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

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.

Conditions

• Down Syndrome
• Congenital 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Carelon Research

  lead OTHER

Principal Investigators

• Maria VanRompay, PhD · Carelon Research

Eligibility

Min Age

60 Months

Max Age

155 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• United States
• Canada

Study Locations