Is NCT06608966 recruiting in Cincinnati, OH?

Yes, NCT06608966 is currently recruiting participants at its Cincinnati, OH location. This epilepsy in children clinical trial is actively enrolling qualified participants.

How do I join the epilepsy in children clinical trial in Cincinnati?

To join this clinical trial in Cincinnati, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Cincinnati clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Epilepsy in Children Clinical Trial in Cincinnati, OH

About This Epilepsy in Children Study in Cincinnati

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.

Sponsor: Children's Hospital Medical Center, Cincinnati

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cincinnati?

Yes, this clinical trial (NCT06608966) has an active research site in Cincinnati, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Epilepsy in Children Treatment Options in Cincinnati, OH

If you're searching for epilepsy in children treatment options in Cincinnati, OH, this clinical trial (NCT06608966) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cincinnati research site is actively enrolling participants for this clinical trial. You'll receive care from experienced epilepsy in children specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all epilepsy in children clinical trials near you to find additional studies recruiting in your area.

Epilepsy in Children Clinical Trial in Cincinnati, OH

Expert Care in Cincinnati

IRB Approved

No-Cost Care

Apply for This Cincinnati Location

Why Participate?

Simple Process