M3-JIA: Making Mindfulness Matter for Children With JIA

Children Clinical Trial

— M3-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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376149
• Other study ID #: 124973
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Lawson Health Research Institute
• Contact: Sarah Wells
• Phone: 519-685-8500
• Email: sarah.wells[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: February 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Children
• Juvenile Idiopathic Arthritis
• Mental Health
• Mental Well-being

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital,	Hamilton	Ontario
Canada	London Health Sciences Centre- Children's Hosptial	London	Ontario
Canada	Sickids	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Brain Canada

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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 — View Citation

Racine N, McArthur BA, Cooke JE, Eirich R, Zhu J, Madigan S. Global Prevalence of Depressive and Anxiety Symptoms in Children and Adolescents During COVID-19: A Meta-analysis. JAMA Pediatr. 2021 Nov 1;175(11):1142-1150. doi: 10.1001/jamapediatrics.2021.24 — View 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 contr — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Does M3 have a positive effect on parents' stress	Parenting Stress Index 4 - short form 36-item scale that helps identify sources of stress. Focused on three major domains of stress: child characteristics, parent characteristics, and situational/demographic factors. A summary and 3 subscale (Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child) scores are generated. Scores in the 81st percentile or higher are indicative of high stress.	baseline, 9 weeks and 2 months later
Other	Does M3 have a positive effect on parents' depression and anxiety	The PROMIS- short forms- depression, anxiety is an 8 question measures for parents personal physical, mental, and social well-being.; Each item on the measure is rated on a 5-point scale with a range in score from 7 to 35 with higher scores indicating greater severity of depression and anxiety.	baseline, 9 weeks and 2 months later
Other	Does M3 have a positive effect on Child's' depression and anxiety	The Revised Child Anxiety and Depression scale- (RCADS) is a 47-item, youth self-report (ages 8-18 years) questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and major depressive disorder. Parent report is obtained for children <8 years old.; Scores below 65 are in the clinically normal range. Scores between 66-69 are in the boardline clinical range and scores above 70 are in the clinical range.	baseline, 9 weeks and 2 months later
Other	Does M3 have a positive effect on children's resiliency	Child &Youth Resiliency Measure (CYRM-R) is a 28 item resiliency self-report measure (ages 5-23 years). It looks at social ecological resiliency in children and adults.; The possible range of scores for the total measure is 17 to 85, with higher scores indicating greater resilience.	baseline, 9 weeks and 2 months later
Other	Does M3 have a positive effect on parent resiliency	Connor Davidson-resilience scale (CD-RISC) is a 25 item measure that looks at resilience or how well one is equipped to bounce back after stressful events, tragedy, or trauma.; evaluated on a five-point Likert scale ranging from 0 to 4: these ratings result in a number between 0-100, and higher scores indicate higher resilience.	baseline, 9 weeks and 2 months later
Primary	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	Effects of M3 on health related quality of life of children with JIA	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.	baseline, 9 weeks and 2 months later
Secondary	Effects of M3 on health quality of life for parents	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.	baseline, 9 weeks and 2 months later
Secondary	Does M3 have a positive effect on children's severity of JIA	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.	baseline, 9 weeks and 2 months later
Secondary	Does M3 have a positive effect on children's executive function	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.	baseline, 9 weeks and 2 months later