Making Mindfulness Matter May Improve Quality of Life in Young Children With Epilepsy: Pilot RCT

OBJECTIVE Chronic disease detrimentally affects health-related quality of life (HRQOL) in children, with family environment often playing a significant role. This study evaluated the effect of Making Mindfulness Matter (M3), a community-based family mindfulness program, on HRQOL in children with epilepsy (CWE). METHODS This pilot randomized trial included children aged 4–10 years diagnosed as having epilepsy for at least 6 months and their parents in Ontario, Canada. Participants were randomly assigned (1:1) to an M3 or wait-list control group. M3 is an 8-week mindfulness program that was delivered synchronously online by nonclinician staff of an epilepsy support agency, with weekly group sessions for parents (1.5 hours) and children (1 hour). The primary outcome was child HRQOL, as measured by the parent-reported 55-item Quality of Life in Childhood Epilepsy (QOLCE-55) before randomization and 9 weeks later. Secondary outcomes included HRQOL subscales (cognitive, emotional, social, physical), as well as an additional assessment at 18 weeks for the intervention arm only. RESULTS Seventy-two families were randomized, with data from 65 (32 intervention, 33 control) available and analyzed. M3 was associated with a clinically meaningful 7-point mean increase in HRQOL (95% CI, 2–12) compared with controls at the 9-week follow-up. Findings from exploratory secondary analyses revealed that improvements were observed in cognitive (mean, 12; 95% CI, 5–19) and emotional functioning (mean, 6; 95% CI, 1–10) and maintained in the intervention arm by the 18-week follow-up (mean HRQOL, 4; 95% CI, 0–8). CONCLUSION M3 shows preliminary evidence of improving HRQOL in CWE, indicating the potential of low-cost, community-based interventions to support family well-being.