Thank you for your interest in this study. 

You are being invited to take part in a research study being carried out by Kristina Micallef Pule, who is a Master’s student at the School of Psychology, University of Galway, and by Professor Brian M. Hughes, who is Kristina’s academic supervisor. 

Professor Hughes is a professor of psychology, but also, most importantly, he is a parent to a 19-year-old young man who has Prader-Willi Syndrome. 

Before you decide whether you wish to take part or not, you should read the information provided below and, if you wish, discuss with family, friends, etc. Take your time and ask questions – don’t feel rushed and don’t feel under pressure to make a quick decision. You should be clear about the risks and benefits of taking part in this study so that you can make a decision that’s right for you. This process is known as ‘Informed Consent’. 

You don’t have to take part in this study. Choosing not to take part will not have any consequences. Our study is being conducted in a university context and we are not involved with any healthcare agencies providing services to persons with PWS. As such, your choice to participate or not participate will have no effect on the services that you and your family are currently receiving. 

However, the information gathered in this study is intended to be useful in shedding light on what it is like to live with and care for a person with PWS, and so we hope it will help to improve the services that everyone receives in the future. 

If you choose to participate, you can always change your mind later. You can change your mind and withdraw from the study without ever having to give us a reason. After you have completed your questionnaires, your information will be stored anonymously. If you want to withdraw from the study, you will need to do so before this happens as, afterwards, we will not be able to identify your responses in order to retract them.  

If you ever have any questions about the questionnaire or the research project, you can always contact one or both of the researchers. 

This study is being carried out to investigate how families deal with the experience of living with and caring for a loved one who has PWS. Families know that life with PWS can often be difficult. Previous studies have suggested that parents and siblings experience a lot of stress. We want to conduct research to examine how families are coping with these challenges, and what helps them to do this well. 

Most previous studies have been very small and have been conducted a long time ago. We want to conduct a more systematic larger-scale study that paints a clearer and more up-to-date picture of these issues, focusing on Ireland’s PWS community. 

Through the data collected from this study, we hope to be able to identify the factors that help or hinder well-being in families who have a loved one with PWS. 

This study is being carried out by a Master’s student and a Professor of Psychology (and PWS parent) at the University of Galway. The study is not funded by any organisation. The PWSAI is assisting us with the logistics of rolling out the study.

You are being asked to take part because you are a parent of a person who has PWS. 

Unfortunately, you cannot take part if you are under the age of 18. Also, as our questionnaires are prepared in English language, you cannot take part if you are unable to communicate comfortably in English. 

The study will be conducted using a set of questionnaires. Our study is looking at families. One or both parents in a single family can participate.  

We will be asking you to fill out some questionnaires. In most cases the questions will be of a ‘tick-the-box’ format, asking you to choose between options (rather than asking you to type in any words or sentences). The questions will ask you a range of questions about your lives, such as your personal well-being, your access to social support, and your feelings of stress. We will also ask you about how you feel your family gets along with each other. And we will ask you about how your other children too – who do not have PWS – and how they are doing. Specifically, we will ask you about your PWS loved one’s eldest sister or brother. 

Please note that your children will not have to complete any questionnaires themselves. 

The questionnaires should take around 20 minutes to complete. 

Some sections of the questionnaires will include standard questions used by psychologists to screen people for mental health issues. However, we will not use clinical tests that formally diagnose mental health problems. 

We will provide the questionnaires online so that you can complete them conveniently. If you want to complete the questionnaires in person with us, we will endeavour to facilitate that for you. You will never be asked to include any identifiable information within these questionnaires. 

We know that our loved ones with PWS are wonderful and affectionate people. Nonetheless, we also know that they face many challenges and that caring for them can be difficult for all the family. Filling out questionnaires about these issues can be hard. As such, we will provide you with whatever information we can about supports you might want to access to help deal with the stress that can arise. 

We want as many families as possible to participate in this research so that our dataset is as informative and broad-ranging as it can be. Both researcher and supervisor will be available and reachable via email should you wish to speak further about your experience.

The data collected in the study will be analysed by the researchers and the findings will be published. All findings will be described in terms of different categories of people (for example, ‘parents’ or ‘siblings’). In other words, the published findings will never describe any single family or person’s situation. This is because we want to ensure that your privacy is always respected and that you always feel free to share your perspective knowing that this is the case. 

By participating in this study, you will be contributing to a body of research that aims to improve the lives of individuals with PWS and their families.  

We want as many participants as possible so that our study can produce a strong dataset. If we are successful, then our study can help to highlight – with empirical evidence — the challenges faced by families with PWS and the factors that might help them deal with those challenges. 

Answering questions about these challenges is difficult. In this study, there is a risk that you might feel mental distress as a result of completing the questionnaires. We want to assure you that, in our view as researchers, the questions are not unduly intrusive or traumatic. The study is an opportunity for you to record how you are doing and to contribute to an evidence base on the experience of living with PWS. If you find the questions unwelcome or uncomfortable, you can withdraw at any time without having to explain yourself to us.  

You may be anxious that participating in the study might affect your relationship with the health services. However, this is not the case. As noted above, the study is being organised in a university context which is entirely unconnected to the health services. Taking part in this study will not affect your access to services in any way, positively or negatively.  

The data provided will be analysed and presented within the findings section of a written report (or multiple such reports). No information that can ever be used to identify you will be included. 

The results will be published in scientific journals and presented at PWS (and other) conferences around the world. They will also be submitted as part of a Master’s thesis at the University of Galway.  

We will explain the findings in a public-facing website and, most likely, via a media release to the press. We will work with PWSAI and other similar agencies internationally to promote the findings in the public domain. We may also prepare other types of reports describing the data, such as submissions to relevant government departments or national consultation exercises. 

In summary, by participating in this research, your experiences will become part of an empirical dataset on families with PWS that can be used to make an evidence-based case for improvements in the services that families like yours receive. 

All data will be stored on secure and encrypted university computer systems. These systems are compliant with all data protections laws and standards, and will only be accessible by the researchers. The data will be anonymised straight away so that your personal identities are not discernible from the digital records. As per legal and ethical requirements, the anonymised dataset will be stored for seven years after which it will be digitally erased. 

All your data will be kept strictly private and confidential subject to all legal requirements.  

(The only legal requirement to share data that could ever arise would be if you tell us about criminal activities that we are then mandated to report to the police. Our questionnaire will not ask you any questions about such matters.) 

Our questionnaires will ask about your well-being. However, although we are psychologists, we are researchers and not clinicians.  

This means that we will not use clinical questionnaires or any method that produces a formal clinical diagnosis. And of course, we will not pass on any personal results relating to your health or wellbeing to any third party. 

You can contact the researcher (Kristina Micallef Pule) via k.micallefpule1@universityofgalway.ie or the research supervisor (Professor Brian Hughes) via brian.hughes@universityofgalway.ie should you require any more information, have any further questions, or would like to discuss your experience further.  

If you wish to contact a neutral third party, email psychology@universityofgalway.ie to communicate with the Head of the University of Galway’s School of Psychology.