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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925663
• Other study ID #: R21HD083335
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2016
• Est. completion date: June 28, 2018

Study information

• Verified date: July 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 28, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion criteria

• 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

Exclusion criteria

• 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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• EFI-E
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child behavioral and emotional functioning: Behavior Assessment Schedule for Children-2		3-months
Other	Treatment Feasibility	Treatment Feasibility and Acceptability Questionnaire	3-months
Other	Executive functioning-BRIEF		5-months
Other	Executive functioning-BRIEF		8-months
Other	Adherence-SImple Med Pillbox or MEMS TrackCaps		8-months
Primary	Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)		3-months
Secondary	Adherence: SimpleMed Pillboxes or MEMS TrackCaps		3-months
Secondary	Quality of life: PedsQL Epilepsy Module		3-months
Secondary	Seizures	A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.	3-months