HOBSCOTCH-YOUTH and Young Adults

Browse trials for

• Epilepsy 1,848
• Cognitive Dysfunction 3,872
• Seizures 766

Keywords

• Epilepsy
• Seizures
• Cognitive Dysfunction, Cognitive Disorder
• Memory and thinking problems
• Epilepsy Self-Management

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's planned enrollment of 300 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.

Study arms

• Other
  HOBSCOTCH-YOUTH and Young Adults Intervention

  Participants will receive the HOBSCOTCH (ages 18-29) or HOBSCOTCH-YOUTH (ages 13 -17) program consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam or by phone); * 1 educational session (on webcam); * 6 HOBSCOTCH intervention sessions (webcam or by phone); * 1 wrap-up and maintenance planning session.

  Other: HOBSCOTCH/HOBSCOTCH-YOUTH

Interventions

• OtherHOBSCOTCH/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 of the HOBSCOTCH program for youth ages 13 - 17 who have epilepsy.

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 intervention

2. 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 intervention

3. 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 intervention

4. 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 intervention

Secondary 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 intervention

2. 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 intervention

3. 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 intervention

4. 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 intervention

5. 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).

   The Brief Epilepsy Anxiety Survey Instrument (brEASI) is an 8 item, self-administered, validated questionnaire designed to screen for anxiety disorders in people with epilepsy. It consists of 8 items scored on a 4-point Likert scale (0 - 3) with higher scores and a higher sum of all scores indicating greater degrees of anxiety.

   Time frame: Baseline, 3 months and 6 months post HOBSCOTCH intervention

6. 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).

   The Personal Impact of Epilepsy Scale (PIES) is a validated 25-item self-reported questionnaire developed to measure the overall impact of epilepsy on a person's life, with specific focus on seizures, medication side effects, comorbidities, and overall quality of life (QOL). Items are scored using a 5-point Likert scale (0 - 4) with higher scores and a higher total sum indicating a greater perceived negative personal impact of epilepsy.

   Time frame: Baseline, 3 months and 6 months post HOBSCOTCH intervention

7. 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).

   The BRIEF-SR is a standardized self-report of executive functioning designed for ages 11 to 18 years measuring an adolescent's perspective on cognitive, emotional, and behavioral self-regulation in everyday life. It consists of 80 items rated by the adolescent using a 3-point Likert scale (1-never, 2-sometimes, 3-often). Raw scores are summed and converted to a T score (50/10) with a higher score indicating greater difficulty in executive functioning.

   Time frame: Baseline, 3 months and 6 months post HOBSCOTCH-YOUTH intervention

8. 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.

   The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a self-report questionnaire completed by a parent or guardian to assess executive function in their child. It contains 86 items scored by the parent using a 3-point Likert scale (1-Never, 2-Sometimes, 3-Often). Raw scores are summed and converted to a T-Score (50/10) with higher scores indicating greater perceived difficulties with executive function.

   Time frame: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention

9. 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.

   The Affiliate Stigma Scale is a validated instrument designed to measure the extent of self-stigmatization experienced by associates (e.g., family members, caregivers) of someone with a stigmatized disability. It contains 22 items using a 4-point Likert scale (1 - 4) with higher scores and total scores indicating a greater degree of perceived self-stigma.

   Time frame: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention

10. 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).

    YAWE and YWE will self-report their seizure activity, Yes or No, using a smartphone app(lication). The smart phone app was developed by the HOBSCOTH Institute at Dartmouth and is used clinically in the HOBSCOTCH program.

    Time frame: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention

11. 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).

    YAWE and YWE will self-report their medication adherence activity, Yes or No, using a smartphone app(lication). The smart phone app was developed by the HOBSCOTH Institute at Dartmouth and is used clinically in the HOBSCOTCH program.

    Time frame: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention

12. 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).

    YAWE and YWE will self-report their use of memory strategies, Yes or No, using a smartphone app(lication). The smart phone app was developed by the HOBSCOTH Institute at Dartmouth and is used clinically in the HOBSCOTCH program.

