Participant Information Statement

Health/Social Science Research – Parent/Caregiver

South Western Sydney Local Health District (SWSLHD)

Murrumbidgee Local Health District (MLHD)

A ‘Digital Support’ for Child and Family Health Services for

Title developmental surveillance: Using the Watch Me Grow web-
app to address a critical COVID-19 service delivery gap
Short Title A ‘Digital Support’ for Child and Family Health Services
Protocol Number 1.0

Project Sponsor NSW Ministry of Health COVID-19 Research Grants Round 2

Coordinating Principal
Professor Valsamma Eapen
Investigators

Professor Valsamma Eapen (SWSLHD)

Site Principal Investigators
A/Professor John Preddy (MLHD)

South Western Sydney Local Health District (SWSLHD)

Locations
Murrumbidgee Local Health District (MLHD)

1 Introduction

You and your child are invited to take part in the research project “A ‘Digital Support’ for Child and
Family Health Services for developmental surveillance. You have been invited to participate because
the Child and Family Health Service (CFHS), refugee health service, supported playgroup, parenting
groups, Karitane services, GP practices, special paediatric clinics, or Sustaining NSW families
programs in your area is participating in this research. All parents/caregivers of children aged 6
months to 3 years old living in the area covered by these services or groups are invited to participate
at recruitment in this research project.

This Participant Information Statement tells you about the research project. It explains the processes
involved with taking part. Knowing what is involved will help you decide if you want to take part in the
research.

Please read this information carefully. Ask questions about anything that you don’t understand or
want to know more about. Before deciding whether or not to take part, you might want to talk about it
with your CFHN, health worker, or family and friends. Participation in this research is voluntary. If
you don’t wish to take part, you don’t have to.

If you decide you want to take part in the research project, you will be asked to sign the consent
section. By signing it you are telling us that you:
• Understand what you have read
• Consent to take part in the research project
• Consent to be involved in the research described
• Consent to the use of your personal and health information as described.
You will be given a copy of this Participant Information Statement to keep.

HREC ETH01418 MASTER Participant Information Sheet – Version 3.1, 27 May 2021
A ‘Digital Support’ for Child and Family Health Services for developmental surveillance:
Using the Watch Me Grow web-app to address a critical COVID-19 service delivery gap

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2 What is the purpose of this research?

The purpose of this ‘Digital Support for CFHS’ research project is to compare whether linkage to
services through a web tool will result in improvements in family wellbeing. Wellbeing includes three
areas (for this study): child development, parental mental health, and unmet psychosocial needs.

Many CFHN Clinics in NSW have closed due to the COVID-19 pandemic, so some children have
missed out on developmental checks with their CFHN. To address this, the WMG-E web tool will
provide the questions from the Blue Book/Personal Health Record (PHR) online, along with
questionnaires about mental health and unmet psychosocial needs (e.g. financial wellbeing). Based
on your responses, you will be recommended different resources, and for families in the intervention
arm, the families will be connected to services supporting the areas where you expressed risk. The
research findings may lead to future improvements in the way children’s development are monitored
by the CFHS.

3 What does participation in this research involve?

If you consent to your child taking part in the research study, we will ask you to complete the
questions in the WMG-E web tool. These questions will ask you about your child’s development,
your mental health, and your unmet psychosocial needs. The questions should take approximately
10 minutes to complete. You will receive an email with the results of the questions and general
information about children’s growth and development as applicable to your child’s age. The WMG-E
web tool will also provide these results to the study team, who can use them to connect you with the
appropriate services in your area. Should these questionnaires identify a developmental concern,
your CFHN will get in touch with you and may refer your child for further assessments if needed. You
will also be given a $20 Coles/Myer gift voucher or parking voucher at survey completion.

The WMG-E web tool will send you reminders when it is time to complete the next screening after 6
and 12 months from when you first decided to join the study. You will also be given a $20
Coles/Myer gift voucher or parking voucher after 6 and 12 months of survey completion.

4 Do I have to take part in this research project?

Participation in any research project is voluntary. If you do not wish to take part, you do not have to.
If you decide to take part and later change your mind, you are free to withdraw from the project at
any stage. If you do decide to take part, you will be given a copy of this Participant Information to
keep (via email).

Your decision whether to take part or not to take part, or to take part and then withdraw, will not
affect your routine care, your relationship with CFHN or your relationship with your relevant health
authority (state or health district), organisation, or the researchers conducting the study.

5 What are the possible benefits of taking part?

We cannot guarantee or promise that you will receive any benefits from this research. However, by
participating in this study you may become more aware of children’s growth and development in
general and about the signs and symptoms of developmental delay. You may also become more
aware of your own mental health experience and be linked with services that address your unmet
psychosocial needs. This information and knowledge may be of benefit for your ongoing monitoring
of your child’s development.

We hope to use information that we get from this research study to benefit others by ensuring that
early identification of children with developmental or behavioural disorders can occur early so that
they can receive early intervention services and supports, which in turn may improve their school
readiness.
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6 What are the possible risks and disadvantages of taking part?

There are no major risks associated with this project. However, if you experience discomfort or
feelings of distress while completing the questions, you can stop participating at any time. You
can also tell your CFHN or a member of the research team and they will provide you with
assistance and a list of locally available support services and their contact details.

7 What if I withdraw from this research project?

If you do consent to participate in this research project, you may withdraw at any time. If you decide
to withdraw from the project, you can do so by completing the ‘Withdrawal of Consent Form’ which is
provided at the end of the Consent Form. Alternatively, you can call the research team and tell them
you no longer want your child to participate.

If you decide to leave the research project, the researchers will not collect additional personal
information from you, although personal information already collected will be retained to ensure that
the results of the research project can be measured properly and to comply with law. You should be
aware that data collected up to the time you withdraw will form part of the research project results. If
you do not want your data to be included, you must tell the researchers when you withdraw from the
research project.

