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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 4Years - 6Years
All Genders
ID05997680

A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease a Feasibility Study Prior to a Randomised Controlled Trial

Led by Anne Gallagher · Updated on 2024-11-29

24

Participants Needed

2

Research Sites

21 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

This research aims to evaluate the feasibility of a parent-child yoga intervention designed to reduce attention deficits in children aged 4 to 6 years with congenital heart disease CHD. Children with CHD often face neurodevelopmental challenges, including a higher risk of attention deficit hyperactivity disorder ADHD. This study is a preliminary step before conducting a larger randomized controlled trial RCT to test the effectiveness of this intervention in improving attention and long-term academic and psychosocial outcomes for these children and their families. The study is a single-blind, two-center, two-arm randomized feasibility trial involving 24 parent-child pairs. Participants will be randomly assigned in a 21 ratio to either an 8-week parent-child yoga program plus standard clinical care or standard clinical care alone with a waitlist option for yoga after the study. The yoga sessions last 45 minutes each week and include active and calming parts embedded in stories suitable for the childs developmental level. Parents and children will also be encouraged to practice 5-minute at-home exercises three times a week throughout the 8-week period and continue up to a 6-month follow-up. Participants will undergo three neurodevelopmental assessments before the intervention, immediately after, and six months later. The study will monitor recruitment, dropout, and adherence rates acceptability of randomization variation in yoga delivery and data completeness. These measurements will help determine the feasibility of the procedures and inform the sample size for the future full-scale RCT. Overall participation spans about eight months including the intervention and follow-up periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 4Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of congenital heart disease requiring heart surgery
  • Aged 4 to 6 years old
  • Poor attentional skills confirmed 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 pause medication 48 hours before assessments
Not Eligible

You will not qualify if you...

  • Medical reasons preventing safe practice of yoga
  • Severe developmental or intellectual delay preventing study participation
  • Severe physical handicap requiring special adaptations for yoga
  • Families who do not speak French or English
  • Children involved in a structured weekly yoga program for at least one month in the past year

Research Team

A

Anne Gallagher, PhD

M

Marie-Noëlle Simard, PhD

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