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Completed

NCT Number: NCT02560415

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

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).

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental

Device

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

Comparator

Behavioral

Treatment as usual

Primary outcomes

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

    Time frame: at baseline and 6 months

Secondary outcomes

  1. change from baseline in Vineland II at 6 months

    Time frame: at baseline and 6 months

  2. change from baseline in Child Behavior Check List at 6 months

    Time frame: at baseline and 6 months

  3. change from baseline in Wechsler Intelligence scale at 6 months

    Time frame: at baseline and 6 months

  4. change from baseline in Social Communication Questionnaire at 6 months

    Time frame: at baseline and 6 months

  5. change from baseline in Parental Stress Index at 6 months

    Time frame: at baseline and 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • European Commission

Registry information

Official study 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

Acronym: MICHELANGELO

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2015
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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