Recruiting

Yoga Intervention

Sponsor:

Anne Gallagher

Code:

NCT05997680

Conditions

Congenital Heart Disease

Child Development

Neurodevelopmental Disorders

Parents

Eligibility Criteria

Sex: All

Age: 4 - 6

Healthy Volunteers: Not accepted

Interventions

Parent-child yoga

Study Details

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.

Conditions

Congenital Heart Disease

Child Development

Neurodevelopmental Disorders

Parents

Study ID

NCT05997680

Start date

Oct 1, 2023

Status verified date

Nov, 2024

Completion date

Oct 1, 2025

Anticipated

Primary completion date

May 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 6

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Parent-child yoga

The 45-minute yoga sessions are structured to include an opening and a closing ritual that remain the same throughout the 8 weeks, between which an active and a calming parts are scheduled. The active and calming parts are embedded in stories that align with the developmental level and interests typical of 4-to-6-year-olds. Each session is clearly structured with each exercise and transition well described in the Yoga for Little Hearts Yoga Program Manual. In addition to the yoga sessions, at-home exercises (5 min) including breathing, meditation and mindfulness activities will be explained to participants. We will ask them to practice them at home at least 3 times every week, for the 8-week duration of the intervention. Including the yoga session and home exercises, the 8-week intervention thus includes at least 60 minutes of yoga per week. Parents will be encouraged to pursue the at-home exercises after the end of the 8-week yoga program, up to the 6-month follow-up.

Primary outcome measure

  • Recruitment rate [ Time Frame: 2 months prior to the intervention. ]
  • Dropout and withdrawal rates [ Time Frame: The 8 weeks of the intervention. ]
  • Adherence [ Time Frame: The 8 weeks of the intervention. ]
  • Acceptability of the randomisation process [ Time Frame: Months prior to the intervention. ]
  • Variation in delivery of the intervention [ Time Frame: The 8 weeks of the intervention. ]
  • Missing data assessment [ Time Frame: 2 weeks following each wave of assessments (T0, T1, T2). ]
  • Standard deviations of the main outcome to be evaluated in the full RCT [ Time Frame: 2 weeks following the post-intervention wave of assessments (T1). ]

Central Contacts and Locations

Locations

Centre hospitalier universitaire Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T1C5

Contacts

Centre universtaire de santé McGill

Recruiting

Montréal, Quebec, Canada, H4A3J1

Contacts

More Information

Sponsor

Anne Gallagher

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Keywords

  • Neurodevelopment
  • Attention
  • Yoga
  • Motor Skills
  • Parenting Stress
  • Congenital Heart Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anne Gallagher on 2024-11-29.