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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental
Comparator
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Serious Game, Controlled trial, Denver model

Eligibility Criteria

5 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1: Experimental

    2: Comparator

    Arm Description

    Gaming Open Library for Intervention in Autism at Home plus Treatment as usual

    Treatment as usual

    Outcomes

    Primary Outcome Measures

    change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months

    Secondary Outcome Measures

    change from baseline in Vineland II at 6 months
    change from baseline in Child Behavior Check List at 6 months
    change from baseline in Wechsler Intelligence scale at 6 months
    change from baseline in Social Communication Questionnaire at 6 months
    change from baseline in Parental Stress Index at 6 months

    Full Information

    First Posted
    September 21, 2015
    Last Updated
    September 24, 2015
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    European Commission
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02560415
    Brief Title
    Gaming Open Library for Intervention in Autism at Home (GOLIAH /MICHELANGELO)
    Acronym
    MICHELANGELO
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    European Commission

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    Autism Spectrum Disorder, Serious Game, Controlled trial, Denver model

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1: Experimental
    Arm Type
    Experimental
    Arm Description
    Gaming Open Library for Intervention in Autism at Home plus Treatment as usual
    Arm Title
    2: Comparator
    Arm Type
    Active Comparator
    Arm Description
    Treatment as usual
    Intervention Type
    Device
    Intervention Name(s)
    Experimental
    Intervention Description
    Gaming Open Library for Intervention in Autism at Home plus Treatment as usual
    Intervention Type
    Behavioral
    Intervention Name(s)
    Comparator
    Intervention Description
    Treatment as usual
    Primary Outcome Measure Information:
    Title
    change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months
    Time Frame
    at baseline and 6 months
    Secondary Outcome Measure Information:
    Title
    change from baseline in Vineland II at 6 months
    Time Frame
    at baseline and 6 months
    Title
    change from baseline in Child Behavior Check List at 6 months
    Time Frame
    at baseline and 6 months
    Title
    change from baseline in Wechsler Intelligence scale at 6 months
    Time Frame
    at baseline and 6 months
    Title
    change from baseline in Social Communication Questionnaire at 6 months
    Time Frame
    at baseline and 6 months
    Title
    change from baseline in Parental Stress Index at 6 months
    Time Frame
    at baseline and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Cohen, MD, PhD
    Organizational Affiliation
    Groupe hospitalier Pitié-Salpêtrière, Paris, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28344643
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    27199777
    Citation
    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.
    Results Reference
    derived

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

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