THRIVE: Trial of Healthy Relationships Initiatives for the Very Early years

What is the THRIVE trial?

The THRIVE trial has been set up to help address the needs of women who have additional health and social care needs in pregnancy such as those who have experienced mental health difficulties, domestic abuse, substance misuse or have been in care. There are a number of parenting support groups running in Scotland that are designed to improve the health and wellbeing of mothers and their babies. The trial aims to find out if two such groups, Enhanced Triple P for Baby and Mellow Bumps benefit mothers by improving their wellbeing and the relationship between them and their baby compared to current treatments being offered. We are also interested in finding out if one group is more helpful to mothers and their child and if the benefits carry on as the infant grows. This kind of research may help health professionals to offer the right kind of help to give mothers and their babies the best start in life.

Why have I been selected?

You have been asked to take part in the study because you are currently pregnant and your health or social care professional has suggested that you might be interested in helping us with our research.

What will taking part involve?

If you expressed interest in taking part in the study one of our researchers will arrange to meet you at your home (or a different location of your choice), so that they can answer any questions that you may have about it. You can bring your partner, a family member or friend along to discuss the study with us. If you decide to take part you will be asked to complete a consent form. You will then be asked to complete the first questionnaire of the study. This visit should take about 1 hour and in order to thank you for your time we will offer you a voucher (£15) so that you can buy something for yourself or for your baby.

You will be contacted again at the following times:

1. Within 8 weeks of completing the first questionnaire a researcher will contact you to tell you if you will be attending an Enhanced Triple P for Baby Mellow Bumps or routine maternity care. You cannot choose which group you will be in. If you are in the Enhanced Triple P for Baby or Mellow Bumps groups you will continue to receive your routine maternity care. We will cover of the cost of the group and arrange for a taxi to take you to and from the venue. If you are in the routine maternity care group you will receive your routine maternity care alone and will not take part in Enhanced Triple P for Baby or Mellow Bumps sessions.

2. For the Enhanced Triple P for Baby or Mellow Bump groups you will contacted after your baby is 6 weeks old in order to arrange the postnatal part(s) of the groups. You may also be asked to take part in a telephone interview to discuss your experiences of the postnatal part of the groups. These telephone interviews should take no more than 30 mins.

3. When your baby is 6 months old we would like to take a short video recording (15 minutes) of you and your baby together, perhaps when you are playing together. You will be asked to fill out a questionnaire similar to the one you did before, it will also include a questionnaire on your experiences of being a parent. This visit will take about one hour, and in order to thank you for your time we will offer you a £15 voucher so that you can buy something for yourself or for your baby. When your baby is around 18 months old we will ask you to complete the same tasks you completed when your baby was around 6 months old. We will also you to complete a short questionnaire on your baby’s language development. This visit will take about 1 hour and 15 minutes and in order to thank you for your time we will offer you a £15 voucher so that you can buy something for yourself or your baby.

4. You may also be asked to take part in a one-to-one interview to discuss your experience of taking part in the study with a member of the research team. The interviews will take place at different points throughout your involvement in the trial. Interviews will be conducted face-to-face in your home or another location of your choice. The interview(s) will take no more than 1 hour and in order to thank you for your time we will offer you a £15 voucher so that you can buy something for yourself or your baby

Finally, we would like to access routine information such as the weight of your baby along with information about the services you use after your baby is born. We would also like to find out how your baby grows by looking at the health information that is collected routinely as children grow up including information from social work, education and justice departments.

Will my involvement be confidential?

Yes. The answers you give will be completely anonymous. However, if we feel that you are or your baby is at risk we will need to contact your health or social care professional in order to keep you safe. All data will be stored in a locked filing cabinet and will only be seen by the researchers and authorised persons to check that the study is being carried out correctly. All of these people will have a duty of confidentiality to you as a participant. This means that they will not discuss your information with anyone that is not involved in the study. Your personal contact details will be stored away from your other answers. This means that the people analysing the information will not be able to see your name.

Video footage taken during the assessments of you and your baby will also be stored in locked filing cabinets and will only be viewed by members of the research team. An external researcher will look at the video footage to make sure that we are analyzing it correctly.

If you become distressed during a group session, assessment or a telephone consultation, the researcher or group facilitator might want to contact your care coordinator, GP or Health Visitor so that they can offer you help and support. With your consent, she may contact these health care professionals for you.

What will happen to the results of the study?

Once all the data has been collected and analysed, the findings will be written up in a report which will be sent to academic journals to be published and the findings will be presented at academic conferences. A summary report of the findings will also be written for participants. If you would like a copy of this summary, you will receive it when the study has finished.

How can I change my contact details?

Each time we see you we will double check your details with you and you will have the opportunity to make changes. If you would like to change any contact details between these times you can call us on 0800 389 2129 or email us at either sphsu-thrive@glasgow.ac.uk or thrive@sphsu.mrc.ac.uk and we will update your details for you.

Who has approved the study?

This study has been reviewed and approved by the West of Scotland NHS Research Ethics Committee (3).

 

Information Sheet

Click on the link below to download

Participant Information Sheet: Mother