Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Factorial
Treatments tested in this trial
Epilepsy Journey web-based modules
BehavioralParticipants 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
BehavioralTherapist 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.
Treatment groups
310 Participants
are divided into 4 treatment groupsGroup A: Epilepsy Journey web-based modules aloneExperimental treatment 1 intervention
Group B: Epilepsy Journey web-based modules + telehealth with a therapistExperimental treatment 2 interventions
Group C: Telehealth with a therapist aloneExperimental treatment 1 intervention
Group D: Treatment as UsualNo intervention 0 interventions
Trial outcomes
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.
Time frame
26-weeks post-randomizationSecondary outcomes
1
PedsQL™ Epilepsy Module - Impact Subscale (Adolescent report)
The PedsQL Epilepsy Module is reliable epilepsy-specific health-related quality of life (HRQOL) measure for youth 2-25 years with epilepsy. Five key domains will be assessed, including Impact, Cognitive Functioning, Executive Functioning, Sleep, and Mood/Behavior. Scores range from 0-100, with higher scores representing better HRQOL. Clinical cut-offs have been established for the measure, with scores below the cut-off representing concerning HRQOL: Impact \[Parent=60.7; Child=64.39\], Cognitive \[Parent=38.11; Child=50.97\], Executive Functioning \[Parent=46.65; Child=57.15\], Sleep \[Parent=42.07; Child=43.90\], and Mood/Behavior \[Parent=54.14; Child =53.30\].
Time frame
26-weeks post-randomization2
PedsQL™ Epilepsy Module - Cognitive Functioning Subscale (Adolescent report)
The PedsQL Epilepsy Module is reliable epilepsy-specific HRQOL measure for youth 2-25 years with epilepsy. Five key domains will be assessed, including Impact, Cognitive Functioning, Executive Functioning, Sleep, and Mood/Behavior. Scores range from 0-100, with higher scores representing better HRQOL. Clinical cut-offs have been established for the measure, with scores below the cut-off representing concerning HRQOL: Impact \[Parent=60.7; Child=64.39\], Cognitive \[Parent=38.11; Child=50.97\], Executive Functioning \[Parent=46.65; Child=57.15\], Sleep \[Parent=42.07; Child=43.90\], and Mood/Behavior \[Parent=54.14; Child =53.30\].
Time frame
26-weeks post-randomization3
PedsQL™ Epilepsy Module - Executive Functioning Subscale (Adolescent report)
The PedsQL Epilepsy Module is reliable epilepsy-specific HRQOL measure for youth 2-25 years with epilepsy. Five key domains will be assessed, including Impact, Cognitive Functioning, Executive Functioning, Sleep, and Mood/Behavior. Scores range from 0-100, with higher scores representing better HRQOL. Clinical cut-offs have been established for the measure, with scores below the cut-off representing concerning HRQOL: Impact \[Parent=60.7; Child=64.39\], Cognitive \[Parent=38.11; Child=50.97\], Executive Functioning \[Parent=46.65; Child=57.15\], Sleep \[Parent=42.07; Child=43.90\], and Mood/Behavior \[Parent=54.14; Child =53.30\].
Time frame
26-weeks post-randomization4
PedsQL™ Epilepsy Module -Sleep Subscale (Adolescent report)
The PedsQL Epilepsy Module is reliable epilepsy-specific HRQOL measure for youth 2-25 years with epilepsy. Five key domains will be assessed, including Impact, Cognitive Functioning, Executive Functioning, Sleep, and Mood/Behavior. Scores range from 0-100, with higher scores representing better HRQOL. Clinical cut-offs have been established for the measure, with scores below the cut-off representing concerning HRQOL: Impact \[Parent=60.7; Child=64.39\], Cognitive \[Parent=38.11; Child=50.97\], Executive Functioning \[Parent=46.65; Child=57.15\], Sleep \[Parent=42.07; Child=43.90\], and Mood/Behavior \[Parent=54.14; Child =53.30\].
Time frame
26-weeks post-randomizationOther outcomes
1
Behavior Rating Inventory of Executive Function (2nd edition) -Global Executive Composite T-score (parent)
The parent-reported BRIEF-2 GEC 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.
Time frame
66-weeks post-randomization2
PedsQL™ Epilepsy Module - Impact Subscale (Adolescent report)
The PedsQL Epilepsy Module is reliable epilepsy-specific HRQOL measure for youth 2-25 years with epilepsy. Five key domains will be assessed, including Impact, Cognitive Functioning, Executive Functioning, Sleep, and Mood/Behavior. Scores range from 0-100, with higher scores representing better HRQOL. Clinical cut-offs have been established for the measure, with scores below the cut-off representing concerning HRQOL: Impact \[Parent=60.7; Child=64.39\], Cognitive \[Parent=38.11; Child=50.97\], Executive Functioning \[Parent=46.65; Child=57.15\], Sleep \[Parent=42.07; Child=43.90\], and Mood/Behavior \[Parent=54.14; Child =53.30\].
Time frame
66-weeks post-randomization3
PedsQL™ Epilepsy Module - Cognitive Functioning Subscale (Adolescent report)
The PedsQL Epilepsy Module is reliable epilepsy-specific HRQOL measure for youth 2-25 years with epilepsy. Five key domains will be assessed, including Impact, Cognitive Functioning, Executive Functioning, Sleep, and Mood/Behavior. Scores range from 0-100, with higher scores representing better HRQOL. Clinical cut-offs have been established for the measure, with scores below the cut-off representing concerning HRQOL: Impact \[Parent=60.7; Child=64.39\], Cognitive \[Parent=38.11; Child=50.97\], Executive Functioning \[Parent=46.65; Child=57.15\], Sleep \[Parent=42.07; Child=43.90\], and Mood/Behavior \[Parent=54.14; Child =53.30\].
Time frame
66-weeks post-randomization4
PedsQL™ Epilepsy Module - Executive Functioning Subscale (Adolescent report)
The PedsQL Epilepsy Module is reliable epilepsy-specific HRQOL measure for youth 2-25 years with epilepsy. Five key domains will be assessed, including Impact, Cognitive Functioning, Executive Functioning, Sleep, and Mood/Behavior. Scores range from 0-100, with higher scores representing better HRQOL. Clinical cut-offs have been established for the measure, with scores below the cut-off representing concerning HRQOL: Impact \[Parent=60.7; Child=64.39\], Cognitive \[Parent=38.11; Child=50.97\], Executive Functioning \[Parent=46.65; Child=57.15\], Sleep \[Parent=42.07; Child=43.90\], and Mood/Behavior \[Parent=54.14; Child =53.30\].
Time frame
66-weeks post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Medical University of South Carolina
Collaborator
Children's Hospital of Orange County
Collaborator
University of Georgia
Collaborator
University of Iowa
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov