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

NCT ID: NCT02560415

Last Updated: 2015-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-06-30

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1: Experimental

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

Group Type: EXPERIMENTAL

Experimental

Intervention Type: DEVICE

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

Comparator

Intervention Type: BEHAVIORAL

Treatment as usual

2: Comparator

Treatment as usual

Group Type: ACTIVE_COMPARATOR

Comparator

Intervention Type: BEHAVIORAL

Treatment as usual

Interventions

Experimental

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

Intervention Type: DEVICE

Comparator

Treatment as usual

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Cohen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe hospitalier Pitié-Salpêtrière, Paris, France

References

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.

Reference Type: DERIVED

PMID: 28344643 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27199777 (View on PubMed)

Other Identifiers

EU: FP7-ICT-2011-7 (n°288241)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IDRCB2014-A-00170-47 - P120914

Identifier Type: -

Identifier Source: org_study_id