Aleya Marzuki is a graduate psychology student at the University of Cambridge and she is currently recruiting participants aged 12 to 19 for a study titled Early Onset OCD.
The purpose of this research is to study the mental functions and behaviours of young people with obsessive-compulsive disorder. The participants will need to complete a few computer tasks that are like games or puzzles. They would also need to complete a few questionnaires. With the participant’s consent, their parents/siblings will be invited to complete the same task. Each participant will be paid £8 an hour for their time and be reimbursed for any travel expenses.
Please take time to read the information below and to discuss it with your parent or guardian. Do contact Aleya at firstname.lastname@example.org if you're interested or have any queries. (Participant Information Sheet for parents/siblings is attached below)
Part 1 tells you the purpose of this study and what will happen to you if you take part. Part 2 gives you more detailed information about the study.
Why have I been invited?
You have been invited because you are a young person who has obsessive-compulsive disorder.
Do I have to take part?
It is up to you to decide to join the study. We will describe the study and go through this information sheet. If you agree to take part, we will then ask you to sign a consent form. You are free to withdraw at any time, without giving a reason. This would not affect the standard of care you receive.
What will happen to me if I take part?
If you decide to take part, then you will first be interviewed via telephone by a psychiatrist, who will ask you questions in order to ensure that you are suitable for this study. If you are indeed suitable for the study, then we will invite you to participate and arrange a testing session at a mutually convenient date and time. On the day of testing, you will first be interviewed briefly by a psychiatrist – either from the University of Cambridge or from the Trust in which you are receiving treatment --in order to gather information about the symptoms of obsessive-compulsive disorder you experience. Then, you will be asked to perform simple computerised tasks that involve evaluating items, such as letters or numbers or pictures, and responding to them by pressing buttons. The tasks are perceived as simple games or puzzles and do not usually present volunteers with any significant problems. Finally, you will be asked to complete several questionnaires that assess clinical characteristics, such as severity of obsessive-compulsive symptoms and anxiety.
For participants willing to travel to Cambridge for testing: All study procedures will take place in a dedicated testing room in the Behavioural and Clinical Neuroscience Institute, Downing Site, Cambridge, CB2 3EB or in the Herchel Smith Building, Addenbrooke’s Site, Cambridge, CB2 0SZ. Otherwise, study procedures will take place in your local Trust, in a testing room on a Trust site. Following the interview with the psychiatrist, computerised tests and questionnaires will be intermixed. After you have completed 2 tests (or after approximately 45 minutes), we will let you have a 5-10 minute break. For example, you will complete 1 tests on the computer, then 1 questionnaire, then you will have a break. The testing session will be no longer than 3 hours.
Expenses and payments
Each family will be compensated for their time at the rate of £8 per hour (one person); additionally, you will be reimbursed for travel expenses.
What are the possible disadvantages and risks of taking part?
In the unlikely event that you become agitated during the testing session, then we will suspend the session, and the researcher or psychiatrist will discuss with you what has caused you to become upset. We will resume only if you wish to continue.
What are the possible benefits of taking part?
You would have the pleasure of knowing that you made a contribution to the understanding of obsessive-compulsive disorder. However, there will be no direct therapeutic benefits of taking part in this study.
What happens when the research study stops?
When data from several volunteers have been collected, they will be analyzed and written up for publication in a scientific journal. The results may also be presented at scientific meetings or during lectures at academic institutions. Data will be presented without reference to your name or other identifiers.
What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. The detailed information on this is given in Part 2.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The details are included in Part 2.
What if relevant new information becomes available?
If new information pertains specifically to your health, you will be informed. Otherwise, new information will be disseminated through traditional scientific channels (journal articles and conference presentations).
What will happen if I don’t want to carry on with the study?
You are free to withdraw at any time, without giving a reason. This will not affect the standard of care you receive. If you withdraw from the study, any data that has been collected from you will be destroyed.
What if there is a problem?
If you have a concern(s) about the study, you can bring it immediately to the attention of the experimenter, Aleya Marzuki (telephone: 07845667907; email: email@example.com), and/or you can contact the Chief Investigator, Professor Barbara Sahakian, whose contact information can be found on the last page of the Participant’s Sheet, attached below.
Will my taking part in this study be kept confidential?
All data are handled in compliance with the relevant UK statutory and Data protection laws. All information that is collected from or about you during the course of the study will be kept strictly confidential. All data will be catalogued by participant identification number, thus strictly without reference to participant name or other identifiers. All consent forms, clinical scales, and questionnaires, and the master list linking names with participant identification numbers will be stored in a locked cabinet in a locked office in the Department of Experimental Psychology at the University of Cambridge and will be accessible only to the members of the study team and regulatory authorities, who monitor the quality of research, such as the University of Cambridge. If you agree, the clinical scales and questionnaires may be shared with the Trust in which you are receiving treatment. All computerised data will be stored electronically in password-protected files. The data will be evaluated and analyzed by the study team for research purposes only. Analysis will take place in the Department of Psychiatry. The data may be reported in the form of internal reports and scientific papers and presentations. As per established guidelines, research data will be stored for 10 years after the conclusion of the study using participant identification numbers to ensure anonymity. All inquiries concerning access to data held by the Departments of Experimental Psychology and Psychiatry at the University of Cambridge should be addressed to the Administrator, Dr. Jeanne Estabel, in the first instance. Confidentiality will broken only if you disclose information indicating risk of harm to yourself or others, in which case the researcher will notify the appropriate authority.
Will my GP be informed?
Your GP will not be informed of your participation unless you wish it or in the unlikely event that information indicating risk of harm is disclosed (as described above).
What will happen to the results of the research study?
The results will be communication to other members of the study team and will be reported in scientific papers and presentations. You will not be identified in any of the above. The results of the study will contribute to the understanding of obsessive-compulsive disorder.
Who is organising and funding the research?
This study is being organised by the Departments of Experimental Psychology and Psychiatry at the University of Cambridge and in part fulfilment of an MPhil. (Aleya Marzuki). It is being funded by a Wellcome Trust Programme Grant.
Who has reviewed the study?
All research in the NHS is looked at by independent group of people, called a Research Ethics Committee to protect your interests. This study has been reviewed and given a favourable opinion by the Essex 1 Research Ethics Committee.
Are there compensation arrangements if something goes wrong?
In the unlikely event of anything unfavorable happening, the Chief Investigator has arranged insurance for negligent and non-negligent harm to volunteer participants in this research project. If you wish to make a complaint, formally or informally, you could contact the experimenter, the chief investigator (see contact information below), or Dr. Jeanne Estabel, who is the administrator of the Department of Experimental Psychology at the University of Cambridge.
If anything is not clear or you would like more information you can contact Aleya Marzuki at firstname.lastname@example.org
You can also call her on +44(0)7845667907