A Novel Social Emotional Learning Curriculum for Youth With Epilepsy

Not Applicable

Recruiting

• Conditions: Epilepsy
• Interventions: Behavioral: Project Dream Team

• Registration Number: NCT06427967
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Study Start: 2024-07-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novel Social-Emotional Learning (SEL) curriculum	Project Dream Team	Participants assigned to this arm will receive Project Dream Team, the new 5 session SEL curriculum for YWE.

Primary Outcome Measures

Name	Time	Method
Feasibility of study processes	4 months	Number of sessions attended per participant.
Acceptability of the intervention	4 months	A likert scale will be used to assess satisfaction from 1 to 10 where 10 is highly acceptable and 1 is not acceptable.

Secondary Outcome Measures

Name	Time	Method
Change in perceived social support (PSS)	Baseline, 4 months	This outcome will be assessed with the Youth Thrive (YT) Framework Survey Part 1: Social Connections and Concrete Supports combine subscales. Each YT subscale includes 10 to 16 individual Likert scale questions. Scores are generated by assigning values of 1 to 5 to the Likert scale (1 = not at all like me, 5 = very much like me) for 'positive items' and an inverse value scale for 'negative items' and then totalling all the items within the subscale. Higher total scores indicate a higher level of PSS.

Trial Locations

Locations (1)

Boston Medical Center, Neurology and remote; 🇺🇸 Boston, Massachusetts, United States