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

Autism Spectrum Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560415
• Other study ID #: IDRCB2014-A-00170-47 - P120914
• Secondary ID: EU: FP7-ICT-2011
• Status: Completed
• Phase: N/A
• First received: September 21, 2015
• Last updated: September 24, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 8 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Device:
• Experimental
Gaming Open Library for Intervention in Autism at Home plus Treatment as usual

Behavioral:
• Comparator
Treatment as usual

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	European Commission

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months		at baseline and 6 months	No
Secondary	change from baseline in Vineland II at 6 months		at baseline and 6 months	No
Secondary	change from baseline in Child Behavior Check List at 6 months		at baseline and 6 months	No
Secondary	change from baseline in Wechsler Intelligence scale at 6 months		at baseline and 6 months	No
Secondary	change from baseline in Social Communication Questionnaire at 6 months		at baseline and 6 months	No
Secondary	change from baseline in Parental Stress Index at 6 months		at baseline and 6 months	No