Autism Spectrum DisorderNCT04879303
Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
A study testing Robot-assisted social skill intervention and Human-only instruction programme on social skill training in people with Autism Spectrum Disorder and Social Engagement, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study will develop and test a Robotic Intervention Framework for Children with ASD in the real context. The first part of this study will focus on the identification and initial testing of core elements of effective robotic intervention programs to form a practice framework. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder, Social Engagement, Robotic Intervention
- What is being tested?
- Robot-assisted social skill intervention and Human-only instruction programme on social skill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 May 2021to 30 Jun 2022
- Phase
- Interventional
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of autism spectrum disorder
- aged between 5-11
- normal intelligence
Who cannot join
- with self-injurious or aggressive behavior
- with hearing or visual impairment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Education University of Hong Kong
Hong Kong
Eva Yin-han Chung, PhD, +852 29488233, chunge@eduhk.hk
About this study
This study will develop and test a Robotic Intervention Framework for Children with ASD in the real context. The first part of this study will focus on the identification and initial testing of core elements of effective robotic intervention programs to form a practice framework. Pat II will use a randomized control trial to test the efficacy of the robotic intervention programs that incorporated all elements of the framework. Part III will use a qualitative approach to examine the qualitative outcomes of the program with reference to the elements of the practice framework. With a framework that is built upon evidence and tested sufficiently, practice guidelines and intervention protocol will be delineated to ensure success of robotic intervention programs.
- Being tested
- Robot-assisted social skill intervention, Human-only instruction programme on social skill training
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted social skill interventionBehavioural
Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.
Human-only instruction programme on social skill trainingBehavioural
The children will receive only the human-delivered training throughout the 12 sessions, with the content and sequence of activities the same as the robotic intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted social skill intervention | Experimental | Social robotics will be used by the instructor to conduct the social skill training activities. Receives: Behavioral: Robot-assisted social skill intervention |
| Human-only instruction program on social skill training | Active comparator | The children will receive only the human-delivered social skill training. Receives: Behavioral: Human-only instruction programme on social skill training |
| Control | No intervention | There will be no intervention conducted during the tested period |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Autism Diagnostic Observation Schedule
The Autism Diagnostic Observation Schedule (ADOS) is a play-based standardized protocol for observing interaction, communication, repetitive behavior and play. It has a standardized algorithm score on communication and reciprocal social interaction domains that can contribute to diagnosis and to measure change in autistic symptoms during treatment. The ADOS creates an interactive play environment in which the children's social behaviors, use of speech and gestures in social situations can be observed. It is individual-based and will take 30-45 minutes for administering.
Measured: 1 week before the intervention
The Autism Diagnostic Observation Schedule
The Autism Diagnostic Observation Schedule (ADOS) is a play-based standardized protocol for observing interaction, communication, repetitive behavior and play. It has a standardized algorithm score on communication and reciprocal social interaction domains that can contribute to diagnosis and to measure change in autistic symptoms during treatment. The ADOS creates an interactive play environment in which the children's social behaviors, use of speech and gestures in social situations can be observed. It is individual-based and will take 30-45 minutes for administering.
Measured: 1 week after the intervention
Social Responsiveness Scale
The Social Responsiveness Scale (SRS) is a questionnaire which is comprised of 65 items. It systematically collects information on parents' reports of their children's social awareness, cognition, communication, motivation and mannerisms.
Measured: 1 week before the intervention
Social Responsiveness Scale
The Social Responsiveness Scale (SRS) is a questionnaire which is comprised of 65 items. It systematically collects information on parents' reports of their children's social awareness, cognition, communication, motivation and mannerisms.
Measured: 1 week after the intervention
The Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure (COPM) is a validated tool for measuring outcomes of intervention programs on activity participation. It will collect both quantitative and qualitative data. The performance score and satisfaction score on participation of activities will be collected both before and after the intervention to reveal the change of the client throughout the intervention.
