Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03023644
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2017-01-13
Brief Title:
Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease An Intervention Study
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease An Intervention Study
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Childrens 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 childrens 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
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 Childrens 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 childrens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None