HOBSCOTCH-YOUTH and Young Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-29
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
HOBSCOTCH/HOBSCOTCH-YOUTH
Other interventionHOBSCOTCH (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 of the HOBSCOTCH program for youth ages 13 - 17 who have epilepsy.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: HOBSCOTCH-YOUTH and Young Adults InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in quality of life as measured by comparing QOLIE-31 scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE)
The QOLIE-31 (Quality of Life in Epilepsy Inventory-31) is a validated 31-item, patient-reported questionnaire designed to assess health-related quality of life in adults and adolescents with epilepsy, focusing on core aspects such as seizure worries, daily activities, mood, energy, and medication effects. Numerical responses are summed and divided by the total number of items answered with lower scores reflecting better quality of life or fewer perceived difficulties.
Time frame
Baseline, 3 months and 6 months post HOBSCOTCH intervention2
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)
The Cognitive Function sub-scale of the NeuroQOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Time frame
Baseline, 3 months and 6 months post HOBSCOTCH intervention3
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)
The Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48) is a validated instrument designed to measure health-related quality of life (HRQOL) in adolescents aged 11-18 years with epilepsy. It consists of 8 domains and is scored based on a 5-point Likert scale response from 1 - 5 (very poor - excellent). Higher scores reflect better functioning or quality of life.
Time frame
Baseline, 3 months and 6 months post HOBSCOTCH-YOUTH intervention4
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
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5-point Likert scale is used with a higher score indicating a greater level of perceived burden.
Time frame
Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH interventionSecondary outcomes
1
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).
The AESMMI-65 is a 65-item validated scale that assesses use of epilepsy self-management practices. Scores range from 65 to 325, with a higher score indicating more frequent use of self-management strategies.
Time frame
Baseline, 3 months and 6 months post HOBSCOTCH intervention2
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).
The EMQ-R is a validated self-administered, subjective measure designed to assess memory in everyday life. It consists of 13 items scored on a 5-point Likert scale from 0 - 4 with total scores ranging from 0 - 52. Higher scores indicate a greater frequency of self-reported everyday memory failures.
Time frame
Baseline, 3 months and 6 months post HOBSCOTCH intervention3
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).
The Epilepsy Self-Stigma Scale is an eight-item self-report questionnaire designed to measure the extent to which people with epilepsy internalize negative societal attitudes toward their condition. Each item is rated on a 5-point (0- 4) Likert scale and summed with higher scores and a higher sum indicating higher perceived self-stigma.
Time frame
Baseline, 3 months and 6 months post HOBSCOTCH intervention4
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).
The PHQ-8 is a validated self-report, eight-item questionnaire measuring depressive symptom frequency over the past two weeks using a 4-point Likert scale. Scores are summed with higher scores indicating poorer mood and greater self-report of depression.
Time frame
Baseline, 3 months and 6 months post HOBSCOTCH interventionSponsors and contacts
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Source ClinicalTrials.gov
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