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NCT07735715

HOBSCOTCH-YOUTH and Young Adults

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 8 months later, primary endpoint(s) modified.

See at-risk trials from Dartmouth-Hitchcock Medical Center

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 1, 2028 to May 1, 2029 Show 7 more changesShow less
    • Recruitment opened
    • Primary endpoints: details revised at 1 of 4 entries
    • Study completion pushed from Mar 1, 2029 to Jul 31, 2029
    • Interventions: HOBSCOTCH/HOBSCOTCH-YOUTH (Other) to HOBSCOTCH/HOBSCOTCH-YOUTH (Other)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 18 of 21 entries
    • Site details revised
  2. Primary endpoint(s) modified
    • Secondary endpoints: details revised at 2 of 21 entries
    • Collaborators shortened, about 3 words
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention

Secondary (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).
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).
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).
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).
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).
Show 16 moreShow less
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).
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).
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.
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.
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).
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).
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).
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).
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.
Engagement and satisfaction for young adults with epilepsy (YAWE) as measured by CollaboRATE score post HOBSCOTCH intervention.
Engagement and satisfaction for parents of youth with epilepsy (YWE) as measured by CollaboRATE-parent score post HOBSCOTCH intervention.
HOBSCOTCH/HOBSCOTCH-YOUTH fidelity as measured by young adults with epilepsy (YAWE) and youth with epilepsy's (YWE) compliance with weekly homework assignments.
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.
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.
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.
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.

Arms and interventions

HOBSCOTCH-YOUTH and Young Adults InterventionOther

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

Sites

1 site in 1 country

  • Dartmouth-HitchcockLebanon, New Hampshire, United States