Self-management for Youth With Epilepsy Pilot

NCT07876102 | Not Yet Recruiting

• 1 other identifier: STUDY20261117
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy

Keywords

Epilepsy; Self-Management; Adolescents; SMART; Feasibility and Acceptability; Pilot

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12 weeks

Secondary Outcomes (4)

• Change in 30-Day Seizure Count

  Baseline, 12 weeks

• Change in Negative Health Events (NHE) Total Score

  Baseline, 12 weeks

• Change in PedsQL Epilepsy Module Standard Version Total Score

  Baseline, 12 weeks

• Change in PedsQL Epilepsy Module Acute Version Total Score

  Baseline, 12 weeks

Study Arms (1)

Experimental: [SMART-Y]

EXPERIMENTAL

Behavioral: SMART-Y

Interventions

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.

Experimental: [SMART-Y]

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Related Publications (3)

• 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.

  PMID: 27743547 BACKGROUND

• 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.

  PMID: 28215372 BACKGROUND

• 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.

  PMID: 30098003 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Molly K McVoy, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica O Surdam, MPH

CONTACT

216-844-7925; Jessica.Surdam@UHhospitals.org

Carla M Conroy, MPH

CONTACT

216-844-2871; Carla.Conroy@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share