1. Study Title: Relationships between Parental Anxiety, Parental Bedtime & Nighttime Behaviours, and Infant Sleep
Principal Investigator: Dr. Robyn Stremler Robyn.stremler@utoronto.ca Tel #: 416-978-6925
Co-investigator: Dr. Jordana McMurray jordana.mcmurray@utoronto.ca Tel #: 416-899-9465
Co-investigator: Dr. Kristin Cleverley K.cleverley@utoronto.ca Tel #: 416-946-8676
Study Team/Research Contact:
Jordana McMurray, RN, MN, PhD
jordana.mcmurray@utoronto.ca
Study Sponsor and/or Funder:
Study Sponsor: The University of Toronto
Study Funder: This project is supported by a non-funded research grant from Nanit (UdiSense, Inc.) and the Sleep Research Society.
Conflict of Interest:
There are no conflicts of interest to declare related to this study.
Introduction
Throughout this form, “we/our” represents the University of Toronto researchers. You are being invited to take part in our research study. This consent form describes the study and what it means to participate. If there is anything in this form that you do not understand, please contact Jordana McMurray (jordana.mcmurray@utoronto.ca) to explain and/or clarify. You should take as much time as you need to think about your decision to participate or not, and to ask any questions that you may have. If it is helpful to you, you are encouraged to discuss the study with family, friends, or any other members of your community that you trust.
All participation in a research study is voluntary, and you are not under any obligation to participate.
Why am I being asked to participate?
You are being invited to participate in this study because you are a Nanit user, who has one baby between 4- and 6-months old and your baby does not have a serious health condition that could affect sleep (e.g. heart defect, facial or skull difference, metabolic disorder).
Why is this study being done?
This research study is being done to find out how parents’ anxiety and the way they help their baby fall asleep and settle during the night may affect their baby’s sleep. This is important because the results of this study could help to improve infant sleep, parents’ mental health, and overall family well-being during the early stages of parenting.
How long will the study take?
Taking part in this study will take about 15-20 minutes. This includes completing an online questionnaire and agreeing to share 14 days of your baby’s sleep data from your Nanit baby monitor. The entire study, including all the participants involved, should take about 1 month to complete, and the complete results should be known in about 4 months.
How many participants will be in this study?
This study is being conducted by researchers at the University of Toronto in Canada. We are recruiting study participants from the network of Nanit users. A total of 500 parents and their babies are expected to take part in this study.
What will happen in this research study?
All of the activities of this study will be done online and will involve the following:
- Completing an online questionnaire: This will take about 15-20 minutes to complete and will ask you about your baby’s sleep, your sleep, how often you are bothered by symptoms of anxiety and depression, and information about your demographics (e.g., age, sex, race/ethnicity, marital status, level of education, socioeconomic status)
- Agreeing to share 14 days of your baby’s sleep data: If you agree, Nanit will share numerical sleep data from your Nanit baby monitor with the researchers who are conducting this study at the University of Toronto, in Canada. The sleep data shared will be numerical (numbers only) and will not include any video/audio files, names, or any information that could identify you or your baby. The sleep data shared will include the amount of time your baby was asleep each night, how long it took for your baby to fall asleep each night, the longest stretch of continuous sleep your baby had each night, the amount of time your baby was awake each night, and how many times you (or another parent/caregiver) needed to help your baby fall back asleep each night.
What are the risks, harms or discomforts of the study?
While completing the online questionnaire, you may experience some emotional concerns. You can skip questions, take a break, or stop answering at any time. There is an inconvenience of time. The online questionnaire will take about 15-20 minutes to complete.
Despite protections being in place, there is a risk of unintentional release of information. Even though the risk of identifying you from the study data is very small, it can never be completely eliminated.
Are there benefits from being in the study?
While participation will not result in direct personal benefit, study results could help improve ways to support infant sleep, parents’ mental health, and overall family well-being during the early stages of parenting.
What are my responsibilities in this study?
If you choose to participate in this study, you will be expected to:
- Complete the online questionnaire
- Share 14 days of your baby’s sleep data from the Nanit system
Can I choose to leave the study?
It is your choice to take part in this study, and participation is voluntary. You can change your mind at any time during the research study. Withdrawal from the study will not have any effect on you. If you decide to leave the study, you can contact a member of the Nanit Clinical Research department (shambhavi.thakur@nanit.com) to let them know.
Can I withdraw my research data from the research study?
If you no longer want your study information to be used in this research, you can request your data to be withdrawn and destroyed by contacting the Nanit Clinical Research department at shambhavi.thakur@nanit.com. Please note that any study data that has already been de-identified and shared with University of Toronto researchers for data analysis cannot be withdrawn.
Will it cost me anything to be in this study?
You do not have to pay anything to participate in this research study.
Will I be paid and/or reimbursed if I join this study?
You will not receive any payment for taking part in this study; however, your participation may help researchers learn things that could benefit others.
What personal health information will be collected about me as part of this study?
Personal health information (PHI) is any information that is collected about you, your baby, and your health. PHI also includes any information collected from/about you during the study. If you decide to participate in this study, we will collect personal health information about you. This includes things learned from your answers on the questionnaire, and from your baby’s sleep data, shared from the Nanit system. We will only collect the information needed for this study. Studies involving humans sometimes collect information on race and ethnicity, sex and gender, as well as other characteristics of individuals. Providing information on your individual characteristics is voluntary.
How will my privacy be protected?
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. We will respect your privacy. The University of Toronto is also committed to respecting your privacy. No information about you will be given to anyone or be published without your permission, unless the law requires us to do this. Information, collected by Nanit and shared with the University of Toronto will be “de-identified” meaning that all of the identifying information will be removed and replaced with a unique number. This means that the researchers at the University of Toronto will not be able to tell who the information belongs to and will not be able to trace any information back to you personally. Researchers at the University of Toronto will keep de-identified study data in a secure and confidential location for 7 years as per University of Toronto policy, and then it will be destroyed according to the University of Toronto’s policy.
Communication via e-mail is not absolutely secure. We do not recommend that you communicate sensitive personal information via e-mail.
When the results of this study are published, your identity will not be disclosed. You have the right to be informed of the results of this study once the entire study is complete.
Will I receive study results?
Research results will be shared through journal publications, academic conferences, and shared with the Nanit network, parent communities, and advocacy groups. When the results of this study are shared, your identity will not be disclosed.
What are my rights when participating in a research study?
You have the right to receive all information that could help you make a decision about participating in this study. You also have the right to ask questions about this study at any time and to have them answered to your satisfaction. Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected.
By providing consent to participate in this study, you do not give up any of your legal rights against the study’s principal investigator or the University of Toronto for compensation, nor does this form relieve the study’s principal investigator, the University of Toronto or their agents of their legal and professional responsibilities.
Who can I contact if I have questions about the study?
If you have any questions during your participation in this research study, you can contact Jordana McMurray at jordana.mcmurray@utoronto.ca OR any research team member listed at the beginning of this consent form.
Research Ethics Board Contact Information
The study protocol and consent form have been reviewed by the University of Toronto Research Ethics Board (REB). If you have any questions regarding your rights as a research participant, you may contact the Research Oversight and Compliance Office – Human Research Ethics Program at ethics.review@utoronto.ca or 416-946-3273 during business hours.
Consent to Participate in a Research Study
Study Title: Relationships between Parental Anxiety, Parental Bedtime & Nighttime Behaviours, and Infant Sleep
By providing consent, I understand and confirm that:
- I am a Nanit user who has one baby who is between 4 and 6 months old.
- My baby does not have a serious health condition that could affect sleep (e.g. heart defect, facial or skull difference, metabolic disorder, etc.).
- I understand the information presented in this informed consent form.
- I allow access to my personal health information and my baby’s personal health information as explained in this consent form.
- I do not give up any of my legal rights by providing consent.
- I understand I am free to withdraw participation in the study without having to give a reason, and that doing so will not affect me now or in the future.
- I understand that if I choose to withdraw, my data will be removed from the study unless it has already been de-identified and shared for analysis purposes.
- I understand that I am agreeing to share my de-identified questionnaire data and 14 days of my baby’s de-identified sleep data from the Nanit system with researchers at the University of Toronto in Canada.
I consent to participate in this study: