Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01657-36 | Registry Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASD group | Participants aged from 3 years to 4 years and half at inclusion will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks at several times. |
| |
| Control group | Participants aged from 3 years to 4 years and half at inclusion will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks in inclusion visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG-HR | Device | Passation EEG-HR |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to discriminate children language development | 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). | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of speech tracking scores | Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol). | 4 years |
| Evolution of the predictive model | 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. |
Not provided
Inclusion Criteria:
For all participants
For ASD group
For Control group - Matched on age (at +/- 3 months) and gender to ASD group participants.
Exclusion Criteria:
For all participants
For ASD group
- Severe and characterised neurological pathology other than ASD
For Control group
Not provided
Not provided
Child male or female aged from 3 years to 4 years and half at inclusion with ASD or not.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adelaide Aduayi | Contact | +33 1 75 02 16 81 | adelaide.aduayi@eps-etampes.fr | |
| Morgane Da Silva Hennequin | Contact | +33 1 82 26 81 08 | morgane.dasilvahennequin@eps-etampes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mariette Vinurel | Etablissement Public de Santé Barthélemy Durand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etablissement Public de Santé Barthélemy Durand | Étampes | 91150 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D019965 | Neurocognitive Disorders |
| D007802 | Language |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003142 | Communication |
Not provided
Not provided
Not provided
Not provided
Not provided
| ADI-R |
| Diagnostic Test |
Passation of ADI-R scale |
|
|
| ADOS-2 | Diagnostic Test | Passation of ADOS-2 scale |
|
|
| IDE | Diagnostic Test | Passation of IDE scale |
|
|
| MSEL | Diagnostic Test | Passation of MSEL scale |
|
|
| Dunn | Diagnostic Test | Passation of Dunn scale |
|
| 4 years |
| Measures of association by synchronous and diachronic analyses | Measures of association by synchronous and diachronic analyses (mixed generalized linear models for repeated measures). | 4 years |
| D001519 | Behavior |