frame: Day 0). The study lists 2 primary outcomes in all. 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 9 Jun 2020.