M3-JIA: Making Mindfulness Matter for Children With JIA

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• 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). [Срок оценки: Throughout the study enrollment period and over the 8 weeks of intervention.]

Вторичные конечные точки (4)

• Effects of M3 on health related quality of life of children with JIA [Срок оценки: baseline, 9 weeks, 18 weeks and 2 months later.]
• Effects of M3 on health quality of life for parents [Срок оценки: baseline, 9 weeks, 18 weeks and 2 months later.]
• Does M3 have a positive effect on children's severity of JIA [Срок оценки: baseline, 9 weeks, 18 weeks and 2 months later.]
• Does M3 have a positive effect on children's executive function [Срок оценки: baseline, 9 weeks, 18 weeks and 2 months later.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 3 центра

• McMaster Children's Hospital, — Hamilton
• LHSC Children' Hosptial — London
• Sickids — Toronto

Публикации

• 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

Идентификаторы

NCT: NCT06376149 · 124973

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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