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Understanding the Predictive Factors and the Neurocognitive Basis of Developmental Language Disorder

Not Applicable
Not yet recruiting
Conditions
Developmental Language Disorders
Language Development
Interventions
Behavioral: Risk profile screening questionnaire
Procedure: Investigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI)
Behavioral: Online investigation of predictive factors associated with DLD and LANCOM app development
Behavioral: Individual behavioral and cognitive assessment
Behavioral: Automated analysis of language development and environment
Registration Number
NCT04253600
Lead Sponsor
Université Catholique de Louvain
Brief Summary

For most children, language acquisition might appear like an effortless phenomenon, mostly arising from informal daily interaction with their surrounding people. Despite an adequate learning environment however, some children encounter major difficulties in learning their native tongue and develop a Developmental Language Disorder (DLD). Although the existence of a multi-factorial etiology has seemed to reach an agreement, presumably combining genetic and environmental factors to some kind of neural disruption, the underlying mechanisms leading to DLD are, to date, poorly understood.

Many studies have attempted to identify risk factors and early predictors associated with the future development of a language impairment. However, despite the constant efforts to identify early markers able to differentiate between transient and persistent language difficulties, early detection of children who will be developing a DLD remains highly difficult, partially due to the lack of direct and ecological measures of early language and communication development. In addition research on the causal neural correlates of DLD is in its infancy, and often compromised by small sample sizes or analyses methods that lack anatomical specificity to determine the neural correlates of language impairment.

Hence, In order to improve early detection and, therefore, language intervention, this longitudinal research project aims at investigating the early predictive factors as well as the neurocognitive basis of DLD by means of an integrative, multi-dimensional, and multi-methodological approach. To substantially gain insight, this research ideally integrates risk factors at multiple different levels, including the cognitive, neurobiological, parental and environmental level. From a methodological perspective, we will combine direct and indirect behavioral methods with neuroimaging methods in order to propose an early predictive model of language development.

Detailed Description

The present research project can be divided into four main data collection steps. The first step concerns families' recruitment through a principle of population-based screening. Parents and/or caregivers of children aged from 0 to 18 months will be asked to complete a screening questionnaire that aims to evaluate families' general risk profile associated with the development of DLD. A subsample of at-risk and control families will be selected based on the screening phase for longitudinal follow-up. The second step consists of the investigation of the neural correlates of DLD by using a natural-sleep MRI protocol in infants of 6 to 12 months old. The third step concerns the evaluation of predictive factors leading to DLD using indirect measures based on digital assessment of language development, parental and environmental characteristics (i.e., parents will have to fill in online questionnaires every 6 months during a 3-year timeframe). This step will also be dedicated to the development of an application that aims at evaluating early development of language and communication (i.e., LANCOM app). Finally, the fourth step comprises additional in-depth investigation of DLD's predictive factors, by means of direct measures, including individual cognitive and behavioral assessment, as well as an automated analysis of the child's language environment using the Language ENvironment Analysis digital language processor recording device (LENA®). Data collection for this last step will take place once a year over the whole project's timeframe.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
1500
Inclusion Criteria
  • Having a child, preferably aged from 0 to 12 months, and a maximum of 18 months at the time of recruitment
  • Having French as (one of) mother tongue(s)
Exclusion Criteria
  • Severe sensory deprivation resulting in hearing and/or visual impairment (i.e., deafness, blindness) detected at birth
  • Chromosomal abnormalities (e.g., Down syndrome, Turner syndrome, Williams syndrome)
  • Phenylketonuria
  • Cleft lips or palates

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
MRI AcquisitionOnline investigation of predictive factors associated with DLD and LANCOM app developmentThis does not refer to any group intervention. At-risk and control children will take part in a natural-sleep MRI protocol.
MRI AcquisitionRisk profile screening questionnaireThis does not refer to any group intervention. At-risk and control children will take part in a natural-sleep MRI protocol.
MRI AcquisitionInvestigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI)This does not refer to any group intervention. At-risk and control children will take part in a natural-sleep MRI protocol.
MRI AcquisitionIndividual behavioral and cognitive assessmentThis does not refer to any group intervention. At-risk and control children will take part in a natural-sleep MRI protocol.
MRI AcquisitionAutomated analysis of language development and environmentThis does not refer to any group intervention. At-risk and control children will take part in a natural-sleep MRI protocol.
Primary Outcome Measures
NameTimeMethod
Children's behavioral characteristics (indirect measure)From 6 months to 48 months of age

Online questionnaires to be completed by parents, which aims at evaluating children's development, and in particular, their language development.

Cognitive and behavioral characteristics (direct measure) as assessed by standardized batteries of testsFrom 1 year to 4 years of age

Individual cognitive and behavioral assessment evaluating several developmental aspects including language, psychomotor, behavioral and cognitive development, as well as executive and socio-emotional functioning (e.g., EVALObb, EVALO2-6, WPPSI-IV). We will use batteries of neuropsychological standardized evaluation appropriate for the child's age.

Environmental characteristicsFrom 6 months to 48 months of age

Online questionnaires to be completed by parents and evaluating environmental characteristics of the child.

Evaluation of children's language development and environment using the Language ENvironment Analysis digital language processor recording device (LENA)From 1 year to 4 years of age

Automated analysis of language development and environment using the LENA device. An automatic analysis of the recordings, performed by the LENA pro software algorithms, will provide amongst others, a direct and natural measure of the child's number of vocalizations, adult word counts, conversational turns, duration of exposure to electronic media versus to meaningful language.

Parental characteristicsFrom 6 months to 48 months of age

Online questionnaires to be completed by parents and evaluating parental characteristics of the child.

Magnetic Resonance Imagery analyses6-12 months old

Evaluation of neural correlates of DLD using structural (and functional) images. Children aged from 6 months to 12(-18) months will be scanned only once.

Secondary Outcome Measures
NameTimeMethod
Risk profiles analysis based on risk screening online questionnaire0-18 months old (at screening)

Evaluation of different risk profiles associated with the development of DLD (e.g., family risk, environmental risk) based on a risk screening online questionnaire to be completed by the parents.

Trial Locations

Locations (2)

Institute of NeuroScience (IoNS, UCLouvain)

🇧🇪

Woluwe-Saint-Lambert, Belgium

Institut de recherche en sciences psychologiques (IPSY, UCLouvain)

🇧🇪

Louvain-la-Neuve, Belgium

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