Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
CHILD-DS
2 other identifiers
observational
273
2 countries
14
Brief Summary
The study objective is to compare neurodevelopmental (ND) and behavioral outcomes between children with Down syndrome (DS) who had complete atrioventricular septal defect (CAVSD) repair and children from the same clinical sites with DS without major congenital heart disease (CHD) requiring previous or planned CHD surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 11, 2024
October 1, 2023
1.7 years
February 24, 2020
January 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Neurodevelopmental outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
Verbal and non-verbal ratio intelligent quotients (IQs) derived from the Stanford Binet Intelligence Scales will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
1 day
Behavioral outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
Adaptive composite scores from the Vineland Adaptive Behavior Scales will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
1 day
Language abilities compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Using the Peabody Picture Vocabulary Test, Expressive Vocabulary Test, and Leiter International Performance Scale total language, auditory comprehension, and expressive communication will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
1 day
Emotional outcomes compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Using the Repetitive Behavior Scale and Aberrant Behavior Checklist , behavioral and emotional problems will be compared will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
1 day
Social Communication compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Using the Social Communication Questionnaire, social communication, social interactions, play and behavior will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
1 day
Secondary Outcomes (2)
Comorbidities as predictors of neurodevelopment and behavior
1 day
Sociodemographic factors as predictors of neurodevelopment and behavior
1 day
Study Arms (2)
DS with CAVSD Repair
Children ages 5 through 12 years with Down syndrome who had Complete atrioventricular septal defect (CAVSD) repair in the first year of life and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R)
DS without major CHD
Children ages 5 through 12 years with Down syndrome without major Congenital Heart Disease(CHD) and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R)
Interventions
The SB-5 is a comprehensive measure of cognitive and intellectual functioning for individuals from age two through 85 years of age. The SB-5 individually assess a child's functioning in five areas of cognitive functioning: Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual Spatial, and Working Memory. The SB-5 is well established in the existing research literature as an assessment tool to evaluate developmental and intellectual abilities in children with ND disorders.
The VABS-3 are a parent report, interview style measure of adaptive behavior for individuals ages birth through 90 months. The VABS-3 assesses adaptive behavior in four broad domains of Communication, Daily Living Skills, Socialization, and Motor Skills, and includes a Maladaptive Behavior Domain that assesses problem behaviors.
The PPVT-5 is a norm-referenced language measure that evaluates single-word receptive vocabulary. The PPVT-5 provides standard scores for individuals ages 2.6 through 90 years.
The EVT-3 is a norm-referenced language measure that evaluates single-word expressive vocabulary. The EVT-3 provides standard scores for individuals ages 2.6 through 90 years.
The Leiter-3 is a nonverbal measure of cognitive functioning and fluid reasoning skills in individuals ages 3 through 75 years. The Leiter-3 measures nonverbal IQ across four subscales, including Sequential Order (SO), Form Completion (FC), Classification and Analogies (CA), and Figure Ground (FG).
The SCQ is a parent-report measure of social communication, social interactions, play, and behavior.
The ABC-2 is a parent report measure of problematic behavior at home and in the community. It measures behavior on five subscales (1) Irritability, (2) Social Withdrawal, (3) Stereotypic Behavior, (4) Hyperactivity/Noncompliance, and (5) Inappropriate Speech.
The RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors.
Eligibility Criteria
PHN RLS Study participants with DS and CAVSD repair from the PHN sites are eligible to participate in this study. Children with a diagnosis of mosaic DS will be excluded, as these forms of DS show different ND trajectories and are usually excluded. While data on mosaic DS were not collected in the RLS Study, we anticipate few if any to have this diagnosis. The DS comparison group will be required to have no major CHD, defined as CHD that requires CHD surgery (a) in the period between birth and recruitment into the CHILD-DS Study or (b) planned for a future date.
You may qualify if:
- Down Syndrome CAVSD Repair Group:
- Trisomy 21
- Male or Female, ages 5 years through 12 years
- Had CAVSD repair within the first year of life
- Parent or guardian and patient willing to comply with protocol and complete all study assessments; parent or guardian willing to provide written informed consent
- Child able to speak and understand English
- Down Syndrome Comparison Group
- Trisomy 21
- Male or Female, age 5 years through 12 years
- No major CHD, defined as CHD requiring previous or planned CHD surgery
- Parent or guardian and patient willing to comply with protocol and complete all study assessments; parent or guardian willing to provide written informed consent
- Child able to speak and understand English
You may not qualify if:
- Both Groups
- \- Mosaic DS
- Down Syndrome CAVSD Repair Group only - Did not have CAVSD repair in the first year of life
- Down Syndrome Comparison Group only
- \- Major CHD requiring previous or planned CHD surgery - i.e., CHD surgery occurring (a) in the period between birth and time of recruitment into the CHILD-DS Study, or (b) planned for a future date.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carelon Researchlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (14)
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19899, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30033, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Boston Children's Hospital
Boston, Massachusetts, 02111, United States
University of Michigan Health System/Mott Hospital
Ann Arbor, Michigan, 48109, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Columbia College of Physicians and Surgeons
New York, New York, 10032, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84132, United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Biospecimen
We aim to collect saliva samples from study participants during the single study visit at the PHN site, which will be preserved and processed by the PHN Biorepository for DNA storage for future targeted research studies.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria VanRompay, PhD
Carelon Research
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2020
First Posted
April 5, 2022
Study Start
May 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 11, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data is available one year after study closeout and is available indefinitely.
- Access Criteria
- log-in and password
Public Use Datasets are created after study closeout and are made available on the PHN public website. Annotated study data collection forms, Statistical Analysis Program (SAS) datasets, and excel datasets are made available, as well as de-identified study cohort characteristics.