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Intelligent Robotic Interactions for Children With Autism Spectrum Disorders

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05991791
Acronym
I-ROBI
Enrollment
8
Registered
2023-08-15
Start date
2023-10-19
Completion date
2025-09-19
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism spectrum disorder, children, interventional care, robotics, telepresence

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.

Interventions

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

Sponsors

Centre National de la Recherche Scientifique, France
CollaboratorOTHER
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Score of success on the selected task in the ESDM programFrom phase A (baseline) to phase C (post-intervention) = 19 weeksMeasure 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

MeasureTime frameDescription
Time of the child's viewing and movement of the head and body towards the robot (task 1: saying hello)During Phase B = 11 weeksMeasurement 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.

Other

MeasureTime frameDescription
Number of objects given to the robot (task 3 : give an object on verbal request)From phase A (baseline) to phase C (post-intervention) = 19 weeksMeasurement of the number of objects given out of the 5 requested (best score 5/5) in task 3.
Teleoperation success score for therapist (throught UX score)Phase C (from week 5 to 15)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.
Parent satisfaction score on current careDuring phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks).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).
Time of the child's viewing and movement of the head and body towards the therapist (task 1: saying hello)From phase A (baseline) to phase C (post-intervention) = 19 weeksMeasurement 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.
Score of success in the ESDM tasks without teleoperationDuring phase A (to 4 weeks), Phase C (from week 16 to 19This 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.
Score of success in the ESDM tasks with teleoperationDuring phase B (from week 5 to 15)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.
Teleoperation usability score for therapist (throught UMUX score)During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)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
Professional satisfaction score on current care.During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)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).
Response time of the child after the presentation of the imitation exercise (task 2: action imitation)From phase A (baseline) to phase C (post-intervention) = 19 weeksMeasurement of the child's response time during the imitation exercise

Countries

France

Contacts

Primary ContactAmaria BAGHDADLI, Pr
a-baghdadli@chu-montpellier.fr04 67 33 96 96

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026