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Information Sheet for Participation in a Research Project, Yale School of Medicine

Study Title: Screen Development to Detect the Schizophrenic Prodrome (HIC #11627)

Principal Investigator: Scott W. Woods, M.D.

You are invited to participate in a research study to help the Yale PRIME Research Clinic develop a screener that may help identify young people who are at a higher risk or lower risk for developing a psychotic illness. Your participation would be limited to filling out an on-line survey on the schizophrenia.com website. This website contains a lot of information about psychotic illness. No questions will be asked in the survey that would reveal who you are.

In order to decide whether or not you wish to be a part of this research study you should know enough about its risks and benefits to make an informed decision. This information sheet gives you detailed information about the research study. This discussion will cover all aspects of this research: its purpose, the procedures that will be performed, any risks of the procedures, and possible benefits.

Description of Procedures

If you decide to participate in this study, you will spend not more than 5 minutes filling out an on-line survey. The survey asks 12 questions about the signs and symptoms related to the development of psychotic illness. You will be told whether you screen "positive" or "negative." It is important to remember that the survey is not yet fully developed. Even if it were fully developed, it would still be important to understand that having a positive screen does not mean for sure that you have the early symptoms of schizophrenia or psychosis. By the same token, having a negative screen does not mean for sure that you do not have the early symptoms of schizophrenia or psychosis. An on-line survey cannot take the place of a diagnosis form a clinician. After you complete the survey, the website will offer you suggestions about how to access a clinician for diagnosis. After the first 12 questions there are 4 more questions that ask for some information about you, but answering these questions will not reveal your personal identity. The purpose of these 4 questions is to help us learn whether we can improve the survey. We will also ask if you might do anything different because of taking the survey.

Risks and Inconveniences

There is minimal risk involved in this study. The only risk is that you might think about doing something different in your life because of taking the screen. It may be inconvenient for you to devote your time to it. Once again, remember the survey results do not prove anything about you. If you feel that any of the questions are disturbing in any way, you may choose not to answer them or to just stop at any time.

Benefits

There is no direct medical benefit for your participation. If you decide to consult a clinician or doctor, or if you decide make your data from the survey available to your clinician or doctor, you may benefit from early detection and treatment for mental illness as a result of study participation. You may also benefit from education about symptoms of psychosis, so you can get treatment as soon as possible if psychosis does occur at a later date.

The study could benefit society by determining the degree to which a screener may be effective in identifying people who are at risk for developing a psychotic disorder.

Economic Considerations

You will not be paid. You will not be charged for any study procedure.

Confidentiality

Your identity will not become known to the study staff as a result of the procedures of this study. You will remain anonymous while filling out this survey. Information that you record may be used in publications, but only as a part of a large group of other people, and this information could never be linked to who you are.

Voluntary Participation

You are free to decide not to participate in this study and you are free to withdraw from it at any time. If you decide not to participate in the study or if you withdraw from the study, your decision will not affect your future medical care at Yale University or your current caregivers if any.

Questions

We have used some technical terms in this form. Unfortunately, because this study is anonymous, you cannot ask the investigators about anything that you don't understand. Please consider this research and the information sheet carefully - as long as you feel is necessary - before you make a decision. Feel free to print out this information and discuss any questions you have with a clinician, doctor, family member, or friend if you would like before deciding whether to participate.


 


 

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