今天是:2019-06-18 星期二

正念抚育在注意缺陷多动障碍患儿家庭中的运用:自身前后对照研究
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注册号:

Registration number:

ChiCTR1900023808 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

正念抚育在注意缺陷多动障碍患儿家庭中的运用:自身前后对照研究 

Public title:

Applying Mindful Parenting in families with ADHD children: a Self Before-After Controlled Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

正念抚育在注意缺陷多动障碍患儿家庭中的运用:自身前后对照研究 

Scientific title:

Applying Mindful Parenting in families with ADHD children: a Self Before-After Controlled Study 

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:

刘珮 

研究负责人:

钱秋谨 

Applicant:

Liu Pei 

Study leader:

Qian Qiujin 

申请注册联系人电话:

Applicant telephone:

+86 13126580973 

研究负责人电话:

Study leader's telephone:

+86 13466339985 

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:

lpelana@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

qianqiujin@bjmu.edu.cn 

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:

北京市海淀区花园北路51号 

研究负责人通讯地址:

北京市海淀区花园北路51号 

Applicant address:

51 North Huayuan Road, Haidian District, Beijing, China 

Study leader's address:

51 North Huayuan Road, Haidian District, Beijing, China 

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:

北京大学第六医院 

Applicant's institution:

Sixth Hospital Peking University 

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:

2017伦审第(4)号 

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:

北京大学第六医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Sixth Hospital, Peking University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

王雪芹 

Contact Name of the ethic committee:

Wang Xueqin 

伦理委员会联系地址:

北京市海淀区花园北路51号 

Contact Address of the ethic committee:

51 North Huayuan Road, Haidian District, Beijing, China  

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:

北京大学第六医院 

Primary sponsor:

Sixth Hospital Peking University  

研究实施负责(组长)单位地址:

北京市海淀区花园北路51号 

Primary sponsor's address:

51 North Huayuan Road, Haidian District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第六医院

具体地址:

北京市海淀区花园北路51号

Institution
hospital:

Sixth Hospital Peking University

Address:

51 North Huayuan Road, Haidian District, Beijing, China

经费或物资来源:

自费 

Source(s) of funding:

Self financing 

研究疾病:

注意缺陷多动障碍 

Target disease:

Attention Deficit Hyperactivity Disorder 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

探究“正念抚育”项目对ADHD患儿父母抑郁情绪的改善作用,父母教养方式及家庭关系的影响(包括父母自身压力、教养方式、婚姻质量、家庭功能、父母自身的正念水平等);以及能否通过对父母的正念训练间接影响ADHD患儿的行为症状。 

Objectives of Study:

To explore the effect of Mindfulness Parenting on parental depressive symptoms and its influence on parenting style and family relationship (including parental stress, marriage quality, family function, parental mindfulness level, etc.); And whether Mindful Paernting indirectly affect the behavioral symptoms of ADHD children. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.年龄在7-18岁,满足DSM-IV中ADHD诊断标准儿童的父母; 2.性别和年龄不限 3.存在轻中度抑郁症状,贝克抑郁量表评分大于等于14分。 4.无言语沟通障碍,能理解并配合各项治疗措施  

Inclusion criteria

1. parents of children aged 7-18 years and met ADHD diagnostic criteria in DSM-IV; 2. gender and age were not limited; 3. mild to moderate depressive symptoms, and the Beck Depression Scale score was greater than or equal to 14 points; 4. no verbal communication difficulties, can understand and cooperate with various treatment measures.  

排除标准:

1.儿童患有精神分裂症、双相情感障碍、精神发育迟滞、物质依赖;明显躯体或神经系统异常。患儿智商低于70; 2.家长罹患精神分裂症、双相情感障碍、物质滥用。家长目前重度抑郁发作,有自杀风险需要住院治疗。家长目前正在接受抗抑郁药物治疗或心理治疗。明显躯体或神经系统异常,无法完成正念训练的课程。  

Exclusion criteria:

1. Children with schizophrenia, bipolar disorder, mental retardation, material dependence; obvious physical or nervous system abnormalities. The IQ of children is less than 70; 2. Parents suffer from schizophrenia, bipolar disorder and substance abuse. Parents are currently suffering from severe depressive episodes, with suicidal risk requiring hospitalization. Parents are currently receiving antidepressant treatment or psychotherapy. Obvious physical or nervous system abnormalities, unable to complete mindfulness training courses.  

研究实施时间:

Study execute time:

From2017-03-01To 2018-04-01 

干预措施:

Interventions:

组别:

干预组

样本量:

18

Group:

Case series

Sample size:

干预措施:

正念抚育八周课程

干预措施代码:

Intervention:

Mindful Parenting

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第六医院 

单位级别:

三级甲等 

Institution
hospital:

Sixth Hospital Peking University  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

贝克抑郁量表第二版

指标类型:

主要指标 

Outcome:

BDI-II

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自尊量表

指标类型:

次要指标 

Outcome:

Self-Esteem Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

冲动量表

指标类型:

次要指标 

Outcome:

Barratt Impulsiveness Scale-11

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

婚姻量表

指标类型:

次要指标 

Outcome:

Olson Marriage Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

家长压力指数量表

指标类型:

次要指标 

Outcome:

5. Parenting stress index,-short form

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

家庭功能评价量表

指标类型:

次要指标 

Outcome:

6. Family Assessment Device

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Conner's父母评价量表

指标类型:

次要指标 

Outcome:

Conners' Parent Rating Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ADHD评价量表

指标类型:

次要指标 

Outcome:

ADHD Rating Scale-IV

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

正念五因素量表

指标类型:

次要指标 

Outcome:

Five Facet Mindfulness Questionnaire (FFMQ)

Type:

Secondary 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:

标本中文名:

(无)

组织:

-

Sample Name:

None

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

(自身前后对照设计,无随机分组)

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2019.7 Resman 临床试验管理平台

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

2019.7 Resman Research Manager

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-12
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