A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Recruiting · NCT05997680 · Interventional (participants receive a specific treatment) · Lead sponsor: Anne Gallagher
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- diagnosis of CHD requiring heart surgery;
- aged 4 to 6 years old;
- 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;
- 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 criteria
- will be the following:
- 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.
Where it is running
2 locations listed.
- Centre hospitalier universitaire Sainte-Justine - Montreal, Quebec, Canada
- Centre universtaire de santé McGill - Montreal, Quebec, Canada