Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication in ASD

Completed

• Conditions: Autistic Disorder

• Registration Number: NCT02444117
• Lead Sponsor: University Hospital, Tours

Brief Summary

This study aims to identify clinical and biological markers which would allow to evaluate precisely the evolution of children with autism spectrum disorders throughout intervention.

Detailed Description

200 children with autism spectrum disorders (1-12 years old) will be included in a 2 years follow-up study. Both clinical and neurophysiological evaluations (electrophysiological and eye tracking) will be completed at different times of the follow-up. This integrative approach, combining clinical and biological markers, will allow the identification of different developmental trajectories and then a better individuation of treatment in autism spectrum disorders.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• re-education of social communication

Exclusion Criteria

• multi-handicapped associated to ASD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical changes between Baseline and Two years	2 years	Autism Diagnostic Observation Schedule (ADOS)

Secondary Outcome Measures

Name	Time	Method
Repetitive behaviors évaluations at baseline	baseline	Repetitive and Restrictive Behavior Scale (RRBS)
Repetitive behaviors évaluations at one year	1 year	Repetitive and Restrictive Behavior Scale (RRBS)
Social and cognitive evaluations at baseline	baseline	Social and Cognitive Evaluation Battery (SCEB),
Social and cognitive évaluations at 2 years	1 year	Social and Cognitive Evaluation Battery (SCEB),
Social and cognitive évaluations at 1 year	1 year	Social and Cognitive Evaluation Battery (SCEB),
neurophysiological evaluations at baseline	baseline	Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices
neurophysiological evaluations at 1 year	1 year	Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices
neurophysiological évaluations at 2 years	2 years	Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices
Repetitive behaviors at two years	2 years	Repetitive and Restrictive Behavior Scale (RRBS)

Trial Locations

Locations (1)

University hospital Tours; 🇫🇷 Tours, France