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Search / Trial NCT05997680

A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study

Launched by ANNE GALLAGHER · Aug 11, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Neurodevelopment Attention Yoga Motor Skills Parenting Stress Congenital Heart Disease

ClinConnect Summary

This clinical trial is looking into the effects of a parent-child yoga program to help improve attention skills in young children who have congenital heart disease (CHD). The researchers want to see if this yoga intervention can be a helpful way to reduce attention deficits, which can affect children's learning and daily life. Before starting a larger study, they are testing the feasibility of their approach, which means they're checking if they can successfully recruit families, how well families stick with the program, and how the yoga sessions are delivered by different instructors.

To be eligible for this study, children must be between 4 to 6 years old, have a diagnosis of CHD that needs heart surgery, and show signs of attention difficulties. Parents will also need to participate in the 8-week yoga program and complete assessments before, after, and six months later. This study aims to create a supportive environment that could lead to better long-term outcomes for children with CHD, including improved academic performance and overall quality of life. Families will receive more information about what to expect throughout the process and can ask questions as needed.

Gender

ALL

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.

About Anne Gallagher

Anne Gallagher is a dedicated clinical trial sponsor with a commitment to advancing medical research through innovative study designs and rigorous adherence to ethical standards. With extensive experience in managing multi-phase clinical trials, she emphasizes patient safety and data integrity while fostering collaboration among researchers, healthcare professionals, and regulatory bodies. Her focus on transparency and communication ensures that all stakeholders are informed and engaged throughout the trial process, ultimately contributing to the development of groundbreaking therapies that improve patient outcomes.

Locations

Montréal, Quebec, Canada

Montréal, Quebec, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported