A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Recruiting now · Not applicable
Conditions studied: Congenital Heart Disease, Child Development, Neurodevelopmental Disorders, Parents
In brief
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.
Key facts
- Study ID
- NCT05997680
- Run by
- Anne Gallagher
- People needed
- 24
- Starts
- 2023-10-01
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2024-11-29
Who can join
Age: 4 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Centre hospitalier universitaire Sainte-Justine — Montreal, Quebec, Canada (enrolling)
- Centre universtaire de santé McGill — Montreal, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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