Etablissement Public de Santé Barthélemy Durand
Étampes, 91150, France
NCT Number: NCT05586672
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.
Trial opening soon.
Get Notified3 year–4 year
All sexes
Observational
Étampes, 91150, France
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.
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).
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
For Control group
Passation EEG-HR
Passation of ADI-R scale
Other names: AUTISM DIAGNOSTIC INTERVIEW-REVISED
Passation of ADOS-2 scale
Other names: AUTISM DIAGNOSTIC OBSERVATION SCHEDULE 2
Passation of IDE scale
Other names: Inventaire du Développement de l'Enfant, CDI, Child Development Inventory
Passation of MSEL scale
Other names: Mullen Scales of Early Learning
Passation of Dunn scale
Time frame: 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).
Time frame: 4 years
Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol).
Time frame: 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.
Time frame: 4 years
Measures of association by synchronous and diachronic analyses (mixed generalized linear models for repeated measures).
Contact information is provided by the study sponsor or research team.
Adelaide Aduayi
CONTACT
Morgane Da Silva Hennequin
CONTACT
Etablissement Public de Santé Barthélemy Durand
Other
High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder
Acronym: EE-TSA-LANG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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