Parent-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.
Study 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
Sex
ALL
Min age
4 Years
Max age
6 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Recruitment rate — 2 months prior to the intervention. The number of eligible participants contacted, the number of consents to participation and the duration of the recruitment for each of the two waves of recruitment.
Dropout and withdrawal rates — The 8 weeks of the intervention. The number of eligible participants contacted, the number of consents to participation and the duration of the recruitment for each of the two waves of recruitment.
Adherence — The 8 weeks of the intervention. Adherence will be assessed by recording the number of sessions attended by each participant during the 8-week program. Acceptable adherence will be defined as completion of a minimum of 6/8 in-person yoga sessions otherwise the participant will be excluded from the analyses (withdrawals). Moreover, every week, parents will be asked to complete an at-home yoga exercise logbook to track the completion of yoga home practice and information will be collated at the end of the program.
Acceptability of the randomisation process — Months prior to the intervention. The number of refusals to enrol because of randomisation to intervention will be documented.
Variation in delivery of the intervention — The 8 weeks of the intervention. To document the variation between yoga instructors and sites, the instructors will complete an intervention logbook after each session checking all planned steps and exercises that have been completed and detailing all protocol deviations and their reasons. At the end of the 8-week program, the number of deviations, the moments and the groups in which they occurred, and their reasons will be documented in the feasibility form.
Missing data assessment — 2 weeks following each wave of assessments (T0, T1, T2). The missing data will be collected at the end of each neurodevelopmental assessment session by going through all questionnaires completed by the parent. The reasons why the parent did not answer all the questions will be discussed and collected, and the assessment and questionnaires at which the missing data occurred will be noted in the feasibility form.
Standard deviations of the main outcome to be evaluated in the full RCT — 2 weeks following the post-intervention wave of assessments (T1). The Variability score from the K-CPT2 is the main outcome of the future RCT. This data from the feasibility study will allow us to calculate the required standard deviation to be considered in the future RCT in accordance with the minimally clinical important difference (MCID) that should be measured between T0 and T1 for the yoga group.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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