Clinical trial NCT04253600: Understanding the Predictive Factors and the Neurocognitive Basis of Developmental Language Disorder
Official title: Understanding the Predictive Factors and the Neurocognitive Basis of Developmental Language Disorder Original Public Title (French) : Projet ELENA, Etude Sur le développement du Langage Chez l'ENfAnt. Public Title (English) : Study on Infants' Language Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Language Disorders
Language Development
Keywords: Developmental Language Disorders
Predictive factors
Neural correlates
Neurocognitive basis
Language development
Natural-sleep MRI protocol
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 1500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Environmental characteristics
timeFrame: From 6 months to 48 months of age
measure: Parental characteristics
timeFrame: From 6 months to 48 months of age
measure: Children's behavioral characteristics (indirect measure)
timeFrame: From 6 months to 48 months of age
measure: Cognitive and behavioral characteristics (direct measure) as assessed by standardized batteries of tests
timeFrame: From 1 year to 4 years of age
measure: Evaluation of children's language development and environment using the Language ENvironment Analysis digital language processor recording device (LENA)
timeFrame: From 1 year to 4 years of age
measure: Magnetic Resonance Imagery analyses
timeFrame: 6-12 months old
Secondary outcomes:
measure: Risk profiles analysis based on risk screening online questionnaire
timeFrame: 0-18 months old (at screening)
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Institut de recherche en sciences psychologiques (IPSY, UCLouvain)
city: Woluwe-Saint-Lambert
country: Belgium
facility: Institute of NeuroScience (IoNS, UCLouvain)
Study officials:
References: