中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2100043525
最近更新日期： Date of Last Refreshed on：	2021-06-13 00:24:03
注册时间： Date of Registration：	2021-02-21 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	注意缺陷多动障碍基于全面认知功能评估的移动化靶向干预技术的开发与应用
Public title：	Development and application of computerized targeted intervention technology for attention deficit hyperactivity disorder based on multidimensional cognitive function evaluation
注册题目简写：
English Acronym：
研究课题的正式科学名称：	注意缺陷多动障碍基于全面认知功能评估的移动化靶向干预技术的开发与应用
Scientific title：	Development and application of computerized targeted intervention technology for attention deficit hyperactivity disorder based on multidimensional cognitive function evaluation
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：	党宸	研究负责人：	孙黎
Applicant：	Dang Chen	Study leader：	Sun Li
申请注册联系人电话： Applicant telephone：	+86 18813122787	研究负责人电话： Study leader's telephone：	+86 13331091808
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：	576076199@qq.com	研究负责人电子邮件： Study leader's E-mail：	sunlioh@bjmu.edu.cn
申请单位网址(自愿提供)： Applicant website(voluntary supply)：	http://www.pkuh6.cn/	研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：	http://www.pkuh6.cn/
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 Huayuan Road North, Haidian District, Beijing, China	Study leader's address：	51 Huayuan Road North, Haidian District, Beijing, China
申请注册联系人邮政编码： Applicant postcode：	100191	研究负责人邮政编码： Study leader's postcode：	100191
申请人所在单位：	北京大学第六医院
Applicant's institution：	Peking University Sixth Hospital
研究负责人所在单位：	北京大学第六医院
Affiliation of the Leader：	Peking University Sixth Hospital

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：	N/A	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（精神卫生研究所）伦理委员会
Name of the ethic committee：	Ethics Committee of Peking University Sixth Hospital (Institute of Mental Health)
伦理委员会批准日期： Date of approved by ethic committee：	2020-07-22 00:00:00
伦理委员会联系人：	孙洪强
Contact Name of the ethic committee：	Hongqiang Sun
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 Huayuan Road North, 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：

Peking University Sixth Hospital

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 Huayuan Road North, 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：	海淀区花园北路51号
Institution hospital：	Peking University Sixth Hospital	Address：	51 Huayuan Road North, Haidian District

经费或物资来源：

首都卫生发展科研专项项目

Source(s) of funding：

Capital Health Development Scientific Research Project

研究疾病：

注意缺陷多动障碍

Target disease：

Attention Deficit and Hyperactivity 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：

随机平行对照

Study design：

Parallel

研究目的：

注意缺陷多动障碍（ADHD）是一种常见的神经发育障碍性疾病，其儿童期患病率约为 5%左右。与年龄不相称的注意缺陷、冲动和多动是本病的三大核心症状。本病70%会延续至青少年，30-50%会持续终生，该病除了对患者的学业、职业和生活等方面产生广泛而深远的消极影响外，也给其家庭和社会造成沉重的负担；该病可治疗，但未得到适宜治疗，因而是重要的公共卫生问题。 ADHD涉及多个脑区及脑功能网络异常，存在多个领域的认知功能损害，包括注意、抑制、工作记忆、定势切换、计划、空间能力以及言语流畅性和基本的感知觉缺陷等。认知损害是患者学习困难的重要因素，也是家长十分苦恼的问题。因此，恢复患者的认知功能对促进其康复具有重要意义。目前，ADHD的常用治疗方法包括药物和非药物治疗。其中，药物治疗是ADHD的一线治疗选择，然而，尽管药物治疗虽然能够显著改善ADHD的核心症状，但长期随访研究发现，即使ADHD症状改善，其认知功能缺陷却不会完全消失，仍会对患儿社会功能及学业成绩产生持续的影响，因此，ADHD认知功能缺陷的康复日益受到临床医生的关注。近年来，大多数临床指南提出将药物和非药物干预相结合作为ADHD的一线治疗，以期产生不同治疗方式疗效的叠加或者协同。非药物治疗在改善认知功能方面可以在一定程度上弥补单纯药物治疗的不足，认知训练则是基于大脑可塑性理论，通过针对性反复认知训练，加强注意缺陷相关的脑区及脑网络功能，从而改善和提高患者在特定任务状态下的认知加工能力，训练的最终目标是能将这种与特定任务相关的行为改善迁移到日常生活当中。认知训练对于ADHD部分认知缺陷的干预效果已经被证实有效，但仍存在问题。ADHD的认知缺陷的异质性强，目前尚没有可以针对ADHD患者多个认知域功能进行全面评估的测评工具，无法根据患者认知障碍的个体差异进行有针对性的训练，评估和训练相脱节，故以往研究结果显示虽较训练前有改善，但并不能达到正常水平。综上，ADHD患者认知缺陷的表现复杂多样，涉及知觉组织、注意调节、冲突监测等认知域。目前国内外尚未见在全面评价ADHD患者的认知功能缺陷的基础上，有针对性地设计干预训练方案的研究。因此，本研究拟在药物治疗的基础上合并基于ADHD多维度认知评估的电子化靶向认知训练技术，弥补药物治疗方式的不足，以期进一步消除药物治疗的残余症状、改善预后。本研究为进一步优化ADHD 综合治疗的疗效以及如何制定相关的训练方案提供了循证依据，同时为今后该训练方案在我国推广应用做了必要的准备，因而具有极其重要的研究意义。

