Epilepsy journey 2.0 study design and methods: A randomized trial of an executive functioning intervention for adolescents with epilepsy

Angela B. Combs; Janelle L. Wagner; Heather Huszti; Shari L. Wade; Matthew Schmidt; Stacy Buschhaus; Jake Scherra; Sara E. Wetter-Wren; David Ogundairo; Christopher Coffey; Dixie Ecklund; Emine Bayman; Sonal Bhatia; Tracy Glauser; Kristina K. Hardy; Avani C. Modi

doi:10.1016/j.conctc.2026.101605

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Epilepsy journey 2.0 study design and methods: A randomized trial of an executive functioning intervention for adolescents with epilepsy

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Epilepsy journey 2.0 study design and methods: A randomized trial of an executive functioning intervention for adolescents with epilepsy

Angela B. Combs, Janelle L. Wagner, Heather Huszti, Shari L. Wade, Matthew Schmidt, Stacy Buschhaus, Jake Scherra, Sara E. Wetter-Wren, David Ogundairo, Christopher Coffey, …

Contemporary clinical trials communications, Vol.49, 101605

02/2026

DOI: 10.1016/j.conctc.2026.101605

PMID: 41631239

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Abstract

Epilepsy is a common neurological condition that presents unique challenges for adolescents. Executive functioning (EF) deficits contribute to suboptimal academic, social, and quality of life outcomes, yet interventions addressing EF in pediatric epilepsy are lacking. One promising intervention is Epilepsy Journey (EJ), a comprehensive e-health, multi-component problem-solving intervention that incorporates self-guided learning modules and telehealth sessions facilitated by a therapist. This paper describes the methodology, advisory board feedback, changes to the original protocol/intervention, and current progress of a multi-site Phase 3 randomized control trial (RCT; EJ 2.0) to improve EF behaviors. Prior to the RCT, an advisory board comprised of six adolescents, two caregivers, two teachers, and two healthcare providers offered feedback on recruitment/retention, measurement selection, and intervention components. For the RCT, adolescents (age 13–17 years) who meet eligibility criteria for EJ 2.0 are randomized into four groups: EJ modules only, EJ telehealth only, EJ modules with telehealth, or a usual epilepsy care group. Participants in each of the three treatment arms learn about and problem-solve aims related to positive thinking, problem-solving, working memory, organization, inhibition, initiation, task/self-monitoring, emotion regulation, and sleep/stress. The goal is to randomize 232 participants across three sites. The EJ 2.0 study has been strengthened through advisory board feedback, and subsequent protocol changes were critical in the successful launch and execution of the trial to-date. Despite a brief funding gap, the study team has made significant progress in early recruitment. •Executive functioning (EF) deficits can lead to negative outcomes for adolescents with epilepsy.•Prior EF interventions are too narrowly focused, specific to non-seizure conditions, or designed for adults.•Epilepsy Journey 2.0 is an e-health problem-solving intervention designed to improve EF for adolescents with epilepsy.

Technology

Attention

Behavioral intervention

Pediatric epilepsy

Seizures

Teenagers

Details

Title: Subtitle: Epilepsy journey 2.0 study design and methods: A randomized trial of an executive functioning intervention for adolescents with epilepsy
Creators: Angela B. Combs - Cincinnati Children's Hospital Medical Center
Janelle L. Wagner - Medical University of South Carolina
Heather Huszti - Children's Hospital of Orange County
Shari L. Wade - Cincinnati Children's Hospital Medical Center
Matthew Schmidt - University of Georgia
Stacy Buschhaus - Cincinnati Children's Hospital Medical Center
Jake Scherra - Cincinnati Children's Hospital Medical Center
Sara E. Wetter-Wren - Cincinnati Children's Hospital Medical Center
David Ogundairo - University of Georgia
Christopher Coffey - University of Iowa
Dixie Ecklund - University of Iowa
Emine Bayman - University of Iowa
Sonal Bhatia - Medical University of South Carolina
Tracy Glauser - Cincinnati Children's Hospital Medical Center
Kristina K. Hardy - National Institute of Neurological Disorders and Stroke
Avani C. Modi - Cincinnati Children's Hospital Medical Center
Resource Type: Journal article
Publication Details: Contemporary clinical trials communications, Vol.49, 101605
DOI: 10.1016/j.conctc.2026.101605
PMID: 41631239
ISSN: 2451-8654
eISSN: 2451-8654
Publisher: Elsevier Inc
Grant note: National Institutes of Health: National Institute of Neurological Disorders and Stroke: UG3NS129588/UH3NS129588 National Institutes of Health/Eunice Kennedy Schriver National Institute of Child Health and Human Development (NIH) at Cincinnati Children's Hospital Medical Center: T32HD068223
This work was supported by the National Institutes of Health: National Institute of Neurological Disorders and Stroke UG3NS129588/UH3NS129588. This report does not represent the official view of the National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health (NIH), or any part of the US Federal Government. No official support or endorsement of this article by the NINDS or NIH is intended or should be inferred. Dr. Combs's time on this project was supported by the National Institutes of Health/Eunice Kennedy Schriver National Institute of Child Health and Human Development (NIH) T32HD068223 postdoctoral research fellowship at Cincinnati Children's Hospital Medical Center.
Language: English
Date published: 02/2026
Academic Unit: Biostatistics; Anesthesia
Record Identifier: 9985130241202771

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