Improving Neurodevelopment in Adolescents With Congenital Heart Disease

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

NCT02759263•Boston Children's Hospital

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

Age

13 - 16 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

June 1, 2016

Primary Completion Date

September 1, 2018

Completion Date

October 1, 2018

Last Updated

October 23, 2018

Enrollment

ACTUAL participants

Conditions

Congenital Heart DiseaseNeurodevelopmentExecutive FunctionWorking Memory TrainingInfant Open-heart Surgery

Interventions

Cogmed Working Memory Training

BEHAVIORAL

Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

NCT01778504

Neuropsychiatric DisorderNeurological Disorder+2 more

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RECRUITING

Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal

NCT06690151

Heart Disease CongenitalNeurodevelopmental Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Improving Neurodevelopment in Adolescents With Congenital Heart Disease

Inclusion Criteria

Exclusion Criteria

Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal

Cognitive Evaluation of Patients With Eating Disorders

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Feeding Disorders in Children

Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills