AutismNCT06144528
Comparing Imitation and Stereotyped Behaviors in Autistic Children: Robots vs. Human Operators
An observational study of Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- QT robot
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Diagnosis of Autism
- QI ≥ 75
Who cannot join
- Motor deficits due to another clinical condition
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
About this study
Official title: 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.
Read more
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.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- QT robot
- Keywords
- Autism, social robot, imitation, Stereotypies
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Stereotypic Movement Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QT robotOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: QT robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video analysis of performance
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.
Measured: The video analysis needs approximately 15 minutes per child
Secondary outcomes (2)
Heart rate
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.
Measured: The test needs approximately 30 minutes
Heart rate variability
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.
Measured: The test needs approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Messina, Italy
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144528
- Sponsor's protocol ID
- CNR-IRIB-PRO-2023-005
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26353376Zorcec 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.
PubMed 34699714
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Imitative Abilities and Stereotypies: Comparing Robots and Human Operators in Autistic Children
- ClinicalTrials.gov ID
- NCT06144528
- Acronym / sponsor ID
- CNR-IRIB-PRO-2023-005
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- Autism, social robot, imitation, Stereotypies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with autism spectrum condition | – | Other: QT robotThirty 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. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of Autism
- QI ≥ 75
Key exclusion criteria (1 listed)
- Motor deficits due to another clinical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QT robotIn 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. | Other | Children with autism spectrum condition |
Primary outcome
Video analysis of performance
Time frame: The video analysis needs approximately 15 minutes per child
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.
2 secondary outcomes
Heart rate
Time frame: The test needs approximately 30 minutes
Heart rate variability
Time frame: The test needs approximately 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- BackgroundCosta 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
- Background: PubMed 26353376Zheng 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.
- Background: PubMed 34699714Zorcec 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavia Marino principal investigator
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiara Failla (+393921985644, chiara.failla@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video analysis of performance (time frame: The video analysis needs approximately 15 minutes per child). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144528, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.