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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05586672
Study type Observational
Source Etablissement Public de Santé Barthélemy Durand
Contact Adelaide Aduayi
Phone +33 1 75 02 16 81
Email adelaide.aduayi@eps-etampes.fr
Status Not yet recruiting
Phase
Start date January 2, 2023
Completion date June 30, 2028

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