Health TrialsbyHealthPanel

Self-management for Youth With Epilepsy Pilot

ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-17
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

Pilot feasibility and acceptability trial of the SMART-Y intervention in a small group of adolescents (n=18), age 14-17

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 14-17

Diagnosed with epilepsy, per clinician or chart diagnosis

Has parent/guardian that is able/willing to consent (parent does not have to also participate, just has to consent to the youth's participation)

Speaks English

Disqualifiers

Comorbid Dx: moderate-severe intellectual disability

Unable to assent to the study

Unable to meaningfully participate in the intervention sessions or assessments

Trial design

Design model

Single group

Treatments tested in this trial

  • SMART-Y

    Behavioral

    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.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Experimental: [SMART-Y]Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals Cleveland Medical Center

Lead sponsor

Source ClinicalTrials.gov

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