    Time frame: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention

13. Changes in self-reports of wellbeing as measured by comparing daily reports of well-being at baseline and at 3 months post-HOBSCOTCH/HOBSCOTCH-YOUTH intervention in young adults and youth with epilepsy (YAWE and YWE).

    YAWE and YWE will give self-reports of well-being on a 5-point Likert scale (Great, Good, Average, Poor, Very Poor) using a smartphone app(lication). The smart phone app was developed by the HOBSCOTH Institute at Dartmouth and is used clinically in the HOBSCOTCH program.

    Time frame: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention

14. Engagement and satisfaction for young adults with epilepsy (YAWE) and for youth with epilepsy (YWE) and their parents as measured by study attrition and a Participant Satisfaction Survey after completing the HOBSCOTCH/HOBSCOTCH-YOUTH intervention.

    The Participant Satisfaction Survey was developed through the original HOBSCOTH program and is used in clinical practice for quality improvement. It has been modified to address YAWE, YWE and Parent's satisfaction as a result or participating in this study and contains 9 items scored on a 5- point Likert scale with a higher score indicating greater satisfaction with the program. There is also an open-ended portion to give additional feedback.

    Time frame: At 3 months, i.e. after completing the HOBSCOTCH or HOBSCOTCH-YOUTH intervention

15. Engagement and satisfaction for young adults with epilepsy (YAWE) as measured by CollaboRATE score post HOBSCOTCH intervention.

    CollaboRATE is a brief, 3 item patient-reported measure of shared decision making, namely the perception of being informed and then involved in decision-making steps. A 10-point anchor scale from 0 (no effort was made) to 9 (every effort was made) with higher scores representing a greater perception of a shared decision-making effort.

    Time frame: Baseline and at 3 months, i.e. after completing the HOBSCOTCH intervention

16. Engagement and satisfaction for parents of youth with epilepsy (YWE) as measured by CollaboRATE-parent score post HOBSCOTCH intervention.

    CollaboRATE-parent is a brief, 3 item parent-reported measure of shared decision making, namely the perception of being informed and then involved in decision-making steps for their child. A 10-point anchor scale from 0 (no effort was made) to 9 (every effort was made) with higher scores representing a greater perception of a shared decision-making effort

    Time frame: Baseline and at 3 months, i.e. after completing the HOBSCOTCH-YOUTH intervention

17. HOBSCOTCH/HOBSCOTCH-YOUTH fidelity as measured by young adults with epilepsy (YAWE) and youth with epilepsy's (YWE) compliance with weekly homework assignments.

    Homework assignments are given each week in which participants are asked to think about solutions using the Problem Solving Therapy taught in the program. Compliance is measured by Yes (completed homework assignment) or No (did not complete homework assignment).

    Time frame: Week 1 through Week 8 of HOBSCOTCH/HOBSCOTCH-YOUTH intervention

18. Sustainability of improvement on primary outcome measure of quality of life for young adults with epilepsy (YAWE) by comparing scores on the QOLIE-10 (Quality of Life in Epilepsy Inventory) at 3 months and 6 months post HOBSCOTCH intervention.

    Time frame: 3 months and 6 months post HOBSCOTCH intervention

19. Sustainability of improvement on primary outcome measure of subjective cognition for young adults with epilepsy (YAWE) by comparing scores on the Neuro-QOL Cognitive Subscale at 3 months and 6 months post HOBSCOTCH intervention.

    Time frame: 3 months and 6 months post HOBSCOTCH intervention

20. Sustainability of improvement on primary outcome measure of quality of life for youth with epilepsy (YWE) by comparing scores on the QOLIE-AD-48 at 3 months and 6 months post HOBSCOTCH-YOUTH intervention.

    (Quality of Life in Epilepsy Inventory - Adolescents - 48)

    Time frame: 3 months and 6 months post HOBSOTCH-YOUTH intervention

21. Sustainability of improvement on primary outcome measure of caregiver burden for parent/legal guardian of youth with epilepsy as measured by comparing Zarit Burden Interview scores at 3 months and 6 months post-HOBSCOTH-YOUTH intervention by their child.

    Time frame: 3 months and 6 months post HOBSCOTCH-YOUTH intervention

Individual participant data

Plan to share: No