Autism Spectrum DisorderNCT06757673
Effectiveness of Robot-Assisted Intervention and Sensory Integration Therapy in Enhancing Social-Emotional Skills in Children With Autism
A study testing Robot-Assisted Therapy using Kebbi Air and Sensory Integration Therapy in people with Autism Spectrum Disorder and Emotional Regulation, run by National Taiwan University Hospital.
Trial summary
This study is designed to evaluate and compare the impact of robot-assisted intervention using a smart robot (Kebbi Air) and traditional sensory integration therapy on improving social-emotional skills in children diagnosed with autism spectrum disorder (ASD) or suspected ASD. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Emotional Regulation, Sensory Integration Dysfunction
- What is being tested?
- Robot-Assisted Therapy using Kebbi Air and Sensory Integration Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-6 years, regardless of gender.
- Diagnosed with autism spectrum disorder (ASD) or suspected ASD.
- Cognitive ability: Developmental Quotient (DQ) ≥ 70, as assessed by the Comprehensive 4. Developmental Inventory for Infants and Toddlers (CDIIT).Social-emotional ability: DQ < 85, as assessed by CDIIT, indicating challenges in emotional regulation and social skills.
- 5. No significant physical or psychological conditions that could interfere with participation in the intervention.
Who cannot join
- Children younger than 4 years or older than 6 years.
- Cognitive ability: DQ < 70, as assessed by CDIIT, indicating limited learning potential.
- Social-emotional ability: DQ ≥ 85, as assessed by CDIIT, indicating normal emotional and social functioning.
- Any physical or psychological condition deemed by the investigators to interfere with the intervention or assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Robot-assisted Interaction Compared to Sensory Integration for Social Emotion Control in Autism Spectrum Disorder
This study is designed to evaluate and compare the impact of robot-assisted intervention using a smart robot (Kebbi Air) and traditional sensory integration therapy on improving social-emotional skills in children diagnosed with autism spectrum disorder (ASD) or suspected ASD. The study will enroll children aged 4 to 6 years, who will be randomly assigned to one of two groups: the experimental group, which will participate in guided interactions with the smart robot, or the control group, which will receive sensory integration therapy tailored to enhance emotional and social functioning.
The research aims to explore whether interactions with the robot, which are designed to simulate real-world social scenarios, can provide comparable or enhanced benefits compared to traditional sensory integration methods. Pre- and post-intervention assessments will be conducted over a 12-week period, using tools like the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) to measure changes in emotional regulation, sensory processing abilities, and social engagement. The study hypothesizes that the robot-assisted intervention will offer a novel, engaging, and effective approach to supporting the developmental needs of children with ASD.
Read the detailed description
This study aims to evaluate the effectiveness of robot-assisted intervention compared to traditional sensory integration therapy in improving social-emotional regulation skills in children aged 4-6 years diagnosed with autism spectrum disorder (ASD) or suspected ASD. The research is designed as a randomized controlled trial with 12 participants divided into two groups: the experimental group and the control group.
Participants in the experimental group will interact with a smart robot (Kebbi Air) equipped with interactive scripts tailored to simulate real-life social scenarios. These interactions aim to teach emotional regulation and social skills through structured, engaging activities. The control group will receive sensory integration therapy provided by occupational therapists, focusing on enhancing sensory processing and emotional stability through activities targeting visual, auditory, and tactile stimuli.
The intervention will be conducted over a period of 12 weeks, with participants attending weekly 30-minute sessions. Assessments will be conducted before and after the intervention to measure its impact. Tools such as the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) will be used to evaluate changes in emotional regulation, sensory processing, and social skills.
This study hypothesizes that the robot-assisted intervention will be as effective as or even superior to traditional sensory integration therapy, offering an engaging alternative for children with ASD. By combining cutting-edge technology with therapeutic strategies, the research seeks to provide insights into innovative approaches for supporting children's development, with the potential to inform future practices and interventions.
- Being tested
- Robot-Assisted Therapy using Kebbi Air, Sensory Integration Therapy
- Keywords
- Autism Spectrum Disorder, Sensory Integration, Robot-Assisted Therapy, Social-Emotional Skills, Early Intervention, Occupational Therapy
- Medical subject headings
- Autism Spectrum Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Therapy using Kebbi AirDevice
Participants in this group will engage with the Kebbi Air smart robot, which is programmed with interactive scripts designed to enhance social-emotional regulation skills. The intervention includes weekly 30-minute sessions over a 12-week period, where the robot simulates real-life social scenarios and provides verbal and visual responses to guide participants in developing emotional and social skills. Occupational therapists will supervise these sessions to ensure the appropriateness of interactions and provide additional support as needed.
