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

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.

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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Page 1 of 1 (2 locations)

1

Centre hospitalier universitaire Sainte-Justine

Montreal, Quebec, Canada, H3T1C5

2

Centre universtaire de santé McGill

Montreal, Quebec, Canada, H4A3J1