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

再训练和控制疗法 (ReACT) 的多中心可行性临床试验，这是一种针对儿童功能性癫痫发作的身心治疗方法

• 批准号: 10648379
• 负责人: Aaron D Fobian
• 金额: $ 57.45万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10648379
• 关键词: 18 year old; Address; Adherence; Adolescence; Adult; Aftercare; Alabama; Anxiety; Awareness; Behavioral; Benchmarking; Child; Childhood; Clinic; Clinical; Clinical Treatment; Clinical Trials; Code; Cognitive; Cognitive Therapy; Conscious; Data; Diagnosis; Dimensions; E-learning; Electroencephalography; Enrollment; Epilepsy; Evidence based treatment; Family; Family member; Frequencies; Fright; Functional Imaging; Future; Goals; Habits; Hearing; Individual; Intervention; Measures; Medicine; Moods; Parents; Participant; Patients; Pediatric Hospitals; Persons; Placebos; Preparation; Provider; Publishing; Questionnaires; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Schools; Seizures; Selective Serotonin Reuptake Inhibitor; Site; Supportive care; Symptoms; Techniques; Texas; Time; Training; Treatment Side Effects; Unconscious State; Universities; Videotape; Work; adaptive intervention; arm; behavioral clinical trial; clinically significant; college; common symptom; diaries; effective therapy; efficacy trial; emerging adult; experience; follow up assessment; follow-up; imaging study; improved; medical schools; meetings; mind/body; mindfulness; multi-site trial; nervous system disorder; novel; prevent; recruit; response; standard care; standard of care; targeted treatment; treatment planning; web platform; web-based intervention

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.

项目摘要/摘要 功能性癫痫是一种以癫痫样发作为特征的功能性神经功能障碍 没有脑电波的症状是相关的。FS严重削弱了儿童和家庭的能力，使这成为一种 严重的临床和社会负担。最近的研究表明，控制感是 儿科FS治疗。我们之前发表的研究表明，患有FS的儿童感觉能力下降 与匹配的对照组相比，他们对自己的行为有更强的控制力。只有一项随机对照试验(RCT) 到目前为止，已经对儿童FS进行了治疗，评估了再培训和控制治疗 (反应)。由PI开发的Reaction是一种旨在增加控制感的新型适应性干预 通过正念和习惯逆转的原则，这是一种公认的治疗非自愿抽搐的方法。我们最近 已发表的试验性RCT显示，与ACTION相比，REACT导致FS频率显著降低 支持性治疗，在反应后2个月，82%的儿童保持无FS的≥。此外，我们的 初步数据显示，反应后控制感显著改善，控制感增强 反应后与FS频率降低显著相关，表明控制感是有效的靶标 用于改善FS。这项研究的目的是进行一项多点试点可行性临床试验，一个 儿童FS的精神和身体治疗。在这项研究中，54名11-18岁的被诊断为FS的人将被 随机参加Reaction或Catch-IT基于网络的干预(验证用于治疗情绪 儿童)在三个地点：阿拉巴马大学伯明翰分校、耶鲁医学院/耶鲁大学纽约分校 黑文儿童医院和贝勒医学院/德克萨斯儿童医院。FS频率将为 治疗前30天至治疗后2个月。参与者和一名家庭成员将 在治疗前7天、治疗后7天和2个月后完成基线和随访评估 治疗。招聘和保留的可行性将通过实现年度招聘目标和 完成2个月随访的参与者的百分比。会议将被录像，20%的 将使用出版的指南对治疗过程进行编码，以评估介入治疗的保真度 行为临床试验。参与者对回应的忠诚度将根据推荐的百分比进行评估 治疗疗程结束，参与者和家长将报告患者是否使用治疗计划 使用FS日记记录每一集FS。