HOBSCOTCH-YOUTH and Young Adults

Обзор

The goal of this clinical trial is to learn more about the home-based epilepsy self-management program, HOBSCOTCH, for improving cognitive function (thinking and memory) and quality of life specifically in young adults, ages 18 - 29 years, who have epilepsy. It will also learn if a modification of the program for youth with epilepsy, ages 13 - 17, improves thinking and memory and quality of life and reduces stress for their parents. Researchers will enroll 260 young adults with epilepsy and 40 youth with epilepsy and their parent or guardian. Researchers will compare responses to questionnaires and surveys before and after participation in the HOBSCOTCH program to see if thinking, memory and quality of life have improved for young adults and youth with epilepsy and to see if parents have improved quality of life as well. Participants will: * Attend 9 weekly one-hour sessions of the HOBSCOTH program in their homes with a one-on-one coach using their computer or their phone; youth with epilepsy (ages 13 - 17) will attend alongside a parent or legal guardian. * Keep a short daily diary about their seizures and activity in the program using a smart phone app(lication) * Complete surveys and questionnaires before HOBSCOTCH and 3 months and 6 months later. There are no study visits to a medical center. HOBSCOTCH is a virtual or telehealth intervention.

Вмешательства

• Другое HOBSCOTCH/HOBSCOTCH-YOUTH
  HOBSCOTCH (HOme Based Self-Management and COgnitive Training CHanges Lives) is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care, for people with epilepsy and other neurological disorders. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-YOUTH is an adaptation

Первичные конечные точки

• Change in quality of life as measured by comparing QOLIE-10 scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE) [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH intervention]
• Change in subjective cognition as measured by comparing NeuroQOL - Cognitive Function sub-scale scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE) [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH intervention]
• Change in quality of life as measured by comparing QOLIE-AD-48 scores at baseline to 3 months and 6 months post- HOBSCOTCH-YOUTH intervention in youth with epilepsy (YWE) [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH-YOUTH intervention]
• Change in caregiver burden for parent/legal guardian of youth with epilepsy as measured by comparing Zarit Burden Interview scores at baseline to 3 months and 6 months post-HOBSCOTH-YOUTH intervention by their child [Срок оценки: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention]

Вторичные конечные точки (12)

• Change in epilepsy self-management practices as measured by comparing the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE). [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH intervention]
• Changes in functional memory as measured by comparing Everyday Memory Questionnaire - Revised (EMQ-R) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE). [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH intervention]
• Changes in perceived self-stigma as measured by comparing Epilepsy Self-Stigma Scale (ESS) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE). [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH intervention]
• Changes in mood and depression as measured by Patient Health Questionnaire-8 (PHQ-8) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE). [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH intervention]
• Changes in anxiety by comparing Brief-Epilepsy Anxiety Survey Instrument (brEASI) at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE). [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH intervention]
• Changes in perceived personal impact of epilepsy as measured by Personal Impact of Epilepsy Scale (PIES) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE). [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH intervention]
• Change in executive function as measured by comparing Behavioral Rating Inventory of Executive Function - Self Report (BRIEF-SR) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in youth with epilepsy (YWE). [Срок оценки: Baseline, 3 months and 6 months post HOBSCOTCH-YOUTH intervention]
• Change in parent's perception of child's executive function as measured by Behavioral Rating Inventory of Executive Function - Parent Report at baseline to 3 months and 6 months post HOBSCOTCH-YOUTH intervention. [Срок оценки: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention]
• Changes in perceived self-stigma in parents of youth with epilepsy as measured by comparing Affiliate Stigma Scale scores at baseline to 3 months and 6 months post HOBSCOTCH-YOUTH intervention. [Срок оценки: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention]
• Changes in frequency of seizures as measured by comparing daily self-reported seizures at baseline to 3 months post-HOBSCOTCH/HOBSCOTCH-YOUTH intervention in young adults and in youth with epilepsy (YAWE and YWE). [Срок оценки: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention]
• Changes in medication adherence as measured by a daily self-reported diary compared at baseline and at 3 months post-HOBSCOTCH/HOBSCOTCH-YOUTH intervention in young adults and in youth with epilepsy (YAWE and YWE). [Срок оценки: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention]
• Changes in use of memory strategies as measured by comparing daily self-reported use of memory strategies at baseline to 3 months post-HOBSCOTCH/HOBSCOTCH-YOUTH intervention in young adults and in youth with epilepsy (YAWE and YWE). [Срок оценки: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention]

Критерии участия

Критерии включения

• Inclusion Criteria for Young Adults with Epilepsy (YAWE) and Youth with Epilepsy (YWE):

• Age 18 - 29 years for YAWE
• Age 13 - 17 years for YWE
• For YWE at least one parent or legal guardian provides consent and agrees to participate
• Diagnosis of epilepsy (controlled or uncontrolled seizures)
• Subjective cognitive complaints (memory, attention, learning, problem solving, executive function, planning)
• Literate and proficient in English
• Telephone access
• Internet Access.

Inclusion Criteria for Parent of Youth with Epilepsy (YWE):

• Parent or legal guardian of a youth with epilepsy (age 13 - 17 years)
• Literate and proficient in English
• Telephone access
• Internet Access

Критерии исключения

• Active psychosis (any participant)
• Illicit substance abuse (any participant)
• Severe cognitive/intellectual disability (any participant)
• YWE cannot participate without a parent and parent's consent (or legal guardian)
• YWE cannot participate without assent even if a parent or legal guardian gives consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Dartmouth-Hitchcock — Lebanon

Идентификаторы

NCT: NCT07735715 · STUDY02003605

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