ChiCTR2300071366 版本V1.4 版本创建时间2024/04/19 11:17:46 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：

 ChiCTR2300071366 

最近更新日期：

Date of Last Refreshed on：

 2024-01-19 08:42:54 

注册时间：

Date of Registration：

 2023-05-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The Effectiveness of a Sex and Relationship Education training group for Adolescents with Autism Spectrum Disorder Studying in Mainstream Schools of Hong Kong

Public title：

The Effectiveness of a Sex and Relationship Education training group for Adolescents with Autism Spectrum Disorder Studying in Mainstream Schools of Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The Effectiveness of a Sex and Relationship Education training group for Adolescents with Autism Spectrum Disorder Studying in Mainstream Schools of Hong Kong

Scientific title：

The Effectiveness of a Sex and Relationship Education training group for Adolescents with Autism Spectrum Disorder Studying in Mainstream Schools of Hong Kong

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：

Chan Wing Yan Winnie 

研究负责人：

Chan Wing Yan Winnie 

Applicant：

Chan Wing Yan Winnie 

Study leader：

Chan Wing Yan Winnie 

申请注册联系人电话：

Applicant telephone：

 +852 9135 1038

研究负责人电话：

Study leader's
telephone：

+852 9135 1038

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：

 winniechan88@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 winniechan88@gmail.com

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：

1/F, Tung Lee Commercial Building, 91-97 Jervois Street, Sheung Wan, Hong Kong

研究负责人通讯地址：

1/F, Tung Lee Commercial Building, 91-97 Jervois Street, Sheung Wan, Hong Kong

Applicant address：

1/F, Tung Lee Commercial Building, 91-97 Jervois Street, Sheung Wan, Hong Kong

Study leader's address：

1/F, Tung Lee Commercial Building, 91-97 Jervois Street, Sheung Wan, 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：

 2022.499-T

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：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-11-14 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

91-97 Jervois Street, Sheung Wan, Hong Kong

Primary sponsor's address：

91-97 Jervois Street, Sheung Wan, 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)：

The Chinese University of Hong Kong

具体地址：

91-97 Jervois Street, Sheung Wan

Institution
hospital：

The Chinese University of Hong Kong

Address：

91-97 Jervois Street, Sheung Wan

经费或物资来源：

Study leader's own resources

Source(s) of funding：

Study leader's own resources

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：

 其它 

Study phase：

N/A

研究设计：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

The present study aims at establishing an evidence-based and locally-developed SRE training program to ensure more applicable knowledge and skills to be coached to the adolescents with ASD, hence healthy social development of the adolescents with ASD. Researches indicated that increasing knowledge in sex and relationship can reduce their chance of encountering sexual risks, while improving their overall psychosexual development.Also, previous researches indicated that one very crucial element that contributed to the intimate relationship-building of people with ASD was their overall social skills. Thus, knowledge and behavioral skills related to sex and relationship as well as general social skills of the participants will be the major indicators of their changes.  

Objectives of Study：

The present study aims at establishing an evidence-based and locally-developed SRE training program to ensure more applicable knowledge and skills to be coached to the adolescents with ASD, hence healthy social development of the adolescents with ASD. Researches indicated that increasing knowledge in sex and relationship can reduce their chance of encountering sexual risks, while improving their overall psychosexual development.Also, previous researches indicated that one very crucial element that contributed to the intimate relationship-building of people with ASD was their overall social skills. Thus, knowledge and behavioral skills related to sex and relationship as well as general social skills of the participants will be the major indicators of their changes.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Studying in mainstream secondary schools of Hong Kong, or vocational schools of Hong Kong aged 12-17 at the time of trial entry; 2. Having a previous diagnosis of Autism Spectrum Disorder, Autistic Disorder, or Asperger's Disorder from a mental health professional, including psychiatrist, pediatrician and clinical psychologist; 3. Having normal cognitive functioning (a minimum IQ of 70); 4. Being fluent Cantonese; 5. Having a parent or family member who was fluent in Cantonese and willing to participate in the study.

Inclusion criteria

1. Studying in mainstream secondary schools of Hong Kong, or vocational schools of Hong Kong aged 12-17 at the time of trial entry; 2. Having a previous diagnosis of Autism Spectrum Disorder, Autistic Disorder, or Asperger's Disorder from a mental health professional, including psychiatrist, pediatrician and clinical psychologist; 3. Having normal cognitive functioning (a minimum IQ of 70); 4. Being fluent Cantonese; 5. Having a parent or family member who was fluent in Cantonese and willing to participate in the study.

