Introduction

Thank you for your interest in our study, “Social Determinants of Health-Related Quality of Life and Family Adaptation in Families of Children with Congenital Heart Disease, Families of Children with Down Syndrome and Families of Children with Both Congenital Heart Disease and Down Syndrome." The purpose of the study is to examine how social determinants of health (e.g. economic stability, education, health and health care, and where you live) influence child and caregiver health-related quality of life and family adaptation in three groups of families: 1) families of children with Congenital Heart Disease, (2) families of children with Down syndrome and (3) families of children with Congenital Heart Disease and Down syndrome.

Participation in the study includes completing a survey (either online or a paper copy).  In the survey, you will be asked questions about you and your child's quality of life and family adaptation, you will also be asked demographic questions about you and your child, the health care your family receives and where you live (your neighborhood and larger community). In the survey the phrase "your child" refers to your child with Congenital Heart Disease, Down syndrome or both Congenital Heart Disease and Down syndrome.

We are interested in hearing from both mothers and fathers, so if you have a spouse or partner, please ask them to consider participating too.

The questionnaires should take approximately 30-40 minutes to complete. Please answer all the questions based on what you think, not on how you think others might respond. Research studies are designed to obtain new knowledge. There is little chance you or your child will benefit from being in this research study. However, your participation in the study is likely to help researchers gain a better understanding of factors that influence health-related quality of life and adaptation in families living with Congenital Heart Disease, Down syndrome and both conditions. One possible risk to participating in this study is emotional distress. If while completing the survey you become upset about your well-being or that of your child, we encourage you to contact your health care provider or emergency services. There is a small risk of breach of confidentiality. However, our research team has put in place safeguards and data-protection practices to reduce the chance of this happening.

The project has been reviewed by the institutional review board for human subjects research at the University of North Carolina at Chapel Hill and was granted an exemption. Participation in the study is voluntary. All the information you give will be kept confidential. No one except our research team will have access to your information. If you have questions or concerns about the study, please email Dr. Marcia Van Riper (vanriper@email.unc.edu)

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