Family Management of Sleep Problems in Families of Children with Down Syndrome (over 12 months to 24 months)

Consent Form

The purpose of this research study is to learn about sleep habits in children with Down syndrome and how sleep problems are managed by families. We are interested in understanding the relationship between sleep habits and quality of life in families of children with Down syndrome. We are also interested in identifying factors that influence the ability of families of children with Down syndrome to manage sleep problems.

You are being asked to take part in this research study because you have a child with Down syndrome. To participate in this study, your child with Down syndrome must be between 6 months to 72 months (6 years) of age. In addition, you must be at least 18 years old and be able to understand and speak English. Being in a research study is completely voluntary. You can choose not to be in this research study. You can also say yes now and change your mind later.

If you agree to take part in this research, you will be asked to complete a survey (either online or hard copy) that takes between 20-30 minutes to complete. If you choose to complete a hard copy of the survey, you will be asked to return the survey in the pre-addressed, pre-stamped envelope that we will send you when we send you a hard copy of the survey. We expect that 80 parents will complete the survey (40 parents of children with Down syndrome who are 6-24 months of age and 40 parents of children with Down syndrome who are 24-72 months).

At the end of the survey you will be asked if you would be willing to be interviewed, as well as complete a sleep diary on yourself and your child with Down syndrome and have the sleep habits of your child with Down syndrome assessed overnight. The interview will take less than an hour to complete. Only 10-15 families who express interest in participating in the additional parts of this research study (interview, sleep diaries, and overnight measurement of sleep) will be asked to participate. The decision to ask parents to participate in the additional parts of the study will be based on factors such as age of the child with Down syndrome and existence of sleep problems.

The possible risks to you, if you choose to complete the survey for this research are:

-Emotional distress or sadness: If in the process of answering the questions on this survey, you become concerned about your child's health or well-being, please contact your child's health care provider or emergency services. If you become upset or concerned about your own well-being while answering these questions, please contact your health care provider or emergency services

-Breach of confidentiality: There is a small risk that there may be a breach of confidentiality since we will be collecting your name, phone number and email or home address. However, we believe the consequences of a breach of confidentiality are minimal because of the nature of the information we are collecting from you (information about your sleep habits and the sleep habits of your child with Down syndrome, family management of sleep issues and quality of life.

If you agree to be one of the 10-15 parents who agree to interviewed, complete sleep diaries and have your child’s sleep assessed using overnight sleep measures possible risks to you and your child with Down syndrome are:

- Emotional distress or sadness: If you become distressed or sad during the interview, you will be given the opportunity to stop the interview /or reschedule it. In addition, we will talk with you about who you get emotional support from, encourage you to speak with your health care provider and assist you in finding healthcare if requested.

-Physical distress: Around 1 in 100 children get a mild rash from wearing the actigraph band we will be using to assess your child’s sleep at night. You will be advised that if you notice a mild rash under the sensor, you can remove the sensor and notify us. Removal of the band should result in a quick recovery from the rash (within 24 hours). If the rash spreads beyond the placement of the sensor or is combined with significant swelling, you will be advised to contact your primary care physician and contact us.

The possible benefits to you for taking part in this research are:
-Research is designed to benefit society by gaining new knowledge. You may not benefit personally from being in this research study. However, you may benefit from the knowledge that you are helping researchers gain a better understanding of what it is like for families following the birth of a child with Down syndrome.

To protect your identity as a research subject, we will give your answers to the survey a unique ID number and your answers will be kept on a password protected computer. The file linking your name, ID number, and contact information will be kept separate from your answers to the survey in a locked file cabinet in the office of Dr Van Riper (the principal investigator of this study.

If you have any questions about this research, please contact the Investigator named at the top of this form by calling 919-966-4284 or emailing vanriper@email.unc.edu. If you have questions or concerns about your rights as a research subject, you may contact the UNC Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu.

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* 1. If you agree with the following statements, type your name, your phone number and your email or your address in the boxes below - this will make it possible for us to send you a gift card to thank you for participating in our study. Please try to answer all the survey questions - your answers are important to us.
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I have been provided with information about the study and given the opportunity to ask questions (by email or in-person). I willingly agree to participate in this research study.

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