Participant Information Sheet

You are invited to take part in the “Pregnancy, Birth and Trauma (PBT) Study” a research project designed to develop and validate a screening tool for post-traumatic stress disorder (PTSD) related to the perinatal period and to explore if there is an association between adverse childhood experiences and perinatal PTSD symptoms.

This Participation Information Sheet tells you about the research project. It explains what is involved in the study to help you decide whether you want to take part. Please read the following Participant Information Sheet carefully before you make your decision. Ask questions about anything that you don’t understand or want to know more about. Before deciding whether to take part, you might also want to talk about it with a relative, friend or a health care professional.

Introduction

In this PBT study the perinatal period is defined as the time when you are trying to get pregnant, pregnancy, birth and the year after.

The perinatal period is a time where everything is changing for women; your body, hormones, roles, relationships, and responsibilities. While this time can bring great joy, it can also be challenging and at times distressing; some women will experience trauma during this time that can impact on coping, mental health, and the connection with their baby. 

Health services routinely screen for depression and anxiety and other risk factors during the perinatal period using validated tools. These might identify some symptoms of PTSD but are not specific for this. While screening for PTSD across the perinatal period is recommended, there are currently no tools designed for this purpose. Developing a tool that can be used to identify women experiencing symptoms related to trauma, is an important first step to ensure that these women are offered the effective treatments available.

The PBT research team has worked with a large group of perinatal/mental health professionals and women who have experienced perinatal trauma, to develop a tool (a questionnaire) to screen for symptoms of PTSD in the perinatal period.This questionnaire is called the Perinatal PTSD Questionnaire.  The study you are being invited to take part is designed to assess the acceptability and usefulness of the tool.

Additionally, because there is evidence linking negative childhood experiences with an increase in health problems the PBT team are interested in exploring the relationship between adverse childhood experiences and difficulties in the perinatal period. 

Why am I being invited to participate?

We are inviting all women over 18 years of age, receiving antenatal care at Redcliffe Hospital who can read and understand English to participate. Your participation in the PBT study is voluntary. It is up to you to decide whether you take part or not.

What does my participation involve?

First, you will be invited to complete questionnaires online at two times – now or as soon as convenient and again six to eight weeks after your baby’s due date.  At both times, the questionnaires ask for some information about your personal circumstances and the new tool – the Perinatal PTSD Questionnaire which asks about problems you might have experienced during the perinatal period.  The initial survey also includes a questionnaire that asks 10 questions around negative experiences during childhood. For example, you will be asked whether your parents were divorced or separated. These questions will not be asked at the second survey. 

At the completion of the questionnaires you will be sent an email with Counselling/Support resources and a copy of your consent form. If your responses to the Perinatal PTSD Questionnaire at either time indicates that you have had a distressing and or traumatic experience during the perinatal period/s, this email will also invite you to complete a semi-structured interview by telephone that we will use to validate our questionnaire. We will then contact you by telephone within 5 business days to answer any questions you may have and arrange a time to complete the interview.

The semi-structured interview consists of 25 questions designed to diagnose PTSD and severity of symptoms.  We are offering the interview by telephone because women have told us that attending multiple appointments during the perinatal period can be challenging.  However, if you prefer to complete the interview in person, we can make this arrangement with you.  We anticipate the interview will take no longer than 20 minutes. The interview will be completed by a member of the research team who is a qualified health professional and has completed formal training in the interview. The researcher interviewing you will not have seen the answers you provided in the online questionnaire.

You do not have to take part in the interview – it is your choice.  We will ask your consent again before starting this interview.  At the completion of the interview you will again be emailed a list of services you may wish to contact if you would like to discuss any issues or to seek additional support.  You have the right to decline to answer any question without giving a reason and/or terminate the interview at any time.

At every stage of our study, you can ask us questions and have the right to withdraw from participation and have any data collected about you destroyed

Risks/Discomforts

There are no costs associated with participation in this study. You will perhaps be inconvenienced making time to complete the questionnaires and/or interview.  It is possible that you may experience some discomfort or distress being asked about past and current experiences which may have been traumatic. 

If you do become distressed, please tell the researcher who can support you to access any assistance you might require. You always have the right to withdraw from participation at any stage without giving a reason. More generally, if taking part in this study – completing questionnaires or the interview raises any concerns for you, ask the researchers to provide you advice about appropriate referral options to meet your needs. If your responses to questions in the online questionnaire indicate that you are at risk of harm, the online tool will provide you with specific advice on how to access appropriate counselling, support or access to mental health care.

Benefits

There are no immediate benefits for participants. You will not be paid for participation. However, some people find it helpful to know they are contributing to research that may help other people like them in the future.

Is it confidential?

Yes. All information and data collected for the study remains confidential in accordance with the National Health and Medical Research Council (NHMRC) ethical guidelines and the Privacy Act.

Your identity is safeguarded by the removal of all identifying information from the research records and questionnaires. Your survey data will have a unique code assigned, not your name. Your name will be on file but will not be linked with any data collected. For the purpose of any future data verification the researchers will store personal and questionnaire information indefinitely at QIMR Berghofer Medical Research Institute. Access to the survey data is restricted to certain members of the research team. Research data collected will be kept safe, securely stored and is password protected. Results of this research project may be presented in scientific papers in medical literature, or in public talks, but your identity will not be revealed.  In reporting and publishing results from this study your name will not be used. The data collected as part of this study will be combined at analysis with the data from many other people, and as such there will be no way of identifying you as a participant. In accordance with relevant Australian privacy and other relevant laws, you have the right to request access to the information about you that is collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected and if you withdraw consent, you have the right to request data collected from you to be destroyed.  Please inform the research team member named at the end of this document if you would like to access your information.

Who has reviewed the research project?

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC).  The ethical aspects of this research project has been approved by The Prince Charles Hospital HREC EC00168

What if I have questions?

If you have any questions or concerns about this research project, or email us at perinatal-mental-health@health.qld.gov.au - attention Tracey Mackle or you may contact us by telephone 0408151138

If you have any concerns or complaints regarding the conduct of this study, you may contact the Research Governance Officer Redcliffe Hospital ph 07 38837243.