Web-based Intervention to Improve Executive Functioning in Teens With

Status Completed

Clinical Trial 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).

Clinical Trial Description

Epilepsy is a common childhood condition affecting approximately 326,000 youth in the United States. Adolescents with epilepsy are at significant risk for poor social and academic outcomes, neurobehavioral comorbidities (i.e., 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 1/3 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 (e.g., 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 Design

Related Conditions & MeSH terms

Epilepsy

Clinical Trial Details

NCT number	NCT02925663
Study type	Interventional
Source	Children's Hospital Medical Center, Cincinnati
Contact
Status	Completed
Phase	Phase 2
Start date	October 10, 2016
Completion date	June 28, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms