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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 6
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Centre hospitalier universitaire Sainte-Justine
RECRUITING
Montreal
Centre universtaire de santé McGill
RECRUITING
Montreal
Contact Information
Primary
Anne Gallagher, PhD
anne.gallagher.hsj@ssss.gouv.qc.ca
514-345-4931
Backup
Marie-Noëlle Simard, PhD
marie-noelle.simard@umontreal.ca
514-345-4931
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 24
Treatments
Experimental: Yoga group
Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.
No_intervention: Waitlist control group
Participants with CHD undergoing neurodevelopmental assessments at the same time as the yoga group participants and benefiting from standard of care only during the 8 weeks of the intervention. The yoga intervention will be made available to all waitlist control group participants once their trial wave is completed.
Related Therapeutic Areas
Sponsors
Leads: Anne Gallagher
Collaborators: Centre Universitaire de Santé McGill, Heart and Stroke Foundation of Canada

This content was sourced from clinicaltrials.gov