Making Mindfulness Matter© in Children With Epilepsy

NCT04020484 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2023-06-28

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020484 on ClinicalTrials.gov