e-GOLIAH in Autistic Spectrum Disorders

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: e-GOLIAH
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Incremental Cost-utility ratio (ICUR) at 6 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) | 6 months | 
| Comparison of Incremental cost-effectiveness ratio (ICER) between the 2 groups | ICER use the Vineland II scale (undetermined minimum and maximum)composite score, average score : 100, higher scores mean a better outcome) | 6 and 12 months | 
| Comparison of the out of pocket payment for the consumption of treatments linked to the TSA between the 2 groups | Amount remaining payable by the patient after deduction of reimbursements received by health insurance | 12 months | 
| Budget impact analysis (BIA) of e-GOLIAH in the management of children diagnosed with TSA for health insurance | Budget impact analysis (BIA) will be measured by direct resources consumed and quantified using the SNIIRAM/SNDS database | 3 years | 
| Comparison of Quality of life between the 2 groups | 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) | 6 and 12 months | 
| Comparison of Adaptive symptoms between the 2 groups | 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) | 6 and 12 months | 
| Comparison of Autistic symptoms between the 2 groups | 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) | 6 and 12 months | 
| Comparison of Social interactions between the 2 groups | 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) | 6 and 12 months | 
| Comparison of Parental Stress between the 2 groups | Use the Parental Stress Index scale, 36 items coded from 1 to 5 (score min : 0 ; max: 180, higher scores mean a worse outcome) | 6 and 12 months | 
| The child's acceptability to the e-GOLIAH game at home | interview with clinical team by phone contact every twice a month for 12 months | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-GOLIAH, e-GOLIAH-ECO, Autistic Spectrum Disorders, Children, Tablet, Games, Serious Game