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| ID | Type | Description | Link |
|---|---|---|---|
| EU: FP7-ICT-2011-7 (n°288241) | Other Grant/Funding Number | ERNB: 140190-31 |
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| Name | Class |
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| European Commission | OTHER |
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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).
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Experimental | Experimental | Gaming Open Library for Intervention in Autism at Home plus Treatment as usual |
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| 2: Comparator | Active Comparator | Treatment as usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Device | Gaming Open Library for Intervention in Autism at Home plus Treatment as usual |
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| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months | at baseline and 6 months |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cohen, MD, PhD | Groupe hospitalier Pitié-Salpêtrière, Paris, France | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28344643 | Derived | Jouen AL, Narzisi A, Xavier J, Tilmont E, Bodeau N, Bono V, Ketem-Premel N, Anzalone S, Maharatna K, Chetouani M, Muratori F, Cohen D; MICHELANGELO Study Group. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. Child Adolesc Psychiatry Ment Health. 2017 Mar 22;11:17. doi: 10.1186/s13034-017-0154-7. eCollection 2017. | |
| 27199777 |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Comparator | Behavioral | Treatment as usual |
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| 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 |
| Derived |
| Bono V, Narzisi A, Jouen AL, Tilmont E, Hommel S, Jamal W, Xavier J, Billeci L, Maharatna K, Wald M, Chetouani M, Cohen D, Muratori F; MICHELANGELO Study Group. GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. Front Psychiatry. 2016 Apr 28;7:70. doi: 10.3389/fpsyt.2016.00070. eCollection 2016. |