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Not yet recruiting NCT07735715

HOBSCOTCH-YOUTH and Young Adults

No phase Interventional Epilepsy Cognitive Dysfunction, Cognitive Disorder Memory and Thinking Problems

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HOBSCOTCH/HOBSCOTCH-YOUTH.
Who it may be relevant to
Registry conditions: Epilepsy, Cognitive Dysfunction, Cognitive Disorder, Memory and Thinking Problems. Basic parameters: 13 years — 29 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention]
Secondary outcome measures (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). [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: 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. [Time frame: 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. [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Dartmouth-Hitchcock — Lebanon

Identifiers

NCT: NCT07735715 · STUDY02003605

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