Intelligent Robotic Interactions for Children With Autism Spectrum Disorders

Study Overview
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Brief Summary
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For several years, studies have been developed on the contribution of social robots as a tool for interventions for children with autism spectrum disorders (ASD). One of the recommended intervention models is the ESDM (Early Start Denver Model). It consists of setting up an individualized, intensive program (at least 20 hours per week) through the pleasure of play. The teacher follows the motivation and interests of the child, and it is the child who chooses the activities. Studies published in recent years tend to show that robots bring benefits to ASD children, particularly in the treatment of social interactions and in clinical settings. However, there is no scientific consensus on the generalized contribution and effect over time of these interventions. Moreover, a robotic solution controlled by a practitioner through a telepresence system allows for a better adaptability to the responses and desires of the children during the interventions. The investigators believe that such a solution would allow for better assessment of progress in the core skills of expressive communication and imitation and greater engagement during interventions.

Official Title
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Adapted and Individualized Intelligent Robotic Interactions to the Ability Spectrum of Children With Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Early Start Denver Model (ESDM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient living in the Hérault department (France), Patient with a diagnosis of ASD confirmed by a psychiatrist or a psychologist and receiving current care according to the ESDM model in the MPEA Peyre Plantade child psychiatry service. Exclusion Criteria: Patients Failure to obtain written informed consent after a cooling-off period Participating in another type of program other than ESDM Not being affiliated to a French social security system or being a beneficiary of such a system Therapist History of epilepsy for health professionals (therapists)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Children with autism spectrum disorders<br> | Other: Early Start Denver Model (ESDM)<br>* Phase A 4 individual sessions (1 per week) Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM Satisfaction Evaluation - Parent Satisfaction Evaluation - Therapist Phase B : 11 sessions (1 per week) Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM with the help of the robot Pepper Satisfaction Evaluation - Parent Satisfaction Evaluation - Therapist Phase C : 4 sessions (1 per week) Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM without the help of the robot Pepper Satisfaction Evaluation - Parent Satisfaction Evaluation - Therapist All sessions will also be filmed and recorded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of success on the selected task in the ESDM program | Measure the success score for the selected task using the ESDM scoring grid. As soon as the child successfully completes one of the different learning stages, a success score is given to the task. This score will be maximum if all the learning stages of the task considered have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)). The ESDM scoring grid will be completed by the research therapists at the end of each session. | From phase A (baseline) to phase C (post-intervention) = 19 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of the child's viewing and movement of the head and body towards the robot (task 1: saying hello) | Measurement of the viewing and movement times toward the robot, as well as the response time from the analysis of the videos made during the sessions using the Pepper robot. Data from the robot: - Video recording by camera of the sessions of the whole room (camera independent of the robot) - Video return by the camera installed on the robot - Audio feedback from the therapist, the robot and the child. | During Phase B = 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telepresence, Autism spectrum disorder, children, interventional care, robotics