Sensory Integration TherapyBehavioural
Participants in this group will receive traditional sensory integration therapy guided by occupational therapists. The therapy focuses on improving sensory processing and emotional regulation through structured activities targeting visual, auditory, and tactile stimuli. Each session is conducted weekly, lasting 30 minutes, for a total of 12 weeks. The therapy aims to help children adapt to sensory inputs and enhance their ability to engage in social interactions and manage emotions effectively.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Intervention | Experimental | Participants in this group will engage with the Kebbi Air smart robot, which delivers scripted social-emotional skill-building activities over a 12-week period. Receives: Device: Robot-Assisted Therapy using Kebbi Air |
| Sensory Integration Therapy | Active comparator | Participants in this group will receive traditional sensory integration therapy, guided by occupational therapists, focusing on improving sensory processing and social-emotional regulation. Receives: Behavioral: Sensory Integration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social-Emotional Regulation Skills
Changes in emotional regulation, including anxiety, withdrawal, and aggression, were assessed using the Achenbach System of Empirically Based Assessment (ASEBA), specifically the Child Behavior Checklist for Ages 1½-5 (CBCL/1½-5). This caregiver-reported tool evaluates behavioral and emotional functioning in children aged 1.5 to 5 years. It assesses seven syndrome scales, including Emotional Reactivity, Anxiety/Depression, Somatic Complaints, Withdrawal, Attention Problems, Aggressive Behavior, and Sleep Problems. DSM-oriented scales identify issues such as affective, anxiety, and attention-deficit/hyperactivity problems. Items are rated on a 3-point Likert scale (0 = Not True, 1 = Somewhat True, 2 = Very True), with higher scores indicating greater severity. This tool tracks changes in emotional regulation over time.
Measured: Baseline (pre-intervention) and after 12 weeks (post-intervention).
Sensory Processing Abilities
Sensory processing challenges and their impact on social participation were evaluated using the Sensory Processing Measure (SPM), a standardized tool for children aged 5 to 12 years. The SPM identifies sensory difficulties across domains: Social Participation, Vision, Hearing, Touch, Body Awareness (Proprioception), Balance and Motion (Vestibular), and Planning and Ideas (Praxis). Items are rated on a 4-point Likert scale (1 = Never, 4 = Always). Scores are categorized as Typical, Some Problems, or Definite Dysfunction, with higher scores indicating greater challenges. The SPM provides insights into how sensory processing affects a child's behavior and participation across various environments.
Measured: Baseline (pre-intervention) and after 12 weeks (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start7 Jan 2025 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Yunlin University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757673
- Sponsor's protocol ID
- 202410030RINE
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet decided whether to share Individual Participant Data (IPD). The primary reasons include the need to consider privacy protection regulations, institutional policies, and the sensitive nature of the collected data. Additionally, the investigators need to ensure that data sharing can be conducted in compliance with ethical guidelines. The research team plans to evaluate the feasibility of data sharing after the study is completed, taking into account practical considerations and recommendations from regulatory authorities or ethics committees.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Robot-assisted Interaction Compared to Sensory Integration for Social Emotion Control in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06757673
- Acronym / sponsor ID
- 202410030RINE
- Keywords
- Autism Spectrum Disorder, Sensory Integration, Robot-Assisted Therapy, Social-Emotional Skills, Early Intervention, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Yunlin University of Science and Technology
- Study start
- 7 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 3 Jan 2025 (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.
This study is designed to evaluate and compare the impact of robot-assisted intervention using a smart robot (Kebbi Air) and traditional sensory integration therapy on improving social-emotional skills in children diagnosed with autism spectrum disorder (ASD) or suspected ASD. The study will enroll children aged 4 to 6 years, who will be randomly assigned to one of two groups: the experimental group, which will participate in guided interactions with the smart robot, or the control group, which will receive sensory integration therapy tailored to enhance emotional and social functioning.
The research aims to explore whether interactions with the robot, which are designed to simulate real-world social scenarios, can provide comparable or enhanced benefits compared to traditional sensory integration methods. Pre- and post-intervention assessments will be conducted over a 12-week period, using tools like the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) to measure changes in emotional regulation, sensory processing abilities, and social engagement. The study hypothesizes that the robot-assisted intervention will offer a novel, engaging, and effective approach to supporting the developmental needs of children with ASD.
Detailed description
This study aims to evaluate the effectiveness of robot-assisted intervention compared to traditional sensory integration therapy in improving social-emotional regulation skills in children aged 4-6 years diagnosed with autism spectrum disorder (ASD) or suspected ASD. The research is designed as a randomized controlled trial with 12 participants divided into two groups: the experimental group and the control group.
Participants in the experimental group will interact with a smart robot (Kebbi Air) equipped with interactive scripts tailored to simulate real-life social scenarios. These interactions aim to teach emotional regulation and social skills through structured, engaging activities. The control group will receive sensory integration therapy provided by occupational therapists, focusing on enhancing sensory processing and emotional stability through activities targeting visual, auditory, and tactile stimuli.
The intervention will be conducted over a period of 12 weeks, with participants attending weekly 30-minute sessions. Assessments will be conducted before and after the intervention to measure its impact. Tools such as the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) will be used to evaluate changes in emotional regulation, sensory processing, and social skills.
