Status:
UNKNOWN
e-GOLIAH in Autistic Spectrum Disorders
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
University Hospital, Montpellier
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-6 years
Phase:
NA
Brief Summary
Randomized open-label study comparing children aged 3 to 6 years with autism and normal cognitive development or mild cognitive impairment receiving the usual treatment plus intensive use of eGOLIAH (...
Detailed Description
In a context of increasing prevalence of Autism Spectrum Disorder (ASD) and the heterogeneity of children's profiles and abilities, early diagnosis is crucial in order to implement intensive, individu...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Child with autism confirmed by a validated instrument (ADI-R or ADOS)
- Aged 3 to 6 years;
- Parent(s) agree to get involved in the constraint of using the SG 5 times / week at home for 2 periods of 3 months.
- Signature of the informed consent form by the 2 holders of parental authority or the only holder of parental authority present
- Affiliation to a social security scheme (except AME)
- Non-inclusion criteria :
- Children with behavioral problems;
- Unstabilized comorbid organic pathology;
- Moderate and severe cognitive deficit (Intellectual Quotient less than 55);
- Multi or polyhandicap.
- Medication that may cause visual or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments
- Degenerative diseases or any other disease that could interfere with the evaluations planned during this study (known epilepsy and/or history of seizures, etc.)
- Photosensitive persons in order to avoid situations that could induce epileptic seizures in them
Exclusion
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05271955
Start Date
June 15 2022
End Date
December 15 2024
Last Update
April 25 2022
Active Locations (12)
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1
Fondation Lenval - Hôpitaux Pédiatriques de Nice- CHU Lenval
Nice, Alpes Maritimes, France, 06200
2
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, Bas-Rhin, France, 67091
3
Centre Hospitalier Universitaire de Toulouse
Toulouse, Haut-Garonne, France, 31059
4
Centre Hospitalier Universitaire de Montpellier
Montpellier, Hérault, France, 34295