Improving Neurodevelopment in Adolescents With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759263
• Other study ID #: IRB-P00022266
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Executive Function
• Heart Defects, Congenital
• Heart Diseases
• Infant Open-heart Surgery
• Neurodevelopment
• Working Memory Training

Intervention

Behavioral:
• Cogmed Working Memory Training
Cogmed Working Memory Program will be used as a computerized home-based intervention. Families will receive a link for downloading a web-based software program. The program will be installed on a computer at a family's home by a research assistant. Parents and adolescents will be actively involved, and during the installation session, adolescents will complete several practice trials. The 25 sessions will be completed individually by the adolescent with parental supervision. For the first 5 sessions, the participant trains on the same set of games; on the 6th session and every 5th session thereafter, a new task is introduced and replaces one of the initial tasks. At the end of each session, the adolescent can play an age-appropriate computerized game as a reward. After each session, results are uploaded by parents to a secure website, to keep track of the participant's progress. Families will be contacted weekly to check program function and discuss concerns.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children’s Hospital	The Children's Heart Foundation, Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).	Post-treatment assessment (up to 2 weeks after the cessation of the intervention)