Clinical trial NCT04020484: Making Mindfulness Matter© in Children With Epilepsy
Official title: A Live-Online Mindfulness-based Intervention for Families of Children With Epilepsy: Making Mindfulness Matter© Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy in Children
Mindfulness
Quality of Life
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-07-16
Enrollment: 73
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: No age restriction on parent participating in parent/child dyad

Inclusion Criteria:

1. Children aged 4 to 10 years diagnosed with epilepsy a minimum of 6 months ago, as per the International League Against Epilepsy (ILAE) 2014 operational definition\*
2. Children have reasonable comprehension of spoken language and can follow simple instructions
3. Children with epilepsy and their parents\*\* are willing to attend all intervention sessions
4. Children with epilepsy and parents have an adequate understanding of English

   * Operational (practical) clinical definition of epilepsy (Fisher et al. 2014):

     1. At least two unprovoked (or reflex) seizures occurring\>24 h apart, or
     2. One unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years, or
     3. Diagnosis of an epilepsy syndrome

        * Parents: refers to parent or guardian self-identifying as most responsible for child's day-to-day care

Exclusion criteria are:

1. Progressive or degenerative neurological disorder;
2. Other major co-morbid non-neurological disorders (e.g. cystic fibrosis, Crohn's disease, diabetes, renal failure);
3. Concurrent enrollment in other intervention trials
4. Child or parent regularly practice complementary health interventions such as meditation
5. Scheduled to undergo epilepsy surgery during study period

Primary outcomes:
measure: Feasibility of Making Mindfulness Matter© (M3) as a family treatment for children with epilepsy and their parents
timeFrame: Throughout the study enrollment period and over the 8 weeks of intervention.
Secondary outcomes:
measure: Effect of M3 on Health Related Quality of Life of children with epilepsy
timeFrame: baseline, 8 weeks, 17 weeks
measure: Effect of M3 on Health Related Quality of Life of parents
timeFrame: baseline, 8 weeks, 17 weeks
measure: Does M3 have a positive effect on children's externalizing problems
timeFrame: baseline, 8 weeks, 17 weeks
measure: Does M3 have a positive effect on children's internalizing problems
timeFrame: baseline, 8 weeks, 17 weeks
measure: Does M3 have a positive effect on children's adaptive skills
timeFrame: baseline, 8 weeks, 17 weeks
measure: Does M3 have a positive effect on children's executive function
timeFrame: baseline, 8 weeks, 17 weeks
measure: Does M3 have a positive effect on children's severity of epilepsy
timeFrame: baseline, 8 weeks, 17 weeks
measure: Does M3 have a positive effect on parents' depression
timeFrame: baseline, 8 weeks, 17 weeks
measure: Does M3 have a positive effect on parents' anxiety
timeFrame: baseline, 8 weeks, 17 weeks
measure: Does M3 have a positive effect on parents' stress
timeFrame: baseline, 8 weeks, 17 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Epilepsy Southwestern Ontario
state: Ontario
Study officials:
affiliation: Western University
name: Kathy Nixon Speechley, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: CAMH
name: Klajdi Puka, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University
name: Karen Bax, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puka K, Bax K, Andrade A, Devries-Rizzo M, Gangam H, Levin S, Nouri MN, Prasad AN, Secco M, Zou G, Speechley KN. A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter(c). Trials. 2020 Nov 11;21(1):922. doi: 10.1186/s13063-020-04792-3.