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

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early Start Denver Model (ESDM)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring Autism spectrum disorder, children, interventional care, robotics, telepresence

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital La Colombière - CHU de Montpellier

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Children with autism spectrum disorders

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 28, 2023
Last Updated
August 7, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, France
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1. Study Identification

Unique Protocol Identification Number
NCT05991791
Brief Title
Intelligent Robotic Interactions for Children With Autism Spectrum Disorders
Acronym
I-ROBI
Official Title
Adapted and Individualized Intelligent Robotic Interactions to the Ability Spectrum of Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
August 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism spectrum disorder, children, interventional care, robotics, telepresence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children with autism spectrum disorders
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Early Start Denver Model (ESDM)
Intervention Description
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
Primary Outcome Measure Information:
Title
Score of success on the selected task in the ESDM program
Description
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.
Time Frame
From phase A (baseline) to phase C (post-intervention) = 19 weeks
Secondary Outcome Measure Information:
Title
Time of the child's viewing and movement of the head and body towards the robot (task 1: saying "hello")
Description
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.
Time Frame
During Phase B = 11 weeks
Other Pre-specified Outcome Measures:
Title
Time of the child's viewing and movement of the head and body towards the therapist (task 1: saying "hello")
Description
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.
Time Frame
From phase A (baseline) to phase C (post-intervention) = 19 weeks
Title
Response time of the child after the presentation of the imitation exercise (task 2: action imitation)
Description
Measurement of the child's response time during the imitation exercise
Time Frame
From phase A (baseline) to phase C (post-intervention) = 19 weeks
Title
Number of objects given to the robot (task 3 : give an object on verbal request)
Description
Measurement of the number of objects given out of the 5 requested (best score 5/5) in task 3.
Time Frame
From phase A (baseline) to phase C (post-intervention) = 19 weeks
Title
Teleoperation success score for therapist (throught UX score)
Description
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.
Time Frame
Phase C (from week 5 to 15)
Title
Parent satisfaction score on current care
Description
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 Frame
During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks).
Title
Professional satisfaction score on current care.
Description
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").
Time Frame
During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)
Title
Score of success in the ESDM tasks without teleoperation
Description
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.
Time Frame
During phase A (to 4 weeks), Phase C (from week 16 to 19
Title
Score of success in the ESDM tasks with teleoperation
Description
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.
Time Frame
During phase B (from week 5 to 15)
Title
Teleoperation usability score for therapist (throught UMUX score)
Description
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
Time Frame
During phase A (to 4 weeks), Phase B (to 15 weeks), Phase C (to 19 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amaria BAGHDADLI, Pr
Phone
04 67 33 96 96
Email
a-baghdadli@chu-montpellier.fr
Facility Information:
Facility Name
Hôpital La Colombière - CHU de Montpellier
City
Montpellier
Country
France

12. IPD Sharing Statement

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Intelligent Robotic Interactions for Children With Autism Spectrum Disorders

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