Objectives of Study：

Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder with a childhood prevalence of about 5%. Attention deficit, impulsivity and hyperactivity disproportionate to age are the three core symptoms of this disease. 70% of the disease will continue to teenagers, and 30-50% will last for life. In addition to the extensive and far-reaching negative impact on the patient's studies, occupation and life, the disease also causes a heavy burden on the family and society; The disease is treatable, but it is not properly treated, and therefore is an important public health problem. ADHD involves multiple brain areas and abnormal brain function networks, and there are cognitive impairments in multiple areas, including attention, inhibition, working memory, set switching, planning, spatial ability, speech fluency, and basic sensory defects. Cognitive impairment is an important factor for patients with learning difficulties, and it is also a very distressing problem for parents. Therefore, restoring the cognitive function of patients is of great significance to promoting their rehabilitation. At present, the common treatment methods for ADHD include drug and non-drug treatment. Among them, drug therapy is the first-line treatment option for ADHD. However, although drug therapy can significantly improve the core symptoms of ADHD, long-term follow-up studies have found that even if the symptoms of ADHD improve, the cognitive deficits will not completely disappear, and they will still be affected. Children's social function and academic performance have a continuous impact. Therefore, the rehabilitation of ADHD cognitive deficits has attracted increasing attention from clinicians. In recent years, most clinical guidelines have proposed combining drugs and non-pharmaceutical interventions as the first-line treatment of ADHD, in order to produce superimposition or synergy of the effects of different treatment methods. Non-drug therapy can make up for the deficiency of drug therapy to a certain extent in improving cognitive function. Cognitive training is based on the theory of brain plasticity. Through targeted repeated cognitive training, it can strengthen the brain area and brain network functions related to attention deficit. , So as to improve and improve the cognitive processing ability of patients in a specific task state. The ultimate goal of training is to transfer the improvement of this specific task-related behavior to daily life. Cognitive training has been proven effective in the intervention of some cognitive deficits in ADHD, but there are still problems. The cognitive deficits of ADHD are highly heterogeneous. Currently, there is no evaluation tool that can comprehensively evaluate the functions of multiple cognitive domains in ADHD patients, and it is impossible to conduct targeted training, evaluation and training according to the individual differences of patients with cognitive impairment. It is out of touch, so previous research results show that although it is improved compared with before training, it does not reach the normal level. In summary, the performance of cognitive deficits in ADHD patients is complex and diverse, involving cognitive domains such as perceptual organization, attention adjustment, and conflict monitoring. At present, there is no research at home and abroad to design a targeted intervention training program based on a comprehensive evaluation of the cognitive deficits of ADHD patients. Therefore, this study intends to incorporate electronic targeted cognitive training technology based on multi-dimensional cognitive assessment of ADHD on the basis of drug therapy to make up for the shortcomings of drug therapy, in order to further eliminate the residual symptoms of drug therapy and improve the prognosis. This study provides an evidence-based basis for further optimizing the efficacy of ADHD comprehensive treatment and how to formulate related training programs. At the same time, it has made necessary preparations for the promotion and application of this training program in my country in the future, so it has extremely important research significance.

