Status:

COMPLETED

Making Mindfulness Matter© in Children With Epilepsy

Lead Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborating Sponsors:

Canadian Institutes of Health Research (CIHR)

Conditions:

Epilepsy in Children

Mindfulness

Eligibility:

All Genders

4-10 years

Phase:

NA

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 ...

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...

Eligibility Criteria

Inclusion

  • No age restriction on parent participating in parent/child dyad
  • Inclusion Criteria:
  • 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\*
  • Children have reasonable comprehension of spoken language and can follow simple instructions
  • Children with epilepsy and their parents\*\* are willing to attend all intervention sessions
  • Children with epilepsy and parents have an adequate understanding of English
  • Operational (practical) clinical definition of epilepsy (Fisher et al. 2014):
  • At least two unprovoked (or reflex) seizures occurring\>24 h apart, or
  • 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
  • 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:
  • Progressive or degenerative neurological disorder;
  • Other major co-morbid non-neurological disorders (e.g. cystic fibrosis, Crohn's disease, diabetes, renal failure);
  • Concurrent enrollment in other intervention trials
  • Child or parent regularly practice complementary health interventions such as meditation
  • Scheduled to undergo epilepsy surgery during study period

Exclusion

    Key Trial Info

    Start Date :

    December 2 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 11 2023

    Estimated Enrollment :

    73 Patients enrolled

    Trial Details

    Trial ID

    NCT04020484

    Start Date

    December 2 2019

    End Date

    April 11 2023

    Last Update

    June 28 2023

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    Epilepsy Southwestern Ontario

    London, Ontario, Canada, N5W 6A8