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

BACKGROUND: 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 childre...

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Autores principales: Puka, Klajdi, Bax, Karen, Andrade, Andrea, Devries-Rizzo, Margo, Gangam, Hema, Levin, Simon, Nouri, Maryam N., Prasad, Asuri N., Secco, Mary, Zou, Guangyong, Speechley, Kathy N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657360/
https://www.ncbi.nlm.nih.gov/pubmed/33176853
http://dx.doi.org/10.1186/s13063-020-04792-3
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author Puka, Klajdi
Bax, Karen
Andrade, Andrea
Devries-Rizzo, Margo
Gangam, Hema
Levin, Simon
Nouri, Maryam N.
Prasad, Asuri N.
Secco, Mary
Zou, Guangyong
Speechley, Kathy N.
author_facet Puka, Klajdi
Bax, Karen
Andrade, Andrea
Devries-Rizzo, Margo
Gangam, Hema
Levin, Simon
Nouri, Maryam N.
Prasad, Asuri N.
Secco, Mary
Zou, Guangyong
Speechley, Kathy N.
author_sort Puka, Klajdi
collection PubMed
description BACKGROUND: 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). METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04020484. Registered on July 16, 2019. 
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spelling pubmed-76573602020-11-13 A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter© Puka, Klajdi Bax, Karen Andrade, Andrea Devries-Rizzo, Margo Gangam, Hema Levin, Simon Nouri, Maryam N. Prasad, Asuri N. Secco, Mary Zou, Guangyong Speechley, Kathy N. Trials Study Protocol BACKGROUND: 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). METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04020484. Registered on July 16, 2019.  BioMed Central 2020-11-11 /pmc/articles/PMC7657360/ /pubmed/33176853 http://dx.doi.org/10.1186/s13063-020-04792-3 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Puka, Klajdi
Bax, Karen
Andrade, Andrea
Devries-Rizzo, Margo
Gangam, Hema
Levin, Simon
Nouri, Maryam N.
Prasad, Asuri N.
Secco, Mary
Zou, Guangyong
Speechley, Kathy N.
A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©
title A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©
title_full A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©
title_fullStr A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©
title_full_unstemmed A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©
title_short A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©
title_sort live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of making mindfulness matter©
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657360/
https://www.ncbi.nlm.nih.gov/pubmed/33176853
http://dx.doi.org/10.1186/s13063-020-04792-3
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