Improving Neurodevelopment in Adolescents With Congenital Heart Disease

NCT ID: NCT02759263

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-10-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cogmed Working Memory Training

Intervention Type: BEHAVIORAL

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

The Children's Heart Foundation

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jane W. Newburger

MD, Commonwealth Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane W Newburger, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Calderon J, Wypij D, Rofeberg V, Stopp C, Roseman A, Albers D, Newburger JW, Bellinger DC. Randomized Controlled Trial of Working Memory Intervention in Congenital Heart Disease. J Pediatr. 2020 Dec;227:191-198.e3. doi: 10.1016/j.jpeds.2020.08.038. Epub 2020 Aug 19.

Reference Type: DERIVED

PMID: 32827526 (View on PubMed)

Other Identifiers

IRB-P00022266

Identifier Type: -

Identifier Source: org_study_id