Epilepsy Journey 2.0: An Intervention to Improve Executive Functioning in Adolescents With Epilepsy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 17
Healthy Volunteers: f
View:

• Age between 13-17 years at the time of enrollment

• Child lives at home with primary caregiver and is enrolled in school (excluding summer breaks).

• Confirmed diagnosis of epilepsy with seizures that are categorized as either generalized or focal in onset. Epilepsy is defined as: 1) At least two unprovoked seizures occurring more than 24-hours apart; or 2) One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures.

• Primary language of English

• Screening Inclusion: On the parent-reported Behavior Rating Inventory of Executive Function-2nd edition (BRIEF-2), have executive functioning deficits defined as at least 2 subclinical (60\<T\<65) or one clinical BRIEF-2 subscale T scores (T≥65).

• Parent/legal guardian(s) willing to sign an IRB approved informed consent

• Participant willing to sign an Institutional Review Board approved assent

Locations
United States
California
Childrens Hospital of Orange County
RECRUITING
Orange
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Avani C Modi, Ph.D.
avani.modi@cchmc.org
513-636-4864
Backup
Stacy Buschhaus
stacy.buschhaus@cchmc.org
513-636-3920
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 310
Treatments
Experimental: Epilepsy Journey web-based modules alone
Participants assigned to Epilepsy Journey modules will independently review web-based EJ modules. Participants will be targeted to complete 10 EJ modules (\~15-30 minutes each session) within 14 weeks.
Experimental: Epilepsy Journey web-based modules + telehealth with a therapist
Participants will receive both the Epilepsy Journey web-based modules and telehealth sessions with a therapist weekly. Participants will review 10 modules independently (\~15-30 minutes) and complete 10 telehealth sessions (\~30-45 minutes each session) within a 14-week time frame.
Experimental: Telehealth with a therapist alone
Participants will meet with a therapist for 10 telehealth sessions (30-45 minutes each session) within a 14-week time frame.
No_intervention: Treatment as Usual
Participants will receive no active behavioral health treatment components and will be followed in usual epilepsy care for 14 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of South Carolina, University of Iowa, University of Georgia, Children's Hospital of Orange County, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov