Registration and Study Information

We are inviting mothers who have given birth in the last 3 years (with their first or subsequent child) and currently experience anxiety symptoms and want to reduce or manage their alcohol use to take part. As part of the enrolment process, we will review your current circumstances to ensure that a primarily digital support program is appropriate for your needs and circumstances.

The study is being carried out by a team of researchers, psychologists and mothers who have lived experience of anxiety and risky drinking in the early parenting years. You can learn more about the team here on the study website.
This study is being funded by the Medical Research Future Fund 2023 Childhood Mental Health Research Grant (#2036098) and Dr Prior’s NHMRC 2024 Investigator Grants EL1 (#2034538).

Step 1 – Suitability assessment: If you provide your consent after reading this Participation Information Statement, you will be asked to register for an account by providing your contact details (name, phone number, email address and password). All details will remain confidential. You will then be asked to complete a brief 10-minute survey comprising questions that will be used to determine whether this study might be suitable for you.

Following this, one of our study psychologists will contact you to arrange a 15-minute phone call. This call gives us a chance to get to know you, understand what you need right now, and make sure that a digital program is the right type of support for your needs right now.

If the Healthy Mum, Healthy Bub study seems like a good fit for your current circumstances after this call, you will proceed to Step 2. If the study is not deemed suitable for you, we will provide you with a list of alternative options for seeking assistance and support.

Step 2 – Baseline assessment: Next, you will be asked to complete a more detailed survey about your mental health, use of alcohol, and your family and social support. We will also ask for some basic demographic information, information about what health services you use, and some information about your infant’s health and wellbeing. We expect this survey will take 30-40 minutes to complete.

Step 3 – Group allocation and program completion (6-weeks): After completing the baseline survey, you will be randomly allocated into one of two groups. Random allocation means that neither you nor the study team choose which group you are allocated into; this is determined by chance (like a toss of a coin). You will have a 50% chance of being allocated to:

1. The Healthy Mum, Healthy Bub program

This group will receive access to a digital program which includes 6 online modules. Each module consists of an audio component (approximately 45 minutes) and accompanying worksheet (approximately 15-30 minutes), both of which focus on developing skills to help you manage your anxiety and alcohol use. A new module will be made available each week, and you will be provided with weekly personalised feedback based on the information you provide in the worksheets. This group will also be offered two brief telehealth consultations with one of our study psychologists in Weeks 1 and 4. These sessions will help tailor the program to each person. With your permission, the psychologist’s side of the conversation will be audio‑recorded for quality control.

2. Waitlist control

This group will be placed on a waitlist and offered the opportunity to receive the Healthy Mum, Healthy Bub program (the digital program plus telehealth support) following completion of the study period (4 months after baseline). In the meantime, a list of existing support services for postnatal, mental health, alcohol use, or parenting concerns will be provided, and participants are able to access these (or other support services) without restriction.

Step 4 – Follow-up surveys: Regardless of which condition you are randomly allocated to, you will be asked to complete an online follow-up survey 2- and 4-months after the initial (baseline) survey. These surveys will take approximately 30-40 minutes each to complete and will allow us to assess your progress over time, including any changes in your mental health and alcohol use. For those randomly allocated to the Healthy Mum, Healthy Bub program, we will also ask for your feedback on the program. You will be reimbursed with a $50 voucher for your time completing each survey. For those in the waitlist control group who later access the Healthy Mum, Healthy Bub program, we will ask you to complete an additional, brief 15-20-minute ‘post-program’ survey (2-month after gaining access) to evaluate your experience with the program. You will receive a $30 e‑gift voucher for completing this brief survey.

To help ensure that the survey responses we collect are genuine and valid, we use Google reCAPTCHA technology to confirm that responses are submitted by a real person rather than an automated system. We also conduct data‑quality checks on all survey responses to identify any patterns that may indicate invalid or non‑genuine data. If your survey responses do not meet the required data‑quality standards, they will be removed from the research dataset, and we will notify you of this decision. You will not be reimbursed for your time in these instances.

Being in this study is completely voluntary and you do not have to take part. Your decision will not affect your current or future relationship with the researchers, The University of Sydney, other institutions involved in this research, or the funders. If you decide to take part in the study and then change your mind later, you are free to withdraw at any time without giving a reason. Should you decide to discontinue your participation in the study at any time, you may fill in the ‘Revocation of Consent’ form, accessible from the ‘Consent’ page on the Healthy Mum, Healthy Bub study website.

If you decide to withdraw, we will not collect any more information from you. Any information that we have already collected will be kept in our study records and will be included in the study results. If you prefer that your data is NOT included from the study results, you must inform the research team at the time you withdraw.

There are no costs for participating in this study.

