Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
Key facts
- Who runs it
- Carelon Research
- Where
- Ann Arbor, Atlanta, Boston, Charleston, Cincinnati, Houston, Indianapolis, Kansas City, New York, Philadelphia, Salt Lake City, Washington D.C., and Wilmington, United StatesSee the 13 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Completed
- People taking part
- 273 people enrolled
- Started
- 1 May 2022
- Ended
- 31 Dec 2023
- Type of study
- Observational, 2 groups
- Treatments tested
- Stanford Binet Intelligence Scales, Fifth Edition
- Vineland Adaptive Behavior Scales Third Edition
- Peabody Picture Vocabulary Test, Fifth Edition
- Expressive Vocabulary Test, Third Edition
- Leiter International Performance Scale, Third Edition
- Social Communication Questionnaire, Current Form
- Aberrant Behavior Checklist
- Repetitive Behavior Scale, Revised
- Record updated
- 11 January 2024
Who can take part
- Age
- 60 months to 155 months
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Mosaic DS; Down Syndrome CAVSD Repair Group only - Did not have CAVSD repair in the first year of life; Down Syndrome Comparison Group only
- Both Groups
Where in United States
Also in 1 other country, 1 site
- University of Michigan Health System/Mott HospitalAnn Arbor, United StatesNo longer taking part
- Children's Healthcare of Atlanta at EglestonAtlanta, United StatesNo longer taking part
- Boston Children's HospitalBoston, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesNo longer taking part
- Baylor College of Medicine/ Texas Children's HospitalHouston, United StatesNo longer taking part
- Riley Children's HospitalIndianapolis, United StatesNo longer taking part
- Children's Mercy HospitalKansas City, United StatesNo longer taking part
- Columbia College of Physicians and SurgeonsNew York, United StatesNo longer taking part
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesNo longer taking part
- Primary Children's HospitalSalt Lake City, United StatesNo longer taking part
- Children's National HospitalWashington D.C., United StatesNo longer taking part
- Alfred I duPont Hospital for ChildrenWilmington, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 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)
Treatment: Stanford Binet Intelligence Scales, Fifth Edition, Vineland Adaptive Behavior Scales Third Edition, Peabody Picture Vocabulary Test, Fifth Edition, Expressive Vocabulary Test, Third Edition, Leiter International Performance Scale, Third Edition, Social Communication Questionnaire, Current Form, Aberrant Behavior Checklist, and Repetitive Behavior Scale, Revised
- 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)
Treatment: Stanford Binet Intelligence Scales, Fifth Edition, Vineland Adaptive Behavior Scales Third Edition, Peabody Picture Vocabulary Test, Fifth Edition, Expressive Vocabulary Test, Third Edition, Leiter International Performance Scale, Third Edition, Social Communication Questionnaire, Current Form, Aberrant Behavior Checklist, and Repetitive Behavior Scale, Revised
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 11 January 2024