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

NCT04879303 | Unknown

• 1 other identifier: R1230
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Social Engagement; Robotic Intervention

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

Robot-assisted social skill intervention

EXPERIMENTAL

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

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.

Behavioral: Human-only instruction programme on social skill training

Control

NO INTERVENTION

There will be no intervention conducted during the tested period

Interventions

Robot-assisted social skill intervention BEHAVIORAL

Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.

Robot-assisted social skill intervention

Human-only instruction programme on social skill training BEHAVIORAL

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.

Human-only instruction program on social skill training

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• clinical diagnosis of autism spectrum disorder
• aged between 5-11
• normal intelligence

You may not qualify if:

• with self-injurious or aggressive behavior
• with hearing or visual impairment

Sponsors & Collaborators

• Education University of Hong Kong: lead

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 38231380 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Eva Yin-han Chung, PhD

  The Education University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Yin-Han Chung, PhD

CONTACT

+852 29488233; chunge@eduhk.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 10, 2021
• Study Start: May 3, 2021
• Primary Completion: October 1, 2021
• Study Completion: June 30, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)