Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study
Condition: Congenital Heart Defect; Executive Function; Children; Neurodevelopmental Disorders; Working Memory; Infant Open Heart Surgery
MeSH terms: Heart Diseases; Heart Defects, Congenital; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD),
      making it the most common birth defect. With recent medical advances, more children with CHD
      survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with
      CHD. These survivors face challenges in terms of their cognitive and behavioral development.
      For many, the limitations affect their academic achievement, social adaption and, ultimately,
      their quality of life. Among the most disabling limitations are those that pertain to the
      ability to maintain attention, plan and organize activities, regulate emotions, and develop
      problem-solving strategies. Collectively, these are referred to as executive functions (EF)
      because they are higher-order abilities that enable one to coordinate complex behaviors.
      Additionally, impaired EF also underlie mental health disorders. In spite of the abundance of
      evidence that children with CHD struggle with EF, there is little to offer them in the way of
      evidence-based interventions to prevent or mitigate these problems.

      The investigators propose to conduct the first randomized trial to evaluate the efficacy of
      an intervention, the Cogmed Working Memory Program, in improving the neurodevelopment
      outcomes of children with critical CHD after infant open-heart surgery. Children who meet
      eligibility criteria and who agree to participate will be randomly assigned to an
      intervention or control group. Children in the intervention group will complete 25 35-40
      minute sessions of Cogmed training, spread over for 5 weeks. This Program is a set of
      home-based, child-friendly, computerized activities. The control group will receive the
      standard of care for children with CHD. Children's scores on EF and related
      neurodevelopmental tests will be evaluated before the intervention group completes Cogmed
      training, at the conclusion of their training, and 3 months later. The latter assessment will
      indicate whether any gains in EF skills of the children in the intervention group are
      sustained after training. Parents and teachers will also complete questionnaires about
      children's EF, attention, and social behaviors to determine whether training affects
      behaviors of the intervention group at home and in school. The investigators will also
      identify the medical and surgical characteristics of children who benefit most from Cogmed
      training. This information will be helpful in targeting the intervention most efficiently in
      the future.
    


Intervention name(s): Cogmed Working Memory Training
Intervention type(s): Behavioral
Intervention description(s): Cogmed Working Memory Program will be used as a computerized home-based intervention. Families will an iPad with a web-based software program. The 25 sessions will be completed individually by the child with parental supervision. For the first 5 sessions, the participant trains on the same set of games; on the 6th session and every 5th session thereafter, a new task is introduced and replaces one of the initial tasks. At the end of each session, the child can play an age-appropriate computerized game as a reward. After each session, results are uploaded by parents to a secure website, to keep track of the participant's progress. Families will be contacted weekly to check program function and discuss concerns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Congenital Heart Disease; Neurodevelopmental Disorders; Children; Executive Function; Working Memory; Cognitive interventions; Infant Open Heart Surgery