e-GOLIAH in Autistic Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

— e-GOLIAH-ECO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05271955
• Other study ID #: APHP200052
• Secondary ID: 2020-A03389-30
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: David COHEN, Professor, Child Psychiatrist
• Phone: 01 42 16 23 51
• Email: david.cohen[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Disease

Intervention

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

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.

Locations

Country	Name	City	State
France	Centre Hospitalier d'Amiens	Amiens	Somme
France	Centre Hospitalier Universitaire de Montpellier	Montpellier	Hérault
France	Centre Hospitalier Universitaire de Nancy	Nancy	Meurthe-et-Moselle
France	Fondation Lenval - Hôpitaux Pédiatriques de Nice- CHU Lenval	Nice	Alpes Maritimes
France	Assistance Publique - Hôpitaux de Paris, Site de la Pitié-Salpêtrière	Paris	Ile De France
France	Assistance Publique - Hôpitaux de Paris, Site de Necker	Paris	Ile De France
France	Centre Hospitalier Sainte-Anne / GHU Paris Psychiatrie et Neurosciences	Paris	Ile De France
France	Centre Hospitalier Universitaire de Paris - Centre Hospitalier d'Henri Laborit	Poitiers	Vienne
France	Centre Hospitalier Universitaire de Strasbourg	Strasbourg	Bas-Rhin
France	Centre Hospitalier Universitaire de Toulouse	Toulouse	Haut-Garonne
France	Centre Hospitalier Universitaire de Tours	Tours	Indre-et-Loire
France	Centre Hospitalier de Versailles - André Mignot	Versailles	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (5)

Bieleninik L, Geretsegger M, Mössler 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 Ó, 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. Erratum in: JAMA. 2021 Apr 13;325(14):1473. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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