Recruiting

Mindfulness

Sponsor:

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

Code:

NCT06376149

Conditions

Juvenile Idiopathic Arthritis

Children

Mental Health

Mental Well-being

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Interventions

M3 Intervention group

M3 Waitlist Group

Study Details

Brief summary:

The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level.

Conditions

Juvenile Idiopathic Arthritis

Children

Mental Health

Mental Well-being

Study ID

NCT06376149

Start date

Sep 12, 2024

Status verified date

Mar, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children aged 4 to 12 years diagnosed with JIA
  • Children have reasonable comprehension of spoken language and can follow simple instructions
  • Children with JIA and their caregivers are willing to attend intervention sessions and have access to technology and internet to attend the online sessions.
  • Children with JIA and their caregivers have an adequate understanding of English

Exclusion Criteria:

  • Other major co-morbid disorders (e.g. Crohn's disease, diabetes, renal failure).
  • Concurrent enrollment in other intervention trials or practicing any complementary health interventions such as yoga, meditation, or daily mindfulness practice.

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Experimental: Intervention Group

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.

Interventions:

Behavioural: Making Mindfulness Matter© (M3)

other: Other: Waitlist Control

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 Follow-up questionnaire and extended follow up questionnaires at comparable times to families in the intervention arm. With one extra set of questionnaires at the completion of the intervention. 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.

Interventions:

Behavioural: Making Mindfulness Matter© (M3)

Interventions

M3 Intervention group

The M3© program offered online concurrently for parents and children (4-12 years of age). Each parent session is 90 minutes long, and each child session is 60 minutes long. Parents and children learn similar concepts, at developmentally appropriate levels.

M3 Waitlist Group

The M3© program offered online concurrently for parents and children (4-12 years of age). Each parent session is 90 minutes long, and each child session is 60 minutes long. Parents and children learn similar concepts, at developmentally appropriate levels.

Primary outcome measure

  • conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s). [ Time Frame: Throughout the study enrollment period and over the 8 weeks of intervention. ]

Central Contacts and Locations

Central contacts

Sarah Wells

519-685-8500sarah.wells@lhsc.on.ca

Roberta Berard, MD

519-685-8266roberta.berard@lhsc.on.ca

Locations

McMaster Children's Hospital,

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Karen Beatie

(905) 521-2100beattik@mcmaster.ca

Michelle Dr. Batthish

(905) 521-2100batthim@mcmaster.ca

LHSC Children' Hosptial

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Sarah Wells

519-685-8500sarah.wells@lhsc.on.ca

Roberta Dr. Berard

519-685-8500roberta.berard@lhsc.on.ca

Principal Investigator:

Dr. Berard

Sickids

Recruiting

Toronto, Ontario, Canada, M5G 1E8

Contacts

Andrea Knight

(416) 813-1500andrea.knight@sickkids.ca

More Information

Sponsor

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

Last update posted

Jun 11, 2025

Last verified

Mar, 2025

Keywords

  • M3
  • mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-06-11.