Status:
RECRUITING
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Lead Sponsor:
Anne Gallagher
Collaborating Sponsors:
Centre Universitaire de Santé McGill
Heart and Stroke Foundation of Canada
Conditions:
Congenital Heart Disease
Child Development
Eligibility:
All Genders
4-6 years
Phase:
NA
Brief Summary
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...
Detailed Description
Context Congenital heart disease (CHD) is the most common structural birth defect, affecting up to 1% of newborns. Half of children with CHD present neurodevelopmental impairments, including signific...
Eligibility Criteria
Inclusion
- To be eligible for the study, children need to meet the following inclusion criteria:
- diagnosis of CHD requiring heart surgery;
- aged 4 to 6 years old;
- 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;
- parent willing to participate to the 8-week parent-child yoga intervention and the pre/post/6-month follow-up assessments;
- 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:
- having a medical contraindication to the practice of yoga;
- confirmed diagnosis of severe developmental or intellectual delay that would prevent successful completion of the planned study testing;
- presence of severe physical handicap that would preclude the child from participating in the yoga intervention without special adaptation;
- families who do not speak French or English (less than 3% of families followed in our clinics);
- 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:
- by consulting the child's medical record;
- during a child medical visit at one of the sites or a virtual visit with the research team by administering the K-CPT2.
Exclusion
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05997680
Start Date
October 1 2023
End Date
October 1 2025
Last Update
November 29 2024
Active Locations (2)
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1
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
2
Centre universtaire de santé McGill
Montreal, Quebec, Canada, H4A3J1