A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures

This study aims to conduct a multi-site pilot feasibility Randomized Controlled Trial (RCT) at the University of Alabama at Birmingham, Yale College of Medicine/Yale New Haven Children's Hospital and Baylor College of Medicine/Texas Children's Hospital. Participants with functional seizures (FS) will be screened for eligibility over a phone call and eligible participants will be invited for a baseline visit. Participants with FS and their parent/guardian will then complete a baseline visit and 2 follow-up visits via HIPAA-compliant Zoom, 1 in-person initial therapy session and 11 video telehealth follow-up therapy sessions via HIPAA-compliant Zoom. During the initial baseline visit, participants and their family member/caregiver will complete several questionnaires assessing demographics, mood, relationships with friends and family, as well as past and current FS symptoms. Participants will receive a functional seizure diary to record all episodes during the course of the study. This visit will last about an hour and a half to 2 hours. They will then be randomized to 12 sessions of either Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) or Retraining and Control Therapy (ReACT). CATCH-IT involves the parent and child completing Cognitive Behavioral Therapy (CBT) modules on the web-based CATCH-IT platform, and they will meet with a CATCH-IT coach 12 times to discuss the modules and plan how to apply this to their life and their FS. ReACT includes 12 sessions with a therapist that will discuss a plan for managing FS. The first session for each intervention will be in-person with the subsequent 11 sessions conducted via video telehealth. Individual study teams from the 3 participating sites will conduct the ReACT or CATCH-IT interventions at their respective sites. The first therapy session will last about 2 hours and the subsequent 11 telehealth sessions will last about an hour. There will be 2 follow-up visits via HIPAA-compliant Zoom which will follow the same protocol as the baseline visit. The first follow-up visit will be one week after the 12th therapy session, and the second follow-up visit will be two months after the 12th therapy session. Both these sessions will last about an hour. Participants will also have the opportunity to undergo the therapy to which they were not randomized to after completing the 2-month follow-up after 12th therapy session. There will be two long term follow-up visits via HIPAA-compliant Zoom, at 6 months after the final intervention session and at 12 months after the final intervention session where participants and parents will complete few questionnaires. Both these visits will last about 45 minutes.