NCT02759263

Improving Neurodevelopment in Adolescents With Congenital Heart Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Congenital Heart Disease
• Neurodevelopment
• Executive Function
• Working Memory Training
• Infant Open-heart Surgery

Interventions

Type	Name	Description
BEHAVIORAL	Cogmed Working Memory Training	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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-09-01
• Completion: 2018-10-01
• First posted: 2016-05-03
• Last updated: 2018-10-23

Locations

1 site across 1 country: United States