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Improving Neurodevelopment in Adolescents With Congenital Heart Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Jane W. Newburger, Boston Children's Hospital
Sponsor:
Collaborators:
Thrasher Research Fund
The Children's Heart Foundation
Information provided by (Responsible Party):
Jane W. Newburger, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT02759263
First received: April 22, 2016
Last updated: February 24, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Congenital Heart Disease Neurodevelopment Executive Function Working Memory Training Infant Open-heart Surgery Behavioral: Cogmed Working Memory Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Other
Official Title: Pilot Study of Executive Function Intervention to Improve Neurodevelopmental Outcomes in Adolescents With CHD

Resource links provided by NLM:


Further study details as provided by Jane W. Newburger, Boston Children's Hospital:

Primary Outcome Measures:
  • 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). [ Time Frame: Post-treatment assessment (up to 2 weeks after the 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).


Estimated Enrollment: 60
Study Start Date: June 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Working Memory Intervention
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.
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.
No Intervention: Control group - Standard of Care
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).

  Eligibility

Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of cyanotic 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02759263

Contacts
Contact: Johanna Calderon, PhD 8572185063 johanna.calderon@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Johanna Calderon, PhD    857-218-5063    johanna.calderon@childrens.harvard.edu   
Sub-Investigator: Johanna Calderon, PhD         
Sponsors and Collaborators
Boston Children’s Hospital
Thrasher Research Fund
The Children's Heart Foundation
Investigators
Principal Investigator: Jane W Newburger, MD Boston Children’s Hospital
  More Information

Responsible Party: Jane W. Newburger, MD, Commonwealth Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02759263     History of Changes
Other Study ID Numbers: IRB-P00022266
Study First Received: April 22, 2016
Last Updated: February 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 21, 2017