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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to assess the feasibility of conducting a future fully powered multi-site efficacy Randomized Controlled Trial (RCT) comparing two treatments for pediatric functional seizures (FS). In this study, 11-18-year-olds diagnosed with FS will be randomized to 12 sessions of Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) at 3 sites: University of Alabama at Birmingham, Yale School of Medicine/Yale New Haven Children's Hospital and Baylor College of Medicine/Texas Children's Hospital. Feasibility of recruitment will be measured by the percentage of planned participant enrollment target obtained at each site and overall during the 18 months of planned enrollment. Acceptability will be assessed using the Acceptability Questionnaire. Participant retention will be measured by the percent of enrolled participants that complete the 2-month follow-up visit at each site and overall. For treatment fidelity assessment, 20% of each therapist's sessions will be randomly chosen and assessed for fidelity. Patient adherence will be measured in two ways: 1) the percent of ReACT or CATCH-IT sessions completed at each site and overall and 2) for ReACT, the percent of times participants report using the treatment plan during FS episodes (measured by FS diary) and for CATCH-IT, the number of times parents and children spend using CATCH-IT each week (measured by the CATCH-IT platform). These data will be used to support a future fully-powered multi-site RCT assessing the efficacy of ReACT for pediatric FS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 18
Healthy Volunteers: f
View:

• Males and females ages 11-18

• Diagnosis of functional seizures

• Internet access for telehealth sessions and CATCH-IT

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Aaron Fobian, PhD
afobian@uabmc.edu
205-934-2241
Time Frame
Start Date: 2024-03-18
Estimated Completion Date: 2027-08
Participants
Target number of participants: 108
Treatments
Experimental: ReACT Intervention
During the initial visit participant will be randomized to either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) intervention.~ReACT includes 12 sessions with a therapist that will discuss a plan for managing FS.~Participants will have 12 therapy sessions. The first session will be in-person which will last 2 hours and the subsequent 11 sessions will be conducted via video telehealth and each session will last 1 hour.
Active_comparator: CATCH-IT Intervention
During the initial visit participant will be randomized to either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) intervention.~CATCH-IT involves the parent and child completing 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.~Participants will have 12 therapy sessions. The first session will be in-person which will last 2 hours and the subsequent 11 sessions will be conducted via video telehealth and each session will last 1 hour.
Related Therapeutic Areas
Sponsors
Collaborators: Yale University, Baylor College of Medicine
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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