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.
Males and females ages 11-18
Diagnosis of functional seizures
Internet access for telehealth sessions and CATCH-IT
Comorbid epilepsy
Less than 4 functional seizures per month
Other paroxysmal nonepileptic events (e.g. hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
Participation in other therapy
Parallel
ReACT
BehavioralReACT includes 12 sessions with a therapist that will discuss a plan for managing FS.
CATCH-IT
BehavioralCATCH-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.
Feasibility of Recruitment
Feasibility of recruitment will be measured by the percentage of the planned participant enrollment target obtained at each site and overall during the 18 months of planned enrollment. This includes any participant who completes informed consent/assent.
Acceptability
Acceptability will be assessed using the Acceptability Questionnaire. The Acceptability Questionnaire is based on a published theoretical framework for assessment of acceptability of healthcare interventions and assesses acceptability of being randomized to ReACT vs. CATCH-IT, acceptability of the treatment received and presence of treatment side effects associated with ReACT or CATCH-IT, including all side effects associated with mindfulness. For each reported side effect, the duration, tolerability, perceived unpleasantness, impact on functioning and acceptability based on treatment benefit will be obtained.
Participant Retention
With the goal of analyzing data from the subsequent efficacy trial with an intention-to-treat analysis, participant retention will be measured by the percent of enrolled participants that complete the 2-month follow-up visit at each site and overall.
Participant Adherence
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).
Treatment Fidelity
Fidelity will be stratified by site and therapist/coach, such that 20% of each therapist/coach's sessions will be randomly chosen for fidelity assessment. The ReACT Fidelity Rating Scale includes assessment of the therapists' correct use of the ReACT Treatment Determination Tool, therapeutic alliance and empathy with the patient and family, development of opposing responses and use of motivators to reinforce progress. Fidelity to CATCH-IT sessions will be measured by the CATCH-IT coach fidelity scale, which assesses conduct of the motivational interview, review of the CATCH-IT sessions, therapeutic alliance and empathy with the patient and family.
Functional seizure frequency
FS Diaries will be completed in REDCap by parents and children to prospectively track FS frequency from 7 days prior to treatment through 12 months post treatment, including date, time, location, duration and nature of symptoms. Those in ReACT will report if they used their treatment plan for each FS and track each FS they prevented with the plan. They will retrospectively report FS for the 3 weeks prior to initial screening. Discrepancies in parent and adolescent report will be discussed and rectified to improve accuracy
Sense of Agency scale
Sense of Control Scale is a single question which asks, "How much control do you believe you have over your FS?" at baseline and post follow-up visits. Scores range from 0-3 with a higher score indicating no control over functional seizures.
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University of Alabama at Birmingham
Lead sponsor
Yale University
Collaborator
Baylor College of Medicine
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