8 What happens when the research project ends?

Should you wish to be provided with the findings of the research study, we will provide you with a
summary of the results when the research project is completed. Please indicate in the Consent Form
if you wish to receive the findings of the study by adding your email or postal address. We will only
use these details to send you the results of the research.

9 What will happen to information about me?

By signing the consent form you consent to the research team collecting and using personal
information about you for the research project.

Your responses to questionnaires are anonymous and cannot identify you. Any information obtained
in connection with this research project that can identify you will remain confidential. Your
information will only be used for the purpose of this research project and it will only be disclosed with
your permission, except as required by law. The personal information that the research team collects
is your name and your contact details (email address and postal address). This personal information
is only used to keep in touch with you throughout the study. Only the research study team will have
access to your information, and this will be held securely in SWSLHD or UNSW servers.

We are required to keep the data from this study until at least the time of your child’s 25th birthday.
We also ask your permission to keep the data indefinitely in case it is of benefit for use in future
research studies. The scope for future use of this research data is currently unknown as
developmental and psychological science advances quickly. We are not able to tell you exactly what
form future research might take, or the outcomes of that research. Future research might involve
asking different questions of the data, or even recontacting you to find out how your child is doing in
future. Any time there is a request for the data to be used in a project that is unrelated to this current
project, approval from a Human Research Ethics Committee will be required prior to use of the data.
No research will take place using your information unless that research is first reviewed and
approved by a Human Research Ethics Committee, which will make sure the benefits of the
research outweigh the costs to you and your privacy. Information about your child will be released in
a way that will not identify you or them, unless the project involves recontacting you to find out how
your child is doing.

HREC ETH01418 MASTER Participant Information Sheet – Version 3.1, 27 May 2021
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Using the Watch Me Grow web-app to address a critical COVID-19 service delivery gap

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We will store information about your child in a non-identifiable format in REDCap servers held by
UNSW or SWSLHD, under Australian jurisdiction. When data is shared between team members, it
will be secured via password protected files and encrypted file-sharing services.

Information about you may be obtained from your health records held at this and other health
organisations for the purpose of this research. By signing the consent form you agree to the
research team accessing health records if they are relevant to your participation in this research
project.

It is anticipated that the results of this research project will be published and/or presented in a variety
of forums. In any publication and/or presentation, information will be provided in such a way that
neither you nor your child can be identified.

In accordance with relevant Australian and/or Privacy and Personal Information Protection act 1998
(NSW), 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. Please inform the research team member named at the end of this document
if you would like to access your information.

10 Who is organising and funding the research?

This research project is being conducted by Professor Valsamma Eapen. It is being funded by the
NSW Ministry of Health COVID-19 Research Grants Round 2.

11 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 have been
approved by the HREC of SWSLHD. This project will be carried out according to the National
Statement on Ethical Conduct in Human Research (2007). This statement has been developed to
protect the interests of people who agree to participate in human research studies.

12 Further information and who to contact

The person you may need to contact will depend on the nature of your query. If you want any further
information concerning this project or if you have any problems which may be related to your
involvement in the project, you can contact the following member of the research team:

Name: Prof Valsamma Eapen

Position: Professor of Psychiatry/Coordinating Principal Investigator
Location: South Western Sydney Local Health District
Telephone: (02) 9616 4269
Email: v.eapen@unsw.edu.au

Name: A/Professor John Preddy

Position: Site Principal Investigator
Location: Murrumbidgee Local Health District
Telephone: (02) 5943 1140
Email: j.preddy@unsw.edu.au

HREC ETH01418 MASTER Participant Information Sheet – Version 3.1, 27 May 2021
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Using the Watch Me Grow web-app to address a critical COVID-19 service delivery gap

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Name: Ms Teresa Winata
Position: Project Coordinator
Location: South Western Sydney Local Health District
Telephone: (02) 9616 4268
Email: teresa.winata@health.nsw.gov.au

Name: Ms Melissa Smead

Position: Project Coordinator
Location/Site: Murrumbidgee Local Health District
Telephone: (02) 6053 4860
Email: melissa.smead@health.nsw.gov.au

13 Support services contact details

If at any stage during the project you or your child becomes distressed or require additional support
from someone not involved in the research, we will assist you in seeking an appointment with your
CFHN.

Other services you may wish to contact include:

• Healthdirect Australia (nurse on call): 1800 022 222

• Karitane: 1300 227 464
• Raising Children Network: raisingchildren.net.au
• Parentworks: parentworks.org.au
• Perinatal mental health (including postnatal depression): 1300 726 306 panda.org.au
• Men’s Helpline: 1300 78 99 78 mensline.org.au
• Parentline NSW: 1300 1300 52

14 Complaints contact person

This study has been approved by the South Western Sydney Local Health District Human Research
Ethics Committee. Any person with concerns or complaints about the conduct of this study should
contact the Research and Ethics Office, Locked Bag 7103, LIVERPOOL BC NSW 1871 on 02 8738
8304 / fax 02 8738 8310 / email SWSLHD-ethics@health.nsw.gov.au, website:
http://www.swslhd.nsw.gov.au/ethics/default.html and quote [SSA ref no. 2020/STE02335] for
SWSLHD and [SSA ref no. 2021/STE02328] for MLHD.

Thank you for taking the time to consider this study.

If you wish to take part in it, please sign the attached consent form.
This information statement is for you to keep.

HREC ETH01418 MASTER Participant Information Sheet – Version 3.1, 27 May 2021
A ‘Digital Support’ for Child and Family Health Services for developmental surveillance:
Using the Watch Me Grow web-app to address a critical COVID-19 service delivery gap

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