Improving Neurodevelopment in Adolescents With Congenital Heart Disease
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 13 - 16 |
| Updated: | 10/25/2018 |
| Start Date: | June 2016 |
| End Date: | October 2018 |
Pilot Study of Executive Function Intervention to Improve Neurodevelopmental Outcomes in Adolescents With CHD
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.
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.
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.
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Phone: 857-218-5063
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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