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临床试验/NCT07676539
NCT07676539进行中(未招募)不适用

Adolescents With Epilepsy Reaching Goals Through Optimal Self-Management

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
8
试验地点
1
主要终点
Enrollment Rate

研究概览

简要总结

The goal of this clinical trial is to learn if a telehealth intervention (Surviving and Thriving in the Real World; STRW) is helpful to improve daily living skills for teens and young adults with epilepsy. It will also learn about the acceptability, feasibility, and satisfaction of the intervention. The main questions it aims to answer are:

  • Is STRW an acceptable, feasible, and satisfactory intervention for teens/young adults and their caregivers?
  • Does STRW improve daily living skills (e.g., cooking, laundry, money management) for teens and young adults with epilepsy?

This is a nonrandomized pilot trial and all participants who enroll will:

  • Participate in weekly caregiver/teen dyads ( approximately 60 minutes) focused on improving daily living skills with a trained therapist for 15 weeks.
  • Participate in weekly caregiver groups (approximately 90 minutes) focused on supporting caregivers in coaching their teens in daily living skills development led by 2 trained therapists for 14 of the 15 intervention weeks.
  • Complete measures of adaptive functioning (to evaluate daily living skills; parent and teen-report) at the start of the study and post-intervention. Additional measures will also be collected.
  • Have the option to complete post-intervention interviews to provide feedback on the intervention components.

详细描述

Epilepsy is a common childhood neurological condition and disproportionately affects adolescents and young adults (AYAs) compared to younger children. An estimated 1.1 million AYAs with epilepsy will become adults and with this transition to adulthood, youth with epilepsy often have increased challenges, including social stigma, reduced health-related quality of life, and perceived lack of independence. Some of these challenges may be related to deficits in executive functioning (EF), and as many as 30-50% of AYAs with epilepsy demonstrate EF deficits. EF has also been shown to impact adaptive functioning. Daily living skills (DLS), a component of adaptive functioning, are essential for managing independent living into adulthood. Age-appropriate DLS are linked to better adult outcomes in youth, including finding and keeping a job, attending college, and living independently. However, research has shown that even with relatively normal cognitive abilities, youth with epilepsy have demonstrated poorer adaptive skills compared to same-age peers, and interventions targeting the acquisition of DLS may be an important mechanism for closing this gap. Surviving and Thriving in the Real World (STRW) is a 15-week evidence-based DLS intervention developed originally for adolescents with autism without an intellectual disability (ID; IQ>70) that has shown promising results for improving DLS. Given the overlap of deficits in adaptive and executive functioning, STRW may be a useful intervention for adolescents with epilepsy to improve DLS in a structured and supported program prior to their transition to adulthood. In the current study, the investigators will deliver STRW for adolescents with epilepsy and test the effectiveness of the virtual intervention with families recruited from Cincinnati Children's Hospital Medical Center (CCHMC). Given the emphasis on increasing DLS for adolescents with challenges in adaptive functioning, adolescents will be screened based on a parent measure of adaptive functioning skills called the Adaptive Behavior Assessment System, Third Edition (ABAS-3) prior to intervention enrollment. The aim is to assess the satisfaction and acceptability of the STRW intervention for caregivers and adolescents completing the intervention and to determine the impact on adaptive functioning from pre- to post-treatment. The intervention will enroll high schoolers (i.e., 9th-12th graders) to examine the impact of the intervention on youth prior to the transition to adulthood. The investigators expect that adolescents and caregivers will rate STRW as satisfactory and acceptable and youth who complete the STRW intervention will demonstrate improvements on the caregiver-reported primary DLS assessment (ABAS-3) from pre-to post-treatment. Adolescent-reported DLS will also be explored.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with epilepsy at least 1 year ago,
  • enrolled in 9th-12th grade (i.e., 14-18 years old at time of enrollment)
  • deficits in adaptive functioning per caregiver report (i.e., standard score below 90 on either the ABAS-3 Practical Domain or General Adaptive Composite [GAC]),
  • not planning to wean off anti-seizure medication (ASM) within the intervention timeframe,
  • and family's primary language is English.

排除标准

  • Parent- or clinician-reported history in the adolescent/young adult of:
  • history of developmental delay (e.g., autism spectrum disorder, pervasive development disorder, history of services for developmental delay or intellectual impairment in the past 5 years, known IQ<70),
  • severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months),
  • currently on the ketogenic diet,
  • and history of epilepsy surgery in the past year.
  • Clinician-reported diagnosis in the adolescent/young adult of:
  • one or more episodes of status epilepticus within the 24 weeks prior to enrollment
  • treatable causes of seizures (for example, identified etiologies including metabolic, neoplastic or active infectious origin),
  • a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome),
  • a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders),
  • non-epileptic events/seizures.

结局指标

主要结局

Enrollment Rate

时间窗: Enrollment

Enrollment rate will be calculated by dividing the number of consented participants by the number of eligible participants.

Retention Rate

时间窗: From enrollment to 1-month post intervention (up to approximately 23 weeks)

Retention will be calculated by dividing the number of participants who completed the study at post-treatment by the number of eligible participants enrolled.

Caregiver Satisfaction and Acceptability

时间窗: Weekly during the intervention (Up to 15 weeks)

The study-specific satisfaction and acceptability surveys will be sent to caregivers after each caregiver group and dyad session attended in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial.

Adolescent/Young Adult Satisfaction and Acceptability

时间窗: Weekly during the intervention (Up to 15 weeks)

The study-specific satisfaction and acceptability surveys will be sent to adolescent and young adult participants after each dyad session completed in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial.

Adaptive Behavior Assessment System, Third Edition, Adult-Other (Caregiver) Form, Practical Domain Standard Score

时间窗: Post-Intervention (Up to 4 weeks Post-Intervention)

The ABAS-3 Adult-Other (Caregiver) Form, Practical Domain Standard Score will be used as a primary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills.

Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Other (Caregiver) Form, Practical Domain Standard Score

时间窗: Post-Intervention (Up to 4 weeks Post-Intervention)

The ABAS-3 Adult-Other (Caregiver) Form, Practical Domain Standard Score will be used as a primary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills.

次要结局

  • Adaptive Behavior Assessment System, Third Edition, Adult-Self Form, Practical Domain Standard Score(Post-Intervention (Up to 4 weeks Post-Intervention))
  • Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Self Form, Practical Domain Standard Score(Post-Intervention (Up to 4 weeks Post-Intervention))

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Avani Modi

Principal Investigator

Children's Hospital Medical Center, Cincinnati

研究点 (1)

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