A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorAnne Gallagher
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Parent-child yoga
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Anne Gallagher
Lead sponsor
St. Justine's Hospital
Sponsor institution
Centre Universitaire de Santé McGill
Collaborator
Heart and Stroke Foundation of Canada
Collaborator
Source ClinicalTrials.gov