e-GOLIAH-ECO: e-GOLIAH in Autistic Spectrum Disorders

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05271955

Collaborator

University Hospital, Montpellier (Other)

150

Enrollment

Locations

Arms

Anticipated Duration (Months)

12.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Device: "e-GOLIAH" Behavioral: Usual care	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Medico-economic Evaluation of the Care by Serious Games in Outpatient Units and at Home for Children With Autism Spectrum Disorders

Anticipated Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 15, 2024

Anticipated Study Completion Date :

Dec 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Children receiving the usual care plus intensive use of e-GOLIAH (experimental group)	Device: "e-GOLIAH" Usual care plus electronic tablet with games application "e-GOLIAH" (Gaming Open Library for Intervention in Autism at Home)
Active Comparator: Control Children receiving only the usual treatment (control group).	Behavioral: Usual care 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.

Arm

Intervention/Treatment

Experimental: Experimental

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

Device: "e-GOLIAH"

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

Active Comparator: Control

Children receiving only the usual treatment (control group).

Behavioral: Usual care

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.

Outcome Measures

Primary Outcome Measures

Comparison of Incremental Cost-Utility Ratio (ICUR) at 12 months between the 2 groups [12 months]
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)

Secondary Outcome Measures

Comparison of Incremental Cost-utility ratio (ICUR) at 6 months between the 2 groups [6 months]
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)
Comparison of Incremental cost-effectiveness ratio (ICER) between the 2 groups [6 and 12 months]
ICER use the Vineland II scale (undetermined minimum and maximum)composite score, average score : 100, higher scores mean a better outcome)
Comparison of the out of pocket payment for the consumption of treatments linked to the TSA between the 2 groups [12 months]
Amount remaining payable by the patient after deduction of reimbursements received by health insurance
Budget impact analysis (BIA) of e-GOLIAH in the management of children diagnosed with TSA for health insurance [3 years]
Budget impact analysis (BIA) will be measured by direct resources consumed and quantified using the SNIIRAM/SNDS database
Comparison of Quality of life between the 2 groups [6 and 12 months]
Measured by the 5-level EQ-5D version and the child-friendly EQ-5D version measured by proxy EQ-5D-5L/EQ-5D-Y(proxy) for the patient and their parent. Scale 0-100 (min score: 0, max score :100, higher scores mean a better outcome)
Comparison of Adaptive symptoms between the 2 groups [6 and 12 months]
Use the Vineland-II Scale of socio-adaptive behavior measured by the composite score with an average to 100 of 4 dimensions: socialization, communication, life skills everyday life, and motricity (undetermined minimum and maximum composite score, average score : 100, higher scores mean a better outcome)
Comparison of Autistic symptoms between the 2 groups [6 and 12 months]
Use the CARS (Child Autism Rating Ladder) scale, 15 items coded from 1 to 4 (score min: 0, max : 60, higher scores mean a worse outcome)
Comparison of Social interactions between the 2 groups [6 and 12 months]
Use the SRS (Social Responsiveness Scale) scale, 65 items coded from 1 to 4 (score min: 0 ; score max : 260, higher scores mean a worse outcome)
Comparison of Parental Stress between the 2 groups [6 and 12 months]
Use the Parental Stress Index scale, 36 items coded from 1 to 5 (score min : 0 ; max: 180, higher scores mean a worse outcome)
The child's acceptability to the e-GOLIAH game at home [6 and 12 months]
interview with clinical team by phone contact every twice a month for 12 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Lenval - Hôpitaux Pédiatriques de Nice- CHU Lenval	Nice	Alpes Maritimes	France	06200
2	Centre Hospitalier Universitaire de Strasbourg	Strasbourg	Bas-Rhin	France	67091
3	Centre Hospitalier Universitaire de Toulouse	Toulouse	Haut-Garonne	France	31059
4	Centre Hospitalier Universitaire de Montpellier	Montpellier	Hérault	France	34295
5	Assistance Publique - Hôpitaux de Paris, Site de la Pitié-Salpêtrière	Paris	Ile De France	France	75013
6	Centre Hospitalier Sainte-Anne / GHU Paris Psychiatrie et Neurosciences	Paris	Ile De France	France	75014
7	Assistance Publique - Hôpitaux de Paris, Site de Necker	Paris	Ile De France	France	75015
8	Centre Hospitalier de Versailles - André Mignot	Versailles	Ile De France	France	78157
9	Centre Hospitalier Universitaire de Tours	Tours	Indre-et-Loire	France	37044
10	Centre Hospitalier Universitaire de Nancy	Nancy	Meurthe-et-Moselle	France	54511
11	Centre Hospitalier d'Amiens	Amiens	Somme	France	80054
12	Centre Hospitalier Universitaire de Paris - Centre Hospitalier d'Henri Laborit	Poitiers	Vienne	France	86021