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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02560415
Acronym
MICHELANGELO
Enrollment
24
Registered
2015-09-25
Start date
2014-09-30
Completion date
2015-06-30
Last updated
2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, Serious Game, Controlled trial, Denver model

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.

Interventions

DEVICEExperimental

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

BEHAVIORALComparator

Treatment as usual

Sponsors

European Commission
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 monthsat baseline and 6 months

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026