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HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD

ConditionsAutism Spectrum DisorderLanguage DevelopmentNeurocognitive DisordersChild Language
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-4
SponsorEtablissement Public de Santé Barthélemy Durand

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Child aged from 3 years to 4 years and half at inclusion.

Information delivered and no parental objection for study participation.

Diagnosis of ASD according to DSM-V criteria.

Expressive language level < 27 months regarding on IDE scale.

Disqualifiers

Any illness or treatment that could significantly alter EEG-HR recording (epilepsy, anti-epileptic treatment, psychotropic drugs...).

Major hearing or vision disorders.

Characterised neurological or psychiatric pathology.

Characteristic language delay.

Trial population

Child male or female aged from 3 years to 4 years and half at inclusion with ASD or not.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • EEG-HR

    Device

    Passation EEG-HR

  • 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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: ASD group6 interventions
Group B: Control group4 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
4 years

Secondary outcomes

1

Comparison of speech tracking scores

Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol).

Time frame
4 years
2

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.

Time frame
4 years
3

Measures of association by synchronous and diachronic analyses

Measures of association by synchronous and diachronic analyses (mixed generalized linear models for repeated measures).

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Etablissement Public de Santé Barthélemy Durand

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: