- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144528
Comparing Imitation and Stereotyped Behaviors in Autistic Children: Robots vs. Human Operators
Exploring Imitative Abilities and Stereotypies: Comparing Robots and Human Operators in Autistic Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Giovanni Pioggia
- Phone Number: +393203390892
- Email: giovanni.pioggia@irib.cnr.it
Study Contact Backup
- Name: chiara failla
- Phone Number: +393921985644
- Email: chiara.failla@irib.cnr.it
Study Locations
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Messina, Italy, 98164
- Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of Autism
- QI ≥ 75
Exclusion Criteria:
- Motor deficits due to another clinical condition
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Children with autism spectrum condition
Thirty Autism Spectrum Disorder (ASD) children with medium-high functioning, aged 4 to 13 years, IQ > 75, in the absence of motor deficits due to another clinical condition.
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In a single session each child will be video-recorded while performing the task.
The participant subjects will perform the same task at two different times, once with the human operator and once with the Qt robot.
Both tasks will have a duration of approximately 4 minutes.
During the first minute, both the operator and the Qt will introduce themselves and ask four questions to the child to deepen the acquaintance.
In the second minute, the operator/Qt will tell a story.
In the third minute, the operator/Qt will ask to imitate 4 motor movements, while in the fourth minute, the operator/Qt will ask to imitate 4 facial expressions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Video analysis of performance
Time Frame: The video analysis needs approximately 15 minutes per child
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The videos of the interviews were analyzed by a single observer.
For each child, the observer evaluated both the child's interactions, one with a person and another with the robot.
The assessment included the child's attention, measured by the frequency and duration of the child's gazes towards the interaction partner.
Additionally, the observer recorded the number of imitations of the partner's actions, limited to a maximum of four imitations.
Finally, to evaluate repetitive and stereotyped behaviors, the observer counted the sequences of these behaviors and the number of repetitions within each sequence.
A sequence was defined as a continuous repetition of the same behavior type, with pauses or interruptions considered as separate sequences.
If the child paused and resumed the same or a different behavior, each restart was counted as a new sequence.
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The video analysis needs approximately 15 minutes per child
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heart rate
Time Frame: The test needs approximately 30 minutes
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The polar sensor detects the electrical activity of the heart and calculates heart rate in beats per minute (bpm).Typically it is worn on the wrist or chest.
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The test needs approximately 30 minutes
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Heart rate variability
Time Frame: The test needs approximately 30 minutes
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The Polar sensor measures the time intervals between successive heart beats and calculates Heart Rate Variability (HRV) in milliseconds (ms).
Typically it is worn on the wrist or chest.
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The test needs approximately 30 minutes
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Flavia Marino, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Publications and helpful links
General Publications
- 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
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNR-IRIB-PRO-2023-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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