Improving Neurodevelopment in Adolescents With Congenital Heart Disease

Completed · Not applicable

Conditions studied: Congenital Heart Disease, Neurodevelopment, Executive Function, Working Memory Training, Infant Open-heart Surgery

In brief

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.

Key facts

Study ID

NCT02759263

Run by

Boston Children's Hospital

People needed

60

Starts

2016-06-01

Expected to finish

2018-10-01

Last updated by the study team

2018-10-23

Who can join

Age: 13 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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