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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©.

Trials
January 1, 1970
Klajdi Puka et al. (11 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the feasibility and effectiveness of an online mindfulness-based intervention (M3) in improving health-related quality of life (HRQOL) and mental health for children with epilepsy (CWE) and their parents.

Results Summary

The study planned to assess whether the M3 intervention, delivered online over 8 weeks, could feasibly improve HRQOL and mental health outcomes (stress, behavioral, depressive, and anxiety symptoms) in CWE and their parents, though final results were not provided in the abstract.

Population

Children with epilepsy (ages 4-10 years) and their parents.

Effective Dosage

Not specified

Duration

8 weeks

Interactions

None mentioned

Extracted Claims (2)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Making Mindfulness Matter (M3)
increase
HRQOL and mental health (specifically, stress, behavioral, depressive, and anxiety symptoms)
children with epilepsy (CWE) and their parents
-
positively affects
#1
Making Mindfulness Matter (M3)
increase
HRQOL and mental health
CWE and their parents
-
significantly improve
#2
Abstract

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.

Medical Subject Headings (MeSH)
ChildChild, PreschoolEpilepsyHumansMental HealthMindfulnessParentsQuality of LifeRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations4
Citations/Year0.8
Relative Citation Ratio0.47
NIH Percentile25.4%
Research Impact Scores
APT Score0.25
Weight Score1.61
Normalized Score0.67
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