Consent form: Mother
Title of the study : For a better understanding of borderline personality disorder in mothers: a prospective cohort study from pregnancy to 6 years of age
REB (Research Ethics Board) file #, Hôpital Montfort Hospital: 23-24-01-030
Principal researcher: Dr. Valérie Giroux, mental health program, 613-746- 4621 ext 3521
Research assistant : Corina Lacombe
Phone number in case of emergency 613-746-4621 ext 3521. Of note, this is not a crisis line, but a line available on office hours from Monday to Friday 8hr to 16hr. For any crisis, the crisis line is available at 1-866-996-0991 or 998, or you can present to an emergency department of the nearest hospital.
INTRODUCTION
You are invited to participate in a research study because you are a mother who has been diagnosed with borderline personality disorder (BPD). This consent form provides information to help you make an informed choice. Participation in this study is voluntary. Please read it carefully and ask any questions you may have. You must have all your questions answered to your satisfaction before making a decision about your participation in this research study.
This is a study of a duration of 7 years, from pregnancy to 6 years of your child. During the study, your psychiatric follow-up will be with the principal researcher, Dre Valérie Giroux. You will also have access to the possibility of follow-up with other health professionnals at the outpatient clinic and/or psychotherapy groups, according to your clinical needs.
You can refuse to take part or decide to withdraw at any time. Your decision will not affect the future care you will receive outside the study. If you have any questions, please ask the research assistant.
ARE THERE ANY CONFLICTS OF INTEREST?
There are no conflicts of interest in this study.
WHY IS THIS STUDY BEING CARRIED OUT?
The aim of this study is to better understand the impact of borderline personality disorder (BPD) on the mental health of mothers, their children and the mother-child relationship. This will help to improve the care offered to mothers with BPD and their children.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
We plan to recrute 20 mothers for this study.
WHAT WILL HAPPEN DURING THIS STUDY?
During the study, the principal researcher will act as your psychiatrist first taking care of your mental health and offer appropriate plan of treatment. The second half of your appointment will be taking the measures for the study, through : observations, standardized scales and taking your pulse. The mesures obtained will be stored in an electronic database, protected by a password. Access to the database will be restricted to those involved in the research project.
If you prefer not to share certain information, please speak to the research assistant.
You will be asked to participate in clinical assessments every 3 months during pregnancy up to 1 year postpartum, and then every 6 months thereafter. Each interview will last approximately 30-60 minutes, except for the first one which will last 90-120 minutes and will take place at Montfort Hospital or the Aline-Chrétien Health Hub.
Your pulse will also be measured, every 3 months during pregnancy and the first year postpartum, and then every 6 months. The pulse is an indicator of physical health and emotions.
Here are the scales used and what they are aiming to measure. :
BEST, DERS-SF | Symptoms of borderline personality disorder |
PRFQ | Parental capacity to understand emotions and behaviours of your child |
Parental Stress Scale | Parental stress |
Relationship questionnaire | How you attach to others |
EPDS | Depression during pregnancy and in the first year postpartum |
Coparenting scale | Relationship with the other parent |
- MAAS (during pregnancy)
- PBQ (3 months after delivery)
- MIRS (6 and 12 months after delivery)
- Mind-mindedness
- Ambiance brief
| Mother-infant relationship |
The purpose of these questionnaires is to assess your mental health and the parent-child relationship.
We will use the information you provide for research purposes only. Some questions are personal. You may refuse to answer them, if you wish.
Your pulse will also be measured, every 3 months during pregnancy and the first year postpartum, and then every 6 months. The pulse is an indicator of physical health and emotions.
Sample of saliva will be taken to assess oxytocin levels during the second trimester and every 6 months from 6 to 24 months. Oxytocin is an hormone produced by the body, which permit to attach to others. The saliva samples will served to only measured the oxytocin levels.The samples will be used for these purposes only and will not be sold. Once these analyses have been completed, they will be destroyed. These samples will not be used for genetic testing. Neither you, nor other health care providers will receive any reports concerning the analyses performed on your samples. Furthermore, these reports will not become part of your medical record.
In order to contact you at various times during the study, we will take your contact information (telephone number and e-mail address). Personal information (full name, telephone number, e-mail address) will not be entered in the database and will be kept in a secure electronic document, protected by a password.
WHAT ARE THE RESPONSIBILITIES OF STUDY PARTICIPANTS?
If you decide to participate in this study, you will :
- Participate in clinical assessment interviews (30-40 minutes).
- Complete questionnaires (15-30 minutes per point of evaluation).
- Agree to the collection saliva to assess oxytocin levels (less than 1 minute).
- Pulse to be taken (approximately 1 minute).
HOW LONG WILL I BE PARTICIPATING IN THE STUDY?
The study is scheduled to take 7 years to complete, and the results should be available in approximately 8 years.
DO PARTICIPANTS HAVE THE OPTION OF WITHDRAWING FROM THE STUDY?
You may decide to end your participation in this research project at any time, without giving a reason. If you choose to withdraw, we encourage you to contact the research assistant.
If you decide to withdraw your participation to the study, your psychiatric follow-up will continue for the duration of your clinical needs.
At any time, you may withdraw your consent to the use of data collected about you for the purposes of this study. Simply inform the research assistant. However, this decision will also entail your withdrawal from the study.
The researchers will use the data collected for the purposes of the study prior to your withdrawal. However, no information will be collected once your authorization has been withdrawn.
You may ask the researchers not to use the data collected about you for the purposes of this study.
