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A cluster randomized controlled trial of a group mindfulness-based cognitive programme for adolescents in Hong Kong: Its Effect on Smartphone Behavior, Symptoms of Smartphone Addiction and Resilience
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注册号：

Registration number：

 ChiCTR2000033273 

最近更新日期：

Date of Last Refreshed on：

 2020-05-26 14:06:39 

注册时间：

Date of Registration：

 2020-05-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A cluster randomized controlled trial of a group mindfulness-based cognitive programme for adolescents in Hong Kong: Its Effect on Smartphone Behavior, Symptoms of Smartphone Addiction and Resilience

Public title：

A cluster randomized controlled trial of a group mindfulness-based cognitive programme for adolescents in Hong Kong: Its Effect on Smartphone Behavior, Symptoms of Smartphone Addiction and Resilience

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Mindfulness-based cognitive management of addictive/excessive smartphone use in adolescents

Scientific title：

Mindfulness-based cognitive management of addictive/excessive smartphone use in adolescents

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：

Dr. Anson Tang Chui Yan 

研究负责人：

Dr. Anson Tang Chui Yan 

Applicant：

Dr. Anson Tang Chui Yan 

Study leader：

Dr. Anson Tang Chui Yan 

申请注册联系人电话：

Applicant telephone：

 +852 34686832

研究负责人电话：

Study leader's
telephone：

+852 34686832

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：

 ansontang@twc.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 ansontang@twc.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：

中國香港特別行政區九龍何文田衛理道31號

研究负责人通讯地址：

中國香港特別行政區九龍何文田衛理道31號

Applicant address：

31 Wylie Road, Homantin, Kowloon, Hong Kong, China

Study leader's address：

31 Wylie Road, Homantin, Kowloon Hongkong

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：

香港東華學院護理學院

Applicant's institution：

School of Nursing, Tung Wah College

研究负责人所在单位：

香港東華學院護理學院

Affiliation of the Leader：

School of Nursing, Tung Wah College

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：

 REC2019046

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：

Research Ethics Committee, Tung Wah College

Name of the ethic committee：

Research Ethics Committee, Tung Wah College

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-10-14 00:00:00

伦理委员会联系人：

Research Ethics Committee, Tung Wah College

Contact Name of the ethic committee：

Research Ethics Committee, Tung Wah College

伦理委员会联系地址：

中國香港特別行政區九龍何文田衛理道31號

Contact Address of the ethic committee：

Tung Wah College, 31 Wylie Road, Homantin, Kowloon, Hongkong

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

東華學院

Primary sponsor：

Tung Wah College

研究实施负责（组长）单位地址：

中國香港特別行政區九龍何文田衛理道31號

Primary sponsor's address：

Tung Wah College, 31 Wylie Road, Homantin, Kowloon, Hongkong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

東華學院

Source(s) of funding：

Tung Wah College

研究疾病：

Excessive/addictive smartphone use  

Target disease：

Excessive/addictive smartphone use

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：

随机平行对照 

Study design：

Parallel 

研究目的：

The primary objective is to investigate the group by the time interaction effects of a group mindfulness-based cognitive programme on resilience, smartphone behavior and the symptoms of smartphone addiction in adolescents. There are two secondary objectives: (1) To identify adolescents with smartphone addictive symptoms using Smartphone Addiction Scale-Short Version; (2) To investigate the association of socio-demographic factors, smartphone behavior and resilience with smartphone addiction symptoms in adolescents.  

Objectives of Study：

The primary objective is to investigate the group by the time interaction effects of a group mindfulness-based cognitive programme on resilience, smartphone behavior and the symptoms of smartphone addiction in adolescents. There are two secondary objectives: (1) To identify adolescents with smartphone addictive symptoms using Smartphone Addiction Scale-Short Version; (2) To investigate the association of socio-demographic factors, smartphone behavior and resilience with smartphone addiction symptoms in adolescents.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Schools recruitment:
The exclusion criteria are
1) it is an international school and
2) there are currently interventions being implemented by the school to manage students smartphone behaviors.
Participants recruitment:
Exclusion criteria are:
1) adolescents aged < 10 years or > 11 years;
2) adolescents are not enrolling in class level 5;
3) adolescents do not possess a smartphone or cannot access smartphone;
4) adolescents have intellectual disabilities;
5) adolescents cannot understand, speak and write Cantonese.

