M3-JIA: Making Mindfulness Matter for Children With JIA

Not Applicable

Recruiting

• Conditions: Mental Well-being; Juvenile Idiopathic Arthritis; Children; Mental Health

• Registration Number: NCT06376149
• Lead Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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.

Detailed Description

This pilot RCT is essential to refine the implementation of the intervention to families with a child with JIA and collect information pertaining to the feasibility and effectiveness of the intervention in preparation for a subsequent multicentred trial across Canada. The investigator will propose to test if the M3© program improves the child's health related quality of life (HRQOL) and mental health for Children with JIA and caregivers. Additionally, to address the knowledge gap on the relationship between mental health and disease outcomes in JIA. M3 is a promising mindfulness-based intervention which may have mental health benefits for children with JIA and caregivers.

Study Timeline

• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-19
• Study Start: 2024-09-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).	Throughout the study enrollment period and over the 8 weeks of intervention.	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. The minimum score being 0 with the highest score being 10 where the higher the score means the better the outcome.

Secondary Outcome Measures

Name	Time	Method
Effects of M3 on health related quality of life of children with JIA	baseline, 9 weeks, 18 weeks and 2 months later.	Peds Quality of life (PedsQL) is a 23-item measure for children ages 2-18 years that emphasizes a functional approach to quality of life by examining the child's sense of well-being and ability to engage in physical and social activities, to concentrate, think and remember, and to regulate behaviour. Generates an overall Peds-QL score, and four subscale scores: cognitive, emotional, social, and physical functioning. Parent report is obtained for children \<6 years old.; The investigators will calculate the minimum clinically important difference (MCID). To calculate the MCID for the Peds-QL, the Patient Centred Global Ratings of Change will be used, a 5-item scale where respondents indicate the amount of change relative to baseline. Rating from -7 (much worse) through 0 (no change) to +7 (much better). This information will allow us to calculate the MCID for the Ped-QL, and thereby identify the proportion of patients who experience a clinically meaningful change following intervention.
Effects of M3 on health quality of life for parents	baseline, 9 weeks, 18 weeks and 2 months later.	The Peds-QL Family Impact module is a 36-item measure designed to measure the impact of pediatric chronic health conditions on parents and the family. It measures parent self-reported physical, emotional, social, and cognitive functioning, communication, and worry, as well as parent-reported family daily activities and family relationships. Generates an overall score. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better outcomes.
Does M3 have a positive effect on children's severity of JIA	baseline, 9 weeks, 18 weeks and 2 months later.	The pediatric Symptom check list is a 17-question screening tool that is used to improve the recognition and treatment of psycho social problems in children ages 4 to 17 years as a parent reported measure.; The total score is calculated by adding together the score for each of the 17 items. A score of 15 and over is considered at risk.
Does M3 have a positive effect on children's executive function	baseline, 9 weeks, 18 weeks and 2 months later.	Behavioral Rating Inventory of Executive Function 2 (BRIEF) 63-item scale measuring parent-rated executive function and self-regulation in children. Generates a global executive composite, cognitive regulation index, emotion regulation index, behavior regulation index. Persons with T-score above 60 in a given scale are categorized as 'at-risk' for that domain.

Trial Locations

Locations (3)

McMaster Children's Hospital,; 🇨🇦 Hamilton, Ontario, Canada

LHSC Children' Hosptial; 🇨🇦 London, Ontario, Canada

Sickids; 🇨🇦 Toronto, Ontario, Canada