Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation

Study Overview
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Brief Summary
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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.

Official Title
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Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation

Conditions
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Autism Spectrum Disorder, Social Engagement, Robotic Intervention

Intervention / Treatment
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* Behavioral: Robot-assisted social skill intervention
* Behavioral: Human-only instruction programme on social skill training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of autism spectrum disorder aged between 5-11 normal intelligence Exclusion Criteria: with self-injurious or aggressive behavior with hearing or visual impairment

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted social skill intervention<br>Social robotics will be used by the instructor to conduct the social skill training activities. | Behavioral: Robot-assisted social skill intervention<br>* Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.<br>|
| Active Comparator: Human-only instruction program on social skill training<br>The children will receive only the human-delivered social skill training. | Behavioral: Human-only instruction programme on social skill training<br>* 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.<br>|
| No Intervention: Control<br>There will be no intervention conducted during the tested period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 week after the intervention |