Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Epilepsy Journey 2.0: An Intervention to Improve Executive Functioning in Adolescents With Epilepsy
2 other identifiers
interventional
310
1 country
3
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedStudy Start
First participant enrolled
November 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
April 25, 2025
April 1, 2025
4 years
September 20, 2024
April 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Behavior Rating Inventory of Executive Function (2nd edition) Global Executive Composite T-score (parent)
The parent-reported BRIEF-2 Global Executive Composite T-score will be used as the primary outcome measure. T-scores are linear transformations of raw scores, where 50 points represent the mean, and 10 points represent the standard deviation. T-scores provide information about an individual's score relative to a normal standardization sample, based on age and sex. T-scores ≥ 65 are considered clinically significant.
26-weeks post-randomization
Secondary Outcomes (5)
PedsQLâ„¢ Epilepsy Module - Impact Subscale (Adolescent report)
26-weeks post-randomization
PedsQLâ„¢ Epilepsy Module - Cognitive Functioning Subscale (Adolescent report)
26-weeks post-randomization
PedsQLâ„¢ Epilepsy Module - Executive Functioning Subscale (Adolescent report)
26-weeks post-randomization
PedsQLâ„¢ Epilepsy Module -Sleep Subscale (Adolescent report)
26-weeks post-randomization
PedsQLâ„¢ Epilepsy Module -Mood/Behavior Subscale (Adolescent report)
26-weeks post-randomization
Other Outcomes (7)
Behavior Rating Inventory of Executive Function (2nd edition) -Global Executive Composite T-score (parent)
66-weeks post-randomization
PedsQLâ„¢ Epilepsy Module - Impact Subscale (Adolescent report)
66-weeks post-randomization
PedsQLâ„¢ Epilepsy Module - Cognitive Functioning Subscale (Adolescent report)
66-weeks post-randomization
- +4 more other outcomes
Study Arms (4)
Epilepsy Journey web-based modules alone
EXPERIMENTALParticipants 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.
Epilepsy Journey web-based modules + telehealth with a therapist
EXPERIMENTALParticipants 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.
Telehealth with a therapist alone
EXPERIMENTALParticipants will meet with a therapist for 10 telehealth sessions (30-45 minutes each session) within a 14-week time frame.
Treatment as Usual
NO INTERVENTIONParticipants will receive no active behavioral health treatment components and will be followed in usual epilepsy care for 14 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- Parent/legal guardian(s) willing to sign an IRB approved informed consent
- Participant willing to sign an Institutional Review Board approved assent
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Medical Center, Cincinnatilead
- Medical University of South Carolinacollaborator
- Children's Hospital of Orange Countycollaborator
- University of Georgiacollaborator
- University of Iowacollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (3)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avani Modi, Ph.D.
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The PI of the study is masked to treatment condition. Outcome assessors for the NIH toolbox measure will also be masked.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2024
First Posted
September 23, 2024
Study Start
November 11, 2024
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
January 31, 2029
Last Updated
April 25, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Final submission and release of the study data to the Archived Clinical Research Datasets Repository will occur at the time of publication of the primary manuscript or at the end of the performance period, whichever comes first. Study data deposited in the Repository will be available to the research community in perpetuity.
- Access Criteria
- All deidentified study data that are not designated as restricted use will be made available as public use data to the research community in accordance with the NINDS Archived Clinical Research Dataset Repository guidelines. Users of the public use data must register with NINDS and agree to the terms of use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting and prohibiting attempts to identify study participants. Data users also agree not to share or redistribute any data downloads. Further, users agree to destroy the dataset at the end of the research project.
This project will include demographic, medical, psychosocial and executive functioning data for adolescents with epilepsy. The raw questionnaire data and NIH Toolbox data will be stored within secure databases and environments. Protected Health Information (PHI) (e.g., respondent identifiers) will be restricted and maintained in a secure file until study results are published. All other scientific data (e.g., Scaled scores, contextual data) will be both preserved and shared. Prior to sharing, all data will be de-identified so that it is HIPAA-compliant. Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the NINDS Archived Clinical Research Datasets Repository, which houses NINDS clinical trial data.