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New treatment option for Congenital Heart Disease
Official title A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
ClinicalTrials.gov ID: NCT05997680
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 6
You may be able to join if
- To be eligible for the study, children need to meet the following
- 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...
- parent willing to participate to the 8-week parent-child yoga intervention and the pre/post/6-month follow-up assessments;
You likely can't join if
- 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%)...
See the full eligibility criteria
- To be eligible for the study, children need to meet the following
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.