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  • Improving neurodevelopmental outcomes in children with congenital heart disease: protocol for a randomised controlled trial of working memory training

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Paediatrics
Protocol
Improving neurodevelopmental outcomes in children with congenital heart disease: protocol for a randomised controlled trial of working memory training
  1. Johanna Calderon1,2,
  2. David C Bellinger2,
  3. Catherine Hartigan3,
  4. Alison Lord3,
  5. Christian Stopp3,
  6. David Wypij3,4,
  7. Jane W Newburger3,5
  1. 1 Boston Children’s Hospital, Department of Psychiatry, Boston, Massachusetts, USA
  2. 2 Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA
  3. 3 Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts, USA
  4. 4 Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA
  5. 5 Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA
  1. Correspondence to Dr Johanna Calderon; johanna.calderon{at}childrens.harvard.edu

Abstract

Introduction Executive function (EF) impairments are among the most prevalent neurodevelopmental morbidities in youth with congenital heart disease (CHD). To date, no studies have investigated the efficacy of cognitive interventions to improve EF outcomes in children with CHD.

Methods and analysis This is a single-centre, single-blinded, two-arm randomised controlled trial to test the efficacy of Cogmed Working Memory Training (Cogmed) versus standard of care in children with CHD after open-heart surgery in infancy. Participants will consist of 100 children with CHD aged 7–12 years who underwent open-heart surgery before the age of 12 months. Participants are randomly allocated to either an intervention group including training on the home-based Cogmed intervention for a duration of approximately 5 weeks or a control group who receive the standard of care. We will evaluate the efficacy of Cogmed at post-treatment and 3 months after completion of the intervention. Baseline, post-treatment and 3-month follow-up assessments will include specific measures of EF, cognitive and social functioning, and attention deficit hyperactivity disorder (ADHD) symptoms. The primary outcome of this study is the change in standardised mean score on the List Sorting Working Memory test from the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function. Secondary outcomes include measures of social skills, inhibitory control, cognitive flexibility and behavioural EF as well as ADHD symptoms as measured by the Behavior Rating Inventory of Executive Function, Second Edition, and the Conners Third Edition. The efficacy of the intervention will be evaluated by comparing within-subject differences (baseline to post-treatment, baseline to 3-month follow-up) between the two groups using an intention-to-treat analysis.

Ethics and dissemination This study has received Institutional Review Board (IRB) approval from Boston’s Children’s Hospital IRB (P00022440) and the Human Protection Agency from the US Department of Defense.

Trial registration number NCT03023644; Pre-results.

  • working memory
  • congenital heart disease
  • executive function intervention
  • cogmed
  • infant heart surgery

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-023304

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    Footnotes

    • Patient consent for publication Not required.

    • Contributors JC, DCB and JWN are the primary investigators and, together with DW, designed and established this research study. JC and JWN were responsible for ethics applications and reporting. JC, DCB, CH and AL are responsible for data collection and implementation of the intervention. JC will take lead roles on preparation for publication of the clinical outcomes of the study. JWN, DCB, DW, CS, CH and AL will contribute to the preparation of publications within their respective fields of expertise. DW and CS will take on a lead role of the statistical analysis for the study. JC drafted the final version of this manuscript. All authors critically reviewed and approved the final version. All data from this study will be submitted to peer-review journals and for presentation at national and international scientific conferences.

    • Funding This research was funded by the US Department of Defense, Clinical Trials awards (grant number W81XWH-16-1-0741).

    • Competing interests None declared.

    • Ethics approval Full ethical approval for this study has been obtained by the Boston Children’s Hospital’s Institutional Review Board (IRB) (IRB number P00022440) and has also been reviewed and approved by the Human Protection Agency from the US Department of Defense. All parent/guardians and children will give written informed consent or assent to participate prior to entering into the trial.

    • Provenance and peer review Not commissioned; externally peer reviewed.