Starting Page - Consent Form

Researchers:
Principal Investigator: Hua Li, RN, PhD, Assistant Professor, College of Nursing, University of Saskatchewan. Email: hua.li@usask.ca, Phone: (306) 966-2158
Research Assistant: Alana Glecia (Demkiw), BA(hons), MA, College of Nursing, University of Saskatchewan, Email: agd262@usask.ca
 
Introduction
You are invited to participate in a research project entitled “Psychometric Properties of the Affective Lability Scale -18 in Pregnancy and Postpartum Women.”

Mood swings have always been associated with women during their pregnancy and postpartum period. This seemly ‘harmless’ phenomenon has been seen as ‘normal’ part of women’s life; therefore, little attention has been paid to it, particularly how to assess maternal mood swings. However, studies of mood swings in general population showed a strong relationship between mood swings and other mood disorders such as depression and anxiety. This project will use the questionnaire of Affective Lability Scale -18 to measure your mood swings to test whether these questions can assess maternal mood swings efficiently. This project will also test several other factors, such as: whether maternal mood swings are related to other maternal mood symptoms and infant temperaments and infant/mother attachment; in what ways COVID-19 has effected maternal mental health; experiences of abuse and stigma; coping strategies employed by mothers as well as their resilience; and mental health literacy.

Your participation is voluntary. If you decide to participate, you are still free to withdraw at any time and without giving any reasons for your decision.

Please take time to read the following information carefully, and you can call or email the research staff to explain any information that you do not clearly understand. You may ask as many questions as you need (contact information provided above). Please feel free to discuss this with your family, friends or your health care professionals before you decide.
 
Who is eligible to participate?
Canadian mothers who are either currently pregnant, or up to 12 months postpartum.

Who is conducting the study?
The study is supported by the Canadian Institute of Health Research Seed Grant, College of Nursing, University of Saskatchewan.
                                                                       
Why is this study being conducted?
There are needs for a reliable measurement that assesses perinatal women’s mood swings in order to enhance the quality of research in perinatal women’s health and well-being. Additionally, we hypothesize that maternal mental health among pregnant and perinatal mothers has been effected by the COVID-19 pandemic, and would like to examine in what ways, if at all, COVID-19 has effected maternal mental health.

What will the study involve?
The study will involve filling an online survey that will take approximately 20-30 minutes.

Are there benefits of being involved in this study?
Although there may be no immediate benefits, it is hoped that information gained from this study can be used in the future to benefit you and other pregnant and postpartum women.

Are there possible risks of being involved in this study?
· There are no known or anticipated risks to you by participating in this research.
· However, the survey includes some sensitive questions about your experiences, such as whether you have experienced domestic violence. These questions may cause emotional or psychological distress.
· If you become upset or unwell, there is a list of provincial and federal mental health resources at the bottom of each page, as well as at the end of the survey. You can also seek support services by contacting your family doctor or calling 8-1-1. In an emergency, please call 9-1-1.
· Please only answer those questions you are comfortable with.

What happens if I decide to withdraw?
Your participation is voluntary. You can withdraw from this study without giving a reason by choosing to stop completing the survey at any point and closing your browser. Any data contributed will be destroyed beyond recovery. You can contact the researcher if you have questions.

Should you want your data to be withdrawn after the survey is completed, please contact the project research assistant, Alana Glecia, at agd262@usask.ca. You are able to withdraw your data up until June 2024. After that, there are no guarantees that your data will be able to be withdrawn due to data pooling, publication, and dissemination.

What will the study cost me?
You will not be charged for the study. All participants deemed legitimate will be entered into a draw for an honorarium of a $50 Amazon online gift card, with five opportunities to win. At the completion of the survey, a page will open to enter your email address, name, and home address. This information will be required if you desire to be a part of the draw, as well as to ensure individuals are not submitting multiple entries. If you are one of the five draw winners, in you will be contacted at the email you have provided. This information will only be used for these purposes, as well as for re-identifying data if need be. See below for more information on participant confidentiality.
Will my participation be kept confidential?
In Saskatchewan, the Health Information Protection Act (HIPA) defines how the privacy of your personal health information must be maintained so that your privacy will be respected. All identifying information will be removed (it will not be attached to any information, nor mentioned in any study report, nor be made available to anyone except the research team). It is the intention of the research team to publish the results of this research in scientific journals and to present the findings at related conferences and workshops, but your identity will not be revealed.

We will de-identify the data by removing your email address from the surveys but maintain a master-list that would allow for researchers to re-identify the data, as well as reach out to you should you be one of the winners of the five gift cards. The PI will store all physical data from this study by storing the data in a locked cabinet at the College of Nursing in PI’s office, and electronic data will be stored on the PI’s USask OneDrive. We will store the master-list separately from the data. The data will be stored at the University of Saskatchewan secure online cabinet storage. After 5 years post-publication, all data collected will be destroyed beyond recovery.

It is the intention of the research team to publish the results of this research in scientific journals, but your identity will not be revealed in any publications nor will anyone be able to connect the results, which will be presented in aggregate and without identifiers, to an individual participant.
 
Who do I contact if I have questions?
If you have any questions or desire further information about the study before or during participation, you can contact Cheryl Besse at 306-966-7540 or email: cheryl.besse@usask.ca; Hua Li at 306-966-2158 or email: hua.li@usask.ca.

This research project has been approved on ethical grounds by the University of Saskatchewan Behavioural Research Ethics Board.  Any questions regarding your rights as a participant may be addressed to that committee through the Research Ethics Office ethics.office@usask.ca (306) 966-2975. Out of Saskatoon, participants may call toll free (888) 966-2975.

Consent to Participate:
· I have read (or someone has read to me) the information in this consent form.
· I understand the purpose and procedures and the possible risks and benefits of the study.
· I am free to withdraw from this study at any time for any reason, and the decision to stop taking part will not affect my future medical care.
· I understand that by proceeding to the next step, I give informed consent, but I do not waive any of my legal rights.

Question Title

* Are you at least 18 years old, and give your consent?

If you find that completing this questionnaire causes you distress, please contact your healthcare provider immediately. Alternatively, you could call:

National Crisis Hotlines: Crisis Services Canada 1-833-456-4566 or text 45645
British Columbia Helpline: Canadian Mental Health Association - British Columbia Division 1-800-555-8222;
HeretoHelp 1-800-661-2121
Alberta Crisis Hotlines: Distress Centre 403-266-4357
Saskatchewan Crisis Hotlines: Saskatoon Crisis Intervention Service 306-933-6200; Mobile Crisis Services 306-757-0127
Manitoba Crisis Hotlines: Klinic Crisis Line 1-888-322-3019
Yukon Crisis Hotlines: Yukon Crisis Line 403-668-9111
Northwest Territories Crisis Hotlines: Northwest Territories Help Line 1-800-661-0844
Nunavut Crisis Hotlines: Nunavut Kamatsiaqtut Help Line 1-800-265-3333
Ontario Crisis Hotlines: Ontario Mental Health Helpline 1-866-531-2600
Quebec Crisis Hotlines: Centre de Prevention du Suicide de Quebec 1-866-277-3553
Newfoundland and Labrador Crisis Hotlines: Mental Health Crisis Line 1-888-737-4668
New Brunswick Crisis Hotlines: Chimo Helpline 1-800-667-5005
Prince Edward Island Crisis Hotlines: The Island Helpline 1-800-218-2885
Nova Scotia Crisis Hotlines: Mental Health Mobile Crisis Line 1-888-429-8167

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