Brief Summary

Randomized open-label study comparing children aged 3 to 6 years with autism and normal cognitive development or mild cognitive impairment receiving the usual treatment plus intensive use of eGOLIAH (experimental group) with children receiving only the usual treatment (control group). eGOLIAH (Gaming Open Library for Intervention in Autism at Home) is an accessible online platform for digital games inspired by the principles of the Early Start Denver Model (ESDM), one of the care programs validated in the management of young ASD. The duration per patient will be one year. The exposure to e-GOLIAH for the experimental group will be done with the recommendation of intensive exposure to the game (5 sessions\> ½ hour per week). Clinical variables will be assessed at entry, 6 months and 1 year (end of study). The EQ5D questionnaires will be collected by the supervising therapist during the follow-up visit and at the same time as the clinical variables.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

150

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach

1 country

12 active sites

Status

unknown

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

2.5 years study duration

First Submitted

Initial submission to the registry

February 28, 2022

Completed

9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed

3 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed

Last Updated

April 25, 2022

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

February 28, 2022

Last Update Submit

April 15, 2022

Conditions

Autism Spectrum Disorder

Keywords

e-GOLIAHe-GOLIAH-ECOAutistic Spectrum DisordersChildrenTabletGamesSerious Game

Outcome Measures

Primary Outcomes (1)

Comparison of Incremental Cost-Utility Ratio (ICUR) at 12 months between the 2 groups
ICUR use the 5-level EQ-5D version and the child-friendly EQ-5D version (EQ5D-5L/EQ5D-Y) questionnaires (min score : 0 ; max score : 100 ; higher scores mean a better outcome)
12 months

Secondary Outcomes (10)

Comparison of Incremental Cost-utility ratio (ICUR) at 6 months between the 2 groups
6 months
Comparison of Incremental cost-effectiveness ratio (ICER) between the 2 groups
6 and 12 months
Comparison of the out of pocket payment for the consumption of treatments linked to the TSA between the 2 groups
12 months
Budget impact analysis (BIA) of e-GOLIAH in the management of children diagnosed with TSA for health insurance
3 years
Comparison of Quality of life between the 2 groups
6 and 12 months
+5 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Children receiving the usual care plus intensive use of e-GOLIAH (experimental group)

Device: "e-GOLIAH"

Control

ACTIVE COMPARATOR

Children receiving only the usual treatment (control group).

Behavioral: Usual care

Interventions

"e-GOLIAH"DEVICE

Usual care plus electronic tablet with games application "e-GOLIAH" (Gaming Open Library for Intervention in Autism at Home)

Experimental

Usual careBEHAVIORAL

Usual care which combines speech therapy, psychomotor, educational or psychological care with a developmental and / or behavioral orientation and a school life support during schooling.

Control

Eligibility Criteria

Age3 Years - 6 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Child with autism confirmed by a validated instrument (ADI-R or ADOS)
Aged 3 to 6 years;
Parent(s) agree to get involved in the constraint of using the SG 5 times / week at home for 2 periods of 3 months.
Signature of the informed consent form by the 2 holders of parental authority or the only holder of parental authority present
Affiliation to a social security scheme (except AME)
Children with behavioral problems;
Unstabilized comorbid organic pathology;
Moderate and severe cognitive deficit (Intellectual Quotient less than 55);
Multi or polyhandicap.
Medication that may cause visual or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments
Degenerative diseases or any other disease that could interfere with the evaluations planned during this study (known epilepsy and/or history of seizures, etc.)
Photosensitive persons in order to avoid situations that could induce epileptic seizures in them

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Assistance Publique - Hôpitaux de Parislead
University Hospital, Montpelliercollaborator

Study Sites (12)

Fondation Lenval - Hôpitaux Pédiatriques de Nice- CHU Lenval

Nice, Alpes Maritimes, 06200, France

Location

Centre Hospitalier Universitaire de Strasbourg

Strasbourg, Bas-Rhin, 67091, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, Haut-Garonne, 31059, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, Hérault, 34295, France

Location

Centre Hospitalier Universitaire de Tours

Tours, Indre-et-Loire, 37044, France

Location

Centre Hospitalier Universitaire de Nancy

Nancy, Meurthe-et-Moselle, 54511, France

Location

Centre Hospitalier d'Amiens

Amiens, Somme, 80054, France

Location

Centre Hospitalier Universitaire de Paris - Centre Hospitalier d'Henri Laborit

Poitiers, Vienne, 86021, France

Location

Assistance Publique - Hôpitaux de Paris, Site de la Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

Location

Centre Hospitalier Sainte-Anne / GHU Paris Psychiatrie et Neurosciences

Paris, Île-de-France Region, 75014, France

Location

Assistance Publique - Hôpitaux de Paris, Site de Necker

Paris, Île-de-France Region, 75015, France

Location

Centre Hospitalier de Versailles - André Mignot

Versailles, Île-de-France Region, 78157, France

Location

Related Publications (5)

Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.
PMID: 19948568BACKGROUND
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: 28344643BACKGROUND
Bieleninik L, Geretsegger M, Mossler K, Assmus J, Thompson G, Gattino G, Elefant C, Gottfried T, Igliozzi R, Muratori F, Suvini F, Kim J, Crawford MJ, Odell-Miller H, Oldfield A, Casey O, Finnemann J, Carpente J, Park AL, Grossi E, Gold C; TIME-A Study Team. Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):525-535. doi: 10.1001/jama.2017.9478.
PMID: 28787504BACKGROUND
Billeci L, Narzisi A, Tonacci A, Sbriscia-Fioretti B, Serasini L, Fulceri F, Apicella F, Sicca F, Calderoni S, Muratori F. An integrated EEG and eye-tracking approach for the study of responding and initiating joint attention in Autism Spectrum Disorders. Sci Rep. 2017 Oct 19;7(1):13560. doi: 10.1038/s41598-017-13053-4.
PMID: 29051506BACKGROUND
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: 27199777BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

David COHEN, Professor
Assistance Publique - Hôpitaux de Paris
STUDY DIRECTOR

Central Study Contacts

David COHEN, Professor, Child Psychiatrist

CONTACT

01 42 16 23 51 david.cohen@aphp.fr

Anne BISSERY

CONTACT

01 42 16 24 32 anne.bissery@aphp.fr

Study Design

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

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 9, 2022

Study Start

June 15, 2022

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

April 25, 2022

Record last verified: 2022-02

Locations

FR(12)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Experimental

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations