Autism Spectrum Disorder, Child Language, Language Development, Neurocognitive Disorders
Conditions
Keywords
High Resolution electroencephalogram, Child, Autism Spectrum Disorder, Language
Brief summary
The goal of this prospective observational multicentric cohort study is to evaluate the clinical prognostic value of the speech tracking score of language development in children with ASD aged from 3 years to 4 years and half at inclusion. Participants will followed during 4 years with an annual visit. During these visits, each participant will be clinically evaluated (scales and tests) and performed an EEG-HR recording. Two groups will be formed, one with children diagnosed with ASD with language delay, and a control group composed of non-ASD children without language delay, matched on age and gender with the ASD group.
Detailed description
Two groups will be formed, one with children diagnosed with ASD with language delay, and a control group composed of non-ASD children without language delay, matched on age and gender with the ASD group. \- ASD group : For children in the ASD group, 4 visits were planned (inclusion visit, then at one year, two years and three years). During study visit, each child will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks (modulated pure tones, synthetic voice, recorded voice, real voice, with congruent and non-congruent pictorial supports). \- Control group : For children in the control group, 1 visit was planned : data will be collected at the inclusion visit only. During this visit, each child will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks (modulated pure tones, synthetic voice, recorded voice, real voice, with congruent and non-congruent pictorial supports).
Interventions
DEVICEEEG-HR
Passation EEG-HR
DIAGNOSTIC_TESTADI-R
Passation of ADI-R scale
DIAGNOSTIC_TESTADOS-2
Passation of ADOS-2 scale
DIAGNOSTIC_TESTIDE
Passation of IDE scale
DIAGNOSTIC_TESTMSEL
Passation of MSEL scale
DIAGNOSTIC_TESTDunn
Passation of Dunn scale
Sponsors
Etablissement Public de Santé Barthélemy Durand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
Yes
Inclusion criteria
For all participants * Child aged from 3 years to 4 years and half at inclusion. * Information delivered and no parental objection for study participation. For ASD group * Diagnosis of ASD according to DSM-V criteria. * Expressive language level \< 27 months regarding on IDE scale. For Control group - Matched on age (at +/- 3 months) and gender to ASD group participants.
Exclusion criteria
For all participants * Any illness or treatment that could significantly alter EEG-HR recording (epilepsy, anti-epileptic treatment, psychotropic drugs...). * Major hearing or vision disorders. For ASD group \- Severe and characterised neurological pathology other than ASD For Control group * Characterised neurological or psychiatric pathology. * Characteristic language delay.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to discriminate children language development | 4 years | The primary endpoint is the ability to discriminate children whose language development will be favourable (developmental level ≥ 27 months) from those whose language development will be unfavourable (\< 27 months) based on the speech tracking measure (on the EEG-HR at inclusion). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of speech tracking scores | 4 years | Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol). |
| Evolution of the predictive model | 4 years | Evolution of the predictive model by integrating data: clinical, longitudinal evolution of speech tracking, deviation from the mean of the control group speech tracking and evolution of speech tracking. |
| Measures of association by synchronous and diachronic analyses | 4 years | Measures of association by synchronous and diachronic analyses (mixed generalized linear models for repeated measures). |
Countries
France
Contacts
Primary ContactAdelaide Aduayi
Backup ContactMorgane Da Silva Hennequin
Outcome results
None listed