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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EFI-E
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring executive functioning

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    EFI-E

    Arm Description

    10-session web-based modules to teach about executive functioning with videoconferencing with a therapist

    Outcomes

    Primary Outcome Measures

    Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)

    Secondary Outcome Measures

    Adherence: SimpleMed Pillboxes or MEMS TrackCaps
    Quality of life: PedsQL Epilepsy Module
    Seizures
    A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.

    Full Information

    First Posted
    October 3, 2016
    Last Updated
    February 4, 2020
    Sponsor
    Children's Hospital Medical Center, Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02925663
    Brief Title
    Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
    Official Title
    Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 10, 2016 (Actual)
    Primary Completion Date
    January 4, 2018 (Actual)
    Study Completion Date
    June 28, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital Medical Center, Cincinnati

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy
    Keywords
    executive functioning

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Patients are receiving an executive functioning intervention in an open trial design-pre-post
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EFI-E
    Arm Type
    Experimental
    Arm Description
    10-session web-based modules to teach about executive functioning with videoconferencing with a therapist
    Intervention Type
    Behavioral
    Intervention Name(s)
    EFI-E
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)
    Time Frame
    3-months
    Secondary Outcome Measure Information:
    Title
    Adherence: SimpleMed Pillboxes or MEMS TrackCaps
    Time Frame
    3-months
    Title
    Quality of life: PedsQL Epilepsy Module
    Time Frame
    3-months
    Title
    Seizures
    Description
    A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.
    Time Frame
    3-months
    Other Pre-specified Outcome Measures:
    Title
    Child behavioral and emotional functioning: Behavior Assessment Schedule for Children-2
    Time Frame
    3-months
    Title
    Treatment Feasibility
    Description
    Treatment Feasibility and Acceptability Questionnaire
    Time Frame
    3-months
    Title
    Executive functioning-BRIEF
    Time Frame
    5-months
    Title
    Executive functioning-BRIEF
    Time Frame
    8-months
    Title
    Adherence-SImple Med Pillbox or MEMS TrackCaps
    Time Frame
    8-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35873364
    Citation
    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.
    Results Reference
    derived

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

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