CAN MY PARTICIPATION IN THE STUDY BE TERMINATED EARLY?
Your participation in the study may be terminated early, without your consent, for the following reasons, such as:
- The research team decides to end the study.
- The Montfort Hospital Research Ethics Board (REB) withdraws its authorization to continue the study.
Should such a situation arise, the research team will inform you of the reasons for your withdrawal. your psychiatric follow-up will continue for the duration of your clinical needs.
WHAT ARE THE RISKS OR HARMS OF PARTICIPATING IN THIS STUDY?
There are no medical risks associated with participation in this study.
WHAT ARE THE BENEFITS OF PARTICIPATING IN THIS STUDY?
Participants in this study are likely to have a longer duration of psychiatric follow-up than if they were not part of the study. Psychiatric follow-ups at the Montfort outpatient clinic are of short duration and restricted to the active symptom period. For the perinatal clinic, follow-up is usually between 6 and 18 months. The duration of the study is of 7 years.
To the extent permitted by applicable law, these records will not be disclosed or made public, except for
the exceptions. Authorized representatives of the Montfort Hospital REB** may examine your original (identifiable) medical records at the hospital where they will be stored. In doing so, they will verify that the data collected for this study is accurate and complies with relevant laws and guidelines.
**The Montfort Hospital REB, which oversees the ethical conduct of this study.
If we publish the results of this study, your identity will remain confidential. It is anticipated that the data collected during this study will be used for analysis and will be published in scientific journals and/or presented to the scientific community at conferences.
Although it is highly unlikely that anyone will identify you from the research data, this possibility can never be completely ruled out.
A note mentioning your participation in the study may be added to your medical/hospital record.
For research purpose only, the research data may serve to create a data bank, to potentially improve the project. This would implicate a long term use of the research data. The ultimate goal would be to have more data to improve knowledge about mothers with BPD and their children.
Furthermore, the measures obtained during the study could be transmitted outside Canadian borders. Nevertheless, all research data transmitted outside Canada will be coded. This means that it will not contain any personal identifiers, such as your name, address, medical insurance number or contact information. Where applicable, this information will be transmitted in accordance with applicable Canadian privacy legislation. By signing this form, you consent to the disclosure of your encrypted information to organizations outside Canada.
WHAT ARE THE COSTS FOR PARTICIPANTS?
There will be no cost to participate.
WILL PARTICIPANTS BE COMPENSATED FOR THEIR PARTICIPATION IN THIS STUDY?
A remuneration of $50 will be paid for the first interview and $25 for each subsequent meeting.
WHAT ARE THE RIGHTS OF RESEARCH STUDY PARTICIPANTS?
You will be informed as soon as possible of any new information that may affect your decision to continue participating in this study.
You have the right to be informed of the results of this study after its completion. If you wish to be informed of the results, please inform the research assistant.
Your privacy rights are protected by federal and provincial laws that require the application of safeguards to ensure your privacy.
By signing this form, you are not assigning any of your legal rights to Dr. Valérie Giroux or to the participating institutions for the purpose of receiving remuneration. Furthermore, this form does not release Dr. Valérie Giroux or any of her agents from their legal and professional responsibilities.
Before participating in this study, you will receive a copy of this signed and dated consent form.
WHAT HAPPENS IF THE INVESTIGATORS MAKE A DISCOVERY ABOUT A STUDY PARTICIPANT?
In the course of the study, the researchers may make an unexpected discovery about you. For this
study, an unexpected discovery could be the discovery of child abuse or neglect. Legally, a report should then be made to the Children's Aid Society of Ottawa or Valoris.
Also, it may be possible to detect earlier mother-child relationship difficulties and mental health symptoms of your child.
HOW WILL THE CONFIDENTIALITY OF PARTICIPANT DATA BE ENSURED?
If you decide to participate in the study, the research team will collect only the information it needs for this project, and will take appropriate measures to maintain confidentiality. The team will separate your name and contact informations (phone number and email address) from other information, and will use a code rather than your name to identify your data.
TO WHOM SHOULD PARTICIPANTS DIRECT THEIR QUESTIONS?
If you have any questions about participating in this study, or if you experience any research-related harm, you can contact the research assistant or the person in charge at this facility. Here is the contact information for the research assistant:
Name: Corina Lacombe
Telephone number: 514-814-6760
If you have any questions about the rights of participants or ethical issues related to this study, you can speak to someone who has no connection with this research project. You can also contact the Montfort Hospital Research Ethics Board, 745-A Montreal Road, Ottawa, Ontario by telephone at 613-746-4621, ext. 2221 or by e-mail at ethique@montfort.on.ca.
Title of the study : For a better understanding of borderline personality disorder in mothers: a prospective cohort study from pregnancy to 6 years of age
SIGNATURES
- I acknowledge participation in a study of mothers with Borderline Personality Disorder and their children.
- All my questions have been answered.
- I understand the information provided in this informed consent form.
- I authorize access to my medical records and personal medical information, as well as the transfer of my samples, as explained in this consent form.
- By signing this consent form, I do not waive any of my legal rights.
- I understand that my family physician/healthcare provider may be informed of my participation in this study.
- I agree to/authorize the person for whom I am responsible to participate in this study.
- I authorize my contact information (telephone number and e-mail address) to be contacted about my participation in the study at the various times specified.
- I also authorize to give the contact information (telephone number and e-mail address) of the other parent, whom the participation can increase the understanding of BPD in mothers.