ChiCTR2400079857 版本V1.0 版本创建时间2024/01/15 10:42:40 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：

ChiCTR2400079857 

最近更新日期：

Date of Last Refreshed on：

2024-01-15 10:42:34 

注册时间：

Date of Registration：

2024-01-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

青少年精神障碍患者父母负性情绪调节方案的构建及实证研究

Public title：

Construction and empirical study of a negative emotion regulation program for parents of adolescents with mental disorders

注册题目简写：

English Acronym：

研究课题的正式科学名称：

青少年精神障碍患者父母负性情绪调节方案的构建及实证研究

Scientific title：

Construction and empirical study of a negative emotion regulation program for parents of adolescents with mental disorders

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：

唐莹 

研究负责人：

唐莹 

Applicant：

Tang Ying 

Study leader：

Tang Ying 

申请注册联系人电话：

Applicant telephone：

+86 151 8788 9731

研究负责人电话：

Study leader's telephone：

+86 151 8788 9731

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：

2236458104@qq.com

研究负责人电子邮件：

Study leader's E-mail：

2236458104@qq.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：

云南省昆明市五华区西昌路295号

研究负责人通讯地址：

云南省昆明市五华区西昌路295号

Applicant address：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province.

Study leader's address：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province

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：

昆明医科大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Kunming Medical University

研究负责人所在单位：

昆明医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Kunming Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023伦审L第223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：

昆明医科大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Kunming Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-12-28 00:00:00

伦理委员会联系人：

周佳

Contact Name of the ethic committee：

Zhou Jia

伦理委员会联系地址：

昆明医科大学第一附属医院

Contact Address of the ethic committee：

The First Affiliated Hospital of Kunming Medical University

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 871 6532 8585

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：

昆明医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Kunming Medical University

研究实施负责（组长）单位地址：

云南省昆明市五华区西昌路295号

Primary sponsor's address：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

云南

市(区县)：

昆明

Country：

China

Province：

Yunnan

City：

Kunming

单位(医院)：

昆明医科大学第一附属医院

具体地址：

云南省昆明市五华区西昌路295号

Institution
hospital：

The First Affiliated Hospital of Kunming Medical University

Address：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province

经费或物资来源：

无

Source(s) of funding：

No

Target disease：

adolescent mental disorders

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：

1、探索青少年精神障碍患者父母负性情绪的觉察、调节现状和需求。 2、构建青少年精神障碍患者父母负性情绪的调节方案。 3、评价负性情绪调节方案的效果与推广性。  

Objectives of Study：

1. Explore the awareness, adjustment status and needs of negative emotions of parents of adolescents with mental disorders. 2. Construct a program for regulating negative emotions of parents of adolescents with mental disorders. 3. Evaluate the effectiveness and popularization of negative emotion regulation programs.

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.文献研究阶段-系统评价/Meta分析 (1)纳入标准:①10-19岁青少年的父母；②青少年符合ICD-10精神障碍疾病诊断标准；③试验组干预方式涉及情绪干预；④研究结果报告青少年精神障碍患者父母负性情绪情况；⑤研究设计为随机对照实验（RCT）；⑥公开发表。 2.质性研究阶段 (1)患者纳入标准：①10-19岁的青少年；②符合ICD-10精神障碍疾病诊断标准；③面部情绪识别能力正常：④具有正常交流能力；⑤自愿参与 (2)父母纳入标准：①年龄≥18岁；②面部情绪识别能力正常：③无精神疾病、认知功能障碍、面部无瘢痕和残疾；④具有正常交流能力；⑤自愿参与 3.专家会议阶段 (1)纳入标准：①中级职称以上；②本科及以上学历；③从事精神科工作≥5年；④护理学、精神病和精神卫生学、心理学专业领域；⑤6-12人。 4.量性研究阶段-随机对照试验 （1）患者纳入标准：①10-19岁的青少年；②符合ICD-10精神障碍疾病诊断标准；③被同一个主管医生治疗；④具有正常交流能力；⑤自愿参与 （2）父母纳入标准：①年龄≥18岁；②无精神疾病、认知功能障碍、面部无瘢痕和残疾；③具有正常交流能力；④自愿参与

