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

NCT05819268 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Functional Seizures
  • Convulsion, Non-Epileptic

Interventions

BEHAVIORAL

ReACT

ReACT includes 12 sessions with a therapist that will discuss a plan for managing FS.

BEHAVIORAL

CATCH-IT

CATCH-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.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2026-12-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819268 on ClinicalTrials.gov