ChiCTR2300073238 版本V1.1 版本创建时间2023/08/31 17:27:41 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300073238 

最近更新日期：

Date of Last Refreshed on：

 2023-07-05 09:08:38 

注册时间：

Date of Registration：

 2023-07-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Autonomous social robots detect and intervene autism

Public title：

Autonomous social robots detect and intervene autism

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Autonomous social robot improves eye contact of autistic children

Scientific title：

Autonomous social robot improves eye contact of autistic children

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Wing-Chee So 

研究负责人：

Wing-Chee So 

Applicant：

Wing-Chee So 

Study leader：

Wing-Chee So 

申请注册联系人电话：

Applicant telephone：

 +86 166 7563 9002

研究负责人电话：

Study leader's
telephone：

+86 166 7563 9002

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 wingchee@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 wingchee@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Room 212, Ho Tim Building, Faculty of Education, Chinese University of Hong Kong

研究负责人通讯地址：

Room 212, Ho Tim Building, Faculty of Education, Chinese University of Hong Kong

Applicant address：

Room 212, Ho Tim Building, Faculty of Education, Chinese University of Hong Kong

Study leader's address：

Room 212, Ho Tim Building, Faculty of Education, Chinese University of Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 SBRE-22-0306

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Survey and Behavioral Research Ethics Committee

Name of the ethic committee：

Survey and Behavioral Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-06 00:00:00

伦理委员会联系人：

Eva Yeung

Contact Name of the ethic committee：

Eva Yeung

伦理委员会联系地址：

Faculty Office of Social Science, Chinese University of Hong Kong

Contact Address of the ethic committee：

Faculty Office of Social Science, Chinese University of Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 166 7563 9002

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 fssc02@cuhk.edu.hk

研究实施负责（组长）单位：

Department of Educational Psychology, The Chinese University of Hong Kong

Primary sponsor：

Department of Educational Psychology, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Room 212, Ho Tim Building, Faculty of Education, The Chinese University of Hong Kong

Primary sponsor's address：

Room 212, Ho Tim Building, Faculty of Education, The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Department of Educational Psychology, The Chinese University of Hong Kong

具体地址：

Room 212, Ho Tim Building, Faculty of Education, The Chinese University of Hong Kong

Institution
hospital：

Department of Educational Psychology, The Chinese University of Hong Kong

Address：

Room 212, Ho Tim Building, Faculty of Education, The Chinese University of Hong Kong

经费或物资来源：

RGC General Research Fund

Source(s) of funding：

RGC General Research Fund

研究疾病：

Autism Spectrum Disorder  

Target disease：

Autism Spectrum Disorder

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

This study aims to examine whether the robot-based intervention (RBI) is effective in promoting eye contact in autistic children, in comparison to the human-based intervention (HBI). There are four hypotheses. H1: Autistic children in the HBI will have fewer eye contact with the agent and less attentive duration than those in the RBI over the four-month intervention. H2: Autistic children in the HBI will be prompted more often by the agent and will be less likely to respond to the prompts than those in the RBI. H3: Autistic children in the RBI will have more eye contact with adults (their parents and human experimenter) than those in the HBI at the end of intervention. Such learning outcome will be maintained one month after the intervention. RBI is more effective for autistic children with more severe autism severity and intellectual disabilities than those with less severe autism severity and intellectual disabilities.  

Objectives of Study：

This study aims to examine whether the robot-based intervention (RBI) is effective in promoting eye contact in autistic children, in comparison to the human-based intervention (HBI). There are four hypotheses. H1: Autistic children in the HBI will have fewer eye contact with the agent and less attentive duration than those in the RBI over the four-month intervention. H2: Autistic children in the HBI will be prompted more often by the agent and will be less likely to respond to the prompts than those in the RBI. H3: Autistic children in the RBI will have more eye contact with adults (their parents and human experimenter) than those in the HBI at the end of intervention. Such learning outcome will be maintained one month after the intervention. RBI is more effective for autistic children with more severe autism severity and intellectual disabilities than those with less severe autism severity and intellectual disabilities.

药物成份或治疗方案详述：

Children in the RBI and HBI conditions proceed to eye gaze training. There are two training sessions each week (altogether 32 sessions). The training protocol in the RBI is based on the procedures established in the pilot study. Each time, a child listens to the five stories narrated by the autonomous robot Humane, who also detects the child’s eye gaze at the same time. Humane is also programed to autonomously prompt the child if he/she is not looking at it for 5 seconds for the first 8 weeks of training and 3 seconds for the last 8 weeks of training. Such reduction in off-focus duration increases the level of difficulty in establishing eye contact with Humane. If the child’s eye gaze is back to Humane in 1 second after the prompt, he/she will get praised by Humane. In order to promote the exchange between the robot and the child, Humane will ask the child some questions in between the narrations of two stories, but the response of the child is not mandatory (since some children may be minimally verbal). If the child, however, does not respond to Humane’s prompt for 5 minutes, the training session will suspend. The training protocol in the HBI condition is identical to that in the RBI except that Humane is replaced with a human experimenter, who is not involved in the pretests and posttests. This experimenter will receive training on narrating stories and counting the duration of eye gaze. Both RBI and HBI will be videotaped and undergoing fidelity checks.  

