Skip to main content
OpenTrials
Completed

NCT Number: NCT06427967

A Novel Social Emotional Learning Curriculum for Youth With Epilepsy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Neurology and remote

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of study processes

    Time frame: 4 months

    Number of sessions attended per participant.

  2. Acceptability of the intervention

    Time frame: 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 outcomes

  1. Change in perceived social support (PSS)

    Time frame: 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.

Other outcomes

  1. Change in social emotional skills and behaviors

    Time frame: Baseline, 4 months

    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.

  2. Change in leveraging social support for epilepsy self management

    Time frame: Baseline, 4 months

    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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Charles H. Hood Foundation

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 24, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.