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

September 24, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Experimental
Gaming Open Library for Intervention in Autism at Home plus Treatment as usual
Device: Experimental
Gaming Open Library for Intervention in Autism at Home plus Treatment as usual
Behavioral: Comparator
Treatment as usual
Active Comparator: 2: Comparator
Treatment as usual
Behavioral: Comparator
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months
Time Frame: at baseline and 6 months
at baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline in Vineland II at 6 months
Time Frame: at baseline and 6 months
at baseline and 6 months
change from baseline in Child Behavior Check List at 6 months
Time Frame: at baseline and 6 months
at baseline and 6 months
change from baseline in Wechsler Intelligence scale at 6 months
Time Frame: at baseline and 6 months
at baseline and 6 months
change from baseline in Social Communication Questionnaire at 6 months
Time Frame: at baseline and 6 months
at baseline and 6 months
change from baseline in Parental Stress Index at 6 months
Time Frame: at baseline and 6 months
at baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

European Commission

Investigators

  • Principal Investigator: David Cohen, MD, PhD, Groupe hospitalier Pitié-Salpêtrière, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDRCB2014-A-00170-47 - P120914
  • EU: FP7-ICT-2011-7 (n°288241) (Other Grant/Funding Number: ERNB: 140190-31)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorder

Clinical Trials on Experimental

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe