Principal Investigator: Dr. Justine Dol, Postdoctoral Fellow, IWK Health, Justine.dol@iwk.nshealth.ca

Co-Investigators:
Dr. Melissa Brooks, Dalhousie University
Dr. Cindy-Lee Dennis, University of Toronto
Dr. Christine Chambers, Dalhousie University
Dr. Jennifer Parker, IWK Health
Dr. Dan Seguin, Mount Saint Vincent University
Dr. Jennifer Goldberg, McMaster University
Funding: IWK Health Project Grant
Ethics: IWK Health REB#71196, Version 3, May 21, 2025
Clinical Trial #: 1031429

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Introduction
We invite you to take part in a research study led by Dr. Justine Dol. This letter explains the study and the process of informed consent. Choosing whether to take part in this research is entirely your choice. There will be no impact on you if you decide not to participate in the research. The information below tells you about what is involved in the research and what you will be asked to do. It also provides details about any benefit, risk, inconvenience or discomfort that you might experience. If you decide to participate in this research, you can change your mind at any time and withdraw from the study with no impact. If you have questions, please contact the lead researcher.

Why are the researchers doing the study?
The purpose of this study is to determine the effectiveness of Essential Coaching Postpartum on birthing parents and non-birthing parents' parenting confidence and mental health. Essential Coaching Postpartum is a text message program that provides first time parents with information about caring for themselves and their babies from birth to six-weeks after birth. All text messages have been developed and tested with parents and postpartum healthcare providers in Nova Scotia. Messages are consistent with the Loving Care books created by Nova Scotia's Department of Health and Wellness.

Up to four patient partners, including birthing parents and non-birthing parents, are involved in this research. Patient partnership is when researchers work together with patients (people who have lived experience of a health condition) to carry out a research study. The patient partners involved in this study will not have access to your personal information or be in direct contact with you. Instead, they will use their expertise to impact the research questions, how this research is being done, and how the study results are shared with others.

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Who Can Take Part in the Research Study?
If you are the birthing parent, you are eligible if you are: (1) early postpartum (< 7 days) with your first child; (2)
understand English; (3) have a cell phone with text and data; and (4) live in Nova Scotia.

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If you are the non-birthing parent, you are eligible if you (1) early postpartum (< 7 days) with their first child
(through birth, adoption, or surrogacy); (2) understand English; (3) have a cell phone with text and data; and (4) live in Nova Scotia.

You will not be eligible if you: (1) have a newborn die or are expected to die prior to leaving the hospital; (2) have no access to mobile phone, either personal or shared; (3) are unwilling to receive text messages; (4) decline or withdraw to participate; or (5) participated in a previous version of this project (e.g., either the development or evaluation). Both caregivers are not required to participate, however, participation of the other parent, if applicable, is encouraged. You also are not required to have given birth at IWK Health to be involved, as long as you gave birth in Nova Scotia.

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What Will I Be Asked to Do?
If you want to participate, you will be randomly placed (like flipping a coin) into one of two groups. One group will receive messages from Essential Coaching Postpartum and the other will be a control group. The intervention group will receive a daily text message in the morning (10am) and evening (5pm) for the first three weeks, followed by a daily text message at 10am for the following three weeks. All messages will be sent within six-weeks after your baby was born. The control group will not receive any study messages during the six-week period. Your group assignment will not impact your care provided in the hospital or in the community during the postpartum period. Your participation in this study does not require any in-person visits to IWK Health and you are allowed to access any postpartum care that you would normally.

Both groups will be asked to complete a baseline survey upon enrollment and a follow-up survey at 6 weeks and 6 months postpartum. The surveys will be sent to you in a link by text message and can be completed online whenever is convenient for you. The survey should take approximately 20 minutes for baseline and 6-month follow-up and 30 minutes for the six-week follow-up. You may choose not to answer any questions or stop the survey at any time.

The surveys at each timepoint are similar. You will be asked questions about yourself and your baby, such as demographics and your birthing experience. You will also complete standardized questionnaires to help us understand your confidence in caring for your baby and your mental health. For participants in the intervention group, you will also be asked to provide feedback on the messages during the six-week follow-up survey.

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What are the burdens, harms, or potential harms?
You may or may not benefit directly from participating in this study, even if you are assigned to the intervention group. If you become upset during the survey, you can take a break from the survey, decide not to answer specific questions, or stop the survey completely. At the end of the survey, local resources where you can seek support are provided, if needed.

Please be aware that these text messages will not replace the need to visit a healthcare provider if you have a concern about yourself or your newborn. The system will not be able to respond to any emergency (i.e., the messages are only outgoing and will not be responded to). You should seek professional help in person if you need it. Please contact your public health nurse, family doctor, or emergency rooms as appropriate.

While you will not be required to pay to receive any of the text messages, you may incur charges to respond to the eligibility screening questionnaires, depending on your cell phone package. You will also be responsible for any expenses related to using data if any of the links provided are clicked on.

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What are the potential benefits?
Participating in the study might benefit you personally by increasing your knowledge about caring for yourself and your baby in the first 6-weeks postpartum. It will also help us learn things that will benefit others and improve postnatal care in Halifax.

What will I receive for taking part?
To thank you for your time, you will receive a $5 e-gift card upon completion of each survey. If you complete all​​ surveys, you will be entered into a draw for a $250 e-gift card. A total of 4 draws will be held - one for the birthing parents in the control group, one for the birthing parents in the intervention group, one for the non-birthing parents in the control group, and one for the non-birthing parents in the intervention group.

How will my information be protected?
Only Dr. Justine Dol and the research team working on this study will have access to your data. Confidentiality will be maintained through using a code instead of your name on all files. Any names or identifying information will be removed on survey data and your name will not be used in any reports or publications. Data will be shared with the research team through secure electronic files that are password protected, if necessary. In the survey, data will be collected about your demographics (e.g., age, number of children) and your child's birth (e.g., date of birth, delivery method).

Your name, phone number, your partners phone number (if applicable), child's name and child's date of birth will be disclosed as part of this study to TextIt and stored with Amazon Web Services in the United States for the purpose of transmitting the SMS messages in this study. After the study has ended your contact information will be deleted. See the European Union General Data Protection Regulation for more information on TextIt's and AWS' privacy practices. Please be aware that once your identified data are sent outside of Canada, they may be accessed by regulatory authorities in other countries who may not have the same privacy laws as we do.

 

Please note that, in the rare event that we should learn anything during the course of your participation in our study that would cause us to believe that you or your child is in danger, Dr. Justine Dol will follow-up with you directly via email or phone call. Further, in accordance with provincial laws, in the rare event that we learn anything during the course of your participation in our study that would cause us to believe that your child was being harmed, we would be required to report this to a child protection agency. If any issues do arise as a result of your participation in our study, you are encouraged to contact Dr. Justine Dol at Justine.dol@iwk.nshealth.ca

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Can I withdraw from the study?
You are free to leave the study at any time. If you decide to stop participating at any point in the study, you can also decide whether you want any of the information you shared with us up to that point to be removed. Basic
demographic information will be maintained to determine if any differences exist between participants who withdrew and those who continued involvement.

Are there any conflicts of interest or possible profit from commercialization of the study results?
There are no conflicts of interest to disclosure nor possible profit from commercialization of the study results.

How will I be informed of the study results?
A summary of the results will be provided if you would like, approximately 12 months after study completion.

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What are my research rights?
Nothing written here about treatment or compensation in any way alters your right to claim damages. Your signature on this form indicates that you have understood to your satisfaction the information regarding participation in the research project and agree to participate as a subject. In no way does this waive your legal rights nor release the investigator(s), sponsors, or involved institution(s) from their legal and professional responsibilities. If you become ill or injured as a direct result of participating in the study, necessary medical treatment will be available at no additional cost to you. You are free to withdraw from the study at any time without jeopardizing the health care you are entitled to receive. If you have any questions at any time during or after the study about research in general you may contact the Research Office of the IWK Health Centre at (902) 470-7879, Monday to Friday between 8:00 a.m. and 4:00 p.m. or by email at researchethicsiwk@iwk.nshealth.ca.

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What if I have any questions about the study?

We are happy to talk with you about any questions or concerns you may have about your participation in this research study. Please contact Dr. Justine Dol (Justine.dol@iwk.nshealth.ca) at any time with questions, comments, or concerns about the research study. We will also tell you if any new information comes up that could affect your decision to participate. If you have any ethical concerns about your participation in this research, you may also contact Research Ethics, IWK Health Centre at 902-470-7978, Monday to Friday, 8am-4pm.