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

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 Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Social Engagement; Robotic Intervention
• Intervention / Treatment: Behavioral: Robot-assisted social skill intervention; Behavioral: Human-only instruction programme on social skill training

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Yin-han Chung, PhD; Phone Number: +852 29488233; Email: chunge@eduhk.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Education University of Hong Kong
    • Contact: Eva Yin-han Chung, PhD; Phone Number: +852 29488233; Email: chunge@eduhk.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted social skill intervention; Social robotics will be used by the instructor to conduct the social skill training activities.	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.
Active Comparator: Human-only instruction program on social skill training; The children will receive only the human-delivered social skill training.	Behavioral: 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.
No Intervention: Control; There will be no intervention conducted during the tested period

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Education University of Hong Kong
• Investigators: Principal Investigator: Eva Yin-han Chung, PhD, The Education University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: R1230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No