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

Recruiting now · Not applicable

Conditions studied: Functional Seizures, Convulsion, Non-Epileptic

In brief

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.

Key facts

Study ID

NCT05819268

Run by

University of Alabama at Birmingham

People needed

108

Starts

2024-03-18

Expected to finish

2027-08-01

Last updated by the study team

2026-03-17

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females ages 11-18
• Diagnosis of functional seizures
• Internet access for telehealth sessions and CATCH-IT

You may not qualify if…

• 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
• Severe intellectual disability
• Severe mental illness (active delusions/hallucinations)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.