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NCT06608966 · ClinicalTrials.gov registry record · NA
Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
A NA study of Executive Dysfunction and Epilepsy in Children, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- NA
- Development phase
- 310
- Enrollment target
- 3
- Study locations
NCT06608966: Recruiting NA study of Executive Dysfunction and Epilepsy in Children, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT06608966 is a NA study of Executive Dysfunction and Epilepsy in Children that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 310 participants, above the 120-participant average among 17 other Executive Dysfunction trials with a reported enrollment target (158% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06608966, a NA study of Executive Dysfunction and Epilepsy in Children, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- NA
- Development phase
- 310 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention (Epilepsy Journey) to improve executive functioning in adolescents with epilepsy. The two components include web-based modules and problem-solving telehealth sessions with a therapist focused on executive functioning. This trial aims to answer the following questions: 1. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving executive functioning in adolescents with epilepsy? 2. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving quality of life in adolescents with epilepsy? Participants will be randomly assigned to one of four groups: 1) Epilepsy Journey web-based modules and telehealth sessions, 2) Epilepsy Journey web-based modules only, 3) telehealth sessions with a therapist only, or 4) treatment as usual. Participants will: * Independently review Epilepsy Journey web-based modules focused on executive functioning skills (\~15-30 minutes) and/or have weekly telehealth sessions (\~30-45 minutes) with a therapist for 14 weeks. * Complete measures of executive functioning (parent and teen-report) and quality of life (teen-report) at the start of the study, 14-, 26-, and 66- weeks after randomization. The NIH toolbox will be completed at the start of the study and 26-weeks after randomization. Additional measures will also be collected.
Primary Outcome
The parent-reported BRIEF-2 Global Executive Composite T-score will be used as the primary outcome measure. T-scores are linear transformations of raw scores, where 50 points represent the mean, and 10 points represent the standard deviation. T-scores provide information about an individual's score relative to a normal standardization sample, based on age and sex. T-scores ≥ 65 are considered clinically significant.
Conditions Studied
Interventions
- BEHAVIORAL Epilepsy Journey web-based modules
- BEHAVIORAL Telehealth with a therapist
Study Locations (3)
California
- Childrens Hospital of Orange County - Orange
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2024-11-11 |
| Est. Completion | 2029-01-31 |
| Phase | NA |
What NCT06608966 shows while recruiting
NCT06608966 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 17 other Executive Dysfunction trials with a reported enrollment target (158% higher).
The record links to 2 conditions, with Executive Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Epilepsy Journey web-based modules is the first listed.
NCT06608966 reports a single indexed study location in California, Ohio, South Carolina.
Frequently Asked Questions
What is clinical trial NCT06608966 about?
NCT06608966 is a clinical study titled "Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy". The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention (Epilepsy Journey) to improve executive functioning in adolescents with epilepsy. The two components include web-based modules and problem-solving telehealth sessions with a the...
What is the current status of trial NCT06608966?
This trial is currently recruiting. It is a NA study. The enrollment target is 310 participants. The study started on 2024-11-11. Estimated completion is 2029-01-31.
What conditions does trial NCT06608966 study?
This clinical trial studies the following conditions: Executive Dysfunction, Epilepsy in Children.
What interventions are being tested in trial NCT06608966?
The interventions under investigation include: Epilepsy Journey web-based modules (BEHAVIORAL), Telehealth with a therapist (BEHAVIORAL).
Who is sponsoring clinical trial NCT06608966?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06608966 being conducted?
This trial has 3 study locations across California, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06608966's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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