What's involved?

What will you be asked to do?

We would like to invite you to participate in this original research project and you should only participate if you want to; choosing not to take part will not disadvantage you or your child in any way.

1. Information and consent

First, you and your child will receive information sheets about the study to explain what participation involves.
We would like to make sure that you give well informed consent. That is, if you have questions after reading the information, please feel free to contact our research team either by email, mail or phone (see contact us for more details) (link).

Once you and your child have decided to participate, both should sign the consent forms and send them back to us. We will also ask you to fill in a short parents' questionnaire. This will check for medical and other reasons for potential inclusion or exclusion from the study.

2. Computer programme at home

We will then give you a phone call to tell you whether you can take part in the study and give information about your next step on the journey.

Your child will be asked to install a software programme on a computer with internet connection at home and run the programme - this will include completing several questionnaires that focus on how your child feels (e.g. fearful, happy etc.) and on his or her personality and thinking style. Furthermore, there will be some reaction time tasks - these can be a lot of fun but also challenging for your child!

We will send your child the information on how to do this by mail or email.

We will ask that you allow your child the time and space to complete these tests in privacy so as to facilitate honest and focused responding.

3. Assessment session at our research institute

Once we have received the data from the home testing, you and your child will be invited to participate in another assessment session that will take place at the Research Centre.

At the research institute, we would like YOU to share your impressions of your child as well as to tell us about yourself. Therefore, we will ask you to answer questions using a computer and take part in an interview.

In the interview, we will ask you about common psychological symptoms such as depression and anxiety, as well as drug and alcohol use and other risk-taking behaviours in your child.

On the same day, we will ask YOUR CHILD to take part in an interview, to do some more reaction tasks.

Your child will also be asked to perform a number of tasks while lying in a magnetic resonance or MR scanner. These tasks measure the thinking style and reaction times. While doing the tasks, the scanner takes pictures of the working brain.

In order to be able to do analyses on specific genetic characteristics we would like to take a blood sample from your child on the day you are at the Research Centre for the purpose of DNA extraction.

4. Follow-up:

About 2 years after these assessments we will call all participants and inquire in a telephone interview, how they are doing and if they have changed their behaviour or attitudes as compared to 2 years earlier.

Confidentiality:

'Will our data be kept confidentially?'

We do not make your details known to third parties and keep the information you give us confidential. In particular, information revealed to us will remain confidential from the other members of your family. Therefore, your child's responses will also be kept confidential.

Personal data and results from the studies will be stored in such a manner that no unauthorized person will be able to access them. When personal data and biological material are to be transferred to another research site, it will be transferred in anonymized coded form only.

All personal data e.g. name and address will be kept strictly separate from the questionnaires, the interview and the DNA and image data. All information will be pseudonymized before being used for scientific analysis. "Pseudoymized" means that the questionnaires, the interview, and the results of the imaging will be kept under a special code number when sent for analysis. Personal data will not be disclosed to the scientists carrying out the scientific analyses.

'Would there be any potential risks for my child or me if we were to participate in the study?'

Psychological assessment:

Answering the questionnaires and doing the interview are not associated with any risks for your child or yourself. Similarly, the reaction time tasks do not cause any harm to your child.

Magnetic Resonance Imaging (MRI) studies:

Magnetic Resonance Imaging or MRI is a standard non-invasive clinical procedure involving no radiation. Therefore, MRI can be safely applied to adolescent volunteers. The magnetic fields produce no known tissue damage of any kind. The studies do not involve the administration of contrast agents. MRI can interfere with magnetic body implants. It is therefore essential to screen all volunteers undergoing MRI before they enter the MR suite. In addition, electronic devices may malfunction in the MR environment. We therefore strictly exclude from MR scanning all volunteers carrying such a device, even if there is doubt as to its presence. The radiofrequency used for MR imaging may be absorbed by heat conducting materials, and thus lead to increases in temperature. This can occur, for instance, with large tattoos (which contain iron particles) or dental bridges. Again, this will be investigated carefully by a trained medical doctor and the volunteer will only be allowed to enter the MR suite if no harm can ensue.

Some persons undergoing an MRI may feel confined, closed-in, or frightened. We make sure that the volunteer in the scanner is able to notify the radiographer of this at any time and that they can be removed from the magnet in less than 2 minutes. It is our experience that use of visual stimulation further reduces the feeling of a confinement since the volunteer looks at a visual stimulus and not at the bore of the magnet.

The tasks your child will complete while lying in the scanner do not cause any harm and are without any risk.

Unexpected findings:

The proposed MR procedures are research specific and of minimal medical diagnostic value. The images will not be examined by a neuroradiologist on a routine basis. However, should a physician involved in the analysis incidentally observe a suspicious finding, the scan will be shown to a board certified neuroradiologist. If the neuroradiologist considers the finding to be potentially pathological, you will be contacted and informed by the medical doctor who carried out the initial consent procedure. The neuroradiologist will explain the finding and we will offer further specific investigation. However, it should be noted that you may decline an additional procedure.

'What happens if we want to cancel the participation once we have agreed to participate?'

Participation in this study is entirely voluntary. You and/or your child may withdraw your consent at any time during the study. The withdrawal need not be explained or justified, and it will not have any adverse effects on you or your child. However, once anonymized data has been transferred to the database it will no longer be possible to withdraw your child's data or samples as this data base will not convey participant identity.