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e-GOLIAH in Autistic Spectrum Disorders

NCT05271955 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-04-25

No results posted yet for this study

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 (experimental group) with children receiving only the usual treatment (control group).

eGOLIAH (Gaming Open Library for Intervention in Autism at Home) is an accessible online platform for digital games inspired by the principles of the Early Start Denver Model (ESDM), one of the care programs validated in the management of young ASD.

The duration per patient will be one year. The exposure to e-GOLIAH for the experimental group will be done with the recommendation of intensive exposure to the game (5 sessions\> ½ hour per week).

Clinical variables will be assessed at entry, 6 months and 1 year (end of study).

The EQ5D questionnaires will be collected by the supervising therapist during the follow-up visit and at the same time as the clinical variables.

Conditions

Interventions

DEVICE

"e-GOLIAH"

Usual care plus electronic tablet with games application "e-GOLIAH" (Gaming Open Library for Intervention in Autism at Home)

BEHAVIORAL

Usual care

Usual care which combines speech therapy, psychomotor, educational or psychological care with a developmental and / or behavioral orientation and a school life support during schooling.

Sponsors & Collaborators

  • University Hospital, Montpellier

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • David COHEN, Professor · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2024-12-15
Completion
2024-12-15

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271955 on ClinicalTrials.gov