Feasibility of using Making Mindfulness Matter© for children with epilepsy and their parents: A pilot randomized controlled trial

Objective Children with epilepsy (CWE) often experience poor health-related quality of life (HRQOL), and family environment plays a central role in how CWE cope with challenges. Our aim was to evaluate the feasibility of delivering a family-based mindfulness program (Making Mindfulness Matter©, M3©) synchronously online for CWE and their parents, to support families facing HRQOL-related challenges.Methods This was a parallel, 1:1 randomized controlled trial comparing M3© to waitlist control, recruiting families of CWE aged 4-10 years in Ontario, Canada. M3© is an eight-week concurrent parent-child program teaching mindfulness skills for managing stress and building family resiliency, delivered live-online by epilepsy agency staff. Feasibility data were collected through self-administered questionnaires from parents, program facilitators, and research staff. A mixed-methods process evaluation (descriptive statistics, qualitative content analysis) examined participation rate, session attendance, attrition, missing data, quality of session delivery by facilitators, proportion of curriculum units delivered, and participant adherence and satisfaction.Results Of 298 dyads screened, 72 were randomized (intervention = 35, control = 37; 31 % participation). Time commitment was a key barrier to recruitment and retention. Fifteen M3© groups were completed, and 61 dyads participated. Session fidelity was high (80-100 % curriculum delivered), and most families attended > 75 % of sessions. Families were engaged, practiced skills weekly, and were satisfied with the program.Conclusion M3© was delivered as intended and well-received by participating families, providing preliminary evidence supporting its feasibility as a community-based on-line treatment complementary to clinical care. Findings support further evaluation of M3© in multi-centre trials and highlight time commitment as an important consideration for future recruitment and retention strategies.