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

NCT03023644 | Completed DMC

• 1 other identifier: IRB-P00022440
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Defect; Executive Function; Children; Neurodevelopmental Disorders; Working Memory; Infant Open Heart Surgery

Keywords

Congenital Heart Disease; Neurodevelopmental Disorders; Children; Executive Function; Working Memory; Cognitive interventions; Infant Open Heart Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cogmed Working Memory Training

EXPERIMENTAL

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.

Behavioral: Cogmed Working Memory Training

Standard of Care

NO INTERVENTION

Children randomly assigned to the control group will receive the standard of care recommended for patients with critical CHD. This includes cardiac surveillance and neurodevelopmental counseling and screening at our Cardiac Neurodevelopmental Program if needed. Once enrolled in our study, a child in the control group will not receive Cogmed intervention or any other cognitive intervention that targets executive functions or ADHD symptoms until after the 3-month follow-up neurodevelopmental evaluation is performed, i.e., 5-6 months after initial enrollment. Like children assigned to the intervention group, controls can continue on treatments that are already in place for other neurodevelopmental disabilities (e.g., speech therapy, occupational services).

Interventions

Cogmed Working Memory Training BEHAVIORAL

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.

Cogmed Working Memory Training

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Open heart surgery before age 12 months of life
• Ages between 7 years 0 months and 12 years 11 months
• ≥6 months post-cardiac surgery at enrollment
• Cardiology follow-up (clinic or inpatient) at BCH or other affiliated center in the last 6 years.
• English and/or Spanish speaking
• Informed consent of parent/guardian as well as assent of child

You may not qualify if:

• Known chromosomal anomalies and/or genetic syndromes
• Severe physical and/or sensory impairments (hearing, visual, or psychomotor) that would prevent use of the computerized program and tablets
• 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.
• Scheduled to undergo major cardiac interventions in the 6 months following enrollment
• Received, receiving, or scheduled to receive Cogmed or any other computerized behavioral training program targeting executive functions or ADHD

Sponsors & Collaborators

• Boston Children's Hospital: lead
• United States Department of Defense: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Calderon J, Bellinger DC, Hartigan C, Lord A, Stopp C, Wypij D, Newburger JW. Improving neurodevelopmental outcomes in children with congenital heart disease: protocol for a randomised controlled trial of working memory training. BMJ Open. 2019 Feb 19;9(2):e023304. doi: 10.1136/bmjopen-2018-023304.

  PMID: 30782877 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Study Officials

• Jane W Newburger, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, Commonwealth Professor of Pediatrics

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: February 21, 2017
• Primary Completion: December 1, 2019
• Study Completion: September 30, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)