Parent-child yoga to help children with congenital heart disease focus better
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study Prior to a Randomised Controlled Trial
This study is testing if parent-child yoga can help children with congenital heart disease focus better and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | St. Justine's Hospital Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT05997680 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the procedures for a future randomized controlled trial that will test the effectiveness of a parent-child yoga intervention in reducing attention deficits in children with congenital heart disease (CHD). The study will assess recruitment rates, adherence to the intervention, and the acceptability of the randomization process among families. By gathering data on these factors, the researchers hope to determine the appropriate sample size for a larger trial. The ultimate goal is to improve academic and psychosocial functioning in children with CHD through this innovative intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 6 years with a diagnosis of congenital heart disease requiring surgery and exhibiting poor attentional skills.
Not a fit: Patients with severe developmental disorders or medical contraindications to yoga may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance attention and overall quality of life for children with congenital heart disease.
How similar studies have performed: Previous studies have shown promising results for parent-child yoga interventions in improving attention in various populations, suggesting potential success for this approach in children with CHD.
Eligibility criteria
Show full inclusion / exclusion criteria
To be eligible for the study, children need to meet the following inclusion criteria: 1. diagnosis of CHD requiring heart surgery; 2. aged 4 to 6 years old; 3. poor attentional skills measured with Variability score (0.5 standard deviation below norms) at the Kiddie Conners Continuous Performance Test, 2nd Edition (K-CPT2), a sensitive measure for attentional impairments. This inclusion criteria is important since yoga intervention has shown larger effects on attention in children with greater difficulties before the intervention; 4. parent willing to participate to the 8-week parent-child yoga intervention and the pre/post/6-month follow-up assessments; 5. for children with ADHD medication (approx. 5% of the 4-to-6-year-olds at our neurocardiac clinic), parent accept to temporary stop it to at least 48h prior to each assessment. Exclusion criteria will be the following: 1. having a medical contraindication to the practice of yoga; 2. confirmed diagnosis of severe developmental or intellectual delay that would prevent successful completion of the planned study testing; 3. presence of severe physical handicap that would preclude the child from participating in the yoga intervention without special adaptation; 4. families who do not speak French or English (less than 3% of families followed in our clinics); 5. children who have been engaged in a structured weekly yoga program for at least a month in the past year (based on our parents' poll, less than 5%). However, parents included could have past or actual experience in practicing yoga. Eligibility will be determined: 1. by consulting the child's medical record; 2. during a child medical visit at one of the sites or a virtual visit with the research team by administering the K-CPT2.
Where this trial is running
Montreal, Quebec and 1 other locations
- Centre hospitalier universitaire Sainte-Justine — Montreal, Quebec, Canada (Recruiting)
- Centre universtaire de santé McGill — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Anne Gallagher, PhD
- Email: anne.gallagher.hsj@ssss.gouv.qc.ca
- Phone: 514-345-4931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.