RECRUITING

Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy

Conditions

Epilepsy in Children Executive Dysfunction adolescents executive functioning seizures epilepsy behavioral trial web-based intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-11

Study Completion:2029-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06608966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Avani C Modi, Ph.D.

CONTACT

513-636-4864

avani.modi@cchmc.org

Stacy Buschhaus

CONTACT

513-636-3920

stacy.buschhaus@cchmc.org

Principal Investigator

Avani Modi, Ph.D.

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Childrens Hospital of Orange County

Orange, California, 92868

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Avani Modi, Ph.D., PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11

Study Completion Date2029-01-31

Study Record Updates

Study Start Date2024-11-11

Study Completion Date2029-01-31

Terms related to this study

Keywords Provided by Researchers

adolescents
executive functioning
seizures
epilepsy
behavioral trial
web-based intervention

Additional Relevant MeSH Terms

Epilepsy in Children
Executive Dysfunction