Clinical trial NCT05991791: Intelligent Robotic Interactions for Children With Autism Spectrum Disorders
Official title: Adapted and Individualized Intelligent Robotic Interactions to the Ability Spectrum of Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism spectrum disorder
children
interventional care
robotics
telepresence
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2023-08-15
Enrollment: 8
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Score of success on the selected task in the ESDM program
timeFrame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
Secondary outcomes:
measure: Time of the child's viewing and movement of the head and body towards the robot (task 1: saying "hello")
timeFrame: During Phase B = 11 weeks
Other outcomes:
measure: Time of the child's viewing and movement of the head and body towards the therapist (task 1: saying "hello")
timeFrame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
measure: Response time of the child after the presentation of the imitation exercise (task 2: action imitation)
timeFrame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
measure: Number of objects given to the robot (task 3 : give an object on verbal request)
timeFrame: From phase A (baseline) to phase C (post-intervention) = 19 weeks
measure: Teleoperation success score for therapist (throught UX score)
timeFrame: Phase C (from week 5 to 15)
measure: Parent satisfaction score on current care
timeFrame: During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks).
measure: Professional satisfaction score on current care.
timeFrame: During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)
measure: Score of success in the ESDM tasks without teleoperation
timeFrame: During phase A (to 4 weeks), Phase C (from week 16 to 19
measure: Score of success in the ESDM tasks with teleoperation
timeFrame: During phase B (from week 5 to 15)
measure: Teleoperation usability score for therapist (throught UMUX score)
timeFrame: During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)
Locations:
city: Montpellier
country: France
facility: Hôpital La Colombière - CHU de Montpellier
Study officials:
References: