之旅2.0研究设计和方法:对患有的青少年进行执行功能干预的随机试验
Angela B Combs1, Janelle L Wagner2, Heather Huszti3
1Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Contemporary clinical trials communications
|February 3, 2026
概括
这项研究介绍了Epilepsy Journey 2.0,一种旨在改善青少年执行功能 (EF) 的电子健康干预措施. 该试验包括一项随机对照试验,将干预的不同组成部分与常规护理进行比较.
科学领域:
- 神经学 神经学
- 儿科健康 儿科健康
- 数字健康干预措施 数字健康干预措施
背景情况:
- 执行功能 (EF) 缺陷在患有的青少年中很常见,会对学术,社会和生活质量产生负面影响.
- 目前专门针对儿科的EF缺陷的现有干预措施有限.
- 之旅 (EJ) 是一个有前途的电子健康,解决问题的干预,结合了自我引导的模块和治疗师领导的远程医疗会议.
研究的目的:
- 描述多站点第三阶段随机对照试验 (RCT; EJ 2.0) 的方法,咨询委员会反,协议修改和进展.
- 评估EJ 2.0干预措施在改善青少年执行功能行为的有效性.
主要方法:
- 一个多部位的第3期RCT (EJ 2.0) 涉及患有的13-17岁的青少年.
- 参与者被随机分为四组:只有EJ模块,只有EJ远程医疗,具有远程医疗的EJ模块,或通常的护理.
- 干预手臂的重点是解决与积极思维,工作记忆,组织,抑制,情绪调节和睡眠/压力相关的问题.
主要成果:
- 在RCT之前,一个咨询委员会就招聘,保留,测量和干预组件提供了有价值的反.
- 研究小组在早期招聘方面取得了重大进展,尽管短暂的资金缺口.
- 通过咨询反进行的协议更改对于试验的成功启动和执行至关重要.
结论:
- 欧洲日报2.0研究能够提供关于儿童中EF缺陷的电子健康干预的关键数据.
- 咨询委员会的投入显著提高了干预设计和试验执行.
- 早期招聘进展表明,对EJ 2.0干预的可行性和参与者的兴趣.
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