Gaming Open Library for Intervention in Autism at Home (GOLIAH /MICHELANGELO)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Experimental; Comparator
Intervention type(s): Device; Behavioral
Intervention description(s): Gaming Open Library for Intervention in Autism at Home plus Treatment as usual; Treatment as usual
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Serious Game; Controlled trial; Denver model