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EpilepsySMART-Y pilotNCT07876102

Self-management for Youth With Epilepsy Pilot

A study testing SMART-Y in people with Epilepsy, run by University Hospitals Cleveland Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 14 to 17 years
Conditions the study is for
Epilepsy
What is being tested?
SMART-Y
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
Nov 2026to Oct 2027
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 14 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Comorbid Dx: moderate-severe intellectual disability
  • Unable to assent to the study
  • Unable to meaningfully participate in the intervention sessions or assessments

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jessica O Surdam, MPH contact

216-844-7925

Jessica.Surdam@UHhospitals.org

Carla M Conroy, MPH contact

216-844-2871

Carla.Conroy@UHhospitals.org

About this study

Official title: Self-management for Youth With Epilepsy (SMART-Y) Phase 3

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

Read the detailed description

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.

Conditions
Epilepsy
Being tested
SMART-Y
Keywords
Epilepsy, Self-Management, Adolescents, SMART, Feasibility and Acceptability, Pilot
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMART-YBehavioural

    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.

Study groups in NCT07876102
Study groupRoleWhat they receive
Experimental: [SMART-Y]ExperimentalNot described
Receives: Behavioral: SMART-Y

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 12 weeks

Secondary outcomes (4)

  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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876102
Sponsor's protocol ID
STUDY20261117
Acronym
SMART-Y pilot
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is an internal pilot study.

Publications

  • Sajatovic M, Tatsuoka C, Welter E, Perzynski AT, Colon-Zimmermann K, Van Doren JR, Bukach A, Lawless ME, Ryan ER, Sturniolo K, Lhatoo S. Targeted Self-Management of Epilepsy and Mental Illness for individuals with epilepsy and psychiatric comorbidity. Epilepsy Behav. 2016 Nov;64(Pt A):152-159. doi: 10.1016/j.yebeh.2016.08.012. Epub 2016 Oct 12.

    PubMed 27743547

  • Sajatovic M, Jobst BC, Shegog R, Bamps YA, Begley CE, Fraser RT, Johnson EK, Pandey DK, Quarells RC, Scal P, Spruill TM, Thompson NJ, Kobau R. The Managing Epilepsy Well Network:: Advancing Epilepsy Self-Management. Am J Prev Med. 2017 Mar;52(3 Suppl 3):S241-S245. doi: 10.1016/j.amepre.2016.07.026.

    PubMed 28215372

  • Sajatovic M, Colon-Zimmermann K, Kahriman M, Fuentes-Casiano E, Liu H, Tatsuoka C, Cassidy KA, Lhatoo S, Einstadter D, Chen P. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. Epilepsia. 2018 Sep;59(9):1684-1695. doi: 10.1111/epi.14527. Epub 2018 Aug 10.

    PubMed 30098003

Questions about this trial

What is this clinical trial studying?

A study testing SMART-Y in people with Epilepsy, run by University Hospitals Cleveland Medical Center.

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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Jessica O Surdam, MPH (216-844-7925, Jessica.Surdam@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility 1 - Session Attendance Rate (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07876102, which also lists 3 linked publications.

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 15 Oct 2026.

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