Making Mindfulness Matter© in Children With Epilepsy

NCT04020484 | Completed

• 1 other identifier: 6558
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy in Children; Mindfulness; Quality of Life

Outcome Measures

Primary Outcomes (1)

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

  The investigators will track the number of patients contacted, response rate, attrition and reasons for non-participation and attrition. At the start of each session, parents will complete a one-page (12-item) semi-structured questionnaire evaluating treatment fidelity, at home utilization of M3 skills. At the end of each session, parents will complete an overall feedback form on the intervention. Facilitators will complete a two-page questionnaire providing feedback on the session. At the start and end of the M3 program, children will be asked to complete a feeling face questionnaire rated on a 3-point scale about topics discussed in the group such as how our brain works when upset and what is mindfulness.

  Throughout the study enrollment period and over the 8 weeks of intervention.

Secondary Outcomes (10)

• Effect of M3 on Health Related Quality of Life of children with epilepsy

  baseline, 8 weeks, 17 weeks

• Effect of M3 on Health Related Quality of Life of parents

  baseline, 8 weeks, 17 weeks

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

  baseline, 8 weeks, 17 weeks

• Does M3 have a positive effect on children's internalizing problems

  baseline, 8 weeks, 17 weeks

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

  baseline, 8 weeks, 17 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Making Mindfulness Matter© (M3)

Waitlist Control

OTHER

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.

Behavioral: Making Mindfulness Matter© (M3)

Interventions

Making Mindfulness Matter© (M3) BEHAVIORAL

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.

Also known as: M3E

Intervention Group; Waitlist Control

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Epilepsy Southwestern Ontario

London, Ontario, N5W 6A8, Canada

Location

Related Publications (1)

• 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.

  PMID: 33176853 BACKGROUND

Study Officials

• Kathy Nixon Speechley, Ph.D

  Western University

  PRINCIPAL INVESTIGATOR

• Klajdi Puka, Ph.D

  CAMH

  PRINCIPAL INVESTIGATOR

• Karen Bax, Ph.D

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Blinding of participants and program facilitators (i.e. the staff delivering the M3 program) will be difficult to completely achieve given the nature of the intervention. The investigators will attempt to ameliorate bias by explaining to participants and program facilitators that the study is interested in evaluating the intervention to be given to all participants, however, in planning the logistics of the intervention, some participants will receive the intervention in the very near future, whereas others will receive the intervention in approximately 12 weeks. In so doing, the investigators hope to eliminate any biases associated with the participants' and program facilitators' perception or biases of being assigned to the treatment or control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: July 16, 2019
• Study Start: December 2, 2019
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)