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Trial record 11 of 35 for:    Specific Language Impairment 1

Better Understanding Slow Language Impairment (SLI:COGGEN)

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ClinicalTrials.gov Identifier: NCT03660995
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief 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 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.

Condition or disease Intervention/treatment Phase
Slow Language Impairment Behavioral: Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Better Understanding Slow Language Impairment: Cognitive and Genetic Mechanisms
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2022

Arm Intervention/treatment
Experimental: SLI children Behavioral: 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.


Active Comparator: Control children Behavioral: 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.





Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. DNA sampling [ Time Frame: Day 0 ]
    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.



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660995


Contacts
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Contact: Christine RAYNAUD 0326784649 ext +33 craynaud@chu-reims.fr

Locations
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France
Damien JOLLY Not yet recruiting
Reims, France
Contact: Christine RAYNAUD       craynaud@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03660995     History of Changes
Other Study ID Numbers: PO18001
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Reims:
Slow language impairment
semantic
pragmatic
procedural learning
genotype

Additional relevant MeSH terms:
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Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms