M3-JIA: Making Mindfulness Matter for Children With JIA

NCT06376149 | Recruiting

• 1 other identifier: 124973
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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

Keywords

M3; mindfulness

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  Throughout the study enrollment period and over the 8 weeks of intervention.

Secondary Outcomes (4)

• Effects of M3 on health related quality of life of children with JIA

  baseline, 9 weeks, 18 weeks and 2 months later.

• Effects of M3 on health quality of life for parents

  baseline, 9 weeks, 18 weeks and 2 months later.

• Does M3 have a positive effect on children's severity of JIA

  baseline, 9 weeks, 18 weeks and 2 months later.

• Does M3 have a positive effect on children's executive function

  baseline, 9 weeks, 18 weeks and 2 months later.

Other Outcomes (5)

• Does M3 have a positive effect on parents' stress

  baseline, 9 weeks, 18 weeks and 2 months later.

• Does M3 have a positive effect on parents' depression and anxiety

  baseline, 9 weeks, 18 weeks and 2 months later.

• Does M3 have a positive effect on Child's' depression and anxiety

  baseline, 9 weeks, 18 weeks and 2 months later.

Study Arms (2)

Experimental: Intervention Group

OTHER

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)

Behavioral: M3 Intervention group

Other: Waitlist Control

OTHER

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)

Behavioral: M3 Waitlist Group

Interventions

M3 Intervention group BEHAVIORAL

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.

Experimental: Intervention Group

M3 Waitlist Group BEHAVIORAL

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.

Other: Waitlist Control

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Brain Canada: collaborator

Study Sites (3)

McMaster Children's Hospital,

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

LHSC Children' Hosptial

London, Ontario, N6A 5W9, Canada

RECRUITING

Sickids

Toronto, Ontario, M5G 1E8, Canada

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile; Psychological Well-Being

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Personal Satisfaction; Behavior

Study Officials

• Roberta Berard, MD

  LHSC Children's Hospital/ Lawson Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Wells

CONTACT

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

Roberta Berard, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will be blinded to their group assignment: all participants will be told that they will receive the intervention. Program facilitators will be blinded to participant group assignment order, since sessions for both study arms would run on a rolling basis. The statistician will also be blinded to the group assignment and order.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 19, 2024
• Study Start: September 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)