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NCT06608966 · Children's Hospital Medical Center, Cincinnati

Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy

What this study is about

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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • 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

Exclusion criteria

  • Parent or clinician-reported history in the adolescent of:
  • 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)
  • 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)
  • prior (3-months) or current history of trauma and/or stressor-related disorders (e.g. PTSD)
  • recent or current significant medical disease (i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic or endocrine)
  • brain injury or brain tumor; and/or
  • epilepsy surgery
  • any other medical and/or psychological condition that takes treatment precedence over the study intervention
  • Clinician-reported diagnosis in the adolescent of
  • epilepsy whose seizures are categorized only as either unknown onset or unclassified onset (defined as insufficient information to determine onset)
  • epilepsy currently being treated at the time of enrollment by 3 or more antiseizure medications (ASMs) (excluding rescue medication use)
  • epilepsy with a history of failure to achieve seizure freedom despite adequate use of 4 different anti-seizure medications
  • a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome)
  • a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders)
  • one or more episodes of status epilepticus within the 24 weeks prior to enrollment; and/or
  • treatable causes of seizures, for example identified etiologies including metabolic, neoplastic, or active infectious origin.
  • non-epileptic event/seizures
  • Adolescents currently on the ketogenic diet
  • Participation in a trial of an investigational drug or device within 30 days prior to screening

Where

  • Orange, California
  • Cincinnati, Ohio
  • Charleston, South Carolina

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations

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1 of 310 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Orange

California

Location available
RECRUITING

Cincinnati

Ohio

Location available
RECRUITING

Charleston

South Carolina

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

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Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Epilepsy in Children Treatment in Orange?

Join others in California exploring innovative treatment options through clinical research

Epilepsy in Children Treatment Options in Orange, California

If you're searching for Epilepsy in Children treatment in Orange, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Orange, Cincinnati, Charleston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Epilepsy in Children. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 310 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Epilepsy in Children?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Epilepsy in Children

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Epilepsy in Children Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06608966. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.