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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879303
• Other study ID #: R1230
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2021
• Source: Education University of Hong Kong
• Contact: Eva Yin-Han Chung, PhD
• Phone: +852 29488233
• Email: chunge[@]eduhk.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Robot-assisted social skill intervention
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 training
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.

Locations

Country	Name	City	State
Hong Kong	The Education University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Education University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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