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Epilepsy journey 2.0 study design and methods: A randomized trial of an executive functioning intervention for adolescents with epilepsy
Journal article   Open access   Peer reviewed

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
PMCID: PMC12861245
PMID: 41631239
url
https://doi.org/10.1016/j.conctc.2026.101605View
Published (Version of record) Open Access

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

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