HOBSCOTCH-YOUTH and Young Adults

NCT07735715 | Not Yet Recruiting

• 1 other identifier: STUDY02003605
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Epilepsy; Cognitive Dysfunction, Cognitive Disorder; Memory and Thinking Problems

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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)

  The QOLIE-10 (Quality of Life in Epilepsy Inventory-10) is a validated 10-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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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).

  Baseline, 3 months and 6 months post HOBSCOTCH intervention

Study Arms (1)

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.

Other: HOBSCOTCH/HOBSCOTCH-YOUTH

Interventions

HOBSCOTCH/HOBSCOTCH-YOUTH OTHER

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.

HOBSCOTCH-YOUTH and Young Adults Intervention

Eligibility Criteria

• Age: 13 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Epilepsy Wellness Advocates: collaborator

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Epilepsy; Cognitive Dysfunction; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine T. Kiriakopoulos, MD, MPH, MSc

  Dartmouth-Hitchcock/Geisel School of Medicine-Dartmouth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wren M Kaden, BA

CONTACT

603-650-4225; wren.m.kaden@hitchcock.org

Trina K Dawson, BA

CONTACT

603-650-4225; trina.k.dawson@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Departments of Neurology, Health Policy & Clinical Practice Dartmouth-Hitchcock Health | Geisel School of Medicine at Dartmouth

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)