Introduction Preschoolers and school-aged children with congenital heart disease (CHD) are at higher risk of attention deficit hyperactivity disorder (ADHD) compared with the general population. To this day, no randomised controlled trial (RCT) aiming to improve attention has been conducted in young children with CHD. There is emerging evidence indicating that parent–child yoga interventions improve attention and reduce ADHD symptoms in both typically developing and clinical populations.
Methods and analysis This is a single-blind, two-centre, two-arm trial during which 24 children with CHD and their parents will be randomly assigned to (1) a parent–child yoga intervention in addition to standard clinical care or (2) standard clinical care alone. All participants will undergo standardised assessments: (1) at baseline, (2) immediately post-treatment and (3) 6 months post-treatment. Descriptive statistics will be used to estimate the feasibility and neurodevelopmental outcomes. This feasibility study will evaluate: (1) recruitment capacity; (2) retention, drop-out and withdrawal rates during the yoga programme and at the 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 instructors and use of home-based exercises between participants; (6) proportion of missing data in the neurodevelopmental assessments and (7) SD of primary outcomes of the full RCT in order to determine the future appropriate sample size.
Ethics and dissemination Ethical approval has been obtained by the Research Ethics Board of the Sainte-Justine University Hospital. The findings will be disseminated in peer-reviewed journals and conferences and presented to the Canadian paediatric grand round meetings.
Trial registration number NCT05997680.
- congenital heart disease
- randomized controlled trial
- feasibility studies
- developmental neurology & neurodisability
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M-NS, CL and IG are joint first authors.
Contributors IG had the original idea for the parent–child yoga intervention dedicated to children with CHD and elaborated the first version of the protocol together with AG. IG, AD actively participated to the elaboration of the parent–child yoga intervention. M-NS, AG, CL and IG drafted the manuscript, and all authors revised it thoroughly. AG and M-NS gave the final approval of the protocol version to be published. AG, M-NS, MB-R, BM and SMC participated in the study design and obtained funding. BM conceived the randomisation sequence and statistical analysis plan. MHB, EP, NP, NCP and AD are collaborators from the CHU Sainte-Justine Research Centre and the CINC clinical team.
Funding This work is supported by the Heart and Stroke Foundation of Canada (HSFC) under grant number G-23-0033984 held by AG and M-NS, a Canada Research Chair on Child Neuropsychology and Brain Imaging (#950-232661) held by AG, and by the Fonds de recherche en santé du Québec (FRQS) in partnership with the Fondation des étoiles en recherche pédiatrique under scholarship number BF2-324756 held by CL.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.