Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
NCT ID: NCT05312177
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
273 participants
OBSERVATIONAL
2022-05-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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)
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.
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.
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.
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.
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).
Social Communication Questionnaire, Current Form
The SCQ is a parent-report measure of social communication, social interactions, play, and behavior.
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.
Repetitive Behavior Scale, Revised
The RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors.
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)
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.
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.
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.
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.
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).
Social Communication Questionnaire, Current Form
The SCQ is a parent-report measure of social communication, social interactions, play, and behavior.
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.
Repetitive Behavior Scale, Revised
The RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors.
Interventions
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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.
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.
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.
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.
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).
Social Communication Questionnaire, Current Form
The SCQ is a parent-report measure of social communication, social interactions, play, and behavior.
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.
Repetitive Behavior Scale, Revised
The RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
\- 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.
60 Months
155 Months
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Institutes of Health (NIH)
NIH
Carelon Research
OTHER
Responsible Party
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Principal Investigators
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Maria VanRompay, PhD
Role: PRINCIPAL_INVESTIGATOR
Carelon Research
Locations
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Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
Riley Children's Hospital
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Health System/Mott Hospital
Ann Arbor, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Columbia College of Physicians and Surgeons
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CHILD-DS
Identifier Type: -
Identifier Source: org_study_id
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