Information For Caregivers
What does participation involve?
You will be responsible for ensuring that your child attends the study visits to meet with your study doctor and other study staff. It is important to know that some days in clinic may be quite long and tiresome because the study team will need to take a range of samples from your child as well as monitor their condition. You will need to factor this into the planning of any family or work commitments.
As the caregiver of the participant in this study, you will be required to complete a number of assessments yourself. These assessments will accurately report any changes you see in your child’s condition. At the start of the trial, you will receive some training on how to complete the assessments that you’ll take home. These assessments will need to be completed within 24 hours of the study visit.
It is important to know that you will be responsible for making sure the child takes their study medication according to the dose prescribed by the study team. There will be 2 doses each day, one in the morning, and one in the afternoon or evening. The dose will be dependent on your child’s weight. There should be a minimum of 8 hours between each dose, and it should be given on an empty stomach.
Providing consent on behalf of the participant
Before your child can be enrolled into the clinical trial, they need to provide their consent. Informed consent involves providing the potential participant with all the information they need to make an informed decision about participation in a clinical trial and decide if the treatment is right for them.
Due to the nature of Prader-Willi syndrome you will be required to provide informed consent on behalf of your child.
Understanding that you’ll be deciding to participate in this trial on behalf of your child may take some time and that is okay. You must make this decision independently, without the influence of the study team. However, your study doctor will be able to answer any specific questions you may have that will help you decide.
Accurately completing caregiver assessments
You will be required to complete a number of caregiver assessments. These will help us understand whether individuals see improvement or benefit from taking the study medication. This will also help us understand how your child is progressing throughout the study. Here are a list of important items to keep in mind:
- Ensure you fill out each assessment as accurately as possible.
- The same caregiver should complete each assessment throughout the study.
- Keep in mind the natural bias you will have of wanting to see an improvement in your child’s symptoms and behaviors. This is a natural response, but all assessments should be answered as honestly as possible.
What can you do to minimise this bias?
The good news is that merely being aware of this can help control this bias and help you to objectively assess your child’s progress.
Here are some tips to help you minimise your unintentional bias:
- Objectively provide accurate reports at all times
- Recognise that it is acceptable to report “no change”. You won’t be letting the site staff down if the study treatment doesn’t work
- Recognise that the study drug may not work or may work in ways you do not expect
- Recognise that your own mood or level of optimism/pessimism may influence the score you give on each assessment
Social media
It is strongly encouraged that you don’t publicly post about your child’s involvement in this clinical trial on any social media platforms. This is because it may influence how you and others rate/assess a child’s progress. You may be in similar networks or circles with other families who are participating in this trial and your perspective may influence how they assess their child’s response to the treatment in this trial, and vice versa.
