A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©

Trials

Maryam N. Nouri¹  Simon Levin¹  Andrea Andrade¹  Asuri N. Prasad¹  Karen Bax²  Margo Devries-Rizzo³  Klajdi Puka⁴  Kathy N. Speechley⁵  Guangyong Zou⁶  Mary Secco⁷  Hema Gangam⁸ 

[1] Children’s Health Research Institute, Lawson Health Research Institute, London, Ontario, Canada;Paediatrics, Western University, London, Ontario, Canada;Children’s Hospital at London Health Sciences Centre, London, Ontario, Canada;Children’s Health Research Institute, Lawson Health Research Institute, London, Ontario, Canada;The Mary J. Wright Research and Education Centre, Western University, London, Ontario, Canada;Children’s Hospital at London Health Sciences Centre, London, Ontario, Canada;Health Sciences, Western University, London, Ontario, Canada;Department of Epidemiology & Biostatistics, Western University, Kresge Building, Room K201, 1151 Richmond Street, N6A 5C1, London, ON, Canada;Children’s Health Research Institute, Lawson Health Research Institute, London, Ontario, Canada;Department of Epidemiology & Biostatistics, Western University, Kresge Building, Room K201, 1151 Richmond Street, N6A 5C1, London, ON, Canada;Children’s Health Research Institute, Lawson Health Research Institute, London, Ontario, Canada;Paediatrics, Western University, London, Ontario, Canada;Department of Epidemiology & Biostatistics, Western University, Kresge Building, Room K201, 1151 Richmond Street, N6A 5C1, London, ON, Canada;Robarts Research Institute, London, Ontario, Canada;Epilepsy Southwestern Ontario, London, Ontario, Canada;Paediatrics, Western University, London, Ontario, Canada;

关键词: Behavioral intervention;    Pediatric;    Feasibility;    Quality of life;    Mental health;   

DOI  :  10.1186/s13063-020-04792-3

来源: Springer

【 摘 要 】

BackgroundEpilepsy 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).MethodsThis 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.DiscussionThis 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.Trial registrationClinicalTrials.gov NCT04020484. Registered on July 16, 2019. 

【 授权许可】

CC BY