SPARCS2: Developing Stratified Pathways to Advance Readiness in Children for School 2

What is the study about?

SPARCS2 is a research study designed to understand parents’ experiences and support needs after their baby leaves the neonatal unit, up to the point when their child starts school. You are invited to take part because you are a parent of a child who has experienced specialised neonatal care after their birth.

The interview will cover the following areas:

• Your child’s neonatal journey
• Support you received after leaving the neonatal unit
• Family services after neonatal unit care
• Opportunities to improve support after neonatal unit care
• Some background questions about you and your family

You do not need to answer every question, and can decline any question or stop the interview at any time. Interviews usually take around 30–60 minutes.

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Why is this study important?

We know that some babies who need neonatal care can face challenges with their later health, learning and development. We also know that support for families can vary a great deal after they leave neonatal units. We aim to understand parents’ experiences and where the gaps in support for families are. SPARCS2 aims to help find better ways to support families and children in the years between birth and starting school. Interviews with parents help us to understand your experience in more depth than a survey alone can capture.

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Why have I been asked to take part?

We are inviting parents or carers who are 16 years old or over, live in the UK, and have a child who has been admitted to a neonatal care unit at any time since 2020.

Do I have to take part?

No. It is completely up to you to decide whether to take part. If you agree to be interviewed, you can still change your mind and stop at any point, without giving a reason. Your decision will not affect any care or support you or your child receive, now or in the future.

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What would taking part involve?

If you take part, a member of the research team will contact you to arrange a time to talk that’s convenient for you. The interview will usually be conducted via video call, but for parents who find this difficult, we can also arrange for phone calls, or we may be able to arrange an in-person interview.

You will be asked about your experiences since your baby left the neonatal unit. There are no right or wrong answers - we are interested in your own experience and views. You do not have to answer any question you don’t want to, and you can stop the interview at any time.

As a thank you for your time, you will be offered a £30 voucher on completion of the interview.

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What are the possible benefits of taking part?

There are no tangible benefits to you personally. However, you will be contributing to our knowledge and research on the specific needs and support of families whose babies have needed neonatal care. We aim to help improve support for future families. Some parents also find it valuable to have the space to reflect on and share their experience.

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What are the possible disadvantages and risks of taking part?

Most questions ask about your personal experiences and carry no known risk. Talking about your child’s time in the neonatal unit, and what came afterwards, can sometimes bring up difficult feelings even when this happened some time ago.  

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What happens when the research study stops?  

We plan to save your anonymised information indefinitely, to ensure that we can learn everything possible from this valuable research. See Part 2 for more details on information storage.

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What if there is a problem?

Any complaint about the study or any possible harm you might suffer will be addressed. The detailed information on this is given in Part 2.

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Will my taking part in the study be kept confidential?

Yes. All the information we collect will be handled in strictest confidence. Your data will be referred to by a unique participant number rather than your name, and anything you say will be anonymised before it is used in any report. Everyone involved in this study will keep your data safe and secure. We will follow all privacy rules. Part 2 of this sheet tells you more about this, including what happens to the recording of your interview.

We will make sure no-one can work out who you are from the reports we write. The information you give will be kept entirely confidential from other members of your family and from organisations who provide services or administer benefits that you or your baby may use or receive. In very exceptional circumstances your confidentiality may be broken, for example, if something you tell us indicates that someone is at significant risk of harm.

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What will happen to the results of the research study?

The anonymised findings from this research may be shared with the general public, for example through the internet, in scientific publications, or in TV or radio broadcasts. They may be also shared with other researchers. No-one will be able to identify you or your family from any results or publications.

You will be able to read about the progress of the study and find summaries of the results on the study website: https://www.medschl.cam.ac.uk/department-obstetrics-and-gynaecology.

What will happen if I don’t want to carry on with the study?

You can stop being part of the study at any time, without giving a reason.

If you want to stop being part of the study at any point during the interview, we will ask whether we can keep the parts of the conversation you’ve already shared or whether you would like this deleted. After your interview, you can still contact us to delete your interview at sparcs-contact@medschl.cam.ac.uk or call us on 01223 336883. Once your data have been anonymised and combined with data from other participants for analysis, it will no longer be possible to identify and remove your individual data from the dataset.

