Clinical trial NCT05271955: e-GOLIAH in Autistic Spectrum Disorders
Official title: Medico-economic Evaluation of the Care by Serious Games in Outpatient Units and at Home for Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: e-GOLIAH
e-GOLIAH-ECO
Autistic Spectrum Disorders
Children
Tablet
Games
Serious Game
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: University Hospital, Montpellier
First posted: 2022-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: In a context of increasing prevalence of Autism Spectrum Disorder (ASD) and the heterogeneity of children's profiles and abilities, early diagnosis is crucial in order to implement intensive, individualized, multidimensional therapeutic care and therefore more efficient. In the context of MICHELANGELO (FP7 European Research project), we developed a serious game called GOLIAH for Gaming Open Library for Intervention for Autism at Home. Using the first beta version as functional prototype, we showed that the demonstrator could be used at home with the help of parents in addition to usual care, during a clinical study including 25 participants. Also, Billeci and colleagues showed that, after training, children's improvement in joint attention tasks was correlated with changes in brain activity and connectivity. We then developed a new version e-GOLIAH to open the opportunity to conduct a large clinical study to assess the validity of the tool in terms of children's improvements. The goals of e-GOLIAH are to bring improvements in terms of ergonomics and accessibility to this initial prototype by finalizing the tool and distributing it to therapists, parents and children with ASD, via the Curapy.com web platform. e-GOLIAH provides, in free and open access, a platform for digital games inspired by the principles of ESDM (Early Start Denver Model) allowing intensive training to improve joint attention and imitation, two key skills for early social interaction and communication. It is a more natural, child-centered intervention method practiced at home and involving parents. This innovative solution takes the assessment and management of autism care out of the usual clinical environment. eGOLIAH (Gaming Open Library for Intervention in Autism at Home) is an accessible online platform for digital games that include ten different games with different level of complexity. A key principle is the collaboration between the child and his/her parent to proceed with the games making it interactive by nature, each participant having his own tablet.

The current study e-GOLIAH-ECO is a medico-economic study powered to recruit 150 children. It is a multisite 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).

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 (quality of life) questionnaires will be collected by the supervising therapist during the follow-up visit and at the same time as the clinical variables.

The main objective is to evaluate the 12-month cost-effectiveness of the management of children diagnosed with ASDs using the e-GOLIAH game used at home, compared to usual management.

Secondary objective includes:

(i) To evaluate the cost-effectiveness ratio of the management of patients with ASDs using e-GOLIAH compared to usual management at 12 months of follow-up.

(ii) To explore the remaining ASD-related annual burden of the cost of disease for the two groups studied.

(iii) To evaluate the consequences of the generalization of the management of children diagnosed with ASD using e-GOLIAH, compared to a usual management, from the point of view of the Health Insurance over a period of 3 years.

(iv) To evaluate the impact of the management of children diagnosed with ASD using the e-GOLIAH game used at home, compared to usual management, on the patient's quality of life and that of their responsible parent and the correlation between the two, on adaptive symptoms, on autistic symptoms, on social interactions, on parental stress, at 6 months and at 12 months.

(v) To assess compliance with OS by children and their caregivers. The following scales will be monitored: the EQ5D-3L for quality of life, the Vineland-II scale, the Child Autism Rating Scale (CARS), the Social Responsiveness Scale (SRS), the Parenting Stress Index. In addition the medico-economic data will be monitored from regular interview and social insurance data.

Eligibility criteria: Inclusion criteria :

* 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)

Non-inclusion criteria :

* 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

Primary outcomes:
measure: Comparison of Incremental Cost-Utility Ratio (ICUR) at 12 months between the 2 groups
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of Incremental Cost-utility ratio (ICUR) at 6 months between the 2 groups
timeFrame: 6 months
measure: Comparison of Incremental cost-effectiveness ratio (ICER) between the 2 groups
timeFrame: 6 and 12 months
measure: Comparison of the out of pocket payment for the consumption of treatments linked to the TSA between the 2 groups
timeFrame: 12 months
measure: Budget impact analysis (BIA) of e-GOLIAH in the management of children diagnosed with TSA for health insurance
timeFrame: 3 years
measure: Comparison of Quality of life between the 2 groups
timeFrame: 6 and 12 months
measure: Comparison of Adaptive symptoms between the 2 groups
timeFrame: 6 and 12 months
measure: Comparison of Autistic symptoms between the 2 groups
timeFrame: 6 and 12 months
measure: Comparison of Social interactions between the 2 groups
timeFrame: 6 and 12 months
measure: Comparison of Parental Stress between the 2 groups
timeFrame: 6 and 12 months
measure: The child's acceptability to the e-GOLIAH game at home
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval - Hôpitaux Pédiatriques de Nice- CHU Lenval
state: Alpes Maritimes
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg
state: Bas-Rhin
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
state: Haut-Garonne
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
state: Hérault
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris, Site de la Pitié-Salpêtrière
state: Ile De France
city: Paris
country: France
facility: Centre Hospitalier Sainte-Anne / GHU Paris Psychiatrie et Neurosciences
state: Ile De France
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris, Site de Necker
state: Ile De France
city: Versailles
country: France
facility: Centre Hospitalier de Versailles - André Mignot
state: Ile De France
city: Tours
country: France
facility: Centre Hospitalier Universitaire de Tours
state: Indre-et-Loire
city: Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy
state: Meurthe-et-Moselle
city: Amiens
country: France
facility: Centre Hospitalier d'Amiens
state: Somme
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Paris - Centre Hospitalier d'Henri Laborit
state: Vienne
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: David COHEN, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.