M3-JIA: Making Mindfulness Matter for Children With JIA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: M3 Intervention group, M3 Waitlist Group.
- Who it may be relevant to
- Registry conditions: Juvenile Idiopathic Arthritis, Children, Mental Health, Mental Well-being. Basic parameters: 4 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Randomized-controlled Trial Evaluating the Efficacy of a Live-Online Mindfulness-Based Intervention: The Making Mindfulness Matter© in Children With Juvenile Idiopathic Arthritis Study
Overview
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.
Interventions
- Behavioral 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. - Behavioral 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 measures
- 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.]
Secondary outcome measures (4)
- Effects of M3 on health related quality of life of children with JIA [Time frame: baseline, 9 weeks, 18 weeks and 2 months later.]
- Effects of M3 on health quality of life for parents [Time frame: baseline, 9 weeks, 18 weeks and 2 months later.]
- Does M3 have a positive effect on children's severity of JIA [Time frame: baseline, 9 weeks, 18 weeks and 2 months later.]
- Does M3 have a positive effect on children's executive function [Time frame: baseline, 9 weeks, 18 weeks and 2 months later.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Canada · 3 centers
- McMaster Children's Hospital, — Hamilton
- LHSC Children' Hosptial — London
- Sickids — Toronto
Publications
- Schonert-Reichl KA, Oberle E, Lawlor MS, Abbott D, Thomson K, Oberlander TF, Diamond A. Enhancing cognitive and social-emotional development through a simple-to-administer mindfulness-based school program for elementary school children: a randomized controlled trial. Dev Psychol. 2015 Jan;51(1):52-66. doi: 10.1037/a0038454. PMID 25546595
- 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
- Treemarcki EB, Danguecan AN, Cunningham NR, Knight AM. Mental Health in Pediatric Rheumatology: An Opportunity to Improve Outcomes. Rheum Dis Clin North Am. 2022 Feb;48(1):67-90. doi: 10.1016/j.rdc.2021.09.012. PMID 34798960
Identifiers
NCT: NCT06376149 · 124973