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A Parent–child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol
  1. Marie-Noëlle Simard1,2,
  2. Charles Lepage1,3,
  3. Isabelle Gaudet1,4,
  4. Natacha Paquette1,3,
  5. Amélie Doussau5,
  6. Nancy C Poirier5,6,
  7. Miriam H Beauchamp1,3,
  8. Sylvana M Côté1,7,
  9. Elana Pinchefsky5,8,
  10. Marie Brossard-Racine9,10,
  11. Benoît Mâsse7,11,
  12. Anne Gallagher1,3
  1. 1Centre de recherche, CHU Sainte-Justine, Montréal, Québec, Canada
  2. 2School of Rehabilitation, Université de Montréal, Montréal, Québec, Canada
  3. 3Department of Psychology, Université de Montréal, Montréal, Québec, Canada
  4. 4Department of Health Sciences, Universite du Québec à Chicoutimi, Chicoutimi, Québec, Canada
  5. 5Clinique d'investigation neurocardiaque, CHU Sainte-Justine, Montréal, Québec, Canada
  6. 6Department of Surgery, Division of Cardiac Surgery, Université de Montréal, Montréal, Québec, Canada
  7. 7Department of Social and Preventive Medicine, Université de Montréal, Montréal, Québec, Canada
  8. 8Department of Pediatrics, Université de Montréal, Montréal, Québec, Canada
  9. 9School of Physical and Occupational Therapy, Centre universitaire de santé McGill, Montréal, Québec, Canada
  10. 10Institut de recherche, Centre universitaire de santé McGill, Montréal, Québec, Canada
  11. 11Institut de recherche clinique et appliquée, CHU Sainte-Justine, Montréal, Québec, Canada
  1. Correspondence to Dr Anne Gallagher; anne.gallagher{at}umontreal.ca

Abstract

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
  • behavior
  • feasibility studies
  • developmental neurology & neurodisability
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • 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.