Actively Recruiting

Phase Not Applicable
Age: 11Years - 18Years
All Genders
ID05819268

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

Age: 11Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females ages 11-18
  • Diagnosis of functional seizures
  • Internet access for telehealth sessions and CATCH-IT
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 phone call

Baseline Visit and Enrollment

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)

Treatment

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

Follow-up Visits

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

Long-term Monitoring

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

Loading map...

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

Similar Trials

Accelerated, Left Prefrontal Transcranial Magnetic Stimulati...

Functional Neurological Symptom Disorder

Actively Recruiting

1 location

Establishment of an Interdisciplinary Functional Neurologica...

Functional Neurological Disorder

Actively Recruiting

1 location

Retraining and Control Therapy (ReACT): Cognitive Behavioral...

Convulsion, Non-Epileptic

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here