A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: A Feasibility Study
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ClinicalTrials.gov Identifier: NCT05997680 |
Recruitment Status :
Recruiting
First Posted : August 18, 2023
Last Update Posted : November 24, 2023
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Condition or disease | Intervention/treatment | Phase |
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Congenital Heart Disease Child Development Neurodevelopmental Disorders Parents | Behavioral: Parent-child yoga | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | The intervention team including the research coordinator will not be blinded to intervention allocation. The primary and secondary outcomes of the full trial will be assessed by a research assistant who is not part of the intervention and who will be blinded to intervention allocation. Data will be anonymised, and data quality control will be conducted by staff blinded to the intervention group. The intervention team will be blinded to the initial level of attention functioning. There will be no interference with standard clinical care. All clinical follow-up, therapies and learning-support services received as part of the standard clinical care will be documented in the electronic case report form. Due to the nature of the intervention, participants and their parents will not be blinded. |
Primary Purpose: | Supportive Care |
Official Title: | A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: a Feasibility Study Prior to a Randomised Controlled Trial |
Actual Study Start Date : | October 1, 2023 |
Estimated Primary Completion Date : | May 1, 2025 |
Estimated Study Completion Date : | October 1, 2025 |
Arm | Intervention/treatment |
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Experimental: Yoga group
Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.
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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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Ages Eligible for Study: | 4 Years to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
To be eligible for the study, children need to meet the following inclusion criteria:
- 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.
Exclusion criteria 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 practicing yoga.
Eligibility will be determined:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05997680
Contact: Anne Gallagher, PhD | 514-345-4931 ext 6409 | anne.gallagher.hsj@ssss.gouv.qc.ca | |
Contact: Marie-Noëlle Simard, PhD | 514-345-4931 ext 5114 | marie-noelle.simard@umontreal.ca |
Canada, Quebec | |
Centre hospitalier universitaire Sainte-Justine | Recruiting |
Montréal, Quebec, Canada, H3T1C5 | |
Contact: Anne Gallagher, PhD 5143454931 ext 6409 anne.gallagher.hsj@ssss.gouv.qc.ca | |
Contact: Marie-Noëlle Simard, PhD 5143454931 ext 5114 marie-noelle.simard@umontreal.ca | |
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 | |
Centre universtaire de santé McGill | Recruiting |
Montréal, Quebec, Canada, H4A3J1 | |
Contact: Marie Brossard-Racine, PhD 5149341934 ext 76295 marie.brossardracine@mcgill.ca | |
Principal Investigator: Marie Brossard-Racine, PhD | |
Sub-Investigator: Marie-Ève Bolduc, PhD |
Responsible Party: | Anne Gallagher, Researcher and clinical neuropsychologist, St. Justine's Hospital |
ClinicalTrials.gov Identifier: | NCT05997680 |
Other Study ID Numbers: |
2020-2446 G-23-0033984 ( Other Grant/Funding Number: Heart and Stroke Foundation of Canada ) |
First Posted: | August 18, 2023 Key Record Dates |
Last Update Posted: | November 24, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neurodevelopment Attention Yoga |
Motor Skills Parenting Stress Congenital Heart Disease |
Heart Diseases Heart Defects, Congenital Neurodevelopmental Disorders Cardiovascular Diseases |
Mental Disorders Cardiovascular Abnormalities Congenital Abnormalities |