A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©.
Behavioral intervention
Feasibility
Mental health
Pediatric
Quality of life
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
11 Nov 2020
11 Nov 2020
Historique:
received:
30
06
2020
accepted:
05
10
2020
entrez:
12
11
2020
pubmed:
13
11
2020
medline:
22
6
2021
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT04020484 . Registered on July 16, 2019.
Identifiants
pubmed: 33176853
doi: 10.1186/s13063-020-04792-3
pii: 10.1186/s13063-020-04792-3
pmc: PMC7657360
doi:
Banques de données
ClinicalTrials.gov
['NCT04020484']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
922Subventions
Organisme : CIHR
ID : PJT-159504
Pays : Canada
Références
Educ Psychol (Lond). 2016 Sep 13;36(8):1408-1428
pubmed: 27570322
Clin Trials. 2005;2(2):152-62
pubmed: 16279137
Neurology. 2006 Mar 28;66(6 Suppl 3):S5-12
pubmed: 16567744
Epilepsy Behav. 2019 Jan;90:142-147
pubmed: 30530137
Qual Life Res. 2018 Apr;27(4):969-977
pubmed: 29305781
Epilepsia. 2015 Jun;56(6):864-72
pubmed: 25912151
Epilepsia. 2003 Apr;44(4):591-7
pubmed: 12681010
Arch Womens Ment Health. 2013 Apr;16(2):159-66
pubmed: 23420273
Cochrane Database Syst Rev. 2017 Oct 27;10:CD012081
pubmed: 29078005
Psychol Bull. 1992 Jul;112(1):155-9
pubmed: 19565683
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Curr Probl Pediatr Adolesc Health Care. 2016 Jun;46(6):172-8
pubmed: 26968457
Epilepsia. 2009 Nov;50(11):2344-54
pubmed: 19694788
Epilepsy Behav. 2018 Sep;86:19-24
pubmed: 30036765
Epilepsy Behav. 2016 Apr;57(Pt A):151-154
pubmed: 26953845
J Fam Pract. 1982 Aug;15(2):303-11
pubmed: 7097168
Epilepsia. 2016 Mar;57(3):427-35
pubmed: 26752612
Neurology. 2012 Oct 9;79(15):1548-55
pubmed: 23019268
Pediatrics. 2014 Jun;133(6):e1586-93
pubmed: 24864167
Epilepsia. 2015 Dec;56(12):1950-6
pubmed: 26489775
Neurology. 2009 Aug 18;73(7):526-34
pubmed: 19675309
Epileptic Disord. 2015 Sep;17(3):243-53
pubmed: 26234761
Seizure. 2017 Jan;44:211-216
pubmed: 27646715
Epilepsia. 2016 Apr;57(4):529-37
pubmed: 26864870
Neurology. 2015 Sep 29;85(13):1100-7
pubmed: 26333801
Epilepsia. 2017 Apr;58(4):522-530
pubmed: 28276060
Epileptic Disord. 2016 May;18 Suppl 1:1-86
pubmed: 27210239
Seizure. 2011 Oct;20(8):589-97
pubmed: 21741277
Epilepsy Behav. 2008 Jul;13(1):102-8
pubmed: 18343200
Dev Psychol. 2015 Jan;51(1):52-66
pubmed: 25546595
Epilepsy Behav. 2005 Jun;6(4):488-503
pubmed: 15907744
Epilepsia. 2019 Feb;60(2):358-366
pubmed: 30645767
Epilepsy Behav. 2014 Feb;31:127-8
pubmed: 24397916
Epilepsia. 2017 Apr;58(4):512-521
pubmed: 28276062
Epilepsia. 2015 Jun;56(6):873-81
pubmed: 25940536
Child Adolesc Ment Health. 2012 Nov;17(4):195-208
pubmed: 32847274
Epilepsia. 2006 Dec;47(12):2173-9
pubmed: 17201719
Contemp Clin Trials. 2009 Jul;30(4):289-92
pubmed: 19275948
Epilepsy Behav. 2014 May;34:139-43
pubmed: 24780394
Epilepsy Behav. 2008 Aug;13(2):337-42
pubmed: 18558510
J Psychosom Res. 2004 Jul;57(1):35-43
pubmed: 15256293
Pediatrics. 2011 Dec;128(6):e1532-43
pubmed: 22123895
Epilepsy Behav. 2019 Mar;92:297-305
pubmed: 30731296
Epilepsia. 2018 Mar;59(3):668-678
pubmed: 29377095
Epilepsia. 2017 Nov;58(11):1912-1919
pubmed: 28948997
Epilepsy Behav. 2018 May;82:38-45
pubmed: 29579553
Epilepsy Behav. 2020 Mar;104(Pt A):106904
pubmed: 32000098
Epilepsia. 2020 Jul;61(7):1453-1463
pubmed: 32533789
Trials. 2015 Apr 11;16:150
pubmed: 25872619
J Neurol Neurosurg Psychiatry. 2002 Aug;73(2):116-20
pubmed: 12122166
Epilepsia. 2014 Apr;55(4):475-82
pubmed: 24730690
Dev Psychol. 2016 Nov;52(11):1744-1762
pubmed: 27709999
Perspect Psychiatr Care. 2018 Apr;54(2):324-330
pubmed: 28247409
Stat Med. 2016 May 10;35(10):1616-36
pubmed: 26670388
J Clin Epidemiol. 2000 Feb;53(2):157-61
pubmed: 10729687