Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy

Part of paid clinical trials in Orange, California.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06608966
Status
Recruiting
Apply to this trial

Conditions

  • Epilepsy in Children
  • Executive Dysfunction

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Epilepsy Journey web-based modules — BEHAVIORAL
    Participants assigned to Epilepsy Journey modules will independently review web-based EJ modules focused on executive functioning skills. The modules cover 10 topic areas: Positive Thoughts, Problem-Solving, Initiation, Working Memory, Monitoring, Inhibition, Emotional Control, Organization and Planning, Sleep/Stress, and a Wrap-Up. Participants will complete 10 modules (\~15-30 minutes each session) within a 14-week time frame. The goal is to complete one module per week.
  • Telehealth with a therapist — BEHAVIORAL
    Therapist will cover 10 areas of executive functioning during telehealth sessions, including Positive Thoughts, Problem-Solving, Initiation, Working Memory, Monitoring, Inhibition, Emotional Control, Organization and Planning, Sleep/Stress, and a Wrap-Up. Telehealth sessions with a therapist will occur via HIPAA-compliant videoconference (e.g. Microsoft Teams) each week ideally over the course of 14 weeks.

Study Details

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.

Key Dates

Start date
Nov 11, 2024
Status verified
Apr 2025
Primary completion
Oct 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Behavior Rating Inventory of Executive Function (2nd edition) Global Executive Composite T-score (parent) [ Time Frame: 26-weeks post-randomization ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Childrens Hospital of Orange CountyOrangeCalifornia92868
Heather Huszti, Ph.D.
[email protected]
714-509-8481
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Avani Modi, Ph.D.
[email protected]
513-636-4864
Avani C Modi, Ph.D. (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Janelle Wagner, Ph.D.
[email protected]
843-792-3307

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By research site
Childrens Hospital of Orange County· Orange, CACincinnati Children's Hospital Medical Center· Cincinnati, OHMedical University of South Carolina· Charleston, SC

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