This study hypothesizes that the robot-assisted intervention will be as effective as or even superior to traditional sensory integration therapy, offering an engaging alternative for children with ASD. By combining cutting-edge technology with therapeutic strategies, the research seeks to provide insights into innovative approaches for supporting children's development, with the potential to inform future practices and interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Intervention | Experimental | Device: Robot-Assisted Therapy using Kebbi AirParticipants in this group will engage with the Kebbi Air smart robot, which delivers scripted social-emotional skill-building activities over a 12-week period. |
| Sensory Integration Therapy | Active comparator | Behavioral: Sensory Integration TherapyParticipants in this group will receive traditional sensory integration therapy, guided by occupational therapists, focusing on improving sensory processing and social-emotional regulation. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4-6 years, regardless of gender.
- Diagnosed with autism spectrum disorder (ASD) or suspected ASD.
- Cognitive ability: Developmental Quotient (DQ) ≥ 70, as assessed by the Comprehensive 4. Developmental Inventory for Infants and Toddlers (CDIIT).Social-emotional ability: DQ < 85, as assessed by CDIIT, indicating challenges in emotional regulation and social skills.
- 5. No significant physical or psychological conditions that could interfere with participation in the intervention.
Key exclusion criteria (4 listed)
- Children younger than 4 years or older than 6 years.
- Cognitive ability: DQ < 70, as assessed by CDIIT, indicating limited learning potential.
- Social-emotional ability: DQ ≥ 85, as assessed by CDIIT, indicating normal emotional and social functioning.
- Any physical or psychological condition deemed by the investigators to interfere with the intervention or assessments.
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 |
|---|---|---|
| Robot-Assisted Therapy using Kebbi AirParticipants in this group will engage with the Kebbi Air smart robot, which is programmed with interactive scripts designed to enhance social-emotional regulation skills. The intervention includes weekly 30-minute sessions over a 12-week period, where the robot simulates real-life social scenarios and provides verbal and visual responses to guide participants in developing emotional and social skills. Occupational therapists will supervise these sessions to ensure the appropriateness of interactions and provide additional support as needed. | Device | Robot-Assisted Intervention |
| Sensory Integration TherapyParticipants in this group will receive traditional sensory integration therapy guided by occupational therapists. The therapy focuses on improving sensory processing and emotional regulation through structured activities targeting visual, auditory, and tactile stimuli. Each session is conducted weekly, lasting 30 minutes, for a total of 12 weeks. The therapy aims to help children adapt to sensory inputs and enhance their ability to engage in social interactions and manage emotions effectively. | Behavioural | Sensory Integration Therapy |
Primary outcome
Social-Emotional Regulation Skills
Time frame: Baseline (pre-intervention) and after 12 weeks (post-intervention).
Changes in emotional regulation, including anxiety, withdrawal, and aggression, were assessed using the Achenbach System of Empirically Based Assessment (ASEBA), specifically the Child Behavior Checklist for Ages 1½-5 (CBCL/1½-5). This caregiver-reported tool evaluates behavioral and emotional functioning in children aged 1.5 to 5 years. It assesses seven syndrome scales, including Emotional Reactivity, Anxiety/Depression, Somatic Complaints, Withdrawal, Attention Problems, Aggressive Behavior, and Sleep Problems. DSM-oriented scales identify issues such as affective, anxiety, and attention-deficit/hyperactivity problems. Items are rated on a 3-point Likert scale (0 = Not True, 1 = Somewhat True, 2 = Very True), with higher scores indicating greater severity. This tool tracks changes in emotional regulation over time.
Sensory Processing Abilities
Time frame: Baseline (pre-intervention) and after 12 weeks (post-intervention).
Sensory processing challenges and their impact on social participation were evaluated using the Sensory Processing Measure (SPM), a standardized tool for children aged 5 to 12 years. The SPM identifies sensory difficulties across domains: Social Participation, Vision, Hearing, Touch, Body Awareness (Proprioception), Balance and Motion (Vestibular), and Planning and Ideas (Praxis). Items are rated on a 4-point Likert scale (1 = Never, 4 = Always). Scores are categorized as Typical, Some Problems, or Definite Dysfunction, with higher scores indicating greater challenges. The SPM provides insights into how sensory processing affects a child's behavior and participation across various environments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Undecided. The investigators have not yet decided whether to share Individual Participant Data (IPD). The primary reasons include the need to consider privacy protection regulations, institutional policies, and the sensitive nature of the collected data. Additionally, the investigators need to ensure that data sharing can be conducted in compliance with ethical guidelines. The research team plans to evaluate the feasibility of data sharing after the study is completed, taking into account practical considerations and recommendations from regulatory authorities or ethics committees.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Therapy using Kebbi Air and Sensory Integration Therapy in people with Autism Spectrum Disorder and Emotional Regulation, run by National Taiwan University Hospital.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LIAO SHUYI, O.T.R (+886963180066, Y01843@ms1.ylh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social-Emotional Regulation Skills (time frame: Baseline (pre-intervention) and after 12 weeks (post-intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.