Clinical trial NCT06144528: Comparing Imitation and Stereotyped Behaviors in Autistic Children: Robots vs. Human Operators
Official title: Exploring Imitative Abilities and Stereotypies: Comparing Robots and Human Operators in Autistic Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism
Autism Spectrum Disorder
Keywords: Autism
social robot
imitation
Stereotypies
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2023-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty children with Autism Spectrum Disorder (ASD) will participate in the study. The children with ASD will be recruited and tested at the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina. To be included in the study the child needs to have an ASD diagnosis based on the Diagnostic and Statistical Manual, fifth edition (DSM-5) criteria from a licensed clinical child neuropsychiatrist but no established intellectual disability (ID) diagnosis.

Brief summary: Virtual QT is a social robot designed to interact with humans in social and educational contexts. Equipped with visual and vocal interfaces, the robot can recognize and respond to various human inputs, providing emotional support and social interaction.

It uses facial expressions, gestures, and movements to communicate, encouraging engagement and supporting learning through playful and educational activities. Its ergonomic design and interactive approach make it suitable for both clinical and educational settings.

The aim of this study is to examine the effectiveness of the QTrobot in interventions for children with Autism Spectrum Disorder (ASD) and to assess whether children's attention and imitation are equally effective with the QTrobot compared to interacting with a human being.

Furthermore, the presence of significant differences between motor and expressive imitation, when interacting with the robot as opposed to a human interlocutor, will be investigated. A key aspect of this investigation is to assess whether the presence of the QTrobot can positively influence the repetitive or stereotyped behaviors exhibited by the children, compared to interaction with a person. Additionally, to further understanding, the children's heart rate will be monitored through the use of a sensor that will allow to evaluate how heart rate affects performance outcomes during interaction with the QTrobot and with a human being.

In this study, children will be recruited to take part in two separate sessions, both involving the same task. During the first session, the task will be carried out between the child and the human operator. Subsequently, in the same task, the child will interact with the QT robot. Throughout both task administrations, the child will wear a sensor to detect their heart rate. Furthermore, all task sessions will be video-recorded to conduct subsequent video analysis and make notes on imitation behaviors and stereotypical actions relevant to the study.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autism
* QI ≥ 75

Exclusion Criteria:

* Motor deficits due to another clinical condition

Primary outcomes:
measure: Video analysis of performance
timeFrame: The video analysis needs approximately 15 minutes per child
Secondary outcomes:
measure: Heart rate
timeFrame: The test needs approximately 30 minutes
measure: Heart rate variability
timeFrame: The test needs approximately 30 minutes
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa AP, Charpiot L, Lera FR, Ziafati P, Nazarikhorram A, van der Torre L, Steffgen GA (2018) Comparison between a person and a robot in the attention, imitation, and repetitive and stereotypical behaviors of children with Autism Spectrum Disorder. In: Proceedings workshop on Social human-robot interaction of human-care service robots at HRI2018
citation: Zheng Z, Young EM, Swanson AR, Weitlauf AS, Warren ZE, Sarkar N. Robot-Mediated Imitation Skill Training for Children With Autism. IEEE Trans Neural Syst Rehabil Eng. 2016 Jun;24(6):682-91. doi: 10.1109/TNSRE.2015.2475724. Epub 2015 Sep 3.
citation: Zorcec T, Ilijoski B, Simlesa S, Ackovska N, Rosandic M, Popcevic K, Robins B, Nitzan N, Cappel D, Blum R. Enriching Human-Robot Interaction with Mobile App in Interventions of Children with Autism Spectrum Disorder. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2021 Oct 26;42(2):51-59. doi: 10.2478/prilozi-2021-0021.