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Evaluating the Efficacy of Central Executive Training (CET) For Young Children With ADHD

2026年8月20日 更新者:Michael J. Kofler、Florida State University
Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET), followed by a randomized controlled trial of CET+BPT for young children with ADHD.

研究概览

详细说明

Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET) [R61 Phase], followed by a randomized controlled trial of CET+BPT for young children with ADHD [R33 Phase].

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

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

  • 姓名:Children's Learning Clinic
  • 电话号码:850-645-7423
  • 邮箱:clc@psy.fsu.edu

学习地点

    • Florida
      • Tallahassee、Florida、美国、32306
        • 招聘中
        • Children's Learning Clinic at Florida State University
        • 接触:
          • Children's Learning Clinic
          • 电话号码:850-645-7423
          • 邮箱:clc@psy.fsu.edu
        • 首席研究员:
          • Michael Kofler, PhD

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

不

描述

Inclusion Criteria:

  • principal ADHD diagnoses (via K-SADS); (b) parent BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range (>90th percentile) based on age and sex; (c) teacher BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range based on age and sex

Exclusion Criteria:

  • (a) gross neurological, sensory, or motor impairment; (b) history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (e.g., disruptive mood dysregulation, conduct, intermittent explosive, reactive attachment); (c) intellectual disability or WPPSI/WISC short-form FSIQ<70; (d) conditions requiring acute intervention, e.g., active suicidality; and (e) non-English speaking child or parent.

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Central executive training
Computerized, adaptive central executive working memory training protocol
有源比较器:Behavioral parent training
Behavioral parent training
其他:Central executive training + concurrent behavioral parent training
Computerized, adaptive central executive working memory training protocol
Behavioral parent training
无干预:Treatment as usual/waitlist

研究衡量的是什么?

主要结果指标

结果测量
大体时间
ADHD Rating Scale (ADHD-RS)
大体时间:Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

次要结果测量

结果测量
措施说明
大体时间
Secondary outcomes (T-scores)
大体时间:Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Informant reports of social skills, emotion regulation, parent-child relationships, and impairments
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Feasibility/acceptability
大体时间:Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Client satisfaction, system usability, expectancies
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

其他结果措施

结果测量
大体时间
Working memory test battery
大体时间:Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Actigraphy (Proportional Integrating Measure)
大体时间:Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Academic performance rating scale
大体时间:Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

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。

调查人员

  • 首席研究员:Michael Kofler, PhD、Florida State University

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 (实际的)

2024年5月1日

初级完成 (估计的)

2030年12月1日

研究完成 (估计的)

2030年12月1日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月20日

首次发布 (实际的)

2026年8月25日

研究记录更新

最后更新发布 (实际的)

2026年8月25日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 4R33MH127031
  • 5R61MH127031 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Anonymized individual participant data that underlie results in a publication will be shared upon reasonable request, subject to approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).

IPD 共享时间框架

During peer review of study manuscript or after publication, after obtaining approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).

IPD 共享访问标准

Approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).

IPD 共享支持信息类型

  • 分析代码

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.

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