Intelligent Robotic Interactions for Children With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

— I-ROBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991791
• Other study ID #: RECHMPL23_0056
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: September 19, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Montpellier
• Contact: Amaria BAGHDADLI, Pr
• Phone: 04 67 33 96 96
• Email: a-baghdadli[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 19, 2025
• Est. primary completion date: March 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• Early Start Denver Model (ESDM)
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

Locations

Country	Name	City	State
France	Hôpital La Colombière - CHU de Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time of the child's viewing and movement of the head and body towards the therapist (task 1: saying "hello")	Measurement of the viewing and movement times toward the therapist, 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.	From phase A (baseline) to phase C (post-intervention) = 19 weeks
Other	Response time of the child after the presentation of the imitation exercise (task 2: action imitation)	Measurement of the child's response time during the imitation exercise	From phase A (baseline) to phase C (post-intervention) = 19 weeks
Other	Number of objects given to the robot (task 3 : give an object on verbal request)	Measurement of the number of objects given out of the 5 requested (best score 5/5) in task 3.	From phase A (baseline) to phase C (post-intervention) = 19 weeks
Other	Teleoperation success score for therapist (throught UX score)	Measurement of the success score (UX) of the teleoperation using the videos of the Pepper robot and according to the successful tasks to be performed during the session (the child and the second practitioner in the room can clearly hear the robot's instructions, the robot's gestures are fluid and is able to point to objects with the hand…). If the therapist was able to initiate each task, the score is 3/3.	Phase C (from week 5 to 15)
Other	Parent satisfaction score on current care	Measurement of satisfaction score using a numerical satisfaction scale (EN). Parents will be asked about their current satisfaction with the care after each phase of the procedure. This will be rated on a scale of 0 to 10, (0 "I am not at all satisfied with the effectiveness of the proposed care" and 10 "I am totally satisfied with the care").	During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks).
Other	Professional satisfaction score on current care.	Measurement of satisfaction score using a numerical satisfaction scale (EN). Professionals will be asked about their current satisfaction with the care after each phase of the procedure. This will be rated on a scale of 0 to 10, (0 "I am not at all satisfied with the effectiveness of the proposed care" and 10 "I am totally satisfied with the care").	During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)
Other	Score of success in the ESDM tasks without teleoperation	This score (observe/total) will be maximum if all the learning stages of the task in question have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score = 7)). This scoring will be done by therapist at the end of each intervention, after the current care.	During phase A (to 4 weeks), Phase C (from week 16 to 19
Other	Score of success in the ESDM tasks with teleoperation	This score (observe/total) will be maximum if all the learning stages of the task in question have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)).The robotics analyses will be performed by a robotic engineer of the LIRMM independent to the project.	During phase B (from week 5 to 15)
Other	Teleoperation usability score for therapist (throught UMUX score)	A User Experience Questionnaire (UMUX) was administered at weeks 5, 10 and 15 to assess the quality and ease of use of the teleoperation system over time. The questionnaires are evaluated on a scale from 0 (minimum score) to 10 (maximum score). 0=Not at all satisfied 10= Totally satisfied	During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)
Primary	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	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