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

Primary Purpose

Autism Spectrum Disorder, Social Engagement, Robotic Intervention

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Robot-assisted social skill intervention
Human-only instruction programme on social skill training
Sponsored by
Education University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Education University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Robot-assisted social skill intervention

Human-only instruction program on social skill training

Control

Arm Description

Social robotics will be used by the instructor to conduct the social skill training activities.

The children will receive only the human-delivered social skill training.

There will be no intervention conducted during the tested period

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2021
Last Updated
August 16, 2021
Sponsor
Education University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04879303
Brief Title
Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
Official Title
Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Education University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Social Engagement, Robotic Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted social skill intervention
Arm Type
Experimental
Arm Description
Social robotics will be used by the instructor to conduct the social skill training activities.
Arm Title
Human-only instruction program on social skill training
Arm Type
Active Comparator
Arm Description
The children will receive only the human-delivered social skill training.
Arm Title
Control
Arm Type
No Intervention
Arm Description
There will be no intervention conducted during the tested period
Intervention Type
Behavioral
Intervention Name(s)
Robot-assisted social skill intervention
Intervention Description
Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.
Intervention Type
Behavioral
Intervention Name(s)
Human-only instruction programme on social skill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Autism Diagnostic Observation Schedule
Description
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.
Time Frame
1 week before the intervention
Title
The Autism Diagnostic Observation Schedule
Description
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.
Time Frame
1 week after the intervention
Title
Social Responsiveness Scale
Description
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.
Time Frame
1 week before the intervention
Title
Social Responsiveness Scale
Description
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.
Time Frame
1 week after the intervention
Title
The Canadian Occupational Performance Measure
Description
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.
Time Frame
1 week before the intervention
Title
The Canadian Occupational Performance Measure
Description
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.
Time Frame
1 week after the intervention
Title
Short sensory profile
Description
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.
Time Frame
1 week before the intervention
Title
Short sensory profile
Description
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.
Time Frame
1 week after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Yin-Han Chung, PhD
Phone
+852 29488233
Email
chunge@eduhk.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Yin-han Chung, PhD
Organizational Affiliation
The Education University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Education University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Yin-han Chung, PhD
Phone
+852 29488233
Email
chunge@eduhk.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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

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