ChiCTR2300077745 版本V1.1 版本创建时间2024/06/18 19:46:54 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：

 ChiCTR2300077745 

最近更新日期：

Date of Last Refreshed on：

 2023-11-17 15:41:36 

注册时间：

Date of Registration：

 2023-11-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

自閉症兒童同理心幹預

Public title：

Intervention on empathy for autistic children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

訓練自閉症兒童變得更有同理心： 基於機器人的幹預與基於人類的幹預的比較計劃

Scientific title：

Training autistic children to be more empathetic: Comparison of robot-based to human-based intervention

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：

蘇詠芝 

研究负责人：

蘇詠芝 

Applicant：

So Wing Chee 

Study leader：

So Wing Chee 

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-23-0002

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：

 2023-09-05 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

具体地址：

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

Institution
hospital：

Department of Educational psychology

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：

本研究旨在檢驗與基於人的幹預（HBI）相比，基於機器人的幹預（RBI）是否能有效訓練自閉症兒童的同理心（情感和認知）。在此介入計劃，225名4至十歲的自閉症兒童將被招募並隨機分配到RBI、HBI、候補名單對照組 。如果兒童被分配到RBI、HBI，孩子都會聽機械人或人類教師講述的48個故事，訓練對八種情緒（快樂、悲傷、憤怒、害怕、內疚、失望、厭惡和驚訝）的理解和識別。 RBI 和 HBI 都將持續兩個月，每週一次。 這項研究將檢查 RBI 和 HBI 學習成果的維持及其將獲得的同理心技能推廣到人與人之間的互動。被分配到候補名單對照組的兒童將在完成研究後接受 HBI 或 RBI。  

Objectives of Study：

In this study, we design intervention (robot-based, RBI, and human-based, HBI) to train autistic children how to recognize and respond empathetically to eight emotions (happy, sad, angry, scared, guilty, disappointed, disgusted, and surprised) will be trained. Both the RBI and HBI will last for two months, once per week. Learning outcomes are evaluated by the behavioral level (through parental reports on anxiety and empathy levels and children’s verbal responses to different emotions in daily-life scenarios) and neurobiological level (salivary oxytocin levels). Maintenance of learning outcomes of both RBI and HBI and their generalization of acquired empathy skills to human-to-human interaction will be examined. 150 autistic children aged 4 to 7 will be recruited and randomly assigned to RBI and HBI. With such a large sample size, we can control the effects of intellectual functioning and autism severity levels. Our hypotheses are listed below: H1: Autistic children randomly assigned to the RBI will have better cognitive and affective empathy, prosocial behaviors, and higher level of oxytocin than those randomly assigned to HBI and wait-list control groups after the two-month intervention. H2: Autistic children randomly assigned to the RBI will be more likely to have their learning outcomes maintained one month after intervention than those randomly assigned to HBI and wait-list control groups.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

參與此項研究的自閉症兒童應該 (1) 被診斷患有自閉症 (2) 沒有聽力或視力障礙; (3) 4-10 歲; (4) 智商 70 或以上; (5) 可以理解至少包含3個成分的短語

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) are aged 4-10, (4) have IQs 70 or above (WPPSI-4th edition; Wechsler Preschool and Primary Scale of Intelligence? - Fourth Edition (Chinese) (Weschler, 2013; Chen et al., 2013), and (5) can comprehend phrases with at least three components.

排除标准：

(1) 未被診斷患有自閉症; (2) 有聽力或視力障礙; (3) <4歲, >10 歲; (4) 智商 < 70 ; (5) 不可以理解至少包含3個成分的短語

Exclusion criteria：

(1) do not have their diagnoses of being on the autism spectrum; (2) have hearing or vision impairment, (3) aged below 4 or older than 10, (4) have IQs lower than 70; (5) cannot comprehend phrases with at least three components.

研究实施时间：

Study execute time：

从 From 2023-12-01 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-12-01 00:00:00 至 To 2025-01-06 00:00:00

干预措施：

Interventions：

组别：

基於機器人的幹預

样本量：

 75

Group：

Robot-based intervention

Sample size：

干预措施：

孩子都會聽機械人講述的48個故事，訓練對八種情緒（快樂、悲傷、憤怒、害怕、內疚、失望、厭惡和驚訝）的理解和識別。

干预措施代码：

Intervention：

There is one training session each week (altogether 8 sessions). For RBI, a child watches the dramas performed by the two Humane robots, who act as John and Peter respectively. After watching each drama, the human experimenter, who is not involved in the pretests and posttests, will ask the child four questions, "What does John feel?", "Why does he feel in this way?", "What would you feel if you were John", "Is Peter behaving appropriately and why?". The experimenter will immediately respond to the child’s answers. If his/her answers are correct, the experimenter will praise the child and restate the response in order to consolidate his/her learning. If the answers are incorrect, the experimenter will thank for the child’s response and provide a correct one.

Intervention code：

组别：

基於人的幹預

样本量：

 75

Group：

Human-based intervention

Sample size：

干预措施：

孩子都會聽人講述的48個故事，訓練對八種情緒（快樂、悲傷、憤怒、害怕、內疚、失望、厭惡和驚訝）的理解和識別。

干预措施代码：

Intervention：

The training protocol in the HBI condition is identical to that in the RBI except that both Humane robots are replaced with two human actors

Intervention code：

组别：

對照組

样本量：

 75

Group：

Waitlist control

Sample size：

干预措施：

該組的兒童在完成研究後將接受 HBI 或 RBI

干预措施代码：

Intervention：

Children in this group will receive either HBI or RBI after completion of research

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港 

市(区县)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 香港中文大學 

单位级别：

 大学 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

中文版的社會兒童共情問卷

指标类型：

主要指标

Outcome：

Empathy Questionnaire, EmQue

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

4 time points

Measure method：

指标中文名：

長處和困難調查表

指标类型：

主要指标

Outcome：

Strength and Difficulties Questionnaire, SDQ

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

4 time points

Measure method：

指标中文名：

家長評定的學前焦慮量表

指标类型：

主要指标

Outcome：

Parent-Rated Preschool Anxiety Scale: Traditional Chinese Version

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

4 time points

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

唾液

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 10 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）：

這項幹預研究有三種條件：RBI、HBI 和對照組，每種條件 75 個。 為了匹配兩種情況下兒童的自閉症嚴重程度和智力功能，從而減少由於這些領域的個體差異而導致的抽樣誤差，我們使用ADOS-2 和WPPSI-4 的中位數分割將所有兒童分為四組，這些中位數測量自閉症嚴重程度和智力功能分別（高ADOS-2 和低WPPSI-4；低ADOS-2 和低WPPSI-4；高ADOS-2 和高WPPSI-4；低ADOS -2 和高WPPSI-4）。 然後，我們將每組中的孩子隨機分配到這三組，使得這三組中每一個的最終樣本具有來自每組的相同比例的樣本。

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

This intervention study has three conditions: RBI, HBI, and cared-as-usual with 75 in each condition. 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 three conditions, such that the final sample for each of the three 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：

未说明

Blinding：

Not stated

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：

在研究開始之前將獲得所有家長的知情同意。 他們的孩子應該口頭同意參與，這是大學機構審查委員會對這個年齡的孩子的要求。 數據將儲存在基於機構的加密雲端伺服器中，只有領導者和她的研究團隊可以存取。

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：

  2023-11-17 15:41:04