Clinical trial NCT06427967: A Novel Social Emotional Learning Curriculum for Youth With Epilepsy
Official title: Beyond Watching and Waiting: A Pilot Study of a Novel Social Emotional Learning Curriculum-Based Intervention Designed for Youth With Epilepsy at Increased Risk of Future Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Youth with epilepsy (YWE)
Positive Youth Development
Social-Emotional Learning
Social Ecological Model
Youth Thrive Framework
Perceived Social Support
Health-Related Quality of Life
Adult Epilepsy Self-Management Measurement Instrument
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Charles H. Hood Foundation
First posted: 2024-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-group pretest-posttest
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor.

Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically.

The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored.

The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE.


Eligibility criteria: Inclusion Criteria:

* Able to read, write, and communicate in English at 3rd grade level
* Active epilepsy diagnosis (currently on anti-seizure medication or does not yet meet remission standards of 10 years without seizure and off all medication)
* Epilepsy diagnosis clinically established for at least 6 months prior to the time of recruitment
* The pediatric neurologist feels the patient would benefit from program participation.
* Able to consistently join meetings on Zoom with functional audio and video reception

Exclusion Criteria:

* During the consent process, if an eligible potential participant feels that participation would pose too much of a burden on their health or mental wellbeing, they will be excluded.

Primary outcomes:
measure: Feasibility of study processes
timeFrame: 4 months
measure: Acceptability of the intervention
timeFrame: 4 months
Secondary outcomes:
measure: Change in perceived social support (PSS)
timeFrame: Baseline, 4 months
Other outcomes:
measure: Change in social emotional skills and behaviors
timeFrame: Baseline, 4 months
measure: Change in leveraging social support for epilepsy self management
timeFrame: Baseline, 4 months
Locations:
city: Boston
country: United States
facility: Boston Medical Center, Neurology and remote
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Department of Neurology
name: Laurie Douglass, MD
role: PRINCIPAL_INVESTIGATOR
References: