Clinical trial NCT05997680: A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Official title: A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study Prior to a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Child Development
Neurodevelopmental Disorders
Parents
Keywords: Neurodevelopment
Attention
Yoga
Motor Skills
Parenting Stress
Congenital Heart Disease
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Centre Universitaire de Santé McGill
name: Heart and Stroke Foundation of Canada
First posted: 2023-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Context

Congenital heart disease (CHD) is the most common structural birth defect, affecting up to 1% of newborns. Half of children with CHD present neurodevelopmental impairments, including significant attention deficits. Compared to the general population, they are at 2.5 to 4 times greater risk for attention deficit hyperactivity disorder (ADHD). Despite the high prevalence of these disabilities, very little interest has been given to the design and implementation of CHD-specific interventions for improving attention. In fact, only one randomised controlled trial (RCT) aimed at improving cognition in adolescents with CHD and revealed promising results for attention and inhibitory control. To date, no RCT aiming to improve attention has been conducted in young children with CHD, although attention has been strongly associated with school readiness and can predict academic skills. Yet, a rich literature supports the notion that early intervention is key to ensure success in the crucial first years of education. There is emerging evidence from RCTs indicating that parent-child yoga interventions improve attention and reduce ADHD symptoms in both typically developing and clinical populations. However, no studies have tested this promising approach in children with CHD although these children have their own challenges. Our ultimate goal is to test the efficacy of a parent-child yoga intervention to reduce attention deficits in children with CHD at school entry. Before launching a full RCT involving multiple sites across Canada, we propose to conduct the 2-site Yoga for Little Hearts feasibility study, which is a necessary and critical step to ensure future assessment and implementation of our parent-child yoga intervention program. Results from this feasibility study will allow us to optimize the subsequent large-scale RCT by preventing procedural and methodological issues.

Aims and hypotheses

The principal objectives of the proposed feasibility study are to evaluate: 1) recruitment rates and capacity; 2) retention, dropout and withdrawal rates during the 8-week parent-child yoga program and at 6-month follow-up; 3) adherence to the intervention; 4) acceptability of the randomisation process by families; 5) heterogeneity in the delivery of the intervention between yoga instructors, and use of home-based exercise between participants; 6) proportion of missing data in the standardized neurodevelopmental assessment instruments and parental questionnaires, and 7) standard deviation of primary outcomes of the full RCT in order to determine an appropriate sample size for the future full trial.

Following this feasibility study, we plan to conduct a full RCT including multiple centers aiming to test the efficacy of our 8-week parent-child yoga intervention in addition to the standard clinical care vs. standard clinical care alone in reducing attention deficits in 4-to-6-year-olds with CHD immediately and 6 months post-intervention.

Population

Children aged 4 to 6 years old with a diagnosis of CHD requiring heart surgery and their parents.

Procedure

The Yoga for Little Hearts feasibility methodology follows the Standard Protocol Items for Randomized Trials recommendations and the Consolidated Standards of Reporting Trials (CONSORT) statement - extension to randomized pilot and feasibility trials. Our proposed study is a single blind, two-center, two-arm randomized waitlist feasibility study. A total of 24 parent-child dyads, including children aged 4 to 6 years old with CHD, will be recruited in two centers and randomly assigned (2:1 allocation; 2 yoga intervention:1 standard of care) to receive either parent-child yoga intervention and standard clinical care (yoga intervention group) or standard clinical care alone with the opportunity to receive the yoga intervention after their participation in the study if desired (waitlist control group).

Two waves of recruitment of 6 parent-child dyads will be held in each of the two participating sites, for a total of 24 dyads recruited over an 18-month period. The two participating sites are the CHU Ste-Justine and the Montreal Children's Hospital (MCH), covering more than half of the pediatric population with CHD in the Québec province. For each recruitment wave and site, 4 of the 6 recruited dyads will receive an 8-week parent-child yoga intervention. Meanwhile, dyads allocated to the waitlist control group (2 of the 6 recruited dyads) will receive the standard of care only, with the opportunity to receive the yoga intervention when their participation in the study will be completed. All participants from the yoga intervention group (n = 16) and the waitlist control group (n = 8) will undergo 3 standardized interdisciplinary neurodevelopmental assessments: 1) at baseline, before randomization (T0); 2) immediately post-intervention (T1); 3) 6-month post-intervention (T2).

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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 2 months prior to the intervention.
measure: Dropout and withdrawal rates
timeFrame: The 8 weeks of the intervention.
measure: Adherence
timeFrame: The 8 weeks of the intervention.
measure: Acceptability of the randomisation process
timeFrame: Months prior to the intervention.
measure: Variation in delivery of the intervention
timeFrame: The 8 weeks of the intervention.
measure: Missing data assessment
timeFrame: 2 weeks following each wave of assessments (T0, T1, T2).
measure: Standard deviations of the main outcome to be evaluated in the full RCT
timeFrame: 2 weeks following the post-intervention wave of assessments (T1).
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier universitaire Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: Centre universtaire de santé McGill
state: Quebec
Study officials:
References:
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