Gaming Open Library for Intervention in Autism at Home (GOLIAH /MICHELANGELO)

Study Overview
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Brief Summary
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To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH). The major objective of the study is to test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the usefulness and acceptability of the gaming platform; (2) how experimental children performed using the different Imitation and JA games; and (3) whether children from the experimental group improved significantly more than children treated as usual (control group).

Detailed Description
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Background: To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH) by mapping the Imitation and Joint Attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. For the purpose of this study, 24 ASD children will be recruited (one half in Pisa and the other half in Paris). They will be divided into two groups: an Experimental group (N=14) and a Control group (N=10). The Control group will not go through the training sessions, they will participate only in the assessment sessions. All patients will be referred to treatment as usual, according to local facilities. The protocol is organized into 3 periods (with two assessments at T0 and T6). During the initial stage of the protocol (T0), all the ASD children (experimental participants and controls) will be evaluated during a clinical session. During the rehabilitation period, only half of the children will participate in the training sessions designed to improve their imitation and joint attention capacities. During the final stage of the protocol (T6), all children will be evaluated again during a second clinical session. The clinical assessments will occur at stage 0 and at stage 6. The same tools will be used for these two assessments. The improvement of children's capabilities will be measured by the progress made between stage 0 and stage 6. The investigators will be able to affirm that the training was beneficial by comparing the clinical session performance between the trained and control children.

Official Title
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Patient-centric Model for Remote Management, Treatment and Rehabilitation of Children With Autism - Michelangelo / GOLIAH (Gaming Open Library for Intervention in Autism at Home) Project

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: Experimental
* Behavioral: Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a current diagnosis of ASD confirmed by clinical assessment and the Autism Diagnostic Interview-Revised; an intellectual quotient ≥ 60; aged between 5 to 8 years. Inclusion in the experimental group was based on parents' motivation to follow such a heavy protocol both at home and for the one session per week at the hospital. Controls were matched for sex, age, IQ, study sites and treatment. Exclusion Criteria: known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Experimental<br>Gaming Open Library for Intervention in Autism at Home plus Treatment as usual | Device: Experimental<br>* Gaming Open Library for Intervention in Autism at Home plus Treatment as usual<br>Behavioral: Comparator<br>* Treatment as usual<br>|
| Active Comparator: 2: Comparator<br>Treatment as usual | Behavioral: Comparator<br>* Treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months |  | at baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in Vineland II at 6 months |  | at baseline and 6 months | 
| change from baseline in Child Behavior Check List at 6 months |  | at baseline and 6 months | 
| change from baseline in Wechsler Intelligence scale at 6 months |  | at baseline and 6 months | 
| change from baseline in Social Communication Questionnaire at 6 months |  | at baseline and 6 months | 
| change from baseline in Parental Stress Index at 6 months |  | at baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, Serious Game, Controlled trial, Denver model