Intelligent Robotic Interactions for Children With Autism Spectrum Disorders

NCT ID: NCT05991791

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2025-09-19

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Children with autism spectrum disorders

Group Type: OTHER

Early Start Denver Model (ESDM)

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital La Colombière - CHU de Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amaria BAGHDADLI, Pr

Role: CONTACT

a-baghdadli@chu-montpellier.fr

04 67 33 96 96

Facility Contacts

Amaria BAGHDADLI, Pr

Role: primary

a-baghdadli@chu-montpellier.fr

References

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.

Reference Type: DERIVED

PMID: 39532363 (View on PubMed)

Other Identifiers

RECHMPL23_0056

Identifier Type: -

Identifier Source: org_study_id