Measured: 1 week before the intervention
The Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure (COPM) is a validated tool for measuring outcomes of intervention programs on activity participation. It will collect both quantitative and qualitative data. The performance score and satisfaction score on participation of activities will be collected both before and after the intervention to reveal the change of the client throughout the intervention.
Measured: 1 week after the intervention
Short sensory profile
The Short Sensory Profile is a validated assessment tool to capture sensory processing behaviors that indicate a low or high threshold to sensory experiences resulting in interference with the performance of daily living tasks. This parent-reported measure is scored on six sensory systems and two behavioral category subscales, namely auditory processing, visual processing, taste and smell processing, body position, movement, touch processing, activity level, and social and emotional responses. Item scores can be calculated and aggregated into the seven factor scores: emotionally reactive, sensory sensitivity, low registration, sensory seeking, sensory defensiveness, oral sensory seeking, and low endurance.
Measured: 1 week before the intervention
Short sensory profile
The Short Sensory Profile is a validated assessment tool to capture sensory processing behaviors that indicate a low or high threshold to sensory experiences resulting in interference with the performance of daily living tasks. This parent-reported measure is scored on six sensory systems and two behavioral category subscales, namely auditory processing, visual processing, taste and smell processing, body position, movement, touch processing, activity level, and social and emotional responses. Item scores can be calculated and aggregated into the seven factor scores: emotionally reactive, sensory sensitivity, low registration, sensory seeking, sensory defensiveness, oral sensory seeking, and low endurance.
Measured: 1 week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start3 May 2021
- Primary completionOct 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Chung Yin-han, Education University of Hong Kong
- Investigators
- Eva Yin-han Chung, PhD, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879303
- Sponsor's protocol ID
- R1230
- Status last verified
- Aug 2021
- First submitted
- 19 Apr 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung EY, Kuen-Fung Sin K, Chow DH. Effectiveness of Robotic Intervention on Improving Social Development and Participation of Children with Autism Spectrum Disorder - A Randomised Controlled Trial. J Autism Dev Disord. 2025 Feb;55(2):449-456. doi: 10.1007/s10803-024-06236-2. Epub 2024 Jan 17.
PubMed 38231380
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
- ClinicalTrials.gov ID
- NCT04879303
- Acronym / sponsor ID
- R1230
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 May 2021 (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 will develop and test a Robotic Intervention Framework for Children with ASD in the real context. The first part of this study will focus on the identification and initial testing of core elements of effective robotic intervention programs to form a practice framework. Pat II will use a randomized control trial to test the efficacy of the robotic intervention programs that incorporated all elements of the framework. Part III will use a qualitative approach to examine the qualitative outcomes of the program with reference to the elements of the practice framework. With a framework that is built upon evidence and tested sufficiently, practice guidelines and intervention protocol will be delineated to ensure success of robotic intervention programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted social skill intervention | Experimental | Behavioral: Robot-assisted social skill interventionSocial robotics will be used by the instructor to conduct the social skill training activities. |
| Human-only instruction program on social skill training | Active comparator | Behavioral: Human-only instruction programme on social skill trainingThe children will receive only the human-delivered social skill training. |
| Control | No intervention | –There will be no intervention conducted during the tested period |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- clinical diagnosis of autism spectrum disorder
- aged between 5-11
- normal intelligence
Key exclusion criteria (2 listed)
- with self-injurious or aggressive behavior
- with hearing or visual impairment
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 social skill interventionSocial robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions. | Behavioural | Robot-assisted social skill intervention |
| Human-only instruction programme on social skill trainingThe children will receive only the human-delivered training throughout the 12 sessions, with the content and sequence of activities the same as the robotic intervention group. | Behavioural | Human-only instruction program on social skill training |
Primary outcome
The Autism Diagnostic Observation Schedule
Time frame: 1 week before the intervention
The Autism Diagnostic Observation Schedule (ADOS) is a play-based standardized protocol for observing interaction, communication, repetitive behavior and play. It has a standardized algorithm score on communication and reciprocal social interaction domains that can contribute to diagnosis and to measure change in autistic symptoms during treatment. The ADOS creates an interactive play environment in which the children's social behaviors, use of speech and gestures in social situations can be observed. It is individual-based and will take 30-45 minutes for administering.
