Improving Neurodevelopment in Adolescents With Congenital Heart Disease

Executive dysfunction can profoundly impact all dimensions of a child's development. Impairments in executive function are a central component of the neurodevelopmental phenotype associated with CHD, and manifest as behavioral dysregulation and problems with attention, working memory, and organization/planning abilities. Identifying effective treatment strategies is vital for providing optimal care for these patients. The Cogmed executive function intervention, an evidence-based computerized neurocognitive program, improves outcomes in several pediatric populations. The investigators propose to conduct a pilot study to evaluate its efficacy in reducing morbidities in patients with CHD. This is a single center, single blinded 2-arm randomized controlled trial to test the immediate post-treatment and 3-month follow-up efficacy of Cogmed intervention versus standard of care in adolescents with CHD.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Executive Function Heart Defects, Congenital Heart Diseases Infant Open-heart Surgery Neurodevelopment Working Memory Training

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of CHD requiring open-heart surgery before age 1 year.
Ages 13-16 years old.
≥ 6 months post-cardiac surgery.
Followed-up at the Cardiology clinic of Boston Children's Hospital.
English and/or Spanish speaking.
Home internet access and a computer on which the Cogmed program can be installed
Informed consent of parent/guardian as well as assent of child.

Exclusion criteria

Chromosomal anomalies and/or genetic syndromes.
Severe physical and/or sensory impairments (hearing, visual, or psychomotor).
IQ scores <85 at baseline
Confirmed diagnosis of an autism spectrum disorder or a severe developmental 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.

Treatment and study plan

Cogmed Working memory training

Behavioral

Cogmed Working Memory Program will be used as a computerized home-based intervention. Families will receive a link for downloading a web-based software program. The program will be installed on a computer at a family's home by a research assistant. Parents and adolescents will be actively involved, and during the installation session, adolescents will complete several practice trials. The 25 sessions will be completed individually by the adolescent 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 adolescent 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.

Primary outcomes

Change from baseline scores at the computerized Working Memory Test from the NIH Toolbox Assessment of Neurological and Behavioral Function at post-treatment assessment (up to 2 weeks after cessation of the intervention).

Time frame: Post-treatment assessment (up to 2 weeks after the cessation of the intervention)

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 adolescents' 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 adolescents of the same age. They are normally distributed (mean=100, SD=15).

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

The Children's Heart Foundation
Thrasher Research Fund

Registry information

Official study title

Pilot Study of Executive Function Intervention to Improve Neurodevelopmental Outcomes in Adolescents With CHD

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: May 3, 2016
Registry last updated: Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed