Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study

Children Clinical Trial

Official title:

Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023644
• Other study ID #: IRB-P00022440
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 30, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Congenital Heart Defect
• Executive Function
• Heart Defects, Congenital
• Heart Diseases
• Infant Open Heart Surgery
• Neurodevelopmental Disorders
• Working Memory

Intervention

Behavioral:
• Cogmed Working Memory Training
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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline scores at the computerized Working Memory Test from the NIH Toolbox Assessment of Neurological and Behavioral Function at post-treatment assessment	This standardized measure assesses the ability to process information across a series of modalities (visual-spatial and verbal), to hold this information in a short-term buffer, and to actively manipulate it mentally. It is considered an excellent composite indicator of children's executive function skills, as it requires the simultaneous implementation of control of attention and working memory abilities on tasks of increasing complexity. Mean scores are automatically computed and are compared to a standardization sample of US children of the same age. They are normally distributed (mean=100, SD=15).	2 weeks