Cerebral palsy pilot study secondary school information leaflet

Information to be read and discussed with children at secondary school level.

We would like to ask you to take part in a research study called the NeuralNET Cerebral Palsy Pilot Study.

Why is this research study being done?

We want to see if a special type of test called a ‘genetic test’ can help us find out why some children have cerebral palsy. We also want to know what children and their families think about this type of genetic test so we can help doctors decide if the test should be offered to all children with cerebral palsy.

What is a genetic test?

Your bodies are made up of billions of cells. In every cell there is a set of instructions for how our bodies look and how they work.

The instructions are made up of something called DNA.

Sometimes there are unexpected changes in DNA and these can cause a difference with how our bodies work. A genetic test is when a scientist looks at someone’s DNA to see if they can find any changes that might cause them to have a certain health condition, such as cerebral palsy.

Why did you ask me?

You have been asked to take part in this study because you have cerebral palsy. We hope that 100 children with cerebral palsy will agree to take part. We are also asking your parents to take part in the study.

Do I have to take part in the study?

No, you do not have to take part in the study if you do not want to. It is your decision. If you decide you do not want to take part, it won’t change how your doctor treats you.

If I am interested in taking part in the study, what will I be asked to do?

We would like you to read this information sheet with your parent/guardian and think about it. If you have any questions you can ask your parents/guardian, or you can ask someone from the study team. You don’t have to agree to take part.

If you are interested in taking part in the study...

You will visit us at the hospital with your parent/guardian. Your visit should take about an hour. We will talk to you about the study and ask if you agree to take part. Your parent/guardian would also need to agree that you can take part.

If you all agree that you can take part, we will ask you to write your name on a form if you are able. Since you are under the age of 16, we will also ask your mum, dad or guardian to write their name on a form.

After the forms have been signed, we will collect a small blood sample from you. Getting the blood sample might hurt a little bit, but we can give you some special spray or cream to make sure you can hardly feel it.

When you turn 16 years old, we will ask you if you want to continue to take part in the study.

Who else will take part in the study?

As part of the study, we would like to ask your parent/guardian some questions about your diagnosis of cerebral palsy and how it affects your life.

We will ask them questions like...

• What health problems do you have?
• How do your health problems affect your daily life?

We will also ask your parent/guardian to answer some questions about what they think and feel about the genetic testing.

Your mum and/or dad will also be asked if they want to take part in the genetic testing part of the study. If they decide to take part, then we will collect a small blood sample from them too.

How does the study use my blood sample and information?

Your blood sample will be sent for a genetic test to look for changes in genes that are known to cause cerebral palsy.

We will ask your doctor for information about your cerebral palsy which we will put in a database.

The results of the genetic test should be ready about 3 months after your blood is collected at the hospital, and we will send your results to your doctor who will then tell you and your parent(s)/guardian(s).

There are two possible kinds of results you can get from the genetic test:

• We might find a gene change in you that can cause cerebral palsy. This would mean that we think your diagnosis of cerebral palsy had a genetic cause.

OR

• We might not find a gene change in you that causes cerebral palsy. This would make it less likely that your diagnosis of cerebral palsy was due to a genetic cause, but it wouldn’t rule out a genetic cause entirely.

In some rare cases, we might tell you about some other changes that are important for your health.

What else does the study do after I get my genetic test result?

A year after your doctor gives you the genetic test result, we will ask your mum, dad or guardian some more questions on a laptop / tablet / phone about what they think and feel about the testing, and we might have a quick chat with them to ask some questions as well. You can join the chat, too, if you want.

Your family will receive £30 for your time after answering these questions.

Will anyone know I’m taking part?

The people in our research team will know you are taking part and so will your doctor. No one else will know because we will not put your name or address on any of the information that you give us.

We will use a special number for you instead. All the information we collect is stored in a safe place and only the people doing the research study can look at it.

Could taking part be helpful for me or other people?

If you take part in the research study, your result might give us more information about your diagnosis of cerebral palsy that could help you or your family.

If we find a genetic cause for your cerebral palsy, there is a possibility that your doctors could change your medicines or treatment. The result might also be important for other people in your family and your doctor will make sure that everyone is told what they need to know or do next.

However, even if your result is not able help you or your family directly, the information from genetic tests in young people like you with cerebral palsy might be able help other children with cerebral palsy in the future.

Could something go wrong if I do the research?

Sometimes, you can get a sore arm or hand after having blood test, or a bruise, but this won’t last for very long.

Sometimes, the results from the genetic testing can be hard to understand or might cause you or your family to worry. Your doctor and other people can help explain what the result means to you and your family, and can help to find support if you are feeling worried.

What happens to what you find out?

We will collect all the information together from all the children in the research study and work out if genetic testing should be offered to other children who have cerebral palsy.

At the end, we will write a report and submit it for publication in medical magazines and on websites so that other researchers, doctors and the public can read it and learn from it.

What if I change my mind and don’t want to do the research anymore?

You can change your mind about taking part in the study at any time. If you decide later that you don’t want to take part, just tell your parent or guardian so they can let us know.

Could anything else happen after this research study?

If we start a new research study we may ask you if you want to take part in it.

What if I have problems with the research or I want to make a complaint?

If you are unhappy about the research, you or your parent/guardian can talk to us or email the complaints team at cuh.pals@nhs.net or call them on 01223 216756.

What if I would like more information or have a question?

If you or your family have any questions, you can contact us at any time.

You can email Emily Li or Heather Pierce at cuh.neuralnetstudy@nhs.net or you can call us at 01223 768614

Thank you for taking the time to read this.

This patient information leaflet - IRAS 317981_NeuralNET CP Pilot Study Child (Secondary School) PIS_v3.0_27/02/2024 - has been converted to a web page.