Inclusion criteria

1. Literature research stage :systematic review/meta analysis (1) Inclusion criteria: ① Parents of adolescents aged 10-19 years old; ② Adolescents meet ICD-10 diagnostic criteria for mental disorders; ③ The intervention method of the experimental group involves emotional intervention; ④ Report of research results The negative emotions of parents of adolescents with mental disorders; ⑤ The research design is a randomized controlled trial (RCT); ⑥ Published publicly. 2. Qualitative research stage (1) Patient inclusion criteria: ① Adolescents aged 10-19; ② Meet the ICD-10 diagnostic criteria for mental disorders; ③ Normal facial emotion recognition ability: ④ Have normal communication skills; ⑤ Voluntary participation. (2) Inclusion criteria for parents: ① age ≥ 18 years old; ② normal facial emotion recognition ability: ③ no mental illness, cognitive dysfunction, facial scars and disabilities; ④ normal communication ability; ⑤ voluntary participation. 3. Expert meeting stage (1) Inclusion criteria: ① Intermediate professional title or above; ② Bachelor degree or above; ③ Engaged in psychiatric work for ≥ 5 years; ④ Nursing, psychiatry and mental health, and psychology professional fields; ⑤ 6-12 people. 4. Quantitative research stage:randomized controlled trial (1) Patient inclusion criteria: ① Adolescents aged 10-19; ② Meet the ICD-10 diagnostic criteria for mental disorders; ③ Treated by the same doctor in charge; ④ Have normal communication skills; ⑤ Voluntary participation. (2) Parent inclusion criteria: ① Age ≥18 years old; ② No mental illness, cognitive dysfunction, facial scars or disabilities; ③ Have normal communication ability; ④ Voluntary participation.

排除标准：

1.文献研究阶段-系统评价/Meta分析 (1)排除标准：①重复发表；②非中、英文；③数据不全；④会议、学位论文、报纸 2.质性研究阶段 （1）患者排除标准：① 合并其他严重疾病，如：恶性肿瘤；②外籍人员；③无法配合完成整个研究 （2）父母排除标准：①患有其他严重疾病，如：恶性肿瘤；②外籍人员；③无法配合完成整个研究 3.专家会议阶段 排除标准：中途退出 4.量性研究阶段-随机对照试验 （1）患者排除标准：① 合并其他严重疾病，如：恶性肿瘤；②面部情绪识别障碍；③外籍人员；④无法配合完成整个研究 （2）父母排除标准：① 合并其他严重疾病，如：恶性肿瘤；②面部情绪识别障碍；③外籍人员；④无法配合完成整个研究 （3）剔除标准：住院时间小于2周

Exclusion criteria：

1. Literature research stage:systematic review/meta analysis (1) Exclusion criteria: ① Duplicate publication; ② Non-Chinese or English; ③ Incomplete data; ④ Conferences, dissertations, newspapers 2. Qualitative research stage (1) Patient exclusion criteria : ① Combined with other serious diseases, such as: malignant tumors; ② Foreign personnel; ③ Unable to cooperate to complete the entire study. (2) Parental exclusion criteria: ①suffering from other serious diseases, such as: malignant tumors; ② Foreign personnel; ③ Unable to cooperate to complete the entire study. 3. Exclusion criteria for the expert meeting stage: dropped out midway 4. Quantitative research stage: randomized controlled trial (1) Patient exclusion criteria: ① Combined with other serious diseases, such as malignant tumors; ② Facial emotion recognition disorder; ③ Foreign personnel; ④ Unable to cooperate to complete the entire study. (2) Parental exclusion criteria: ① Combined with other serious diseases, such as: malignant tumors ; ② Facial emotion recognition disorder; ③ Foreign personnel; ④ Unable to cooperate to complete the entire study. (3) Exclusion criteria: hospitalization time is less than 2 weeks.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从From 2024-01-30 00:00:00 至 To 2025-06-01 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

51

Group：

Intervention group

Sample size：

干预措施：

在常规护理的基础上加上在Corss情绪调节理论的指导下，从认知注意、认知改变、反应调整三部分设计的干预措施：首先带领青少年精神障碍患者父母观看情绪觉察视频并反思，让父母意识到自己与孩子相处过程中容易出现的负性情绪及表现，帮助父母认识自身负性情绪，其次采用健康宣教的方式，给父母讲解青少年患者面对父母负性情绪时常见的心理变化与感受，帮助父母改变产生负性情绪事件的认知;最后，教会父母调节情绪的技巧，应对并调整自身与青少年患者日常相处中的负性情绪，减少自身的负性情绪的传递以减轻青少年患者的心理问题

干预措施代码：

Intervention：

On the basis of routine care and under the guidance of Corss emotion regulation theory, intervention measures are designed from three parts: cognitive attention, cognitive change, and response adjustment.First, parents of adolescent patients with mental disorders are led to watch the emotion awareness video and reflect on it, so that Parents can aware of the negative emotions and manifestations that are likely to occur when getting along with their children, and help parents understand their own negative emotions. Secondly, health education methods are used to explain to parents the common psychological changes and symptoms of adolescent patients when they face negative emotions from their parents.Meanwhile,it can help parents change their cognition of events that generate negative emotions.Finally, teach parents the skills to regulate their emotions, cope with and adjust their own negative emotions in their daily interactions with adolescent patients, and reduce the transmission of one's own negative emotions to alleviate the psychological problems of adolescent patients.

