Congenital Heart Disease Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | October 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 6 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier universitaire Sainte-Justine | Montréal | Quebec |
Canada | Centre universtaire de santé McGill | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Anne Gallagher | Centre Universitaire de Santé McGill, Heart and Stroke Foundation of Canada |
Canada,
Cohen SCL, Harvey DJ, Shields RH, Shields GS, Rashedi RN, Tancredi DJ, Angkustsiri K, Hansen RL, Schweitzer JB. Effects of Yoga on Attention, Impulsivity, and Hyperactivity in Preschool-Aged Children with Attention-Deficit Hyperactivity Disorder Symptoms. J Dev Behav Pediatr. 2018 Apr;39(3):200-209. doi: 10.1097/DBP.0000000000000552. — View Citation
Gaudet I, Paquette N, Bernard C, Doussau A, Harvey J, Beaulieu-Genest L, Pinchefsky E, Trudeau N, Poirier N, Simard MN, Gallagher A; Clinique d'Investigation Neuro-Cardiaque (CINC) interdisciplinary team. Neurodevelopmental Outcome of Children with Congenital Heart Disease: A Cohort Study from Infancy to Preschool Age. J Pediatr. 2021 Dec;239:126-135.e5. doi: 10.1016/j.jpeds.2021.08.042. Epub 2021 Aug 27. — View Citation
Lepage C, Gaudet I, Doussau A, Vinay MC, Gagner C, von Siebenthal Z, Poirier N, Simard MN, Paquette N, Gallagher A. The role of parenting stress in anxiety and sleep outcomes in toddlers with congenital heart disease. Front Pediatr. 2023 Jan 6;10:1055526. doi: 10.3389/fped.2022.1055526. eCollection 2022. — View Citation
Lisanti AJ. Parental stress and resilience in CHD: a new frontier for health disparities research. Cardiol Young. 2018 Sep;28(9):1142-1150. doi: 10.1017/S1047951118000963. Epub 2018 Jul 11. — View Citation
Mak CK, Whittingham K, Boyd RN. Experiences of children and parents in MiYoga, an embodied mindfulness yoga program for cerebral palsy: A mixed method study. Complement Ther Clin Pract. 2019 Feb;34:208-216. doi: 10.1016/j.ctcp.2018.12.006. Epub 2018 Dec 19. — View Citation
Marelli AJ, Ionescu-Ittu R, Mackie AS, Guo L, Dendukuri N, Kaouache M. Lifetime prevalence of congenital heart disease in the general population from 2000 to 2010. Circulation. 2014 Aug 26;130(9):749-56. doi: 10.1161/CIRCULATIONAHA.113.008396. Epub 2014 Jun 18. — View Citation
Wang CC, Weng WC, Chang LY, Chang HY, Wu MH, Wang JK, Lu CW, Lin MT, Chen CA, Chiu SN. Increased prevalence of inattention-related symptoms in a large cohort of patients with congenital heart disease. Eur Child Adolesc Psychiatry. 2021 Apr;30(4):647-655. doi: 10.1007/s00787-020-01547-y. Epub 2020 May 11. — View Citation
Weaver LL, Darragh AR. Systematic Review of Yoga Interventions for Anxiety Reduction Among Children and Adolescents. Am J Occup Ther. 2015 Nov-Dec;69(6):6906180070p1-9. doi: 10.5014/ajot.2015.020115. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate | 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. | |
Primary | Dropout and withdrawal rates | 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. | |
Primary | Adherence | 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. | |
Primary | Acceptability of the randomisation process | The number of refusals to enrol because of randomisation to intervention will be documented. | Months prior to the intervention. | |
Primary | Variation in delivery 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. | |
Primary | Missing data assessment | 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). | |
Primary | Standard deviations of the main outcome to be evaluated in the full RCT | 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). |
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