NCT06144528

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Keywords

Autismsocial robotimitationStereotypies

Outcome Measures

Primary Outcomes (1)

  • 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.

    The video analysis needs approximately 15 minutes per child

Secondary Outcomes (2)

  • Heart rate

    The test needs approximately 30 minutes

  • Heart rate variability

    The test needs approximately 30 minutes

Study Arms (1)

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.

Other: QT robot

Interventions

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.

Children with autism spectrum condition

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Diagnosis of Autism
  • QI ≥ 75

You may not qualify if:

  • Motor deficits due to another clinical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, 98164, Italy

Location

Related Publications (3)

  • 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

    BACKGROUND
  • 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.

    PMID: 26353376BACKGROUND
  • 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.

    PMID: 34699714BACKGROUND

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderStereotypic Movement Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Flavia Marino

    Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Unit

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

December 1, 2023

Primary Completion

February 28, 2024

Study Completion

April 30, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations