Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 7 - 12 |
| Updated: | 4/17/2018 |
| Start Date: | February 21, 2017 |
| End Date: | September 30, 2019 |
| Contact: | Johanna Calderon, PhD |
| Email: | johanna.calderon@childrens.harvard.edu |
| Phone: | 8572185063 |
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 neurodevelopmental
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.
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 neurodevelopmental
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.
Inclusion Criteria:
1. Open heart surgery before age 12 months of life
2. Ages between 7 years 0 months and 12 years 11 months
3. ≥6 months post-cardiac surgery at enrollment
4. Cardiology follow-up (clinic or inpatient) at BCH or other affiliated center in the
last 6 years.
5. English and/or Spanish speaking
6. Informed consent of parent/guardian as well as assent of child
Exclusion Criteria:
1. Known chromosomal anomalies and/or genetic syndromes
2. Severe physical and/or sensory impairments (hearing, visual, or psychomotor) that
would prevent use of the computerized program and tablets
3. Confirmed formal diagnosis of any autism spectrum disorder or a severe developmental
and/or intellectual disorder that would prevent successful completion of the planned
study testing.
4. Scheduled to undergo major cardiac interventions in the 6 months following enrollment
5. Received, receiving, or scheduled to receive Cogmed or any other computerized
behavioral training program targeting executive functions or ADHD
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-5427
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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