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

NCT02759263 NA COMPLETED

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.

Details

Lead sponsor	Boston Children's Hospital
Phase	NA
Status	COMPLETED
Enrolment	60
Start date	2016-06
Completion	2018-10

Conditions

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

Interventions

• Cogmed Working Memory Training

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). — 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).

Countries

United States