Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)

CompletedOBSERVATIONAL
Enrollment

273

Participants

Timeline

Start Date

May 1, 2022

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Down SyndromeCongenital Heart Disease
Interventions
OTHER

Stanford Binet Intelligence Scales, Fifth Edition

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.

OTHER

Vineland Adaptive Behavior Scales Third Edition

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.

OTHER

Peabody Picture Vocabulary Test, Fifth Edition

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.

OTHER

Expressive Vocabulary Test, Third Edition

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.

OTHER

Leiter International Performance Scale, Third Edition

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).

OTHER

Social Communication Questionnaire, Current Form

The SCQ is a parent-report measure of social communication, social interactions, play, and behavior.

OTHER

Aberrant Behavior Checklist

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.

OTHER

Repetitive Behavior Scale, Revised

The RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors.

Trial Locations (14)

10032

Columbia College of Physicians and Surgeons, New York

19104

Children's Hospital of Philadelphia, Philadelphia

19899

Alfred I. duPont Hospital for Children, Wilmington

20010

Children's National Hospital, Washington D.C.

29425

Medical University of South Carolina, Charleston

30033

Children's Healthcare of Atlanta at Egleston, Atlanta

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Children's Hospital, Indianapolis

48109

University of Michigan Health System/Mott Hospital, Ann Arbor

64108

Children's Mercy Hospital, Kansas City

77030

Baylor College of Medicine - Texas Children's Hospital, Houston

84132

Primary Children's Hospital, Salt Lake City

02111

Boston Children's Hospital, Boston

M5G 1X8

Hospital for Sick Children, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Carelon Research

OTHER

NCT05312177 - Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS) | Biotech Hunter | Biotech Hunter