Improving Neurodevelopment in Adolescents With Congenital Heart Disease

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Boston Children's Hospital

Status

Completed

Conditions

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

Treatments

Behavioral: Cogmed Working Memory Training

Study type

Interventional

Funder types

Other

Identifiers

NCT02759263
IRB-P00022266

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

13 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Working Memory Intervention
Experimental group
Description:
The group randomized to the Working Memory intervention will receive Cogmed computerized training of executive function and attention skills. The standard Cogmed RM will be used for this trial arm. This is a child-friendly web-based software program. The investigators will use a version of the program that contains 12 different neurocognitive tasks. Tasks become more difficult as a function of performance on a session-by-session basis. Each training session lasts 35-40 minutes, with one session to be completed per day 5 days each week for 5 weeks, for a total of 25 sessions. The program yields individual session-by-session and task-by- task training results, including the adolescents' responses, time spent on each task, and evolution curves.
Treatment:
Behavioral: Cogmed Working Memory Training
Control group - Standard of Care
No Intervention group
Description:
Adolescents randomly assigned to the control group will receive the standard of care recommended for patients with critical CHD. This includes cardiac surveillance and neurodevelopmental counseling and screening at our Cardiac Neurodevelopmental Program if needed. Once enrolled in our study, an adolescent in the control group will not receive Cogmed intervention or any other cognitive intervention that targets executive functions or ADHD symptoms until after the 3-month follow-up neurodevelopmental evaluation is performed, i.e., 5-6 months after initial enrollment. Like adolescents assigned to the intervention group, controls can continue on treatments that are already in place for other neurodevelopmental disabilities (e.g., speech therapy, occupational services).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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