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注册号: Registration number: |
ChiCTR2600124462 |
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最近更新日期: Date of Last Refreshed on: |
2026-05-12 17:17:58 |
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注册时间: Date of Registration: |
2026-05-12 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
青少年心理危机的多元家庭治疗模式研究 |
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Public title: |
Research on the Multivariate Family Therapy Model for Adolescent Psychological Crisis |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
青少年心理危机的多元家庭治疗模式研究 |
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Scientific title: |
Research on the Multivariate Family Therapy Model for Adolescent Psychological Crisis |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
余恺涛 |
研究负责人: |
唐光政 |
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Applicant: |
Yu Kaitao |
Study leader: |
Tang Guangzheng |
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申请注册联系人电话: Applicant telephone: |
+86 191 1719 4289 |
研究负责人电话:
Study leader's |
+86 151 5713 2507 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
Kaitaoyu@126.com |
研究负责人电子邮件: Study leader's E-mail: |
Hblim2002@163.com |
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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): |
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申请注册联系人通讯地址: |
浙江省杭州市西湖区天目山路 305 号 |
研究负责人通讯地址: |
浙江省杭州市西湖区天目山路 305 号 |
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Applicant address: |
No. 305 Tianmu Mountain Road, Xihu District, Hangzhou, Zhejiang Province, 310013, China |
Study leader's address: |
No. 305 Tianmu Mountain Road, Xihu District, Hangzhou, Zhejiang Province, 310013, China |
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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: |
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申请人所在单位: |
杭州市第七人民医院 |
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Applicant's institution: |
Hangzhou Seventh People’s Hospital |
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研究负责人所在单位: |
杭州市第七人民医院 |
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Affiliation of the Leader: |
Hangzhou Seventh People’s Hospital |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
研(2026年)伦审第(004)号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
杭州市第七人民医院伦理审查委员会 |
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Name of the ethic committee: |
Hangzhou Seventh People's HospitalEthics Committee Approval Letter of BiomedicalResearch Involving Humans |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-01-14 00:00:00 | ||
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伦理委员会联系人: |
张雨桐 |
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Contact Name of the ethic committee: |
zhang yutong |
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伦理委员会联系地址: |
浙江省杭州市西湖区天目山路 305 号 |
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Contact Address of the ethic committee: |
No. 305 Tianmu Mountain Road, Xihu District, Hangzhou, Zhejiang Province, 310013, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 134 5693 3553 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
杭州市第七人民医院 |
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Primary sponsor: |
Hangzhou Seventh People’s Hospital |
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研究实施负责(组长)单位地址: |
浙江省杭州市西湖区天目山路 305 号 |
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Primary sponsor's address: |
No. 305 Tianmu Mountain Road, Xihu District, Hangzhou, Zhejiang Province, 310013, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
国家社会科学基金项目(批准号:22CSH056) |
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Source(s) of funding: |
Youth Project of National Social Science Fund of China(22CSH056) |
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研究疾病: |
青少年心理危机 |
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Target disease: |
Adolescent Psychological Crisis |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
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Study phase: |
0 |
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研究设计: |
随机交叉对照 |
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Study design: |
Cross-over |
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研究目的: |
主要目的:本研究旨在基于杭州市第七人民医院的临床场域,探索多家庭治疗(Multiple Family Therapy, MFT)在干预青少年心理/情绪困扰中的可行性、有效性及其作用机制。通过在真实医疗环境下的前瞻性干预研究,检验MFT在改善青少年心理症状、促进家庭功能恢复、提升亲职效能与家长心理健康方面的作用效果。 |
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Objectives of Study: |
Primary Objective: This study aims to explore the feasibility, effectiveness, and mechanism of Multiple Family Therapy (MFT) in intervening adolescent psychological/emotional distress based on the clinical setting of Hangzhou Seventh People’s Hospital. Through a prospective intervention study conducted in a real‑world clinical environment, it examines the effects of MFT on alleviating adolescents’ psychological symptoms, restoring family functioning, and improving parenting efficacy and parental mental health. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.患者处于高自杀风险期,需靠药物或其他强制措施保证安全 2.不能讲或理解普通话 3.伴随严重智力发展迟缓或其他严重发展障碍(例如严重的自闭症) |
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Exclusion criteria: |
1. The patient is in a high suicide risk period and requires medication or other compulsory measures to ensure safety. 2. Cannot speak or understand Mandarin. 3. Accompanied by severe intellectual developmental delay or other serious developmental disorders (e.g., severe autism). |
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研究实施时间: Study execute time: |
从 From 2026-01-15 00:00:00至 To 2026-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-05-15 00:00:00 至 To 2026-12-31 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
本研究采用简单随机抽样,使用 SPSS 26.0 统计软件生成随机数字序列,将符合入组标准的 60 例青少年及其家庭按 1:1 比例随机分配至对照组(常规服务)与实验组(多元家庭治疗),每组各 30 例。随机序列由不参与临床评估与干预的独立研究人员生成并密封保管,实施者、评估者对分组结果不提前知晓。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Randomization Method: A simple random sampling method is adopted in this study. A random number sequence is generated using SPSS 26.0 statistical software. Sixty eligible adolescents and their families are randomly assigned to the control group (routine services) and the experimental group (Multiple Family Therapy, MFT) at a 1:1 ratio, with 30 cases in each group. The random sequence is generated and sealed by an independent researcher who is not involved in clinical assessment or intervention. Implementers and assessors are blinded to group allocation in advance. |
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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 |
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盲法: |
本研究不设盲。 |
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Blinding: |
Blinding will not be applied in this study. |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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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 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
NA |
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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 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
CRF |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |