(Completed Recruiting)

About This Study

Congenital Heart disease: Impact on Learning and Development in Down Syndrome (CHILD-DS) - The purpose of this study is to learn whether having congenital heart disease and infant heart surgery affects the way children with Down syndrome develop and learn.

Study Locations

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Study Details

Down syndrome (DS) occurs in roughly 1 out of 700 births in the U.S. Half of all children with Down syndrome have congenital heart disease (CHD), often requiring corrective heart surgery. Even though CHD in children without DS is known to be associated with developmental problems, few studies have explored how CHD can affect the development and behavior of children with DS.

In this research study, we want to learn whether having CHD and infant heart surgery affects the way children with DS develop and learn. We would like to compare children with DS who have had CHD and infant heart surgery to children with DS who do not have major CHD and did not require infant heart surgery. This information may help us provide better ways to meet the needs of children with DS and improve their development.

Children between the ages of 5 and 8 years with Down syndrome who either:

  • had a complete atrioventricular septal defect (CAVSD) repair in their first year of life
  • do not have major Congenital Heart Disease


The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form to enter the study.

After you have signed the informed consent form we will:

Complete a Medical History and Services intake form: A member of the research team will review your child’s health information and ask you questions about your child’s medical history, development, and services and supports for your child.

Complete Neurodevelopmental (ND) and Behavioral Assessments: You and your child will be assessed by a member of the study staff who is trained to do ND and behavioral assessments in children with DS. It will take about 2-3 hours for each of you to complete these assessments, but you may be able to complete some of your assessments remotely from home.

Your child’s assessments look at things like:

  • Your child’s language development
  • Your child’s thinking and reasoning skills, which include:
  • Your child’s working memory
  • Your child’s verbal problem solving
  • Your child’s nonverbal problem solving

Your assessments will look at things like:

  • Your child’s behavior and emotions
  • Your child’s daily living skills
  • Your child’s personal and social skills

You will be provided with the results of your child’s ND/behavioral assessments. A brief research summary of the test results will be sent to you. You can reach out to your child’s study team if you need additional information to understand the results of your child’s ND/behavioral assessments.

You and your child will complete one study visit, lasting 2-3 hours.

When we finish the study, we hope to know more about how to improve the care of children with DS, whether or not they had infant heart surgery.

The questionnaires and assessments you complete will be reviewed by a professional. We will also share a report with you showing your child’s results from the ND and behavioral assessments sometime after you and your child have completed the study visit. If there are any clinical concerns that arise from your research visit, you will be referred for a clinical evaluation.

We cannot promise any direct benefits to your child or others from you being in this study.

The possible risks of participating in this study include:

  • Feeling uncomfortable or remembering upsetting situations when answering the study questions
  • Loss of confidentiality
  • Genetic testing/analysis

We will tell you about any new information that may affect your or your child’s health, welfare, or choice to stay in the research.

There will be no extra costs to you if your child is in the study. Your insurance will not be billed for any research-only activities. If referrals are made based on answers to the questionnaires or the results of ND/behavioral assessments, you/your child’s insurance will be responsible for those costs.