EpilepsyNCT07735715
HOBSCOTCH-YOUTH and Young Adults
A study testing HOBSCOTCH/HOBSCOTCH-YOUTH in people with Epilepsy and Cognitive Dysfunction, Cognitive Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 29 years
- Conditions the study is for
- Epilepsy, Cognitive Dysfunction, Cognitive Disorder, Memory and Thinking Problems
- What is being tested?
- HOBSCOTCH/HOBSCOTCH-YOUTH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 13Show fewer
- Literate and proficient in English
- Telephone access
- Internet Access.
- Parent or legal guardian of a youth with epilepsy (age 13 - 17 years)
- Literate and proficient in English
- Telephone access
- Internet Access
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
Elaine T Kiriakopoulos, MD, MPH, MSc - Principal Investigator, MD, MPH, MS, 603-650-4225, elaine.t.kiriakopoulos@dartmouth.edu
About this study
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.
Read more
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.
- Being tested
- HOBSCOTCH/HOBSCOTCH-YOUTH
- Keywords
- Epilepsy, Seizures, Cognitive Dysfunction, Cognitive Disorder, Memory and thinking problems, Epilepsy Self-Management
- Medical subject headings
- Epilepsy, Cognitive Dysfunction, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOBSCOTCH/HOBSCOTCH-YOUTHOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HOBSCOTCH-YOUTH and Young Adults Intervention | Other | 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. Receives: Other: HOBSCOTCH/HOBSCOTCH-YOUTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention
Secondary outcomes (21)
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention
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.
Measured: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention
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.
Measured: At 3 months, i.e. after completing the HOBSCOTCH or HOBSCOTCH-YOUTH intervention
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.
Measured: Baseline and at 3 months, i.e. after completing the HOBSCOTCH intervention
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
Measured: Baseline and at 3 months, i.e. after completing the HOBSCOTCH-YOUTH intervention
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).
Measured: Week 1 through Week 8 of HOBSCOTCH/HOBSCOTCH-YOUTH intervention
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.
Measured: 3 months and 6 months post HOBSCOTCH intervention
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.
Measured: 3 months and 6 months post HOBSCOTCH intervention
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)
Measured: 3 months and 6 months post HOBSOTCH-YOUTH intervention
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.
Measured: 3 months and 6 months post HOBSCOTCH-YOUTH intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2026
- Primary completion1 May 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine T. Kiriakopoulos, Dartmouth-Hitchcock Medical Center
- Investigators
- Elaine T. Kiriakopoulos, MD, MPH, MSc, Principal investigator, Dartmouth-Hitchcock/Geisel School of Medicine-Dartmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735715
- Sponsor's protocol ID
- STUDY02003605
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOBSCOTCH-YOUTH and Young Adults
- ClinicalTrials.gov ID
- NCT07735715
- Acronym / sponsor ID
- STUDY02003605
- Keywords
- Epilepsy, Seizures, Cognitive Dysfunction, Cognitive Disorder, Memory and thinking problems, Epilepsy Self-Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOBSCOTCH-YOUTH and Young Adults Intervention | Other | Other: HOBSCOTCH/HOBSCOTCH-YOUTHParticipants 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. |
Who may qualify
- Ages
- 13 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Inclusion Criteria for Young Adults with Epilepsy (YAWE) and 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOBSCOTCH/HOBSCOTCH-YOUTHHOBSCOTCH (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. | Other | HOBSCOTCH-YOUTH and Young Adults Intervention |
Primary outcome
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)
Time frame: Baseline, 3 months and 6 months post HOBSCOTCH intervention
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.
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
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.
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
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.
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
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.
21 secondary outcomes
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
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).
Time frame: Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention
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.
Time frame: At 3 months, i.e. after completing the HOBSCOTCH or HOBSCOTCH-YOUTH intervention
Engagement and satisfaction for young adults with epilepsy (YAWE) as measured by CollaboRATE score post HOBSCOTCH intervention.
Time frame: Baseline and at 3 months, i.e. after completing the HOBSCOTCH intervention
Engagement and satisfaction for parents of youth with epilepsy (YWE) as measured by CollaboRATE-parent score post HOBSCOTCH intervention.
Time frame: Baseline and at 3 months, i.e. after completing the HOBSCOTCH-YOUTH intervention
HOBSCOTCH/HOBSCOTCH-YOUTH fidelity as measured by young adults with epilepsy (YAWE) and youth with epilepsy's (YWE) compliance with weekly homework assignments.
Time frame: Week 1 through Week 8 of HOBSCOTCH/HOBSCOTCH-YOUTH intervention
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
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
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.
Time frame: 3 months and 6 months post HOBSOTCH-YOUTH intervention
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elaine T. Kiriakopoulos, MD, MPH, MSc principal investigator
Dartmouth-Hitchcock/Geisel School of Medicine-Dartmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOBSCOTCH/HOBSCOTCH-YOUTH in people with Epilepsy and Cognitive Dysfunction, Cognitive Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wren M Kaden, BA (603-650-4225, wren.m.kaden@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline, 3 months and 6 months post HOBSCOTCH intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.