Clinical trial NCT06376149: M3-JIA: Making Mindfulness Matter for Children With JIA
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Children
Mental Health
Mental Well-being
Keywords: M3
mindfulness
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Brain Canada
First posted: 2024-04-19
Enrollment: 74
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The primary objective is to 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).

Measures will be obtained via questionnaires at 3 time points for the intervention group: baseline, 9 weeks and 2 months post-intervention. For the control group questionnaires will be obtained 4 time points: baseline, 9 weeks, 18 weeks and 2 months post intervention.

Additionally, at the start of each session, parents will complete a one-page semi-structured questionnaire evaluating treatment fidelity and at home utilization of M3© skills. At the end of each session, parent participants will complete a one-page structured questionnaire providing feedback on the session, and facilitators will complete the M3© Adherence Checklist, evaluating whether planned activities were completed, and any modifications made.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
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).
timeFrame: Throughout the study enrollment period and over the 8 weeks of intervention.
Secondary outcomes:
measure: Effects of M3 on health related quality of life of children with JIA
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
measure: Effects of M3 on health quality of life for parents
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
measure: Does M3 have a positive effect on children's severity of JIA
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
measure: Does M3 have a positive effect on children's executive function
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
Other outcomes:
measure: Does M3 have a positive effect on parents' stress
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
measure: Does M3 have a positive effect on parents' depression and anxiety
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
measure: Does M3 have a positive effect on Child's' depression and anxiety
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
measure: Does M3 have a positive effect on children's resiliency
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
measure: Does M3 have a positive effect on parent resiliency
timeFrame: baseline, 9 weeks, 18 weeks and 2 months later.
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital,
state: Ontario
city: London
country: Canada
facility: LHSC Children' Hosptial
state: Ontario
city: Toronto
country: Canada
facility: Sickids
state: Ontario
Study officials:
affiliation: LHSC Children's Hospital/ Lawson Research
name: Roberta Berard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.