Exclusion criteria：

Schools recruitment:
The exclusion criteria are
1) it is an international school and
2) there are currently interventions being implemented by the school to manage students smartphone behaviors.
Participants recruitment:
Exclusion criteria are:
1) adolescents aged < 10 years or > 11 years;
2) adolescents are not enrolling in class level 5;
3) adolescents do not possess a smartphone or cannot access smartphone;
4) adolescents have intellectual disabilities;
5) adolescents cannot understand, speak and write Cantonese.

研究实施时间：

Study execute time：

从 From 2019-11-01 00:00:00至 To 2021-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-08-01 00:00:00 至 To 2020-08-31 00:00:00

干预措施：

Interventions：

组别：

intervention

样本量：

 120

Group：

intervention

Sample size：

干预措施：

12-week mindfulness-based cognitive programme

干预措施代码：

Intervention：

12-week mindfulness-based cognitive programme

Intervention code：

组别：

control

样本量：

 120

Group：

control

Sample size：

干预措施：

existing counselling services for students with emotional/behavioral problems at school (treatment as usual)

干预措施代码：

Intervention：

existing counselling services for students with emotional/behavioral problems at school (treatment as usual)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 靑年協會李兆基小學 

单位级别：

 小學 

Institution
hospital：

HKFYG Lee Shau Kee Primary School

Level of the institution：

primary school

测量指标：

Outcomes：

指标中文名：

Smartphone addictive symptoms

指标类型：

主要指标

Outcome：

Smartphone addictive symptoms

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Resilience

指标类型：

主要指标

Outcome：

Resilience

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Smartphone behavior

指标类型：

主要指标

Outcome：

Smartphone behavior

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

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 10 岁 years
最大 Max age 11 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）：

The four participating schools will be randomly allocated into the intervention and control groups by coin toss. The participating schools will be randomly allocated in a ratio of 1:1 to the intervention/control group by the research assistant A (RA-A) who will not involve in participant recruitment.

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

The four participating schools will be randomly allocated into the intervention and control groups by coin toss. The participating schools will be randomly allocated in a ratio of 1:1 to the intervention/control group by the research assistant A (RA-A) who will not involve in participant recruitment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Not stated

Blinding：

Not stated

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）：

Not stated

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

not yet planned

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: The information sheets, the consent forms, the questionnaires and envelopes will be distributed to the parents of the class level 5 students in the participating primary schools via class teachers. The parents are required to indicate the food(s) their child is allergic to, if any, on the consent form. The parents who are willing to participate in the study will return signed consent forms and completed questionnaires in sealed envelopes to the school before starting the intervention (T0). The trainer will record the attendance of each participant in every session throughout the 12-week intervention. To follow up the effect of the intervention on the participants, post-intervention assessments will be conducted on all outcomes in week 4, week 8, by the end (week 12) of the programme and 3 months follow-up (T1-T4). It will take about 20 minutes to complete the questionnaire. RA-B will be responsible for collecting all the questionnaires. The school teachers will not be involved in the data collection to avoid interfering their judgement on the participants. Data Management: The questionnaires will be coded with a personal identification number for each participant to match data from the same person across waves. All the information will be kept strictly confidential and only the research team members have the access right to the raw data. The returned questionnaires will be kept in the principal investigator’s office in a locked cabinet. The data file will be encrypted and saved on the principal investigator’s computer.

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

Data Collection: The information sheets, the consent forms, the questionnaires and envelopes will be distributed to the parents of the class level 5 students in the participating primary schools via class teachers. The parents are required to indicate the food(s) their child is allergic to, if any, on the consent form. The parents who are willing to participate in the study will return signed consent forms and completed questionnaires in sealed envelopes to the school before starting the intervention (T0). The trainer will record the attendance of each participant in every session throughout the 12-week intervention. To follow up the effect of the intervention on the participants, post-intervention assessments will be conducted on all outcomes in week 4, week 8, by the end (week 12) of the programme and 3 months follow-up (T1-T4). It will take about 20 minutes to complete the questionnaire. RA-B will be responsible for collecting all the questionnaires. The school teachers will not be involved in the data collection to avoid interfering their judgement on the participants. Data Management: The questionnaires will be coded with a personal identification number for each participant to match data from the same person across waves. All the information will be kept strictly confidential and only the research team members have the access right to the raw data. The returned questionnaires will be kept in the principal investigator’s office in a locked cabinet. The data file will be encrypted and saved on the principal investigator’s computer.

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：

  2020-05-26 11:48:41
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