Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608966
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Epilepsy Journey 20 An Intervention to Improve Executive Functioning in Adolescents With Epilepsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention Epilepsy Journey to improve executive functioning in adolescents with epilepsy The two components include web-based modules and problem-solving telehealth sessions with a therapist focused on executive functioning This trial aims to answer the following questions
1 Which components of Epilepsy Journey web-based modules or telehealth sessions with a therapist are essential for improving executive functioning in adolescents with epilepsy
2 Which components of Epilepsy Journey web-based modules or telehealth sessions with a therapist are essential for improving quality of life in adolescents with epilepsy
Participants will be randomly assigned to one of four groups 1 Epilepsy Journey web-based modules and telehealth sessions 2 Epilepsy Journey web-based modules only 3 telehealth sessions with a therapist only or 4 treatment as usual
Participants will
Independently review Epilepsy Journey web-based modules focused on executive functioning skills 15-30 minutes andor have weekly telehealth sessions 30-45 minutes with a therapist for 14 weeks
Complete measures of executive functioning parent and teen-report and quality of life teen-report at the start of the study 14- 26- and 66- weeks after randomization The NIH toolbox will be completed at the start of the study and 26-weeks after randomization Additional measures will also be collected
1 Which components of Epilepsy Journey web-based modules or telehealth sessions with a therapist are essential for improving executive functioning in adolescents with epilepsy
2 Which components of Epilepsy Journey web-based modules or telehealth sessions with a therapist are essential for improving quality of life in adolescents with epilepsy
Participants will be randomly assigned to one of four groups 1 Epilepsy Journey web-based modules and telehealth sessions 2 Epilepsy Journey web-based modules only 3 telehealth sessions with a therapist only or 4 treatment as usual
Participants will
Independently review Epilepsy Journey web-based modules focused on executive functioning skills 15-30 minutes andor have weekly telehealth sessions 30-45 minutes with a therapist for 14 weeks
Complete measures of executive functioning parent and teen-report and quality of life teen-report at the start of the study 14- 26- and 66- weeks after randomization The NIH toolbox will be completed at the start of the study and 26-weeks after randomization Additional measures will also be collected
Detailed Description:
Epilepsy is a common pediatric neurological condition affecting 470000 youth in the United States Adolescents with epilepsy are at significant risk for neurobehavioral comorbidities ie depressivebehavioral symptoms and suboptimal social academic and quality of life outcomes Research suggests that 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 contribute to suboptimal functioning EF deficits have been documented in up to 50 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 and promoting optimal functioning in adolescents with epilepsy however none exists for this vulnerable population To fill this gap the investigators successfully developed and tested Epilepsy Journey EJ a comprehensive e-health behavioral multi-component problem-solving intervention that combines 10 self-guided learning modules with 10 telehealth sessions The promising proof-of-concept trial n39 showed high feasibility acceptability patient satisfaction and significant improvements in parent-reported EF behaviors neurobehavioral functioning and quality of life The next logical phase of this research is to conduct a definitive randomized clinical trial to examine whether the two components of treatment EJ modules and telehealth are 1 both essential and 2 have a durable impact on improving parent-reported and performance-based EF behaviors and quality of life Thus the aim of the current proposal is to conduct a multi-site Phase 3 randomized controlled clinical trial RCT using a 2x2 factorial design to examine the efficacy of separate EJ modules and EJ telehealth and combined components of EJ on EF Participants positive for EF deficits n232 will be randomized to one of four arms 1 EJ modules with telehealth sessions 2 EJ modules alone 3 EJ telehealth sessions alone or 4 Usual Care no EJ modules or telehealth sessions Treatment participants will either independently review EJ modules focused on EF skills 15-30 min andor have weekly telehealth sessions 30-45 min with a therapist for 14-weeks The groups will learn and apply problem-solving strategies to their individual EF difficulties Participants will complete measures at baseline 14- 26- and 66- weeks after randomization to examine maintenance of effects There is a critical need for evidence-based interventions to improve executive functioning behaviors in youth with epilepsy If the aims of this study are achieved we will have definitive evidence for addressing EF deficits The investigators expect that EJ modules and EJ telehealth will demonstrate efficacy alone and in combination which will allow patients to select the approach best suited to their specific situation Consequently we can improve long-term outcomes eg neurobehavioral comorbidities academic success social relationships and quality of life in adolescents with epilepsy a high-risk population
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