Children, Juvenile Idiopathic Arthritis, Mental Health, Mental Well-being
Conditions
Keywords
M3, mindfulness
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.
Interventions
BEHAVIORALM3 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.
BEHAVIORALM3 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.
Sponsors
Brain Canada
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Throughout the study enrollment period and over the 8 weeks of intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of M3 on health related quality of life of children with JIA | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
| Effects of M3 on health quality of life for parents | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
| Does M3 have a positive effect on children's severity of JIA | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
| Does M3 have a positive effect on children's executive function | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Does M3 have a positive effect on parents' stress | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
| Does M3 have a positive effect on parents' depression and anxiety | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
| Does M3 have a positive effect on Child's' depression and anxiety | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
| Does M3 have a positive effect on children's resiliency | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
| Does M3 have a positive effect on parent resiliency | baseline, 9 weeks, 18 weeks and 2 months later. | 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. |
Countries
Canada
Contacts
Primary ContactSarah Wells
Backup ContactRoberta Berard, MD
Outcome results
None listed