University of Southampton – ADHD Research Collaboration

Helping doctors worldwide better predict the most effective medicine for each individual child with ADHD more quickly, thereby reducing time and money spent by parents on trailing different ADHD medications for their child.

Background

Many children with ADHD find it hard to focus and often feel the need to move around more. In the UK, over 150,000 children aged 6 to 12 have ADHD. Without treatment, ADHD can cause big problems for them and society. Medicine is an important way to help, but doctors sometimes don’t know which medicine works best for each child right away. This means children might have to switch medicines a few times, which can be frustrating. If the wrong medicine is given, children might not feel good and could stop taking any medicine. This is why it’s really important to find the right medicine based on each child’s needs and preferences.

When the right medication is found, it helps with ADHD and other issues like feeling sad or getting hurt.

The University of Southampton plan to create and test an online system that will help children with ADHD, their caregivers, and doctors work together to find the best medicine for each child. If you decide to take part, then you would be helping The University of Southampton in this research. The University of Southampton can then use this information to develop better support for children and young people with ADHD.

If you child is a patient of The Giaroli Centre and has:

• received an ADHD diagnosis; and
• is under 18 years old

Then if you and your child consent, they are eligible to participate in this University of Southampton research.

The participation involves only the careful and confidential sharing of some of your child’s data from The Giaroli Centre to The University of Southampton, participation does not change any treatment plan whatsoever, it only regards data sharing.

This project only uses the data already available here at The Giaroli Centre, so you and your child won’t need to actively participate.

With consent from both you and your child, The University of Southampton would then carefully, confidentially and securely collect your child’s data from The Giaroli Centre.

Please contact us on research@dr-giaroli.org, we will send both you and your child some specific forms to sign, and further information packs. These forms must be signed by both your child and yourself.

You and your child might not get anything out of this right away, but your child’s information could help with important research.

It could help doctors worldwide in the future find the right medicine for children with ADHD more quickly, without wasting time or money.

No.

Neither your child, nor yourself nor The Giaroli Centre receive any money or financial incentives for whether (or not) you and your child choose to participate in this research.

The Giaroli Centre proudly contributes it’s efforts towards all scientific research collaborations on a charitable basis.

The participation purely involves the consent to share your child’s data.

Your child’s medications and treatment plan is not affected nor changed as a result of participating.

Note: Globally, some other research studies may involve medication trials and ‘placebos’, however that is not the case with this research collaboration with The University of Southampton, which is purely about consent to carefully, confidentially and securely share your child’s data with The University of Southampton’s researchers.

If you and your child consent, then even though one of the The University of Southampton researchers (Sulagna Roy, see contact details below) would look at your child’s personal information (including your name) through the Giaroli Centre’s computer system, this is done under a strict non-disclosure confidentiality agreement (being rules that make sure your child’s information is kept private and safe).

• The researcher will use this information to contact you to ask for your consent to use your child’s data, and, with your consent and your child’s assent, the researcher will extract useful data for research purposes.
• Only the parts that do not include your child’s name or personal details (this is called pseudonymised data) would be sent to researchers at the University of Southampton.
• The Giaroli Centre will share some of your child’s personal info, like their date of birth, gender, ethnicity, and health data (such as their height, weight, medicines, blood pressure, and heart rate) with a research team at the University of Southampton.

Your child’s information will be kept safe, and the University of Southampton research team won’t know it’s your child’s because your child’s name and details will stay with The Giaroli Centre.

You and your child’s participation and the information we collect will stay private.

Only The Giaroli Centre’s research team and some staff from the University of Southampton can look at your child’s data to check things, and they all have to keep your information secret and safe under legal confidentiality agreements in place.

No.

Taking part is 100% optional, and we would need signed consent from both you and your child.

You and/or your child can decide to leave the study at any time, and you don’t have to give a reason.

If you do leave, the University of Southampton still confidentially keep the information they collected about your child prior to them leaving the study, but the University of Southampton will only use your child’s information to help them with the research study.

Please ask us as many questions as you like, by emailing research@dr-giaroli.org

If you or your child is considering taking part or have questions about this study, you can talk to one of the members of the study team. They will do their best to help and give you answers.

• Professor Samuele Cortese
• NIHR Research Professor
• Principal Investigator
• research@dr-giaroli.org

• Sulagna Roy
• Senior Research Assistant & PhD Student
• research@dr-giaroli.org

You and your child’s personal details will stay completely private, and no one will be able to tell it’s your child in any reports or papers without your clear and express written permission.

In the future, the University of Southampton might keep the information for further studies, but it would be pseudonymised so no one can tell who it belongs to.

For the purposes of data protection law, the University of Southampton is the ‘Data Controller’ for this study, we will need to use information from your child’s medical records for this research project. This will be accessed by the members of the Giaroli Centre and one of the researchers from the University (Sulagna Roy) and the below mentioned data will be transferred to the research team at the University of Southampton.

Your name, contact details and any other kind of identifiers will not be shared with the other research staff at the University, except for the researcher (Sulagna Roy), who will look at your child’s personal information (including your name) through the Giaroli Centre’s computer system, this will be done under strict non-disclosure confidentiality clauses (that is rules that make sure you and your child’s information is kept private and safe). The researcher will use this information to contact you to ask for your consent to use your child’s data, and, with your consent and your child’s assent, the researcher will extract useful data for research purposes. Therefore, the data transferred to the University of Southampton will have a code number instead.

This information will include your  child’s date of birth, gender, ethnicity and clinical health related data like psychiatric comorbidities, body mass index (height and weight), medicines in use. Research staff at the University of Southampton will use this information to do the research or to check your records to make sure that the research is being done properly.

The University of Southampton will keep all information about you safe and secure.

Once the University of Southampton has finished the study, they will keep some of the data so that they can check the results. They will write their reports in a way that no-one can work out that your child and you took part in the study.

• You can stop being part of the study at any time, without giving a reason, but the University of Southampton will keep all anonymous information about your child that they may already have.
• The University of Southampton needs manage your child’s records in specific ways for the research to be useful, this may mean that they won’t be able to let you see or change the data that they hold about your child or yourself.
• If you and your child agree to take part in this study, you will both have the option to take part in future research using the data saved from this study.

You can find out more about how the University of Southampton uses data in this study, by:

• emailing University of Southampton’s Data Protection Officer data.protection@soton.ac.uk
• click here to read University of Southampton’s Privacy Notice
• emailing research@dr-giaroli.org