Actively Recruiting
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Led by Anne Gallagher · Updated on 2024-11-29
24
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Anne Gallagher
Lead Sponsor
C
Centre Universitaire de Santé McGill
Collaborating Sponsor
AI-Summary
What this Trial Is About
The proposed study aims to determine the feasibility of the procedures for a future full randomized controlled trial (RCT), which will test the efficacy of a parent-child yoga intervention in reducing attention deficits in children with congenital heart disease (CHD). Specific aims of this single-blind, two-arm, two-center feasibility trial are to evaluate recruitment rates and capacity, withdrawal and dropout rates, adherence to the intervention, acceptability of the randomization process by families, variation in delivery of the intervention between yoga instructors, and standard deviation of main outcomes of the future RCT in order to determine its appropriate sample size. This feasibility study will lead to the first ever RCT to test the efficacy of an intervention strategy for reducing attention deficits in children with CHD. Ultimately, the implementation of this parent-child yoga program will lead to better long-term academic and psychosocial functioning and quality of life for these children and their family.
CONDITIONS
Official Title
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children diagnosed with congenital heart disease requiring heart surgery
- Aged between 4 and 6 years old
- Poor attentional skills as measured by a specific attention test (K-CPT2)
- Parent willing to participate in the 8-week yoga intervention and all assessments
- For children on ADHD medication, parent agrees to stop medication at least 48 hours before each assessment
You will not qualify if you...
- Medical contraindication to practicing yoga
- Severe developmental or intellectual delay preventing study participation
- Severe physical handicap that would prevent participation in yoga without adaptations
- Families who do not speak French or English
- Children who have participated in a structured weekly yoga program for at least one month in the past year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Actively Recruiting
2
Centre universtaire de santé McGill
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
Research Team
A
Anne Gallagher, PhD
CONTACT
M
Marie-Noëlle Simard, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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