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
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
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
NCT ID
NCT02560415
First Posted
September 21, 2015
Last Updated
September 24, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
European Commission
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
Learn more about this trial
Gaming Open Library for Intervention in Autism at Home (GOLIAH /MICHELANGELO)
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