排除标准：

1. Current suicidality or suicidal behavior in the past six months; 2. A current diagnosis of psychotic disorder, including schizophrenia, psychosis, or bipolar disorder; 3. Having concurrent group training on sex and relationship education; 4. Having notable hearing or visual impairment hindering their participation in group activities or receiving group instructions.

Exclusion criteria：

1. Current suicidality or suicidal behavior in the past six months; 2. A current diagnosis of psychotic disorder, including schizophrenia, psychosis, or bipolar disorder; 3. Having concurrent group training on sex and relationship education; 4. Having notable hearing or visual impairment hindering their participation in group activities or receiving group instructions.

研究实施时间：

Study execute time：

从 From 2023-06-05 00:00:00至 To 2024-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-06-05 00:00:00 至 To 2024-02-29 00:00:00

干预措施：

Interventions：

组别：

experimental group

样本量：

 48

Group：

experimental group

Sample size：

干预措施：

SRE training program (15 sessions)

干预措施代码：

Intervention：

SRE training program (15 sessions)

Intervention code：

组别：

control group

样本量：

 48

Group：

control group

Sample size：

干预措施：

SRE training program (15 sessions) after a 5-month waiting period

干预措施代码：

Intervention：

SRE training program (15 sessions) after a 5-month waiting period

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)：

 The Chinese University of Hong Kong 

单位级别：

  

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

The Adolescent Sex and Relationship Knowledge Test

指标类型：

主要指标

Outcome：

The Adolescent Sex and Relationship Knowledge Test

Type：

Primary indicator

测量时间点：

Pre-training and post-training

测量方法：

Measure time point of outcome：

Pre-training and post-training

Measure method：

written test

指标中文名：

The Adolescent Sex and Relationship Behavioral Assessment

指标类型：

主要指标

Outcome：

The Adolescent Sex and Relationship Behavioral Assessment

Type：

Primary indicator

测量时间点：

Pre-training and post-training

测量方法：

Measure time point of outcome：

Pre-training and post-training

Measure method：

performance assessment

指标中文名：

The Adolescent Sex and Relationship Behavioral Observation

指标类型：

主要指标

Outcome：

The Adolescent Sex and Relationship Behavioral Observation

Type：

Primary indicator

测量时间点：

Pre-training and post-training

测量方法：

Measure time point of outcome：

Pre-training and post-training

Measure method：

parent-reported scale

指标中文名：

School Personnel Observation Scale

指标类型：

主要指标

Outcome：

School Personnel Observation Scale

Type：

Primary indicator

测量时间点：

Pre-training and post-training

测量方法：

Measure time point of outcome：

Pre-training and post-training

Measure method：

school personnel-reported scale

指标中文名：

The Social Responsiveness Scale, Second Edition (SRS‐2)

指标类型：

次要指标

Outcome：

The Social Responsiveness Scale, Second Edition (SRS‐2)

Type：

Secondary indicator

测量时间点：

Pre-training and post-training

测量方法：

Measure time point of outcome：

Pre-training and post-training

Measure method：

parent-reported scale

指标中文名：

Parent Sexuality Concerns Inventory (PSCI)

指标类型：

次要指标

Outcome：

Parent Sexuality Concerns Inventory (PSCI)

Type：

Secondary indicator

测量时间点：

Pre-training and post-training

测量方法：

Measure time point of outcome：

Pre-training and post-training

Measure method：

parent-reported scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

scores of the above tests

组织：

Sample Name：

scores of the above tests

Tissue：

NA

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

10 years after publication

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 12 岁 years
最大 Max age 17 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）：

During online recruitment, applicants will be asked to indicate their available time period for the training group out of two choices. Those who can attend the earlier group will become the experimental group and those who choose the latter time period will become the WLC group.

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

During online recruitment, applicants will be asked to indicate their available time period for the training group out of two choices. Those who can attend the earlier group will become the experimental group and those who choose the latter time period will become the WLC 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：

Blinding：

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

否No

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）：

hardcopy and URL

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

hardcopy and URL

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：

The information will be in both hard copy and soft copy form. The hard copy will be stored in locked cabinet. The soft copy will be kept in an encrypted external harddisk. Information obtained will be kept strictly confidential to persons involved in conducting the study. Data will be stored for ten years after the publication of all research data and then destroyed by paper shredder & data cleaning software afterwards.

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

The information will be in both hard copy and soft copy form. The hard copy will be stored in locked cabinet. The soft copy will be kept in an encrypted external harddisk. Information obtained will be kept strictly confidential to persons involved in conducting the study. Data will be stored for ten years after the publication of all research data and then destroyed by paper shredder & data cleaning software afterwards.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-12 15:20:02