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Making Mindfulness Matter© (M3) for Childhood Epilepsy (M3Epilepsy Trial)

N/A

Waitlist Available

Led By Klajdi Puka, Ph.D

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks, 17 weeks

Awards & highlights

M3Epilepsy Trial Summary

This trial is testing whether a mindfulness-based intervention can improve health-related quality of life and mental health for children with epilepsy and their parents.

Eligible Conditions

Childhood Epilepsy
Quality of Life
Mindfulness

M3Epilepsy Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks, 17 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks, 17 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 17 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of Making Mindfulness Matter© (M3) as a family treatment for children with epilepsy and their parents

Secondary outcome measures

Does M3 have a positive effect on children's adaptive skills

Does M3 have a positive effect on children's executive function

Does M3 have a positive effect on children's externalizing problems

+7 more

M3Epilepsy Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist ControlExperimental Treatment1 Intervention

Child-parent dyads randomized to the control arm will continue treatment as usual. Once 4 to 8 dyads are assigned to the control group, participants will be given the baseline questionnaires, They will complete the Baseline and Immediate Follow-up questionnaire at comparable times to families in the intervention arm; they will not complete the Extended Follow-up questionnaire. These dyads will be provided with the intervention at the next scheduled session; the goal is to provide the intervention to controls as soon as possible to avoid differential attrition between the intervention and control arm. During the intervention sessions, they will complete all feasibility surveys pertaining to the intervention and their satisfaction with each intervention session.

Group II: Intervention GroupExperimental Treatment1 Intervention

Child-parent dyads will undergo a standardized 8-week course of Making Mindfulness Matter© (M3). The program will be delivered online using live, interactive sessions to groups of 4 to 8, for 1.5 hours each week for the parent group and 1 hour each week for the child group. Children and parents will attend separate on-line sessions and at the end of each child session, the parent will be asked to join their child on-line for a shared mindful exercise. Once 4 to 8 dyads are assigned to the intervention group, participants will be given the baseline questionnaires and start the intervention in the following week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Making Mindfulness Matter© (M3)

2019

N/A

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,355 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,338 Previous Clinical Trials

25,751,445 Total Patients Enrolled

Klajdi Puka, Ph.DPrincipal InvestigatorCAMH

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total population participating in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research initiative has been recruiting since December 2nd 2019 and is still up for grabs - the listing was last edited on June 3rd 2022. A total of 100 participants are needed from a single site."

Answered by AI

Does this research accommodate participants aged 65 and over?

"This clinical trial is exclusively enrolling paediatric patients aged 4 to 10. In contrast, 149 trials are recruiting those below 18 and 390 are welcoming elderly participants."

Answered by AI

Are there still openings for enrolment in this clinical experiment?

"Affirmative. The information accessible on clinicaltrials.gov indicates that this trial is presently accepting applicants, with its inception being December 2nd 2019 and most recent update made on June 3rd 2022. This research requires 100 participants from a single medical centre."

Answered by AI

Is it feasible for me to become a participant in this experiment?

"This research requires 100 minors aged 4-10 who are currently exhibiting mindfulness. In addition, these prospective participants must meet certain prerequisites: diagnosis of epilepsy in accordance with the International League Against Epilepsy's 2014 guidelines*, no age limit for parents taking part in a parent/child dyad, sufficient language proficiency to comprehend and follow instructions, an agreement to attend all trial sessions, English fluency, two or more unprovoked epileptic episodes within 24 hours apart or one episode and at least 60% risk of recurrence over 10 years; additionally any diagnosed form of epilepsy syndrome. Furthermore their primary caregiver should identify as responsible for daily"

Answered by AI

Recent research and studies

TrialsJournal

A Live-online Mindfulness-based Intervention for Children Living with Epilepsy and Their Families: Protocol for a Randomized Controlled Trial of Making Mindfulness Matter©

Puka, Klajdi, Karen Bax, Andrea Andrade, Margo Devries-Rizzo, Hema Gangam, Simon Levin, Maryam N. Nouri, et al.. 2020. “A Live-online Mindfulness-based Intervention for Children Living with Epilepsy and Their Families: Protocol for a Randomized Controlled Trial of Making Mindfulness Matter©”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-020-04792-3.

TrialsJournal

A Live-online Mindfulness-based Intervention for Children Living with Epilepsy and Their Families: Protocol for a Randomized Controlled Trial of Making Mindfulness Matter©

clinicaltrials.govStudy

2019. "Making Mindfulness Matter© in Children With Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04020484.