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Will my interview be recorded, and what will happen to the recording?

With your permission, your interview will be recorded so that we can accurately capture what you share, rather than relying on handwritten notes.  

Your recording will be transcribed (written up as text), with identifying details removed from the transcript, and the original recording will then be deleted. Direct quotes from your interview may be used anonymously in research outputs, but nothing you say will be attributed to you by name. Transcriptions will be stored in a secure data storage facility at the University of Cambridge and will be accessible to approved members of the study team.  

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How will you use information about me?

We will need to use your name, email and/or telephone number that you provide.  People will use this information to do the research. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

The University of Cambridge is the sponsor of this research. The University of Cambridge is responsible for looking after your information. We will share your information related to this research project with the following types of organisations:

• Academic collaborators
• Commercial collaborators

Research data will be shared with external partners only after your personal identifying information has been removed, hence, it will be impossible for them to identify you.

We will keep all information about you safe and secure.  

• The security of storage will fulfil all regulatory requirements for the control of personal information.  
• Electronic documents will be stored in password protected computers and files  

We may share or provide access to data about you outside the UK for research related purposes to:

• Perform specialised analysis
• Compare to other international data

If this happens, we will only share the data that is needed. We will also make sure you can’t be identified from the data that is shared where possible. This may not be possible under certain circumstances – for instance, if you have a rare illness, it may still be possible to identify you. If your data is shared outside the UK, it will be with the following sorts of organisations:

• Academic collaborators

We will make sure your data is protected. Anyone who accesses your data outside the UK must do what we tell them so that your data has a similar level of protection as it does under UK law. We will make sure your data is safe outside the UK by doing the following:

Some of the countries your data will be shared with have an adequacy decision in place. This means that we know their laws offer a similar level of protection to data protection laws in the UK.

We use specific contracts approved for use in the UK which give personal data the same level of protection it has in the UK. For further details visit the Information Commissioner’s Office (ICO) website: https://ico.org.uk/for-organisations/uk-gdpr-guidance-and-resources/international-transfers/.

We do not allow those who access your data outside the UK to use it for anything other than what our written contract with them says.

We need other organisations to have appropriate security measures to protect your data which are consistent with the data security and confidentiality obligations we have. This includes having appropriate measures to protect your data against accidental loss and unauthorised access, use, changes or sharing.

We have procedures in place to deal with any suspected personal data breach. We will tell you and applicable regulators when there has been a breach of your personal data when this is legally required. For further details about UK breach reporting rules visit the Information Commissioner's Office (ICO) website: https://ico.org.uk/for-organisations/report-a-breach.

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How will you use information about me after the study ends?

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. We will keep your study data for a maximum period of 10 years. The study data will then be fully anonymised and securely archived.

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What are my choices about how my information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. You have the right to ask us to access, remove, change or delete data we hold about you for the purposes of the study. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this. You can also object to our processing of your data. If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

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Where can I find out more about how my information is used?

You can find out more about how we use your information via the study website, by asking one of the study team, by sending an email to sparcs-contact@medschl.cam.ac.uk or by calling us on 01223 336883. If you have any concerns about the use of your personal data you can contact the University’s Data Protection Officer: Information Compliance Office, University of Cambridge, The Old Schools, Trinity Lane, Cambridge, CB2 1TN, telephone 01223 764142, or data.protection@admin.cam.ac.uk.

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Who is organising and funding the research?

This study is organised by the University of Cambridge and funded by UKRI R&DMAP - Opportunity Mission.

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Who has reviewed the study?

The scientific case for performing the study was assessed by UKRI who sent the study to external experts for review. The ethics of the study was assessed by an independent group of people, the North West - Greater Manchester West Research Ethics Committee. Their role is to protect your safety, rights, wellbeing and dignity. Both the scientific case and ethics of the study have been reviewed and given favourable opinion.  

Contact for Further Information  

Professor Catherine Aiken

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (email to sparcs-contact@medschl.cam.ac.uk or telephone 01223 336883). If you remain unhappy and wish to complain formally, you can do this by emailing research_governance@medschl.cam.ac.uk.

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Who insures the study?  

The University of Cambridge will arrange insurance for negligent harm caused as a result of protocol design and for non-negligent harm arising through participation in the study.