此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Diagnostic Accuracy and Safety of the Attention-Deficit/Hyperactivity Disorder Auxiliary Evaluation System (AHEF) in Chinese Children Aged 6 to 12

2026年7月27日 更新者：Chongqing Jinsaixing Medical Technology Co., Ltd

A Multicenter Prospective Clinical Study: Evaluating the Diagnostic Efficacy and Safety of the Attention-Deficit/Hyperactivity Disorder Auxiliary Evaluation System (AHEF) in Chinese Children Aged 6 to 12

This clinical trial aims to evaluate the diagnostic efficacy and safety of the Attention Deficit Hyperactivity Disorder Assessment System (AHEF) in children aged 6 to 12 in China, while ensuring the safety of the subjects and maintaining the scientific integrity of the clinical trial.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

570

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100000
        • Capital Center for Children's Health, Capital Medical University
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、401122
        • Children's Hospital of Chongqing Medical University
        • 接触：
          • Shirong Cai
          • 电话号码：023-68370035/023-63664659
          • 邮箱：chcmull@163.com
    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • The third affiliated hospital of Sun Yat-Sen University
      • Shenzhen、Guangdong、中国、518000
        • Shenzhen Children's Hospital
    • Jiangsu
      • Nanjing、Jiangsu、中国、210000
        • Nanjing Women and children's healthcare hospital
    • Jilin
      • Changchun、Jilin、中国、130000
        • The First Hospital of Jilin University
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、201100
        • Children's Hospital of Fudan University
    • Sichuan
      • Chengdu、Sichuan、中国、610000
        • West China Second University Hospital,Sichuan University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Chinese children aged 6 to 12

描述

Inclusion Criteria:

  • Age range: 6-12 years old, gender not restricted;
  • For children presenting for an initial ADHD diagnostic visit: presenting with common symptoms of ADHD such as inattention, hyperactivity, impulsivity, learning difficulties, behavioral problems, etc., and requiring a comprehensive assessment to confirm the diagnosis; Normal children: showing no obvious abnormal manifestations in family and school life, such as parents or teachers' initial assessment indicating basic health and normal neurodevelopmental behavioral performance, with no relevant medical history;
  • Normal intelligence (Wechsler Intelligence Scale for Children IQ ≥ 85);
  • The patient and/or their guardian have agreed to participate in the study and have signed the informed consent form; for participants aged 8 and above, a pediatric informed consent form must also be signed.

Exclusion Criteria:

  • Suffering from mental disorders or other neurodevelopmental disorders (such as autism spectrum disorder, schizophrenia, bipolar disorder, depressive disorder, tic disorder, reading disorder, anxiety disorders or stress-related disorders that still meet the diagnostic criteria within the last 6 months), neurological diseases such as epilepsy, and brain organic diseases, etc.;
  • Acute stage of respiratory, digestive, circulatory, urinary, immune, endocrine system diseases or acute episodes of chronic diseases (such as common acute symptoms like fever, breathing difficulties, diarrhea, etc.) and those judged by the investigator to potentially affect the research results;
  • Hearing impairment with corrected hearing not within the normal range, visual impairment with corrected vision not within the normal range, visual impairments such as color blindness, and other visual or hearing problems affecting software users;
  • Those previously diagnosed with ADHD or suspected ADHD;
  • Those who have received, are receiving, or plan to receive any psychological treatment for ADHD or non-drug treatment for the nervous system, or other cognitive, psychological-related behavioral intervention treatments in the past 6 months;
  • Those who have received neurological drug treatment (especially ADHD treatment drugs) and are still within 5 half-lives after the last medication at the time of enrollment; those who are currently receiving or plan to receive any ADHD or neurological drug treatment during the trial;
  • Those who have had gaming addiction in the past;
  • Motor conditions (e.g., hand dysfunction) reported by family members or observed by the investigator that would interfere with the trial procedures.
  • Those who have had suicidal thoughts or the investigator judges that they have suicidal impulses, non-suicidal self-harm impulses;
  • Those who are participating in other clinical trials or have not completed other trials within 1 month;
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Sensitivity.
大体时间：Day 1
Day 1
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Specificity.
大体时间：Day 1
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chongqing Jinsaixing Medical Technology Co., Ltd

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月31日

初级完成 (估计的)

2027年1月30日

研究完成 (估计的)

2027年4月4日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年7月2日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • JSX-1003-PCT01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