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

Not Applicable

Completed

• Conditions: Congenital Heart Defect; Children; Neurodevelopmental Disorders; Working Memory; Infant Open Heart Surgery; Executive Function
• Interventions: Behavioral: Cogmed Working Memory Training

• Registration Number: NCT03023644
• Lead Sponsor: Boston Children's Hospital

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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Study Start: 2017-02-21
• Primary Completion: 2019-12-01
• Study Completion: 2020-09-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cogmed Working Memory Training	Cogmed Working Memory Training	The group randomized to the intervention will receive Cogmed computerized training of executive function and attention skills. The standard Cogmed RM will be used for this trial arm. This is a child-friendly web-based software program. The investigators will use a version of the program that contains 12 different neurocognitive tasks. Tasks become more difficult as a function of performance on a session-by-session basis. Each training session lasts 35-40 minutes, with one session to be completed per day 5 days each week for 5 weeks, for a total of 25 sessions. The program yields individual session-by-session and task-by- task training results, including the children's responses, time spent on each task, and evolution curves.

Primary Outcome Measures

Name	Time	Method
Change from baseline scores at the computerized Working Memory Test from the NIH Toolbox Assessment of Neurological and Behavioral Function at post-treatment assessment	2 weeks	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).

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States