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NCT05819268 · ClinicalTrials.gov registry record · NA

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

A NA study of Convulsion, Non-Epileptic and Functional Seizures, sponsored by University of Alabama at Birmingham.

Recruiting
Registry status
NA
Development phase
108
Enrollment target
1
Study location

NCT05819268 is a NA study of Convulsion, Non-Epileptic and Functional Seizures that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 108 participants, below the 345-participant average among 4 other Convulsion, Non-Epileptic trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05819268, a NA study of Convulsion, Non-Epileptic and Functional Seizures, is actively recruiting participants, sponsored by University of Alabama at Birmingham.

RECRUITING
Registry status
NA
Development phase
108 participants
Enrollment target
1
Study location

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.

Interventions

  • BEHAVIORAL ReACT
  • BEHAVIORAL CATCH-IT

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2024-03-18
Est. Completion 2027-08
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT05819268

The ClinicalTrials.gov registry entry for NCT05819268 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 345-participant average among 4 other Convulsion, Non-Epileptic trials with a reported enrollment target (69% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Convulsion, Non-Epileptic appearing as the primary indexed condition, and to 2 interventions - of which ReACT is the first listed.

NCT05819268 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT05819268 about?

NCT05819268 is a clinical study titled "A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment for Pediatric Functional Seizures". 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 Ret...

What is the current status of trial NCT05819268?

This trial is currently recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2024-03-18. Estimated completion is 2027-08.

What conditions does trial NCT05819268 study?

This clinical trial studies the following conditions: Convulsion, Non-Epileptic, Functional Seizures.

What interventions are being tested in trial NCT05819268?

The interventions under investigation include: ReACT (BEHAVIORAL), CATCH-IT (BEHAVIORAL).

Who is sponsoring clinical trial NCT05819268?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05819268 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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