Making Mindfulness Matter© in Children With Epilepsy
Condition: Epilepsy in Children; Mindfulness; Quality of Life
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Epilepsy is a debilitating condition characterized by spontaneous, unprovoked seizures. Up to
      80% of children with epilepsy (CWE) may face cognitive, psychiatric, and/or behavioral
      comorbidities with significant unmet mental health needs. Mindfulness-based interventions may
      provide an ideal vector to target unmet mental healthcare needs in patients with epilepsy and
      their families. The investigators propose the Making Mindfulness Matter© (M3) program as an
      intervention to improve health related quality of life and mental-health for CWE and their
      parents. M3 is live-online parent and child program that incorporates mindful awareness,
      social-emotional learning skills, neuroscience, and positive psychology. This pilot RCT is
      needed to refine the implementation of the intervention to families with a child with
      epilepsy, and collect information pertaining to the feasibility and effectiveness of the
      intervention in preparation for a subsequent multi-centred trial across Canada. Note: Due to
      COVID-19, the format has been modified for online delivery (from community-based) and the
      intervention has been restarted.
    

Detailed description: 
      Recognizing that medical management for chronic illness such as epilepsy does not address the
      stress and co-occurring psychological issues experienced by many patients, mindfulness-based
      interventions have been increasingly utilized. Mindfulness-based interventions are effective,
      well-validated interventions for several adult outcomes including physical and mental health,
      social and emotional well-being, and cognition. Meta-analyses report overall medium effect
      sizes of 0.50 to 0.59 across these outcomes. In a recent Cochrane review of psychological
      interventions for people with epilepsy, three studies specifically examined mindfulness-based
      techniques for adults with epilepsy and determined positive outcomes on mental health, HRQOL
      and seizure outcomes. There has been far less research on mindfulness with children and youth
      than in adults; studies that have been done have been plagued with methodological limitations
      including small numbers, lack of randomization or control groups. However, evidence to-date
      indicates that mindfulness interventions for children and youth are feasible, accepted and
      enjoyed by participants. The few well conducted studies on mindfulness interventions in
      children without physical health issues have reported reduced symptoms of anxiety,
      depression, and stress, reduced maladaptive coping and rumination, and improved behavioural
      and emotional self-regulation and focus. Furthermore, a recent systematic review and
      meta-analysis found that mindfulness interventions were three times more effective in
      alleviating psychological symptoms among children with clinically diagnosed psychological
      disorders (such as anxiety, learning disability and externalizing disorders), compared with
      healthy controls. This suggests that mindfulness interventions may be particularly relevant
      for those with clinical levels of psychological disorders, a particularly relevant finding
      for our study given that children with epilepsy experience greater levels of depression,
      anxiety, learning disability and behavioural comorbidities.

      In addition to the benefits of programs that deliver mindfulness interventions directly to
      children, programs that target parents and parents appear to be effective in improving
      parental functioning and in turn, promote child outcomes. Furthermore, studies are indicating
      that mindfulness-based interventions for parents of children with chronic issues (attention
      deficit hyperactivity disorder, developmental delays, autism) are effective for lessening
      parental stress and mental health problems. Improvements in parent-child relationship and
      improved youth behaviour management have also been found.

      Neither the Cochrane review on the impact of psychological treatments for people with
      epilepsy, nor a recent systematic review on mindfulness interventions in youth found studies
      investigating mindfulness management techniques for CWE. Despite the paucity of studies of
      mindfulness interventions in childhood epilepsy, there is converging evidence to suggest
      studying a mindfulness-based intervention in children and families with epilepsy is
      warranted. There is research pointing to the effectiveness of mindfulness-based interventions
      on psychological symptoms in adults and children, especially in those with relevant clinical
      issues similar to CWE. The investigators believe the M3 program is ideally suited for use
      with CWE and their parents for a number of reasons. The program was developed from the
      validated, widely used, and successful Mind UP program for use in the community and augmented
      to integrate a parent component, and has been shown to be successful in our cohort of young
      children and their parents facing adversity. Importantly, M3 is suitable for children as
      young as 4 years of age, which is particularly important as evidence to date suggests that
      early identification and treatment of epilepsy comorbidities is essential as there may be a
      window of opportunity for early intervention in some children. Interventions must be
      implemented early before problems become entrenched and interfere with the development of
      basic cognitive, behavioral, and social skills crucial for long-term educational, vocational,
      and interpersonal adaptation. The low-cost, interactive online group delivery and
      facilitation by non-clinician staff also allows the program to be scalable to communities
      across Canada and increases its likely sustainability.
    

Intervention name(s): Making Mindfulness Matter© (M3)
Intervention type(s): Behavioral
Intervention description(s): Making Mindfulness Matter© (M3) is an interactive online parent and child program that incorporates mindful awareness, social-emotional learning skills, neuroscience, and positive psychology. This program was modelled after the school-based MindUP™ program for use in the community and augmented to integrate a parent component. M3E is a facilitator-led program that integrates attitudes, skills, and behaviours related to mindfulness and social-emotional learning (SEL). During the 8-week concurrent parent and child manualized program, parents learn the same core principles as children: how our brains work, stress and the brain, mindful breathing, mindful sensing, mindful movement, perspective taking, optimism, and gratitude/acts of kindness.
Other intervention name(s): M3E
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel, partially nested randomized controlled trial (RCT) comparing two arms: intervention (M3) and treatment-as-usual (i.e. wait-list control). Participants will be randomized 1:1 into the intervention or control arm. This study will not interfere with patients' clinical care. The intervention will be delivered online to groups of 4-8 on a rolling basis to minimize wait-times and allow for timely access to the intervention for the waitlist controls. We believe this strategy is very important to increase the odds that families will decide to participate in the study. Sample size calculations showed that 76 child-parent dyads will be required (38 intervention, 38 control), and to account for a liberal 24% attrition rate, 100 child-parent dyads will be recruited.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care