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

Language Development Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04253600
• Other study ID #: ELENA
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2020
• Source: Université Catholique de Louvain
• Contact: Jolijn Vanderauwera, Prof.
• Phone: +32470503454
• Email: jolijn.vanderauwera[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: August 31, 2024
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Developmental Language Disorders
• Disease
• Language Development
• Language Development Disorders
• Language Disorders

Intervention

Behavioral:
• Risk profile screening questionnaire
Families will be asked to complete a LimeSurvey questionnaire that aims at evaluating general risk profiles associated with DLD (e.g., no elevated risk, behavioral risk, environmental risk, familial risk), as well as our exclusion criteria (e.g., hearing deficit).

Procedure:
• Investigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI)
MRI data acquisition will take place during natural sleep in infants aged from 6 to 12 months. First, families will have to complete a security questionnaire to make sure that neither the children nor the accompanying parent have any known contraindication preventing the MRI session and that none of them is wearing any ferro-magnetic elements. Then, families will be welcomed in a calm and child-friendly environment where we will propose them some preparatory games known to facilitate sleep in children. MRI protocol will comprise structural and functional images and won't exceed 30 minutes.

Behavioral:
• Online investigation of predictive factors associated with DLD and LANCOM app development
Parents will be asked to complete a series of online questionnaires every six months. Questionnaires will be created on LimeSurvey and will include different questionnaires, scales, and observations that aim at evaluating children's development, and especially language development, as well as parental and environmental characteristics.
• Individual behavioral and cognitive assessment
Individual cognitive and behavioral assessment will be scheduled once a year, around the child's birth date, and will comprise an extensive battery of standardized evaluation appropriate for the child's age. This individual evaluation will focus on several developmental aspects including language, psychomotor, behavioral and cognitive development, as well as executive and socio-emotional functioning, depending on the age of the children. Evaluations will be adapted to each child's specific profile, while respecting the following administration rules: (1) we will prioritize language development testing, (2) testing sessions will be adapted to each child's pace and possibilities, (3) if a child does not want to take part in the assessment, feels tired, or does not seem to be comfortable with the investigator, tests won't be administered.
• Automated analysis of language development and environment
Following the individual assessment, families will be asked to record their child's language environment over a 2-days' timeframe using the LENA® device, a "small wearable device allowing for large-scale all-day audio recording and automated vocal analyses of speech segments". 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. Data acquisition will take place once a year following our sample selection, with a required recording time per day ranging from 12 to 16 hours.

Locations

Country	Name	City	State
Belgium	Institut de recherche en sciences psychologiques (IPSY, UCLouvain)	Louvain-la-Neuve
Belgium	Institute of NeuroScience (IoNS, UCLouvain)	Woluwe-Saint-Lambert

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Environmental characteristics	Online questionnaires to be completed by parents and evaluating environmental characteristics of the child.	From 6 months to 48 months of age
Primary	Parental characteristics	Online questionnaires to be completed by parents and evaluating parental characteristics of the child.	From 6 months to 48 months of age
Primary	Children's behavioral characteristics (indirect measure)	Online questionnaires to be completed by parents, which aims at evaluating children's development, and in particular, their language development.	From 6 months to 48 months of age
Primary	Cognitive and behavioral characteristics (direct measure) as assessed by standardized batteries of tests	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.	From 1 year to 4 years of age
Primary	Evaluation of children's language development and environment using the Language ENvironment Analysis digital language processor recording device (LENA)	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.	From 1 year to 4 years of age
Primary	Magnetic Resonance Imagery analyses	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.	6-12 months old
Secondary	Risk profiles analysis based on risk screening online questionnaire	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.	0-18 months old (at screening)