Intervention code：

组别：

对照组

样本量：

51

Group：

control group

Sample size：

干预措施：

给与入院常规护理。包括入院评估、环境熟悉，常规的心理护理和知识宣教、出院指导。

干预措施代码：

Intervention：

Provide routine care on admission,which Including admission assessment, environmental familiarization, routine psychological care and knowledge education, and discharge guidance.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南 

市(区县)：

 昆明 

Country：

Chian 

Province：

Yunnan 

City：

Kunming 

单位(医院)：

昆明医科大学第一附属医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Kunming Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

健康问卷抑郁量表

指标类型：

主要指标

Outcome：

PHQ-9

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

广泛性焦虑量表

指标类型：

主要指标

Outcome：

GAD-7

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

情绪调节量表

指标类型：

次要指标

Outcome：

The emotion Regulatio Questionaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

亲子关系问卷

指标类型：

次要指标

Outcome：

Parent-child relationship questionnaire

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：

近红外脑功能成像

组织：

Sample Name：

Functional Near-infrared Spectroscopy

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 10 岁 years
最大 Max age 60 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）：

由一名不知道研究假设的成员（非课题组成员）利用Excel的随机函数Rand生成随机分配序列，在Excel表格中第一列输入受试者编号1-102，第二列输入公式“=INT(RAND()*(B-A)+A)”，设置为在1-3中取整数，则能在第二列中得到随机生成的序号1或者2，把序号1对应的受试者编号判定为对照组，2对应的受试者编号判定为实验组。

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

A member does not know the research hypothesis who uses the random function Rand of Excel to generate a random allocation sequence. In the Excel table, enter the subject number from 1 to 102 in the first column, enter the formula "=INT(RAND()*(BA)+A)" in the second column, and set it to take an integer from 1 to 3, then you can randomly generated serial number 1 or 2 is obtained in the second column. The subject number corresponding to serial number 1 is determined as the control group, and the subject number corresponding to 2 is determined as the experimental 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：

1.研究对象施盲：进行负性情绪干预的青少年精神障碍患者父母不知道自己的分组情况； 2.测评者施盲：所涉及的量表均为自评量表，由不知道分组情况和研究假设的责任护士进行收集；生物学指标由一名医生采集

Blinding：

1.Blinding of research subjects: Parents of adolescents with mental disorders undergoing negative emotion intervention do not know their grouping status. 2.Blinding of evaluators: The scales involved are all self-rating scales, and it is the responsibility of those who do not know the grouping status and research hypotheses. Nurses collect; biological indicators are collected by a physician.

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

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）：

无

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

None

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：

1.质性研究数据采集 （1）采用手机录音进行访谈音频资料收集 2.量性研究数据采集 （1）量表-病历记录表：①患者一般资料问卷(性别、年龄、民族、病程、诊断、是否是首次住院)、健康问卷抑郁量表、广泛性焦虑量表、亲子关系量表；②父母一般资料问卷（年龄、性别、民族、婚姻状况、 居住地、文化程度、工作状态、照顾时间、支付方式）、健康问卷抑郁量表、广泛性焦虑量表、亲子关系量表、情绪调节量表、 （2）生物学采集系统：近红外脑功能成像设备 2.数据管理 （1）访谈音频资料：原始音频资料和转录后文本资料均由U盘备份，由Nvivo软件进行主题分析 （2）量表：纸质量表问卷由研究者本人保管，经双人核对录入Epidate后用SPSS软件进行统计学分析 （3）生物学资料：采集完成后，由研究者从采集电脑中进行数据U盘备份并分析

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

1. Qualitative research data collection (1) Use mobile phone recordings to collect interview audio data. 2. Quantitative research data collection (1) Scale-Medical Record Form: ①Patient general information questionnaire (gender, age, ethnicity, disease course, diagnosis , whether it is the first hospitalization), health questionnaire depression scale, generalized anxiety scale, parent-child relationship scale; ②Parents general information questionnaire (age, gender, ethnicity, marital status, place of residence, education level, working status, care time, payment method), Health Questionnaire Depression Scale, Generalized Anxiety Scale, Parent-Child Relationship Scale, Emotion Regulation Scale. (2) Biological acquisition system: near-infrared functional brain imaging equipment. 2. Data management (1) Interview audio Data: The original audio data and the transcribed text data were backed up by a U disk, and thematic analysis was performed by Nvivo software. (2) Scale: The paper scale questionnaire was kept by the researcher himself. After double checking, it was entered into Epidate and used for statistics analysis using SPSS software. (3) Biological data: After the collection is completed, the researcher will backup the data to a U diske from the collection computer and analyze it.

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：

  2024-01-15 10:42:34