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

What is the THRIVE trial?

There are a number of parenting support programmes running in Scotland that are designed to improve the health and wellbeing of mothers and their babies and promote happy families. The THRIVE trial aims to find out if two such programmes, Enhanced Triple P for Baby (ETPB) and Mellow Bumps (MB) 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 families and if the benefits carry on as the infant grows. This kind of research may help health practitioners to offer the right kind of help to give families the best start in life.

Why have I been selected?

You have been selected to take part in the trial because your partner has agreed to be a part of it. The focus of the study will be on your partner and her relationship with your baby. However, we would also like to speak with the partners of the mum’s in order to hear your views and opinions on becoming a parent and also to find out what you thought about the parenting programmes.

What does it mean for my partner?

Your partner’s involvement in the study will mean that she will be helping us to find out which of the parenting support programmes are most helpful to families in Scotland. If your partner expressed interest in taking part in the study one of our researchers will arrange to meet her so that they could answer any questions that you both may have about it. If she decides to take part she will be asked to complete a consent form.

She will be contacted within 8 weeks to tell her which group she will be taking part in. This will be one of three groups; Enhanced Triple P for Baby, Mellow Bumps or routine maternity care. She will not be able to choose which group she will be in.

We will next be in touch with her when your baby is 6 months old to ask to meet with her again. At this time we would like to take a short video recording (15 minutes) of your partner and baby together, perhaps when she is feeding him/her or playing together. She will also be asked to fill out a questionnaire similar to the one she did before, it will also include questions on how she has found being a parent. This visit will take about 1 hour.

We would like your partner to repeat these tasks again when your baby is 18 months old. At this meeting the researcher will ask her to complete a final questionnaire on your baby’s language development.

In order to thank your partner for her time we will offer her a voucher (£15) that she can use to buy something for herself, your baby or the family.

Finally, we would like to access routine information such as the weight of your baby along with information about the services your partner uses 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.

Some women who participate in the groups may also be asked if they would take part in a one-to-one interview about their experience of taking part in the trial with a member of the research team. These interviews will take place after the interventions have finished and before the baby is born.

What does it mean for me?

If your partner is taking part in the parenting support programmes Triple P for Baby or Mellow Bumps you will be invited to come along to some of the sessions. You do not have to do this; although it might help you both get the most out of the programmes and could help to give your family the best start in life.

As part of this trial a researcher would like to contact the partners of the women taking part in the study. They would like to find out if the partners can affect the bond between the mother and baby and what affect they have on the mother’s involvement in the support groups. They would also like to speak to some partners about their feelings on becoming a parent and their views on the parenting programmes.

If you would like to take part in the trial the researcher will ask your partner for your contact details and arrange to meet you in order to discuss the study and answer any questions you might have. If you are happy to take part in the study you will be asked to sign a consent form. You will then be asked to fill out a short questionnaire on your expectations and experiences of becoming a parent as well as your views on the parenting group your partner is involved in. The researcher will also ask if you would be interested in being interviewed to discuss these topics further. The interview will take place at the beginning of the study during the support groups. You may be asked to take part in a second interview which would take place after your child is born. These interviews would take place at a location that is convenient 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.

Where can I find out more information?

If you would like more information you could go to the 'contact us' section of our website. Alternatively you can contact the THRIVE team by telephone on 0800 389 2129 or email us at either sphsu-thrive@glasgow.ac.uk or thrive@sphsu.mrc.ac.uk.

Will my involvement be confidential?

Yes, the answers you give will be completely anonymous. However, if we feel that you are putting yourself, your partner or your baby at risk we will need to contact the appropriate health or social care professionals. All data will be stored in a locked filing cabinet accessed only by the researcher and other people involved in the research to check that the study is being carried out correctly. All of these people will have a duty of confidentiality to you. This means that they will not discuss you with anyone outside of the study or with any of the other participants. Any information that has your personal information will be stored separate to your answers, also in locked storage.

Who has approved the study?

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