Developmental Language DisordersNCT04253600
Understanding the Predictive Factors and the Neurocognitive Basis of Developmental Language Disorder
A study testing Risk profile screening questionnaire, Investigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI) and Online investigation of predictive factors associated with DLD and LANCOM app development in people with Developmental Language Disorders and Language Development, run by Université Catholique de Louvain at 2 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages Up to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorders, Language Development
- What is being tested?
- Risk profile screening questionnaire, Investigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI) and Online investigation of predictive factors associated with DLD and LANCOM app development
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Apr 2020to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Institut de recherche en sciences psychologiques (IPSY, UCLouvain)
Louvain-la-Neuve, 1348
Jolijn Vanderauwera, Prof., +32470503454, jolijn.vanderauwera@uclouvain.be
Camille Bonnet, +32494172731, camille.bonnet@uclouvain.be
Institute of NeuroScience (IoNS, UCLouvain)
Woluwe-Saint-Lambert, 1200
Jolijn Vanderauwera, Prof., +32470503454, jolijn.vanderauwera@uclouvain.be
Camille Bonnet, +32494172731, camille.bonnet@uclouvain.be
About this study
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
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.
Read the 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.
- Being tested
- Risk profile screening questionnaire, Investigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI), Online investigation of predictive factors associated with DLD and LANCOM app development, Individual behavioral and cognitive assessment, Automated analysis of language development and environment
- Keywords
- Developmental Language Disorders, Predictive factors, Neural correlates, Neurocognitive basis, Language development, Natural-sleep MRI protocol
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk profile screening questionnaireBehavioural
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).
Investigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI)Procedure or surgery
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.
Online investigation of predictive factors associated with DLD and LANCOM app developmentBehavioural
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 assessmentBehavioural
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 environmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MRI Acquisition | Other | This does not refer to any group intervention. At-risk and control children will take part in a natural-sleep MRI protocol. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Environmental characteristics
Online questionnaires to be completed by parents and evaluating environmental characteristics of the child.
Measured: From 6 months to 48 months of age
Parental characteristics
Online questionnaires to be completed by parents and evaluating parental characteristics of the child.
Measured: From 6 months to 48 months of age
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.
Measured: From 6 months to 48 months of age
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.
Measured: From 1 year to 4 years of age
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.
Measured: From 1 year to 4 years of age
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.
Measured: 6-12 months old
Secondary outcomes (1)
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.
Measured: 0-18 months old (at screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisordersStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253600
- Sponsor's protocol ID
- ELENA
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the evaluation of neural correlates, participants have to indicate in the inform consent form, whether they allow the research team to share their data with other researchers or not. Only anonymized MRI data are susceptible to be shared with other researchers if families explicitly mentioned it on inform consent.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04253600
- Acronym / sponsor ID
- ELENA
- Keywords
- Developmental Language Disorders, Predictive factors, Neural correlates, Neurocognitive basis, Language development, Natural-sleep MRI protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Acquisition | Other | 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 environmentThis does not refer to any group intervention. At-risk and control children will take part in a natural-sleep MRI protocol. |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk profile screening questionnaireFamilies 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). | Behavioural | MRI Acquisition |
| 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. | Procedure or surgery | MRI Acquisition |
| Online investigation of predictive factors associated with DLD and LANCOM app developmentParents 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. | Behavioural | MRI Acquisition |
| Individual behavioral and cognitive assessmentIndividual 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. | Behavioural | MRI Acquisition |
| Automated analysis of language development and environmentFollowing 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. | Behavioural | MRI Acquisition |
Primary outcome
Environmental characteristics
Time frame: From 6 months to 48 months of age
Online questionnaires to be completed by parents and evaluating environmental characteristics of the child.
Parental characteristics
Time frame: From 6 months to 48 months of age
Online questionnaires to be completed by parents and evaluating parental characteristics of the child.
Children's behavioral characteristics (indirect measure)
Time frame: 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 tests
Time frame: From 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.
Evaluation of children's language development and environment using the Language ENvironment Analysis digital language processor recording device (LENA)
Time frame: 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.
Magnetic Resonance Imagery analyses
Time frame: 6-12 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.
1 secondary outcome
Risk profiles analysis based on risk screening online questionnaire
Time frame: 0-18 months old (at screening)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Yes. As part of the evaluation of neural correlates, participants have to indicate in the inform consent form, whether they allow the research team to share their data with other researchers or not. Only anonymized MRI data are susceptible to be shared with other researchers if families explicitly mentioned it on inform consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk profile screening questionnaire, Investigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI) and Online investigation of predictive factors associated with DLD and LANCOM app development in people with Developmental Language Disorders and Language Development, run by Université Catholique de Louvain at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jolijn Vanderauwera, Prof. (+32470503454, jolijn.vanderauwera@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Environmental characteristics (time frame: From 6 months to 48 months of age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.