The online surveys include questions about recent mental health experiences and use of alcohol and other drugs. There is some risk that these questions may be upsetting or cause distress. We believe this risk is small, but if you do feel distressed at any stage while completing the surveys, please let the research team know so they can provide or suggest appropriate support. Any information you provide, including any illicit drug use is confidential. We will only share this information if required by law or if there is clear risk of serious harm to yourself or any other person.

Some people may also find it distressing to confront psychological issues, such as anxiety symptoms and/or problems with alcohol use. For example, part of the Healthy Mum, Healthy Bub program involves facing anxiety provoking situations and developing new ways of coping with the anxiety you feel in these situations. While this can be distressing for some people, it is a commonly used treatment technique for improving anxiety, and its effectiveness is supported by extensive research evidence. You do not have to complete these tasks, although if you do not, it may reduce the effectiveness of the treatment.

There is also some risk that modifying alcohol use may initially be associated with withdrawal symptoms and an exacerbation of symptoms of anxiety. If your alcohol use is high, there are also some medical risks, and we advise seeking medical advice before making any significant changes to your current alcohol use.

If you are concerned or become distressed at any stage during the study, we would encourage you to contact the services listed on our Urgent Help page, where you may obtain additional services and 24-hour support. You can also contact the study team who can provide you with additional support or referral options. Please note that the program is not a crisis support service, and therefore there may be a delay to respond to your email, so for immediate assistance please contact one of the support services listed here.

At each follow-up survey time point (2- and 4-months after the initial baseline survey) you will be provided with a list of mental health, alcohol and other drug, and parenting support services, should you need some additional support. If you are allocated to the Healthy Mum, Healthy Bub program, you can log back into the program and access the content until December 2027, when the trial concludes and all program access will cease.

If you are allocated to the waitlist control group, you will receive information about how to access the Healthy Mum, Healthy Bub program and psychologist support after completion of the 4-month follow-up survey. Program content will remain available to you until December 2027, at which point the trial will end and the website will be closed.

The Healthy Mum, Healthy Bub program is based on effective treatment components that have shown benefits in past research to help people reduce their anxiety and/or alcohol use. If you are allocated to this group, you will gain immediate access to the program. If you are allocated to the waitlist control group, you will be able to access the program after you complete the 4‑month follow‑up survey. Therefore, both groups can reasonably expect to see some direct benefits from participating in the trial. Additionally, as part of the program’s focus on reducing anxiety and alcohol use and supporting you to spend more quality time with your children, you may also notice improvements in your relationship with them and in their overall wellbeing.

As a thank you for your time, participants in both groups will receive a $50 e-gift voucher for completing each of the two follow-up surveys (i.e., 2-month survey and 4-month survey). Participants in the waitlist control group who access the Healthy Mum, Healthy Bub program will receive a $30 e-gift voucher for completing the additional post-program survey.

Please note: If your responses to baseline and/or follow-up surveys are deemed ineligible based on our inclusion criteria or failing quality checks, you will not be reimbursed for your participation and will be withdrawn from the study.

By providing your consent, you are agreeing to us collecting information about you for the purposes of this study. Any information you provide us will be stored securely and identifiable information will only be disclosed with your permission, unless we are required by law to disclose material or if we are concerned about your safety or the safety of others.

Data collected will include survey responses, program‑related information (such as worksheet responses and back‑end engagement metrics), and clinical notes and files (e.g., telehealth audio recordings). Data from surveys and the program will be stored by our web development company (Spark Digital) on an external electronic server in Australia while the study is actively running. This data will be deleted from the server upon study completion. All data will also be stored electronically on secure, password protected servers at the University of Sydney. These can only be accessed research staff. We will keep all of your data for 15 years before disposing of it in a confidential manner.

We will keep the information we collect for this study, and we may use it in future projects. By providing your consent you are allowing us to use your information in future projects investigating mental health and substance use. Information will only be used in future projects that have received ethical approval.

We anticipate study findings will be published. You will not be individually identifiable in these publications. We will ask you in the 2-month follow-up survey if you’re happy for us to use your de-identified written or spoken responses in research reports or publications, and whether you’d like to be contacted about possible media opportunities. This is completely optional, and saying no will not affect your participation in the study in any way.

You have a right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by contacting the research team. After the study has been completed and results have been published, a one-page summary of the research findings can be emailed to you

When you have read this information, the research team will be available to discuss it with you further and answer any questions you may have:

Contact the team

healthy-mum-healthy-bub@sydney.edu.au

The ethical aspects of this study have been approved by the Human Research Ethics Committee (HREC) of The University of Sydney (study ID: 2026/HE000270) according to the National Statement on Ethical Conduct in Human Research.

If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the University:

Human Ethics Manager

human.ethics@sydney.edu.au

+61 2 8627 8176