Department of Epidemiology & Biostatistics, Western University, Kresge Building, Room K201, 1151 Richmond Street, London, ON, N6A 5C1, Canada.
Children's Health Research Institute, Lawson Health Research Institute, London, Ontario, Canada.
Trials. 2020 Nov 11;21(1):922. doi: 10.1186/s13063-020-04792-3.
Epilepsy extends far beyond seizures; up to 80% of children with epilepsy (CWE) may have comorbid cognitive or mental health problems, and up to 50% of parents of CWE are at risk for major depression. Past research has also shown that family environment has a greater influence on children's and parents' health-related quality of life (HRQOL) and mental health than epilepsy-related factors. There is a pressing need for low-cost, innovative interventions to improve HRQOL and mental health for CWE and their parents. The aim of this randomized controlled trial (RCT) is to evaluate whether an interactive online mindfulness-based intervention program, Making Mindfulness Matter (M3), can be feasibly implemented and whether it positively affects CWE's and parents' HRQOL and mental health (specifically, stress, behavioral, depressive, and anxiety symptoms).
This parallel RCT was planned to recruit 100 child-parent dyads to be randomized 1:1 to the 8-week intervention or waitlist control and followed over 20 weeks. The intervention, M3, will be delivered online and separately to parents and children (ages 4-10 years) in groups of 4-8 by non-clinician staff of a local community epilepsy agency. The intervention incorporates mindful awareness, social-emotional learning skills, and positive psychology. It is modeled after the validated school-based MindUP program and adapted for provision online and to include a parent component.
This RCT will determine whether this online mindfulness-based intervention is feasible and effective for CWE and their parents. The proposed intervention may be an ideal vector to significantly improve HRQOL and mental health for CWE and their parents given its low cost and implementation by community epilepsy agencies.
ClinicalTrials.gov NCT04020484 . Registered on July 16, 2019.
癫痫的影响远不止于发作本身；高达 80%的癫痫患儿（CWE）可能存在认知或心理健康共病问题，高达 50%的 CWE 父母有罹患重度抑郁症的风险。既往研究还表明，家庭环境对儿童和父母的健康相关生活质量（HRQOL）和心理健康的影响大于癫痫相关因素。目前迫切需要成本低廉、创新的干预措施，以改善 CWE 及其父母的 HRQOL 和心理健康。本随机对照试验（RCT）旨在评估一种互动式在线正念干预方案，即“正念 Matters”（M3），是否可行，以及是否能积极影响 CWE 和父母的 HRQOL 和心理健康（特别是压力、行为、抑郁和焦虑症状）。
本平行 RCT 计划招募 100 对儿童-家长二人组，按 1:1 的比例随机分为 8 周干预组或候补对照组，并随访 20 周以上。干预措施 M3 将由当地社区癫痫机构的非临床工作人员以小组形式（每组 4-8 人）在线分别向父母和儿童（4-10 岁）提供，内容包括正念意识、社会情感学习技能和积极心理学。它是在经过验证的学校正念训练（MindUP）项目的基础上设计的，并进行了改编，以便在线提供并纳入家长部分。
本 RCT 将确定这种在线正念干预措施对 CWE 和其父母是否可行和有效。鉴于其低成本和社区癫痫机构的实施，该拟议干预措施可能是改善 CWE 和其父母 HRQOL 和心理健康的理想选择。
ClinicalTrials.gov NCT04020484。于 2019 年 7 月 16 日注册。
