RecruitingNot ApplicableNCT05997680

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

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

Sponsor

Anne Gallagher

Enrollment

24 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Neurodevelopmental Disorders Congenital Heart Disease Child Development Parents

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 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.

Eligibility

Min Age: 4 YearsMax Age: 6 Years

Inclusion Criteria4

diagnosis of CHD requiring heart surgery;
aged 4 to 6 years old;
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 Criteria8

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALParent-child yoga

The 45-minute yoga sessions are structured to include an opening and a closing ritual that remain the same throughout the 8 weeks, between which an active and a calming parts are scheduled. The active and calming parts are embedded in stories that align with the developmental level and interests typical of 4-to-6-year-olds. Each session is clearly structured with each exercise and transition well described in the Yoga for Little Hearts Yoga Program Manual. In addition to the yoga sessions, at-home exercises (5 min) including breathing, meditation and mindfulness activities will be explained to participants. We will ask them to practice them at home at least 3 times every week, for the 8-week duration of the intervention. Including the yoga session and home exercises, the 8-week intervention thus includes at least 60 minutes of yoga per week. Parents will be encouraged to pursue the at-home exercises after the end of the 8-week yoga program, up to the 6-month follow-up.