Making Mindfulness Matter© in Children With Epilepsy
NCT04020484 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2023-06-28
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.
Conditions
- Epilepsy in Children
- Mindfulness
- Quality of Life
Interventions
- BEHAVIORAL
-
Making Mindfulness Matter© (M3)
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.
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
lead OTHER
Principal Investigators
-
Kathy Nixon Speechley, Ph.D · Western University
-
Klajdi Puka, Ph.D · CAMH
-
Karen Bax, Ph.D · Western University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-02
- Primary Completion
- 2023-04-11
- Completion
- 2023-04-11
Countries
- Canada
Study Locations
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