Intelligent Robotic Interactions for Children With Autism Spectrum Disorders (I-ROBI)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Early Start Denver Model (ESDM)

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amaria BAGHDADLI, Pr; Phone Number: 04 67 33 96 96; Email: a-baghdadli@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Hôpital La Colombière - CHU de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Children with autism spectrum disorders

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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)
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).
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)
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
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Centre National de la Recherche Scientifique, France

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: children; robotics; telepresence; Autism spectrum disorder; interventional care
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: RECHMPL23_0056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No