Actively Recruiting

Phase Not Applicable
Age: 4Years - 6Years
All Genders
NCT05997680

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

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

24

Participants Needed

2

Research Sites

104 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

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.

CONDITIONS

Official 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...

  • Children diagnosed with congenital heart disease requiring heart surgery
  • Aged between 4 and 6 years old
  • Poor attentional skills as measured 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 stop medication at least 48 hours before each assessment
Not Eligible

You will not qualify if you...

  • Medical contraindication to practicing yoga
  • Severe developmental or intellectual delay preventing study participation
  • Severe physical handicap that would prevent participation in yoga without adaptations
  • Families who do not speak French or English
  • Children who have participated in a structured weekly yoga program for at least one month in the past year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centre hospitalier universitaire Sainte-Justine

Montreal, Quebec, Canada, H3T1C5

Actively Recruiting

2

Centre universtaire de santé McGill

Montreal, Quebec, Canada, H4A3J1

Actively Recruiting

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Research Team

A

Anne Gallagher, PhD

CONTACT

M

Marie-Noëlle Simard, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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