NCT05819268 A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
| NCT ID | NCT05819268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Functional Seizures |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2024-03-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2024-03-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Males and females ages 11-18 * Diagnosis of functional seizures * Internet access for telehealth sessions and CATCH-IT Exclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05819268 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 18 Years, studying Functional Seizures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05819268 currently recruiting?
Yes, NCT05819268 is actively recruiting participants. Contact the research team at afobian@uabmc.edu for enrollment information.
Where is the NCT05819268 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05819268 clinical trial?
NCT05819268 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 108 participants.