Clinical trial NCT02759263: Improving Neurodevelopment in Adolescents With Congenital Heart Disease
Official title: Pilot Study of Executive Function Intervention to Improve Neurodevelopmental Outcomes in Adolescents With CHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Neurodevelopment
Executive Function
Working Memory Training
Infant Open-heart Surgery
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: The Children's Heart Foundation
First posted: 2016-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Post-treatment assessment (up to 2 weeks after the cessation of the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jane W Newburger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calderon J, Wypij D, Rofeberg V, Stopp C, Roseman A, Albers D, Newburger JW, Bellinger DC. Randomized Controlled Trial of Working Memory Intervention in Congenital Heart Disease. J Pediatr. 2020 Dec;227:191-198.e3. doi: 10.1016/j.jpeds.2020.08.038. Epub 2020 Aug 19.