A Novel Social Emotional Learning Curriculum for Youth With Epilepsy

NCT06427967 | Completed

• 2 other identifiers: H-438754301210001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of study processes

  Number of sessions attended per participant.

  4 months

• Acceptability of the intervention

  A likert scale will be used to assess satisfaction from 1 to 10 where 10 is highly acceptable and 1 is not acceptable.

  4 months

Secondary Outcomes (1)

• Change in perceived social support (PSS)

  Baseline, 4 months

Other Outcomes (2)

• Change in social emotional skills and behaviors

  Baseline, 4 months

• Change in leveraging social support for epilepsy self management

  Baseline, 4 months

Study Arms (1)

Novel Social-Emotional Learning (SEL) curriculum

EXPERIMENTAL

Participants assigned to this arm will receive Project Dream Team, the new 5 session SEL curriculum for YWE.

Behavioral: Project Dream Team

Interventions

Project Dream Team BEHAVIORAL

Five total sessions, 60-minutes each, with one session every 7 days (+/- 21 days between sessions), Session activities include discussion prompts, interactive learning methods, skill rehearsals, mindfulness / somatic exercises and lecture slides facilitated by a trained facilitator.

Novel Social-Emotional Learning (SEL) curriculum

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• Charles H. Hood Foundation: collaborator

Study Sites (1)

Boston Medical Center, Neurology and remote

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Laurie Douglass, MD

  Boston Medical Center, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One-group pretest-posttest

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: July 16, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)