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

2021년 8월 16일 업데이트: Eva Chung Yin-han, Education University of Hong Kong
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.

연구 개요

연구 유형

중재적

등록 (예상)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Eva Yin-han Chung, PhD
  • 전화번호: +852 29488233
  • 이메일: chunge@eduhk.hk

연구 장소

      • Hong Kong, 홍콩
        • 모병
        • The Education University of Hong Kong
        • 연락하다:
          • Eva Yin-han Chung, PhD
          • 전화번호: +852 29488233
          • 이메일: chunge@eduhk.hk

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

5년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Robot-assisted social skill intervention
Social robotics will be used by the instructor to conduct the social skill training activities.
Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.
활성 비교기: Human-only instruction program on social skill training
The children will receive only the human-delivered 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.
간섭 없음: Control
There will be no intervention conducted during the tested period

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The Autism Diagnostic Observation Schedule
기간: 1 week before the intervention
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
기간: 1 week after the intervention
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
기간: 1 week before the intervention
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
기간: 1 week after the intervention
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
기간: 1 week before the intervention
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
기간: 1 week after the intervention
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
기간: 1 week before the intervention
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
기간: 1 week after the intervention
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Eva Yin-han Chung, PhD, The Education University of Hong Kong

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 5월 3일

기본 완료 (예상)

2021년 10월 1일

연구 완료 (예상)

2022년 6월 30일

연구 등록 날짜

최초 제출

2021년 4월 19일

QC 기준을 충족하는 최초 제출

2021년 5월 7일

처음 게시됨 (실제)

2021년 5월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 8월 16일

마지막으로 확인됨

2021년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

자폐 스펙트럼 장애에 대한 임상 시험

3
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