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Promoting safe and effective use of social media among high functioning autistic young adults in Hong Kong: A randomized controlled trial
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注册号：

Registration number：

 ChiCTR2400081585 

最近更新日期：

Date of Last Refreshed on：

 2024-03-05 16:50:18 

注册时间：

Date of Registration：

 2024-03-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Promoting safe and effective use of social media among high functioning autistic young adults in Hong Kong: A randomized controlled trial

Public title：

Promoting safe and effective use of online social media among young adults with high functioning Autism Spectrum Disorder in Hong Kong: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Promoting safe and effective use of online social media among young adults with high functioning Autism Spectrum Disorder in Hong Kong: A randomized controlled trial

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：

 

研究负责人：

 

Applicant：

LEUNG Wai Shun 

Study leader：

LEUNG Wai Shun 

申请注册联系人电话：

Applicant telephone：

 +852 2702 6002

研究负责人电话：

Study leader's
telephone：

+852 2702 6002

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：

 phil0313@connect.hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 phil0313@connect.hku.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：

研究负责人通讯地址：

Applicant address：

3/F, Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau, Hong Kong

Study leader's address：

3/F, Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau, 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：

Applicant's institution：

Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The 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：

 UW 22-646

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：

Name of the ethic committee：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-09-21 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Ms Clara Leung

伦理委员会联系地址：

Contact Address of the ethic committee：

Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2255 3923

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：

Primary sponsor：

Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong

研究实施负责（组长）单位地址：

Primary sponsor's address：

3/F, Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

具体地址：

Institution
hospital：

Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Address：

3/F, Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau, Hong Kong

经费或物资来源：

Source(s) of funding：

nil

研究疾病：

 

Target disease：

High functioning 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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

 

Objectives of Study：

This research aimed to evaluate the effectiveness of an intervention to promote safe and effective use of social media among autistic young adults in Hong Kong. More specifically, the objectives were to (1) improve their sense of self-efficacy in safe and effective social media use; (2) improve their skills in using social media effectively and safely; (3) promote their awareness of risks associated with social media use; and (4) promote higher affinity towards social media.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

The intervention in the experimental group is a 3-session educational workshop to promote skills and awareness concerning safe and effective use of online social media, targeting young adults with high functioning autism spectrum disorder. No active intervention will be delivered to the participants in control group and they will only 'standard practice' in their community center. No medication is used in this trial. 

纳入标准：

Inclusion criteria

排除标准：

Exclusion criteria：

Exclusion criteria are those: (1) with other mental health comorbidity such as intellectual disability or psychotic disorders; and, (2) non-local non-Chinese speakers

研究实施时间：

Study execute time：

从 From 2022-10-01 00:00:00至 To 2024-02-29 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-11-25 00:00:00 至 To 2023-08-05 00:00:00

干预措施：

Interventions：

组别：

样本量：

 16

Group：

Experimental group

Sample size：

干预措施：

干预措施代码：

Intervention：

Participants in the experimental group would receive a 3-session educational workshop delivered through online to promote safe and effective social media use.

Intervention code：

组别：

样本量：

 18

Group：

Control group

Sample size：

干预措施：

干预措施代码：

Intervention：

Participants in the control group would receive 'standard practice' in their community centers. No active intervention will be delivered.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

China

Province：

Hong Kong China

City：

单位(医院)：

  

单位级别：

  

Institution
hospital：

The University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

Self-efficacy in social media use

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, immediate and one-month after intervention

Measure method：

Online survey

指标中文名：

指标类型：

次要指标

Outcome：

Digital social skills

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, immediate and one-month after intervention

Measure method：

Online survey

指标中文名：

指标类型：

次要指标

Outcome：

Risk propensity concerning social media use

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, immediate and one-month after intervention

Measure method：

Online survey

指标中文名：

指标类型：

附加指标

Outcome：

Affinity towards social media

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, immediate and one-month after intervention

Measure method：

Online survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Nil

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 39 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）：

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

To avoid contamination bias between participants in the same center, randomization was conducted using ‘center’ as the unit instead of ‘individual’. Randomisation was conducted based on pre-determined random numbers generated by computer and independently by the research team.

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：

The design could not be of double-blind design given both the trainers and participants were aware of the content of workshop.

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）：

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

IPD sharing will be conducted within 6 months after the study results have been published through ResMan (www.medresman.org.cn), a platform accessible by public.

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：

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

Data collection will be collected in an electronic format. Online questionnaires will be sent to participants for completion and sent back to research staff within one week. Baseline assessment (Time 0; T0) will be conducted before the delivery of workshop. Within one week after the completion of workshop, a post-intervention assessment (Time 1; T1) will be conducted. In order to investigate the maintenance of treatment effect, another post-intervention follow-up will be conducted 1-month after the completion of the intervention (Time 2; T2). Again, online questionnaires will be sent to participants. All information provided by participants will be kept strictly confidential and handled by research team only. Electronic data will be saved in password-locked computers, and hard copy data will be stored in locked cabinets in the Department of Family Medicine and Primary Care. All data will be kept for 7 years after the completion of the study.

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：

  2024-03-05 16:50:13
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