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Clinical Trials/NCT05991791
NCT05991791
Recruiting
N/A

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

University Hospital, Montpellier1 site in 1 country8 target enrollmentOctober 19, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University Hospital, Montpellier
Enrollment
8
Locations
1
Primary Endpoint
Score of success on the selected task in the ESDM program
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 19, 2023
End Date
September 19, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

  • 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)

Outcomes

Primary Outcomes

Score of success on the selected task in the ESDM program

Time Frame: From phase A (baseline) to phase C (post-intervention) = 19 weeks

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.

Secondary Outcomes

  • Time of the child's viewing and movement of the head and body towards the robot (task 1: saying "hello")(During Phase B = 11 weeks)

Study Sites (1)

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