Ignite Creation Date:
2024-05-06 @ 9:10 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02925663
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2016-10-03
Brief Title:
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy Epilepsy Journey
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy Epilepsy Journey
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Epilepsy is a common childhood condition affecting approximately 326000 youth in the United States Adolescents with epilepsy are at significant risk for poor social and academic outcomes neurobehavioral comorbidities ie internalizing and externalizing symptoms and poor treatment adherence Studies have shown that one potential reason for these poor outcomes are deficits in executive functioning EF defined as the skills necessary for goal-directed and complex activities including problem-solving initiation monitoring organization planning self-regulation and working memory EF deficits have been documented in 13 of youth with epilepsy which is 3 times the prevalence in healthy youth Evidence-based interventions to improve EF could play a critical role in preventing adverse outcomes eg psychological comorbidities non-adherence to the treatment regimen and promoting optimal functioning in adolescents with epilepsy however none exists for this vulnerable population The aim of the current study is to establish the feasibility accessibility acceptability and preliminary effects of an individually-tailored intervention to improve EF in adolescents with epilepsy Executive Functioning Intervention-Epilepsy EFI-E Thirty participants will be recruited who have at least one clinically-elevated EF subscale or at least two at-risk subscale scores 1 standard deviation above the mean on the parent Behavior Rating Inventory of Executive Function BRIEF to qualify for the EFI-E EFI-E will consist of 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 Baseline and post-treatment questionnaires will be completed by adolescents and primary caregivers and electronically-monitored adherence will be obtained throughout the open trial Participants will be in the trial for 9 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None