INFORMATION SHEET (PARENT)
Principal Investigator: Chloe Shu
Co-Investigators: Dr Sarah Egan, Dr Hunna Watson
What are some general things you should know about research studies?
Your adolescent is invited to take part in a research study looking at the effects of different psychological programs in preventing negative psychological outcomes and promoting mental wellbeing. You will need to give permission for her to be in this study. Kindly note that your adolescent does not have to be this study if she does not want to, even if you have already given permission. She is free to choose whether or not to be in this study and may decide to stop being in the study, at any time, for any reason, without penalty.
What is the purpose of this study?
The purpose of this research study is to see if reducing perfectionism or stress can prevent negative psychological outcomes and promote mental wellbeing. This will be conducted via an online program that lasts 8 sessions over 4 weeks. The online program will include some fun video watching, light readings, short and easy quizzes and some simple and enjoyable hands on activities. Your adolescent will also receive a personalised progress report on how she is doing from the start to end of program and even up to 12 months after the program ends!
Are there any criteria to participate in the study?
She is invited to participate in this study if she or has:
2. 14 to 17 years old
3. Internet access either at home or at a location where regular use is possible (e.g. school. library)
4. Adequate English language skills
5. Access to a General Practitioner who would be able to monitor her physical health
6. Body Mass Index (BMI) equal or above 17.
She is not suitable for the study if she is/has:
1. Currently undergoing psychological therapy
2. Current diagnosis of a clinical eating disorder including anorexia nervosa, bulimia nervosa, binge eating disorder, other or unspecified feeding or eating disorders
What will happen if your adolescent takes part in the study?
If she is interested in participating in the study,
1. She will sign the adolescent consent form online and you will sign the consent form on the next page.
2. In a few days, she will be contacted by phone by Chloe Shu. I will be asking her some questions to see if she is suitable for the program. She will also be able to ask me about any questions she may have.
3. If she is suitable, she will be selected for my study and randomly allocated to one of these three groups: an online program for perfectionism, an online program for stress management group and a waitlist control group. If she is not suitable, I will provide you with some information of services you can get extra help from via email.
4. If she is in the perfectionism program or stress management program, she can start the program immediately. There will be 8 sessions and she can log in twice a week over 4 weeks to complete her program. It would be extremely helpful for you to encourage her to participate in each session.
5. If she is in the control group, she will be reminded to login weekly for the next 4 weeks to complete some short questions. She can choose to participate in the perfectionism or stress management program after 12 months.
6. She will be asked to complete some questionnaires prior to starting the intervention, at the end of the program, at 3 months, 6 months and 12 months after the program.
Who will be told the things we learn about your adolescent in this study?
The information we collect about your adolescent will be kept private. Only the people working on this study will be able to look at the information we collect. It will not affect how her doctor or teacher treats her.
All records containing personal information (such as her name) that we collect will be kept strictly confidential and will be locked in a file at Curtin University for at least 25 years, where it will be accessible to others who are qualified to verify the findings. She will be given a three digit code to log onto the online programs and that will be used to identify her data. Results of the study may be presented at meetings or in publications, but her name will not be used.
However, in the event that we notice that your adolescent is actively suicidal, you will be informed via email. We will then provide you with information of services she can get extra help from.
How long will your adolescent’s part in this study last?
She will be invited to participate in the program twice a week over a 4-week period.She will also be asked to complete some questionnaires before she starts the program, at the end of the program and at 3 months, 6 months and 12 months after the program ends. The questionnaires will take a maximum of 30 minutes to complete.
What are the possible risks or discomforts involved from being in this study?
Reducing perfectionism or reducing stress level may increase your adolescent’s quality of life. However, there is no guarantee that she will benefit from the program. She has the right to withdraw from the study at any time.
Alternative treatments and/or medications:
During the program and up to 12 months after the program, we encourage your adolescent to not receive any other forms of therapy, for example visiting a psychologist. If she is on any antidepressant medication, we ask that she must be stable on this medication for at least three months. We also ask that if she is on antidepressant medications, to agree not to alter or change the dosage for the duration of the study i.e. from the start of the program until the 12 month follow-up period. In the event that she does require alternate treatments and/or medications, we ask that she informs the researcher. She will then be withdrawn from the study.
To ensure confidentiality, your adolescent will not be required to provide her name (apart from the adolescent consent form). She will be given a three digit code as her participant number, and it will be used for all questionnaires. The website for programs will be designed and hosted through Squarespace (http://www.squarespace.com), a web-hosting platform for creating and maintain websites. The website for programs will be password protected to limit access to participants, although there are no data collected on this website. Data collection of all questionnaires for the study will be hosted separately using the Qualtrics survey software (http://www.qualtrics.com), which is highly secured (see Qualtrics security statement http://www.qualtrics.com/security-statement/ and privacy statement http://www.qualtrics.com/privacy-statement/). Qualtrics’ servers are protected by high-end firewall systems, with vulnerability scans being conducted regularly. They also use Transport Layer Security (TLS) encryption for all transmitted data. Surveys are protected with passwords and HTTP referrer checking. The data is hosted by third party data centres that are SSAE-16 SOC II certified. All data located within Qualtrics Survey Software will only be accessible by the researcher and will be password protected. At the completion of questionnaires, you will be reminded to close the browser windows.
What if you have questions about this study?
For more information concerning this research or if you feel that being in the study has resulted in any research related injury, emotional or physical discomfort please contact the research team by email: firstname.lastname@example.org Please note that this email service is solely to answer any queries or concerns regarding the interventions and not to be used for contact with a therapist.
What if you have questions about your adolescent’s rights as a research subject?
This study has been approved by the Curtin University Human Research Ethics Committee (Approval Number HR187/2013). The Committee is comprised of members of the public, academics, lawyers, doctors and pastoral carers. Its main role is to protect participants. If needed, verification of approval can be obtained either by writing to the Curtin University Human Research Ethics Committee, c/- Office of Research and Development, Curtin University of Technology, GPO Box U1987, Perth 6845 or by telephoning 9266 9223 or by emailing email@example.com. Any complaints or concerns about the conduct of this research can also be directed here.