The Autism Diagnostic Observation Schedule
Time frame: 1 week after the intervention
The Autism Diagnostic Observation Schedule (ADOS) is a play-based standardized protocol for observing interaction, communication, repetitive behavior and play. It has a standardized algorithm score on communication and reciprocal social interaction domains that can contribute to diagnosis and to measure change in autistic symptoms during treatment. The ADOS creates an interactive play environment in which the children's social behaviors, use of speech and gestures in social situations can be observed. It is individual-based and will take 30-45 minutes for administering.
Social Responsiveness Scale
Time frame: 1 week before the intervention
The Social Responsiveness Scale (SRS) is a questionnaire which is comprised of 65 items. It systematically collects information on parents' reports of their children's social awareness, cognition, communication, motivation and mannerisms.
Social Responsiveness Scale
Time frame: 1 week after the intervention
The Social Responsiveness Scale (SRS) is a questionnaire which is comprised of 65 items. It systematically collects information on parents' reports of their children's social awareness, cognition, communication, motivation and mannerisms.
The Canadian Occupational Performance Measure
Time frame: 1 week before the intervention
The Canadian Occupational Performance Measure (COPM) is a validated tool for measuring outcomes of intervention programs on activity participation. It will collect both quantitative and qualitative data. The performance score and satisfaction score on participation of activities will be collected both before and after the intervention to reveal the change of the client throughout the intervention.
The Canadian Occupational Performance Measure
Time frame: 1 week after the intervention
The Canadian Occupational Performance Measure (COPM) is a validated tool for measuring outcomes of intervention programs on activity participation. It will collect both quantitative and qualitative data. The performance score and satisfaction score on participation of activities will be collected both before and after the intervention to reveal the change of the client throughout the intervention.
Short sensory profile
Time frame: 1 week before the intervention
The Short Sensory Profile is a validated assessment tool to capture sensory processing behaviors that indicate a low or high threshold to sensory experiences resulting in interference with the performance of daily living tasks. This parent-reported measure is scored on six sensory systems and two behavioral category subscales, namely auditory processing, visual processing, taste and smell processing, body position, movement, touch processing, activity level, and social and emotional responses. Item scores can be calculated and aggregated into the seven factor scores: emotionally reactive, sensory sensitivity, low registration, sensory seeking, sensory defensiveness, oral sensory seeking, and low endurance.
Short sensory profile
Time frame: 1 week after the intervention
The Short Sensory Profile is a validated assessment tool to capture sensory processing behaviors that indicate a low or high threshold to sensory experiences resulting in interference with the performance of daily living tasks. This parent-reported measure is scored on six sensory systems and two behavioral category subscales, namely auditory processing, visual processing, taste and smell processing, body position, movement, touch processing, activity level, and social and emotional responses. Item scores can be calculated and aggregated into the seven factor scores: emotionally reactive, sensory sensitivity, low registration, sensory seeking, sensory defensiveness, oral sensory seeking, and low endurance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Derived from this study: PubMed 38231380Chung EY, Kuen-Fung Sin K, Chow DH. Effectiveness of Robotic Intervention on Improving Social Development and Participation of Children with Autism Spectrum Disorder - A Randomised Controlled Trial. J Autism Dev Disord. 2025 Feb;55(2):449-456. doi: 10.1007/s10803-024-06236-2. Epub 2024 Jan 17.
- 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.
Eva Yin-han Chung, PhD principal investigator
The Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted social skill intervention and Human-only instruction programme on social skill training in people with Autism Spectrum Disorder and Social Engagement, run by Education University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 2 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 18 Aug 2021. 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 Hong Kong. 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 Eva Yin-Han Chung, PhD (+852 29488233, chunge@eduhk.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Autism Diagnostic Observation Schedule (time frame: 1 week before the intervention). The study lists 8 primary outcomes in all. 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 NCT04879303, which also lists 1 linked publication.
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 18 Aug 2021.