A multi-site feasibility clinical trial of Retraining and Control Therapy (ReACT), a mind and body treatment for pediatric functional seizures

项目总结/摘要 功能性癫痫（functional seizures，FS）是一种以癫痫样发作为特征的功能性神经系统疾病（functional neurological disorder，FND）。 没有脑电图相关的症状FS严重削弱了儿童和家庭，使其成为 严重的临床和社会负担。最近的研究表明，控制感是一个潜在的目标， 儿科FS治疗。我们先前发表的研究表明，患有FS的儿童感觉能力下降， 对自己行为的控制能力。只有一项随机对照试验（RCT） 到目前为止，已经进行了儿科FS的治疗，评估了再训练和控制治疗 （ReACT）。由PI开发的ReACT是一种新颖的适应性干预措施，旨在增加控制感 通过正念和习惯逆转的原则，一个公认的治疗非自愿抽搐。我们最近 已发表的试点RCT表明，与对照组相比，ReACT导致FS频率显著降低。 支持性治疗，82%的儿童在ReACT后保持无FS ≥2个月。此外，我们的 初步数据表明，ReACT后控制感显著改善， 后ReACT与FS频率降低显著相关，表明控制感是有效的目标 改善FS。本研究的目的是进行ReACT的多中心试点可行性临床试验， 儿童FS的身心治疗。在这项研究中，54名11-18岁被诊断患有FS的青少年将被 随机参与ReACT或基于CATCH-IT的网络干预（经验证用于治疗 儿童）在三个地点：亚拉巴马大学伯明翰分校，耶鲁医学院/耶鲁新 黑文儿童医院和贝勒医学院/德克萨斯儿童医院。FS频率为 从治疗前30天到治疗后2个月测量。参与者和家庭成员将 治疗前7天以及治疗后7天和2个月完成基线和随访评估 治疗招聘和留用的可行性将通过实现年度招聘目标来衡量， 完成2个月随访的参与者百分比。会议将被录像，20%的 将使用已发表的指南对治疗保真度进行编码，以评估干预保真度， 行为临床试验参与者对ReACT的依从性将通过推荐的 完成治疗疗程，参与者和父母将报告患者是否使用了治疗计划， 每次FS发作使用FS日记。

Project Summary/Abstract Functional seizures (FS) are a type of functional neurological disorder (FND) characterized by seizure-like symptoms without EEG correlates. FS are severely debilitating to children and families, making this a significant clinical and societal burden. Recent research has revealed sense of control as a potential target for pediatric FS treatment. Our previously published study demonstrated children with FS have decreased sense of control over their actions compared to matched controls. Only one randomized controlled trial (RCT) for treatment of pediatric FS has been conducted to date, which evaluated Retraining and Control Therapy (ReACT). ReACT, developed by the PI, is a novel, adaptive intervention that aims to increase sense of control via mindfulness and principles of habit reversal, a well-established treatment for involuntary tics. Our recently published pilot RCT demonstrated that ReACT resulted in significantly reduced FS frequency compared to supportive therapy, with 82% of children remaining FS-free for ≥2 months after ReACT. Further, our preliminary data suggest sense of control significantly improves after ReACT, and increased sense of control after ReACT is significantly related to reduced FS frequency, indicating sense of control is an effective target for improving FS. The purpose of this study is to conduct a multi-site pilot feasibility clinical trial of ReACT, a mind and body treatment for pediatric FS. In the study, 54 11-18-year-olds diagnosed with FS will be randomized to engage in ReACT or the CATCH-IT web-based intervention (validated for treating mood in children) at three sites: the University of Alabama at Birmingham, the Yale School of Medicine/Yale New Haven Children’s Hospital and Baylor College of Medicine/Texas Children’s Hospital. FS frequency will be measured from 30 days before treatment to 2 months after treatment. Participants and a family member will complete baseline and follow-up assessments 7 days before treatment and 7 days and 2 months after treatment. Feasibility of recruitment and retention will be measured by meeting annual recruitment goals and the percent of participants who complete the 2-month follow-up. Sessions will be videotaped, and 20% of therapy sessions will be coded for treatment fidelity using published guides to assess intervention fidelity in behavioral clinical trials. Participant adherence to ReACT will be assessed by the percent of recommended treatment sessions completed, and participants and parents will report if the patient used the treatment plan for each FS episode using a FS diary.