Recruiting

Executive Functioning Intervention

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06608966

Conditions

Epilepsy in Children

Executive Dysfunction

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Epilepsy Journey web-based modules

Telehealth with a therapist

Study Details

Brief 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.

Conditions

Epilepsy in Children

Executive Dysfunction

Study ID

NCT06608966

Start date

Nov 11, 2024

Status verified date

Jun, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age between 13-17 years at the time of enrollment
2. Child lives at home with primary caregiver and is enrolled in school (excluding summer breaks).
3. 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.
4. Primary language of English
5. 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).
6. Parent/legal guardian(s) willing to sign an IRB approved informed consent
7. Participant willing to sign an Institutional Review Board approved assent

Exclusion Criteria:

1. Parent or clinician-reported history in the adolescent of:

1. developmental delay (e.g., autism spectrum disorder, pervasive development disorder, history of services for developmental delay or intellectual impairment in the past 5 years, known IQ<70)
2. severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months, depression with active suicidal ideation or suicidal ideation/intent in the past 3 months)
3. prior (3-months) or current history of trauma and/or stressor-related disorders (e.g. PTSD)
4. recent or current significant medical disease (i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic or endocrine)
5. brain injury or brain tumor; and/or
6. epilepsy surgery
7. any other medical and/or psychological condition that takes treatment precedence over the study intervention
2. Clinician-reported diagnosis in the adolescent of

1. epilepsy whose seizures are categorized only as either unknown onset or unclassified onset (defined as insufficient information to determine onset)
2. epilepsy currently being treated at the time of enrollment by 3 or more antiseizure medications (ASMs) (excluding rescue medication use)
3. epilepsy with a history of failure to achieve seizure freedom despite adequate use of 4 different anti-seizure medications
4. a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome)
5. a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders)
6. one or more episodes of status epilepticus within the 24 weeks prior to enrollment; and/or
7. treatable causes of seizures, for example identified etiologies including metabolic, neoplastic, or active infectious origin.
8. non-epileptic event/seizures
3. Adolescents currently on the ketogenic diet
4. Participation in a trial of an investigational drug or device within 30 days prior to screening

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Epilepsy Journey web-based modules

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

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.

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 and Locations

Central contacts

Locations

Childrens Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Heather Huszti, Ph.D.

714-509-8481hhuszti@choc.org

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Avani C Modi, Ph.D.

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Janelle Wagner, Ph.D.

843-792-3307wagnerjl@musc.edu

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • adolescents
  • executive functioning
  • seizures
  • epilepsy
  • behavioral trial
  • web-based intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-06-25.