Improving Neurodevelopment in Adolescents With Congenital Heart Disease

Not Applicable

Completed

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

• Registration Number: NCT02759263
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Study Start: 2016-06
• Primary Completion: 2018-09
• Status Verified: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosis of CHD requiring open-heart surgery before age 1 year.
2. Ages 13-16 years old.
3. ≥ 6 months post-cardiac surgery.
4. Followed-up at the Cardiology clinic of Boston Children's Hospital.
5. English and/or Spanish speaking.
6. Home internet access and a computer on which the Cogmed program can be installed
7. Informed consent of parent/guardian as well as assent of child.

Exclusion Criteria

1. Chromosomal anomalies and/or genetic syndromes.
2. Severe physical and/or sensory impairments (hearing, visual, or psychomotor).
3. IQ scores <85 at baseline
4. Confirmed diagnosis of an autism spectrum disorder or a severe developmental disorder that would prevent successful completion of the planned study testing.
5. Scheduled to undergo major cardiac interventions in the 6 months following enrollment.
6. Received, receiving, or scheduled to receive Cogmed or any other computerized behavioral training program targeting executive functions or ADHD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States