NCT02560415

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

September 21, 2015

Last Update Submit

September 24, 2015

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderSerious GameControlled trialDenver model

Outcome Measures

Primary Outcomes (1)

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

    at baseline and 6 months

Secondary Outcomes (5)

  • change from baseline in Vineland II at 6 months

    at baseline and 6 months

  • change from baseline in Child Behavior Check List at 6 months

    at baseline and 6 months

  • change from baseline in Wechsler Intelligence scale at 6 months

    at baseline and 6 months

  • change from baseline in Social Communication Questionnaire at 6 months

    at baseline and 6 months

  • change from baseline in Parental Stress Index at 6 months

    at baseline and 6 months

Study Arms (2)

1: Experimental

EXPERIMENTAL

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

Device: ExperimentalBehavioral: Comparator

2: Comparator

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Comparator

Interventions

ExperimentalDEVICE

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

1: Experimental
ComparatorBEHAVIORAL

Treatment as usual

1: Experimental2: Comparator

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • Controls were matched for sex, age, IQ, study sites and treatment.

You may not qualify if:

  • known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 28344643DERIVED

  • 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.

    PMID: 27199777DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • David Cohen, MD, PhD

    Groupe hospitalier Pitié-Salpêtrière, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 25, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 25, 2015

Record last verified: 2015-09