Research Project

Healthy and 18 to 35 years?

CAN YOU HELP US ?

Protocol [2009139] : A Mental Health Biomarker Project

Project title: Towards biomarkers predictive of risk of schizophrenia, psychosis and sensory processing disorder.

We are seeking mentally-healthy volunteers with normal vision (may wear glasses) and normal hearing between 18 and 35 years of age, to participate in a research project.

We believe this project is of potential importance in helping to prevent mental illness.

 

If you decide to participate, we need to be sure that you understand why we are doing it, and what it would involve if you agreed to participate. We are therefore providing you with the following information.  Please read it carefully and be sure to ask any questions you have.  You can ring the researchers conducting the research and they will be happy to discuss it with you and answer any questions that you may have. You are also free to discuss it with outsiders if you wish (ie family, friends and/or your local doctor). You do not have to make an immediate decision.  Your participation in this study is purely voluntary, and you are under no pressure to participate. Should you agree to participate in the research project, you may change your mind and withdraw at any stage.

What is the study about?

We are seeking your involvement in a study that aims to assist doctors with the prevention of illness in future generations of Australians, and in particular pick up mental illness early in children, before it has a chance to take hold. If this can be achieved it would not only be a wonderful scientific advance, but also save a lot of people from a lot of future suffering and disability with mental illness. WE have already tested a group of people with a mental illness and we now need an equal number  of mentally-healthy young volunteers to participate  as a comparison control group. Therefore, if you are a person who is fortunate in not having any mental health concerns and you would like to assist us in this way. you should carefully read the information below and take time to think about it.

How does the study work?

Taking part in the study is voluntary and you can withdraw at any stage.  A member of the research team will be ringing to invite you to participate in a one hour clinic visit at Basil Hetzel Research Institute, (opposite the Queen Elizabeth Hospital Car Park). You will be asked to give your written consent to take part before the clinic examination. 

What happens during this study?

If you agree to take part in this study, you will be asked  to attend a clinic visit that will take about an hour.  Appointments are available at either 9.00 or 10.00 am from Tuesdays through to Saturdays. During this visit, you will be asked for some related health information as well as the following:

v  A hearing test  - This will involve listening with earphones to test hearing discrimination in different hearing conditions. It will also involve an ear examination and testing of the ear's muscle's ability to respond to sound coming into the ear canal. There are also speech and earphone tests to determine how accurately and fast sound is processed. All sounds in these tests are in the normal hearing range and these procedures are painless with no associated risk.

v   A vision test - These tests are like the  normal tests that you have at an optician for near and distance vision. Ane eye examination will check for abnormal eye movements and visual patterns on cards and two small flashing lights will be used to determine how accurately and fast you process visual information. These procedures are painless and have no associated risk.

v  A sample of urine (first void in the morning) - to be collected in a container which is included in a collection information pack.

v  A fasting blood test approximately 50mls (about 5 tablespoons) of blood will be taken to measure nutrition and biological markers.  The overnight fast means drinking as much water as you need, but having nothing to eat for at least 8 hours, or from 12 midnight before your appointment. The blood test is taken in the usual way and may involve some minor discomfort and there is a slight risk of discomfort, bruising, bleeding and swelling or rarely, infection, at the site where the blood is taken for testing.

What happens to the results?

Sometimes people who do not have any mental illness problems can turn up with an abnormal test result. This is quite usual and may not a problem to them - perhaps there is a low vitamin level or an unknown problem with  hearing or vision, which can be corrected.  If this does turn out to be the case, we will advise you or your GP about how to correct a vitamin deficiency or about consulting an audiologist or optometrist for further testing. 

What will I get out of this study?

You may not directly benefit from participation in this study, but the knowledge gained from your participation may benefit others. Optional reimbursement of $15 can be provided to you to cover travelling costs if you require this.

What happens to the results?

All data generated from this study will be treated with the utmost confidentiality without reference to your name.. The data collected will be analysed by the research team and the results may publish the findings in academic journals.  Reports or publications will not contain information that can be associated with you.

Voluntary Participation

You should feel free to discuss the matter with a relative, friend or your local doctor. It is important that you understand that your participation in this project is voluntary. If you decide to take part, but later change your mind, you are free to withdraw from the project at any stage. Your involvement in this study will not affect any care and attention that you get at the Adelaide Health Service (including The Queen Elizabeth and Lyell McEwin Hospitals) or from your general practitioner.  You do not waive any legal rights by taking part in the study.

What if I have a question about the study?

If you would like more information about the study or have any questions, you can contact

Natasha Radcliffe   on mobile  0410 584 299 or  Dr Stephanie Fryar-Williams on (mobile) 0414 941 123.

WE NEED TO FINISH THIS PROJECT BEFORE CHRISTMAS, SO PLEASE CALL US TO DISCUSS  YOUR VOLUNTEERING

OR LET US ANSWER ANY QUESTIONS YOU MAY HAVE.

 

This study is in association with The University of Adelaide Department of Psychiatry. The study has been approved by the Adelaide Health Service Ethics of Human Research Committee. Should you wish to speak to a person not directly involved, in particular in relation to matters concerning policies, information about the conduct of the study or your rights as a participant, or should you wish to make a confidential complaint, you may contact the Executive Officer of the Adelaide Health Service Ethics of Human Research Committee on (tel) 8222 6841.