An interventional study of SMART-Y in Epilepsy, sponsored by University Hospitals Cleveland Medical Center. Not yet recruiting. Open to participants aged 14 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Prevention
Pilot feasibility and acceptability trial of the SMART-Y intervention in a small group of adolescents (n=18), age 14-17
Pilot feasibility and acceptability trial of the SMART-Y intervention, which was modified from an evidence-based adult self-management program called Self-management for people with epilepsy and a history of negative health events (SMART). SMART is a remotely delivered/ real-time, group-format epilepsy self-management intervention that targets those who have had recent epilepsy-related complications and emphasizes management of lifestyle and emotions, as well as seizure control.
The study also enrolls peer educators who assist with intervention delivery. Demographic information will be collected from peer educators; however, peer educators do not receive the intervention as study recipients and are not included in analyses of participant outcomes.
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's planned enrollment of 18 is below the median of 50 across 1,228 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →University Hospitals Cleveland Medical Center is the lead sponsor of 293 studies on the registry; 43 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 30 (86%) have results posted.
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Exclusion Criteria:
Behavioral: SMART-Y
SMART-Y is a youth-focused adaptation of SMART ( Self-MAnagement for people with epilepsy and a histoRy of negative health evenTs) developed for adolescents transitioning into adulthood. SMART is a remotely delivered, real-time group intervention that supports epilepsy self-management among individuals with recent epilepsy-related complications. The program emphasizes seizure control, lifestyle management, and emotional health.
Feasibility 1 - Session Attendance Rate
Percentage of scheduled intervention sessions attended during the 12-week intervention period. Each participant will be scheduled to attend 8 weekly intervention sessions; therefore, the total number of scheduled sessions will be calculated as the number of participants enrolled multiplied by 8 sessions.
Time frame: 8 weeks
Feasibility 2 - Intervention Sessions Retention
Proportion of participants who attended 75% of the sessions. Retention to sessions will be calculated as the number of participants attending at least 6 of the 8 scheduled intervention sessions divided by the total number of participants enrolled.
Time frame: 8 weeks
Feasibility 3 - Assessment Retention
Percentage of participants who complete both the baseline and 12-week assessments. Assessment retention will be calculated as the number of participants completing both assessments divided by the number of participants enrolled.
Time frame: 12 weeks
Change in 30-Day Seizure Count
The 30-day seizure count is a standalone frequency metric determined by the total number of distinct clinical seizure events reported by the participant over a 30-day recall period. The score ranges from 0 to no upper limit, where a higher score indicates a worse clinical outcome (more frequent seizures).
Time frame: Baseline, 12 weeks
Change in Negative Health Events (NHE) Total Score
The Negative Health Events (NHE) total score is calculated as the sum of the total number of distinct events occurring over a 6-month recall period across 5 categories: seizures, emergency department visits, inpatient hospital admissions, self-harm attempts, and accidents or traumatic injuries. The total score ranges from 0 to no upper limit, where a higher score indicates a worse clinical outcome (more frequent negative health events).
Time frame: Baseline, 12 weeks
Change in PedsQL Epilepsy Module Standard Version Total Score
The PedsQL Epilepsy Module Standard Version Total Scale Score is a 29-item questionnaire assessing epilepsy-specific health-related quality of life (HRQOL) across five domains (Impact, Cognitive, Sleep, Executive Functioning, and Mood/Behavior) with a standard 1-month recall period. Raw 5-point Likert scale items are reverse-scored and linearly transformed onto a 0 to 100 scale. The Total Scale Score represents the mean of all answered items. The total score ranges from 0 to 100, where a higher score indicates a better epilepsy-specific HRQOL.
Time frame: Baseline, 12 weeks
Change in PedsQL Epilepsy Module Acute Version Total Score
The PedsQL Epilepsy Module Acute Version Total Scale Score is a 29-item questionnaire assessing epilepsy-specific health-related quality of life (HRQOL) across five domains (Impact, Cognitive, Sleep, Executive Functioning, and Mood/Behavior) with an acute 7-day recall period. Raw 5-point Likert scale items are reverse-scored and linearly transformed onto a 0 to 100 scale. The Total Scale Score represents the mean of all answered items. The total score ranges from 0 to 100, where a higher score indicates a better acute, epilepsy-specific HRQOL.
Time frame: Baseline, 12 weeks
No study locations are listed for this record.
Plan to share: No — This is an internal pilot study.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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