Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
The purpose of this study is to establish the feasibility, accessibility, acceptability, and preliminary efficacy of an individually-tailored intervention to improve EF in adolescents with epilepsy (EFI-E).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2016
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
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedStudy Start
First participant enrolled
October 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2018
CompletedFebruary 5, 2020
July 1, 2018
1.2 years
October 3, 2016
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)
3-months
Secondary Outcomes (3)
Adherence: SimpleMed Pillboxes or MEMS TrackCaps
3-months
Quality of life: PedsQL Epilepsy Module
3-months
Seizures
3-months
Other Outcomes (5)
Child behavioral and emotional functioning: Behavior Assessment Schedule for Children-2
3-months
Treatment Feasibility
3-months
Executive functioning-BRIEF
5-months
- +2 more other outcomes
Study Arms (1)
EFI-E
EXPERIMENTAL10-session web-based modules to teach about executive functioning with videoconferencing with a therapist
Interventions
This is 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals.
Eligibility Criteria
You may qualify if:
- Age 13-17 years
- Diagnosis of epilepsy
- Have at least two subclinical (\>1 SD; T score between 60-65) or one clinically-elevated BRIEF subscale (T score \> 65)
- Primary caregiver consent and adolescent assent to participate in study
You may not qualify if:
- Diagnosis of non-epilepsy medical disorders requiring daily medications with the exception of asthma and/or allergies
- Diagnosis of significant developmental disorders (e.g. Autism)
- Inability to read and speak English due to the questionnaires and intervention only been developed in English
- Family lives greater than 100 miles away from CCHMC
- If patient is planning to wean from their antiepileptic medication within the next 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gutierrez-Colina AM, Clifford L, Wade SL, Modi AC. Uncovering Key Elements of an Executive Functioning Intervention in Adolescents: Epilepsy Journey. Clin Pract Pediatr Psychol. 2022 Jun;10(2):150-163. doi: 10.1037/cpp0000410. Epub 2021 Sep 2.
PMID: 35873364DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 6, 2016
Study Start
October 10, 2016
Primary Completion
January 4, 2018
Study Completion
June 28, 2018
Last Updated
February 5, 2020
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share