A Novel Social Emotional Learning Curriculum for Youth With Epilepsy

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Project Dream Team

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center, Neurology and remote

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel Social-Emotional Learning (SEL) curriculum; Participants assigned to this arm will receive Project Dream Team, the new 5 session SEL curriculum for YWE.	Behavioral: Project Dream Team; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived social support (PSS)	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.	Baseline, 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in social emotional skills and behaviors	The Youth Thrive (YT) Framework Survey Part 2: Youth Resilience, Cognitive and Social-Emotional Competence subscales will be used to assess this outcome. 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 greater depth of knowledge, higher mastery over key skills and more frequent use of prosocial behaviors.	Baseline, 4 months
Change in leveraging social support for epilepsy self management	This outcome will be assessed using the 25 subscale items from the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65). The responses are Likert scale-rated from 0 to 5 for positively phrased items, and inversely scored for negatively phrased items. Each subscale will be scored individually and also totaled for a single composite score. Higher scores indicate higher use of effective epilepsy self-management strategies.	Baseline, 4 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Charles H. Hood Foundation
• Investigators: Principal Investigator: Laurie Douglass, MD, Boston Medical Center, Department of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Health-Related Quality of Life; Perceived Social Support; Social Ecological Model; Social-Emotional Learning; Positive Youth Development; Youth with epilepsy (YWE); Youth Thrive Framework; Adult Epilepsy Self-Management Measurement Instrument
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: H-43875; 4301210001 (Other Grant/Funding Number: Charles F. Hood Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No