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Implantation of Total Artificial Heart in Congenital Heart Disease
Published on: July 18, 2014
Improving neurodevelopmental outcomes in children with congenital heart disease: protocol for a randomised controlled
Johanna Calderon1,2, David C Bellinger2, Catherine Hartigan3
1Boston Children's Hospital, Department of Psychiatry, Boston, Massachusetts, USA.
Insights
This study tested Cogmed Working Memory Training for children with congenital heart disease (CHD) after surgery. Results will show if this cognitive intervention improves executive function (EF) in this vulnerable population.
Area of Science:
- Neuroscience
- Pediatric Cardiology
- Cognitive Psychology
Background:
- Executive function (EF) impairments are common in youth with congenital heart disease (CHD).
- No prior studies have assessed cognitive interventions for improving EF in children with CHD.
Purpose of the Study:
- To evaluate the efficacy of Cogmed Working Memory Training (Cogmed) compared to standard care in children with CHD.
- To determine if Cogmed improves executive function, cognitive, and social functioning, and ADHD symptoms in this population.
Main Methods:
- A single-center, single-blinded, two-arm randomized controlled trial involving 100 children (aged 7-12) with CHD who had open-heart surgery before 12 months.
- Participants were randomized to either the Cogmed intervention (approx. 5 weeks) or standard care.
- Outcomes assessed at post-treatment and 3-month follow-up using standardized EF, cognitive, social functioning, and ADHD symptom measures.
Main Results:
- Primary outcome: change in working memory score (List Sorting Working Memory test).
- Secondary outcomes: measures of social skills, inhibitory control, cognitive flexibility, behavioral EF, and ADHD symptoms.
- Intention-to-treat analysis will compare within-subject changes between groups.
Conclusions:
- This trial will provide crucial data on the effectiveness of cognitive interventions for children with CHD.
- Findings may inform future therapeutic strategies to address neurodevelopmental morbidities in this population.
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.
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