A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: A Feasibility Study

August 11, 2023 updated by: Anne Gallagher

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Context

Congenital heart disease (CHD) is the most common structural birth defect, affecting up to 1% of newborns. Half of children with CHD present neurodevelopmental impairments, including significant attention deficits. Compared to the general population, they are at 2.5 to 4 times greater risk for attention deficit hyperactivity disorder (ADHD). Despite the high prevalence of these disabilities, very little interest has been given to the design and implementation of CHD-specific interventions for improving attention. In fact, only one randomised controlled trial (RCT) aimed at improving cognition in adolescents with CHD and revealed promising results for attention and inhibitory control. To date, no RCT aiming to improve attention has been conducted in young children with CHD, although attention has been strongly associated with school readiness and can predict academic skills. Yet, a rich literature supports the notion that early intervention is key to ensure success in the crucial first years of education. There is emerging evidence from RCTs indicating that parent-child yoga interventions improve attention and reduce ADHD symptoms in both typically developing and clinical populations. However, no studies have tested this promising approach in children with CHD although these children have their own challenges. Our ultimate goal is to test the efficacy of a parent-child yoga intervention to reduce attention deficits in children with CHD at school entry. Before launching a full RCT involving multiple sites across Canada, we propose to conduct the 2-site Yoga for Little Hearts feasibility study, which is a necessary and critical step to ensure future assessment and implementation of our parent-child yoga intervention program. Results from this feasibility study will allow us to optimize the subsequent large-scale RCT by preventing procedural and methodological issues.

Aims and hypotheses

The principal objectives of the proposed feasibility study are to evaluate: 1) recruitment rates and capacity; 2) retention, dropout and withdrawal rates during the 8-week parent-child yoga program and at 6-month follow-up; 3) adherence to the intervention; 4) acceptability of the randomisation process by families; 5) heterogeneity in the delivery of the intervention between yoga instructors, and use of home-based exercise between participants; 6) proportion of missing data in the standardized neurodevelopmental assessment instruments and parental questionnaires, and 7) standard deviation of primary outcomes of the full RCT in order to determine an appropriate sample size for the future full trial.

Following this feasibility study, we plan to conduct a full RCT including multiple centers aiming to test the efficacy of our 8-week parent-child yoga intervention in addition to the standard clinical care vs. standard clinical care alone in reducing attention deficits in 4-to-6-year-olds with CHD immediately and 6 months post-intervention.

Population

Children aged 4 to 6 years old with a diagnosis of CHD requiring heart surgery and their parents.

Procedure

The Yoga for Little Hearts feasibility methodology follows the Standard Protocol Items for Randomized Trials recommendations and the Consolidated Standards of Reporting Trials (CONSORT) statement - extension to randomized pilot and feasibility trials. Our proposed study is a single blind, two-center, two-arm randomized waitlist feasibility study. A total of 24 parent-child dyads, including children aged 4 to 6 years old with CHD, will be recruited in two centers and randomly assigned (2:1 allocation; 2 yoga intervention:1 standard of care) to receive either parent-child yoga intervention and standard clinical care (yoga intervention group) or standard clinical care alone with the opportunity to receive the yoga intervention after their participation in the study if desired (waitlist control group).

Two waves of recruitment of 6 parent-child dyads will be held in each of the two participating sites, for a total of 24 dyads recruited over an 18-month period. The two participating sites are the CHU Ste-Justine and the Montreal Children's Hospital (MCH), covering more than half of the pediatric population with CHD in the Québec province. For each recruitment wave and site, 4 of the 6 recruited dyads will receive an 8-week parent-child yoga intervention. Meanwhile, dyads allocated to the waitlist control group (2 of the 6 recruited dyads) will receive the standard of care only, with the opportunity to receive the yoga intervention when their participation in the study will be completed. All participants from the yoga intervention group (n = 16) and the waitlist control group (n = 8) will undergo 3 standardized interdisciplinary neurodevelopmental assessments: 1) at baseline, before randomization (T0); 2) immediately post-intervention (T1); 3) 6-month post-intervention (T2).

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T1C5
        • Recruiting
        • Centre Hospitalier Universitaire Sainte-Justine
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Natacha Paquette, PhD
        • Principal Investigator:
          • Anne Gallagher, PhD
        • Principal Investigator:
          • Marie-Noëlle Simard, PhD
        • Sub-Investigator:
          • Charles Lepage, BSc
        • Sub-Investigator:
          • Amélie Doussau, MSc
        • Principal Investigator:
          • Benoît Masse, PhD
        • Sub-Investigator:
          • Sylvana Côté, PhD
        • Sub-Investigator:
          • Miriam Beauchamp, PhD
        • Sub-Investigator:
          • Elana Pinchefsky, MD
        • Sub-Investigator:
          • Nancy Poirier, MD
      • Montréal, Quebec, Canada, H4A3J1
        • Recruiting
        • Centre universtaire de santé McGill
        • Principal Investigator:
          • Marie Brossard-Racine, PhD
        • Contact:
        • Sub-Investigator:
          • Marie-Ève Bolduc, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga group
Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 2 months prior to the intervention.
The number of eligible participants contacted, the number of consents to participation and the duration of the recruitment for each of the two waves of recruitment.
2 months prior to the intervention.
Dropout and withdrawal rates
Time Frame: The 8 weeks of the intervention.
The number of eligible participants contacted, the number of consents to participation and the duration of the recruitment for each of the two waves of recruitment.
The 8 weeks of the intervention.
Adherence
Time Frame: The 8 weeks of the intervention.
Adherence will be assessed by recording the number of sessions attended by each participant during the 8-week program. Acceptable adherence will be defined as completion of a minimum of 6/8 in-person yoga sessions otherwise the participant will be excluded from the analyses (withdrawals). Moreover, every week, parents will be asked to complete an at-home yoga exercise logbook to track the completion of yoga home practice and information will be collated at the end of the program.
The 8 weeks of the intervention.
Acceptability of the randomisation process
Time Frame: Months prior to the intervention.
The number of refusals to enrol because of randomisation to intervention will be documented.
Months prior to the intervention.
Variation in delivery of the intervention
Time Frame: The 8 weeks of the intervention.
To document the variation between yoga instructors and sites, the instructors will complete an intervention logbook after each session checking all planned steps and exercises that have been completed and detailing all protocol deviations and their reasons. At the end of the 8-week program, the number of deviations, the moments and the groups in which they occurred, and their reasons will be documented in the feasibility form.
The 8 weeks of the intervention.
Missing data assessment
Time Frame: 2 weeks following each wave of assessments (T0, T1, T2).
The missing data will be collected at the end of each neurodevelopmental assessment session by going through all questionnaires completed by the parent. The reasons why the parent did not answer all the questions will be discussed and collected, and the assessment and questionnaires at which the missing data occurred will be noted in the feasibility form.
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).
The Variability score from the K-CPT2 is the main outcome of the future RCT. This data from the feasibility study will allow us to calculate the required standard deviation to be considered in the future RCT in accordance with the minimally clinical important difference (MCID) that should be measured between T0 and T1 for the yoga group.
2 weeks following the post-intervention wave of assessments (T1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anne Gallagher

Collaborators

Heart and Stroke Foundation of Canada
Centre Universitaire de Santé McGill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-2446
  • G-23-0033984 (Other Grant/Funding Number: Heart and Stroke Foundation of Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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