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.

项目总结/文摘