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WELCOME TO THE MELLOW BABIES TRIAL

 

COVID-19 update

In response to COVID-19, we have paused patient recruitment into this study. We are continuing to follow-up people who are already taking part. It may be that we are in touch with you by a different method than usual (for example we may telephone you to complete questionnaires, rather than send them by post). If you have any questions about the study, please get in touch on 01463 255903 (and leave a message) or email mellowbabies@abdn.ac.uk.

You can also find information about COVID-19 from the NHS websites in England, Scotland and Wales.

There is also information about COVID-19 on the government website.

What is Mellow Babies?

The Mellow Babies Trial is a research study looking at whether a group programme called ‘Mellow Babies’ can improve mothers’ and babies’ wellbeing.

Being a parent can be wonderful but also brings some tough challenges. It can be harder if parents are not in a good emotional state themselves. All young children have social and emotional ups and downs, but sometimes problems can continue. Research shows that if families have the right help and support then this can prevent long term problems for the child.

Mellow Babies is a group for mothers who want to develop and improve their relationship with their baby.

The groups look at mothers’ feelings of wellbeing (happiness and sadness / feeling hopeless or not being able to cope as well as they would wish). It also looks at the way mothers talk to and behave with their baby. Mellow Babies aims to help mothers both feel better in themselves and about how they talk and play with their babies.

This research study will compare outcomes for families who take part in Mellow Babies with families who do not take part in Mellow Babies (referred to as ‘usual care’ or ‘comparison group’). Usual care can include a range of things relevant to a specific family, but is likely to include support from health visitors, GPs and maybe other professionals.
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Can I take part?

You may be eligible to take part in the Mellow Babies Trial if:

  • You are a mother over 16 years old
  • Your baby is between 6 and 18 months old
  • You live in the Highland Council region
  • Are experiencing low mood or anxiety, and you would like to develop and improve your relationship with your baby

If you would like to hear more information about the Mellow Babies Trial please contact Avril Donaldson, Research Nurse at the Highland Clinical Research Facility on 01463 255820, or talk to your health visitor or GP.

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If you are interested in taking part, or have any questions?

Key facts about the study and documents

What is this study about?

If you decide to take part, the research nurse will make an appointment to visit you at home. You will be asked to sign a consent form and to answer some questions about your wellbeing. After this you will be chosen at random (like tossing a coin) to either join a Mellow Babies group, or the comparison group (who will not take part in a Mellow Babies group).

If you are randomised to join a Mellow Babies group, a practitioner will contact you to discuss when and where the next Mellow Babies group will be held.

The group lasts 14 weeks, and you may have to wait a few weeks before the next available group starts. Groups run within school hours, and a crèche, transport and refreshments and lunch for you and your baby are provided.

Participants in both the Mellow Babies and comparison groups will be contacted by a researcher to arrange for another study visit about 8 months later, and again when your baby reaches 30 months old. All the research information we collect is treated confidentially and entered directly onto a secure part of this website. Only the research staff can access this.

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You can find out more information about MellowBabies here:

Download documents:

Key contacts

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Organisation

Funding acknowledgement
The Mellow Babies Trial is funded by the National Institute for Healthcare Research Public Health Research committee. It is being run by the University of Aberdeen with support from the NHS Highland Clinical Research Facility (funded by the Chief Scientist Office).

Research Partners

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General Data Protection Regulation (GDPR)

Participant Information

University of Aberdeen/NHS Grampian is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen/NHS Grampian will keep identifiable information about you at least 10 years after the study has finished.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information https://www.abdn.ac.uk/about/privacy/