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临床试验/NCT06427967
NCT06427967已完成不适用

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

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Feasibility of study processes

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
12 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Feasibility of study processes

时间窗: 4 months

Number of sessions attended per participant.

Acceptability of the intervention

时间窗: 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.

次要结局

  • Change in perceived social support (PSS)(Baseline, 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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