Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
A legfontosabb adatok
- Ki végzi
- Carelon Research
- Hol
- Ann Arbor, Atlanta, Boston, Charleston, Cincinnati, Houston, Indianapolis, Kansas City, New York, Philadelphia, Salt Lake City, Washington D.C. és Wilmington (Egyesült Államok)Mind a 13 helyszín megnézéseMég 1 másik országban, 1 helyszínen
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 273 fő vett részt
- Kezdés
- 2022. máj. 1.
- Befejezés
- 2023. dec. 31.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A vizsgált kezelések
- 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
- A regiszteradat frissítve
- 2024. január 11.
Ki vehet részt
- Életkor
- 60 hónap – 155 hónap
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Helyszínek itt: Egyesült Államok
Még 1 másik országban, 1 helyszínen
- University of Michigan Health System/Mott HospitalAnn Arbor, Egyesült ÁllamokNo longer taking part
- Children's Healthcare of Atlanta at EglestonAtlanta, Egyesült ÁllamokNo longer taking part
- Boston Children's HospitalBoston, Egyesült ÁllamokNo longer taking part
- Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, Egyesült ÁllamokNo longer taking part
- Baylor College of Medicine/ Texas Children's HospitalHouston, Egyesült ÁllamokNo longer taking part
- Riley Children's HospitalIndianapolis, Egyesült ÁllamokNo longer taking part
- Children's Mercy HospitalKansas City, Egyesült ÁllamokNo longer taking part
- Columbia College of Physicians and SurgeonsNew York, Egyesült ÁllamokNo longer taking part
- Children's Hospital of PhiladelphiaPhiladelphia, Egyesült ÁllamokNo longer taking part
- Primary Children's HospitalSalt Lake City, Egyesült ÁllamokNo longer taking part
- Children's National HospitalWashington D.C., Egyesült ÁllamokNo longer taking part
- Alfred I duPont Hospital for ChildrenWilmington, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- 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)
Kezelés: 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 és 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)
Kezelés: 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 és Repetitive Behavior Scale, Revised
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2024. január 11.