Intelligent Robotic Interactions for Children With Autism Spectrum Disorders

NCT05991791 | Unknown

• 1 other identifier: RECHMPL23_0056
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (9)

• 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 weeks

• 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 weeks

• 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 weeks

Study Arms (1)

Children with autism spectrum disorders

OTHER

Other: Early Start Denver Model (ESDM)

Interventions

Early Start Denver Model (ESDM) OTHER

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

Children with autism spectrum disorders

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Hôpital La Colombière - CHU de Montpellier

Montpellier, France

RECRUITING

Related Publications (1)

• Fournier C, Michelon C, Granit V, Audoyer P, Bernardot A, Picot MC, Kheddar A, Baghdadli A. Pilot study protocol evaluating the impact of telerobotics interactions with autistic children during a Denver intervention on communication skills using single-case experimental design. BMJ Open. 2024 Nov 12;14(11):e084110. doi: 10.1136/bmjopen-2024-084110.

  PMID: 39532363 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Amaria BAGHDADLI, Pr

CONTACT

04 67 33 96 96; a-baghdadli@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 15, 2023
• Study Start: October 19, 2023
• Primary Completion: March 19, 2025
• Study Completion: September 19, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

FR (1)