Abstract
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.
Highlights
Background and rationale {6a} Epilepsy is a common debilitating condition characterized by spontaneous, unprovoked seizures
Proposed intervention: Making Mindfulness Matter (M3)© Based on the extant knowledge outlined above, together with a critical review of the benefits of psychological interventions, we propose a low-cost, live online intervention targeting both children with epilepsy (CWE) and their parents
We will plan dissemination to relevant patient and clinical interest groups. This protocol describes a funded pilot randomized controlled trial (RCT) evaluating the feasibility of implementing an interactive online mindfulness-based intervention for CWE and their parents
Summary
Methods: participants, interventions, and outcomes Study setting {9} Participants will be recruited from the population of children treated for epilepsy in Southwestern Ontario, Canada by the Division of Neurology, Children’s Hospital at London Health Sciences Center (academic hospital) and the solo pediatric neurology practice in Windsor, ON (community clinic). Provisions for post-trial care {30} Participants randomized to the control arm will be provided with the intervention in the scheduled session, after they have completed the study. M3 sessions may be composed of participants randomized to the intervention arm and/or controls who have completed the study (completed Baseline and Immediate Follow-up questionnaires). Other quality control procedures include providing warning or reminder messages to the research team (e.g., indicating that a participant is not eligible), preventing certain actions (e.g., preventing the randomization of participants unless all inclusion criteria are met and the Baseline questionnaire is completed), notifying the research team if adverse events are reported or if questions have been left blank, and tracking participants’ progression through the study and the time it took participants to complete each questionnaire. We will plan dissemination to relevant patient and clinical interest groups
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