Better Understanding Slow Language Impairment (SLI:COGGEN)

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.

Study Overview

• Status: Recruiting
• Conditions: Slow Language Impairment
• Intervention / Treatment: Behavioral: Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling.

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine RAYNAUD; Phone Number: +33 0326784649; Email: craynaud@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Christine RAYNAUD; Email: craynaud@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2019
• Primary Completion (ANTICIPATED): May 29, 2022
• Study Completion (ANTICIPATED): May 29, 2023

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (ACTUAL): September 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: genotype; pragmatic; Slow language impairment; semantic; procedural learning
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Language Disorders
• Other Study ID Numbers: PO18001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No