Actively Recruiting
A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
Led by University of Alabama at Birmingham · Updated on 2026-03-17
108
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
Y
Yale University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of conducting a larger multi-site randomized controlled trial comparing two treatments for children and teenagers aged 11 to 18 who have functional seizures (FS). This study focuses on testing how well recruitment, retention, acceptability, treatment adherence, and therapy fidelity work across three 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. Participants will be randomly assigned to receive either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT). Both treatments include 12 therapy sessions, with the first session held in person lasting about 2 hours and the following 11 sessions delivered via video telehealth lasting about 1 hour each. ReACT involves working with a therapist to develop a plan to manage seizures, while CATCH-IT uses online CBT modules for the parent and child, supported by 12 coaching sessions. Participants and their caregivers will complete baseline and follow-up visits via secure video calls, including questionnaires about mood, relationships, and seizure symptoms. They will keep a seizure diary throughout the study. Follow-ups occur one week and two months after therapy ends, with additional long-term follow-ups at six and twelve months. Researchers will measure recruitment success, acceptability, retention rates, treatment adherence, seizure frequency, quality of life, and other psychological and functional outcomes to guide future larger trials.
CONDITIONS
Brief Title
A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females ages 11-18
- Diagnosis of functional seizures
- Internet access for telehealth sessions and CATCH-IT
You will not qualify if you...
- Comorbid epilepsy
- Less than 4 functional seizures per month
- Other paroxysmal nonepileptic events such as hypoxic-ischemic phenomena, sleep disorders, or migraine-associated disorders
- Participation in other therapy
- Severe intellectual disability
- Severe mental illness including active delusions or hallucinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 phone call
Duration - 1 day
Participants and their parent/guardian complete questionnaires assessing demographics, mood, relationships, and functional seizure symptoms. Participants receive a seizure diary and are randomized to one of two therapy interventions.
1 baseline visit (in-person)
Duration - Duration of 12 therapy sessions
Participants undergo 12 therapy sessions: the first session is in-person lasting about 2 hours, followed by 11 video telehealth sessions each lasting about 1 hour. Interventions include either Retraining and Control Therapy (ReACT) or CATCH-IT.
1 in-person initial therapy session and 11 video telehealth sessions
Duration - Approximately 2 months
Participants and their parent/guardian complete questionnaires similar to baseline to assess progress and symptoms after therapy completion.
2 follow-up visits via video telehealth; first 1 week after final therapy session, second 2 months after final therapy session
Duration - Up to 12 months after final therapy session
Participants and parents complete additional questionnaires via video telehealth to assess longer-term outcomes 6 and 12 months after the final therapy session.
2 long-term follow-up visits via video telehealth
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
A
Aaron Fobian, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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