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：

1）儿童精神分裂症、情感障碍、精神发育迟滞、孤独症、癫痫等及其它神经系统器质性疾病；
2）明显躯体及神经系统异常、听力或视力明显受损者；
3）目前参加其它非药物治疗者。

Exclusion criteria：

1) Childhood schizophrenia, affective disorder, mental retardation, autism, epilepsy, etc. and other organic diseases of the nervous system;
2) Those with obvious physical and nervous system abnormalities, hearing or vision impaired;
3) Currently participating in other non-drug treatments.

研究实施时间：

Study execute time：

从 From 2021-03-01 00:00:00至 To 2023-06-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-03-01 00:00:00 至 To 2022-09-01 00:00:00

干预措施：

Interventions：

组别：	联合治疗组	样本量：	120
Group：	Combined Group	Sample size：	120
干预措施：	药物+认知训练	干预措施代码：
Intervention：	medication and cognitive training	Intervention code：

组别：	药物治疗组	样本量：	120
Group：	Medicated Group	Sample size：	120
干预措施：	药物（哌甲酯）	干预措施代码：
Intervention：	medication only	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)：	海淀区
Country：	China	Province：	Beijing	City：	Haidian District
单位(医院)：	北京大学第六医院	单位级别：	三级甲等
Institution hospital：	Peking University Sixth Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	北京	市(区县)：	朝阳区
Country：	China	Province：	Beijing	City：	Chaoyang District
单位(医院)：	首都儿科研究所附属儿童医院	单位级别：	三级甲等
Institution hospital：	Children's Hospital Capital Institute of Pediatrics	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	ADHD评定量表家庭版	指标类型：	主要指标
Outcome：	ADHD-RS-IV	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	儿童行为量表	指标类型：	主要指标
Outcome：	child behavior checklist, CBCL	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Conner父母症状问卷	指标类型：	主要指标
Outcome：	parent symptom questionaire, PSQ	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：

标本中文名：	本研究中不涉及人体标本采样	组织：
Sample Name：	N/A	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	7	岁 years
最大 Max age	16	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）：

拟采用采用随机对照研究设计，信封法隐藏。随机化方法采用1:1区组随机方案，按患者入组时间顺序分配随机信封、并使两组被试用药情况（哌甲酯和托莫西汀）、年龄、性别、ADHD亚型、疾病严重程度等均衡可比。

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

It is planned to adopt a randomized controlled study design with envelope method. The randomization method adopts a 1:1 block randomization scheme, and assigns random envelopes according to the time sequence of patients' enrollment, and makes the two groups of trial drugs (methylphenidate and atomoxetine), age,

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：	未说明
Blinding：	Not stated
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	待实验结束文章撰写完成后，通过网络平台ResMan临床试验公共管理平台上传数据，http://www.medresman.org.cn。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	ResMan, http://www.medresman.org.cn.
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：	项目负责人负责总体设计及组织实施，每个临床中心安排一名课题协调员负责项目计划、组织协调和数据管理；并由其他精神科医师及研究生负责纳入患者、临床评估、认知功能评估及统计分析，保证项目保质、保量顺利执行。研究者首先给患者及家长讲解训练软件的使用方法，确保患者能严格按照操作流程来进行训练，并通过后台监控训练过程并导出受试者的训练数据，以保证训练质量。建立资料完备的患者档案，以便定期联系及随访评估，保证患者的培训依从性。数据采用Epidata录入和管理，在原始资料收集一周内录入数据库，数据不完整或有疑问者及时补充核实。数据分析由卫生统计专业人员核查。在课题实施的全程进行质量控制。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The project leader is responsible for the overall design and organization and implementation. Each clinical center arranges a project coordinator to be responsible for project planning, organization and coordination and data management; and other psychiatrists and graduate students are responsible for patient inclusion, clinical evaluation, cognitive function evaluation and Statistical analysis to ensure the smooth implementation of the project quality and quantity. The researcher first explained the use of the training software to the patients and their parents to ensure that the patients can be trained in strict accordance with the operating procedures, and the training process is monitored in the background and the training data of the subjects is exported to ensure the quality of training. Establish patient files with complete data for regular contact and follow-up evaluation to ensure patient training compliance. The data is entered and managed by Epidata, and entered into the database within one week of the original data collection. Those with incomplete data or doubts will be added and verified in time. Data analysis is verified by health statistics professionals. Carry out quality control throughout the implementation of the project.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2021-02-21 07:21:05