Intelligent Robotic Interactions for Children With Autism Spectrum Disorders

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Early Start Denver Model (ESDM)

• Registration Number: NCT05991791
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Study Start: 2023-10-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2025-03-19
• Study Completion: 2025-09-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with autism spectrum disorders	Early Start Denver Model (ESDM)	-

Primary Outcome Measures

Name	Time	Method
Score of success on the selected task in the ESDM program	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Hôpital La Colombière - CHU de Montpellier; 🇫🇷 Montpellier, France