Description for medicine or protocol of treatment in detail：

Children in the RBI and HBI conditions proceed to eye gaze training. There are two training sessions each week (altogether 32 sessions). The training protocol in the RBI is based on the procedures established in the pilot study. Each time, a child listens to the five stories narrated by the autonomous robot Humane, who also detects the child’s eye gaze at the same time. Humane is also programed to autonomously prompt the child if he/she is not looking at it for 5 seconds for the first 8 weeks of training and 3 seconds for the last 8 weeks of training. Such reduction in off-focus duration increases the level of difficulty in establishing eye contact with Humane. If the child’s eye gaze is back to Humane in 1 second after the prompt, he/she will get praised by Humane. In order to promote the exchange between the robot and the child, Humane will ask the child some questions in between the narrations of two stories, but the response of the child is not mandatory (since some children may be minimally verbal). If the child, however, does not respond to Humane’s prompt for 5 minutes, the training session will suspend. The training protocol in the HBI condition is identical to that in the RBI except that Humane is replaced with a human experimenter, who is not involved in the pretests and posttests. This experimenter will receive training on narrating stories and counting the duration of eye gaze. Both RBI and HBI will be videotaped and undergoing fidelity checks.  

纳入标准：

Autistic children are eligible to participate in this study if they (1) have their diagnoses of being on the autism spectrum confirmed by a trained professional who had completed ADOS-2 (Autism Diagnostic Observation Schedule –2nd edition, Lord, 2012) Advanced/Research Training, (2) have no hearing or vision impairment, (3) can follow simple commands (e.g., “No”, “Come here”), (4) are aged 4-6, (5) have IQs 50 or above (WPPSI-4th edition; Wechsler Preschool and Primary Scale of Intelligence? - Fourth Edition (Chinese) (Weschler, 2013; Chen et al., 2013), and (6) can comprehend phrases with at least two components.

Inclusion criteria

Autistic children are eligible to participate in this study if they (1) have their diagnoses of being on the autism spectrum confirmed by a trained professional who had completed ADOS-2 (Autism Diagnostic Observation Schedule –2nd edition, Lord, 2012) Advanced/Research Training, (2) have no hearing or vision impairment, (3) can follow simple commands (e.g., “No”, “Come here”), (4) are aged 4-6, (5) have IQs 50 or above (WPPSI-4th edition; Wechsler Preschool and Primary Scale of Intelligence? - Fourth Edition (Chinese) (Weschler, 2013; Chen et al., 2013), and (6) can comprehend phrases with at least two components.

排除标准：

Autistic children are not eligible to participate in this study if they (1) have hearing or vision impairment; (2) have IQs below 49; and (3) cannot comprehend phrases with at least two components.

Exclusion criteria：

Autistic children are not eligible to participate in this study if they (1) have hearing or vision impairment; (2) have IQs below 49; and (3) cannot comprehend phrases with at least two components.

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-10-01 00:00:00 至 To 2026-01-30 00:00:00

干预措施：

Interventions：

组别：

RBI group

样本量：

 75

Group：

RBI group

Sample size：

干预措施：

Robot-based intervention

干预措施代码：

Intervention：

Robot-based intervention

Intervention code：

组别：

HBI group

样本量：

 75

Group：

HBI group

Sample size：

干预措施：

Human-based intervention

干预措施代码：

Intervention：

Human-based intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Hong Kong Christian Service 

单位级别：

 Non-government organizations 

Institution
hospital：

Hong Kong Christian Service

Level of the institution：

Non-government organizations

测量指标：

Outcomes：

指标中文名：

Chinese versions of Social Communication Questionnaire

指标类型：

主要指标

Outcome：

Chinese versions of Social Communication Questionnaire

Type：

Primary indicator

测量时间点：

pretest, immediate posttest after intervention, one month after intervention

测量方法：

Questionnaire

Measure time point of outcome：

pretest, immediate posttest after intervention, one month after intervention

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 4 岁 years
最大 Max age 6 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

In order to match the autism severity and intellectual functioning of children between both conditions, thereby reducing sampling errors due to the individual variations in these areas, we divide all children into four groups using the median split of ADOS-2 and WPPSI-4 that measure autism severity and intellectual functioning respectively (high ADOS-2 and low WPPSI-4; low ADOS-2 and low WPPSI-4; high ADOS-2 and high WPPSI-4; low ADOS-2 and high WPPSI-4). Then we randomly assign the children in each group to the two conditions, such that the final sample for each of the two conditions has the same proportion of samples from each group.

Randomization Procedure (please state who generates the random number sequence and by what method)：

In order to match the autism severity and intellectual functioning of children between both conditions, thereby reducing sampling errors due to the individual variations in these areas, we divide all children into four groups using the median split of ADOS-2 and WPPSI-4 that measure autism severity and intellectual functioning respectively (high ADOS-2 and low WPPSI-4; low ADOS-2 and low WPPSI-4; high ADOS-2 and high WPPSI-4; low ADOS-2 and high WPPSI-4). Then we randomly assign the children in each group to the two conditions, such that the final sample for each of the two conditions has the same proportion of samples from each group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

None

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

https://www.cos.io/products/osf

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://www.cos.io/products/osf

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Informed consent from all parents prior to the start of the study will be obtained. Their children should give their verbal consent to participation, which is required for children of this age by the institutional review board of the university. The data will be stored in the institution-based and encryped cloud server where only the lead person and her research team can access.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Informed consent from all parents prior to the start of the study will be obtained. Their children should give their verbal consent to participation, which is required for children of this age by the institutional review board of the university. The data will be stored in the institution-based and encryped cloud server where only the lead person and her research team can access.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-07-05 09:08:33