ONLINE PARTICIPANT INFORMATION AND CONSENT FORM
Making Inroads: Trial of an early intervention to address anxiety and alcohol use among young people
The research study is being carried out by the following researchers:
- Chief investigator Dr Lexine Stapinski, from the National Drug & Alcohol Research Centre
- A/Prof Andrew Baillie, from the University of Sydney
- Prof Maree Teesson, from the National Drug & Alcohol Research Centre
- Dr Nicola Newton, from the National Drug & Alcohol Research Centre
- Dr Mark Deady, from the Black Dog Institute
- Ms Erin Kelly, from the National Drug & Alcohol Research Centre
- Ms Katrina Prior (Project Coordinator), from the National Drug & Alcohol Research Centre
- Ms Briana Lees, from the National Drug & Alcohol Research Centre
- Ms Rachel Visontay, from the National Drug & Alcohol Research Centre
- Research Funder: Australian Rotary Health
What does the study involve?
You are invited to take part in a trial of an innovative, online program that seeks to help young people who experience anxiety symptoms and want to reduce or manage their alcohol consumption. The Inroads program aims to enhance anxiety coping skills, explore the interconnection between anxiety and alcohol use, and help young people to avoid harmful drinking patterns. To determine the effectiveness of the Inroads program, it will be compared to an assessment and alcohol information condition in which participants will receive a factsheet containing information and guidelines on safe alcohol use.
2. Do I have to take part in this research study?
Participation in this research is voluntary. Your decisions will not affect your relationship with The University of New South Wales. This Participation Information Statement tells you about the research study and the research tasks involved. Knowing what is involved will help you decide if you want to take part.
3. Why is there a need for the Inroads study?
Anxiety is very common as young people experience the new challenges of early adulthood. Often, people who experience anxiety drink alcohol as a way of coping with these feelings. Some people also experience anxiety as a result of drinking too much. When you are feeling anxious and perhaps drinking more often or more than you would like, alcohol can initially help you relax, but once these effects wear off, alcohol actually makes your feelings of anxiety worse. The Inroads study aims to find effective ways to help young people reduce reliance on alcohol and develop skills to cope with anxiety and life stressors.
4. What does participation in this research require?
Step 1: You will complete a brief 15-minute survey comprising questions that will be used to determine whether this study is suitable for you.
Step 2: If the Inroads study is not suitable for you, we will provide you with a list of alternative options for seeking assistance and support.
If you are eligible to participate, you will be asked to complete an additional survey about your experiences with anxiety and other mental health concerns and experiences (such as trauma and PTSD), as well as your experiences with (and expectations around) drinking alcohol and/or taking other drugs. We will also ask you some basic demographic information, information about what health services you use, and some general information about your quality of life. We expect this survey will take 45 minutes to complete. At the end of this survey we will also ask for information on how to contact you over the course of the study (name, phone number, email, and address) so that you can be contacted 8-weeks and 6-months after the initial survey.
Once the initial survey is completed, you will be randomly allocated to one of two conditions. Random allocation means that neither you nor the study team choose which program you receive; this is determined by chance (like a toss of a coin). You will have a 50% chance of receiving either:
- Inroads program: This group will receive a program that involves 5 online modules which focus on developing skills to help you manage your anxiety and alcohol use. A new module will be accessible each week, and in addition you will have access to support from a trained psychologist either by email, text chat, or over the phone.
- Assessment and Alcohol information: This group will receive an online alcohol factsheet that includes information about risks relating to alcohol use, and guidelines for staying safe. After the completion of the 6-month survey, you will be offered the opportunity to enrol in the Inroads program if you would like to.
Step 3: Regardless of which condition you are randomly allocated to, you will be asked to complete an online survey 8-weeks and 6-months after the initial survey. These follow-up surveys will take approximately 45 minutes to complete, and will allow us to assess your progress and any benefits of the programs. We will also ask for your feedback about the program you participated in.
Step 4: Following random allocation, you will be invited to complete online cognitive tasks at baseline, 8-weeks after the initial survey and 6-months after the initial survey. These tasks involve computer games that are designed to be reasonably challenging. These games will take approximately 30 minutes to complete and will allow us to assess your cognitive functioning. Prior to participation in the online games, a member from the research team will contact you via telephone. In this short conversation, the research team member will provide you with a set of instructions for completing the online games, answer any questions you may have, and confirm that you would like to take part in this component of the study. If you choose to participate in the online games, you will receive an email with a weblink to the online games after this conversation, as well as at 8-weeks and 6-months follow-up.
5. Will I be paid to participate?
If you complete the 8-week and 6-month follow-up surveys, a $30 (per survey) gift voucher from iTunes, JB Hi Fi, or Coles/Myer (your choice) will be mailed to your home address. There is also a bonus reimbursement to those who complete both surveys – you will be entered into a prize draw to win an Apple iphone. The prize winner will be drawn at the end of the study (expected draw date: July 2018) and the winner will be notified via email. Participants who choose to complete the online games component will receive an additional $30 gift voucher each time they complete the games (up to three times).
6. What are the possible benefits to participation?
Participants in both groups can reasonably expect some direct benefit from the intervention. Additional benefits to society include addressing an important knowledge gap about the best ways to address harmful alcohol use in the context of anxiety symptoms.
7. Are there any risks involved?
Some people may find it distressing to talk about or confront psychological issues, anxiety symptoms and/or problems with alcohol use. For example, part of the treatment for anxiety involves facing anxiety provoking situations and developing new ways of coping. This can be distressing for some people; however, it is a commonly used treatment technique which has demonstrated effectiveness in other research. You do not have to complete these tasks, although if you do not, it may reduce the effectiveness of the treatment.
There is also some risk that modifying alcohol use will be associated with withdrawal symptoms and an exacerbation of symptoms of anxiety. In fact, if your alcohol use is high there are also some medical risks, and we advise seeking medical advice before making any significant changes to your current alcohol use.
If you are concerned or become distressed at any stage we would encourage you to contact the services listed at the end of this information sheet, where you may obtain additional services and 24-hour support. You can also contact the study team at firstname.lastname@example.org who can provide you with additional support or referral options, however please note that there may be a delay to respond, so for immediate assistance please contact one of the hotlines listed.
8. What will happen to the information about me?
By clicking on the ‘I agree to participate in this survey’ button you consent to the research team collecting and using information from the surveys and treatment sessions offered as part of the study. If you agree to participate in the online games, you also consent to the research team collecting and using information from the online cognitive tasks offered as an additional component of this study. Any information obtained in connection with this research study that can identify you will remain strictly confidential, except as required by law or when there is an immediate and specified risk of harm that can only be averted by disclosing information.
At the start of the project, you will be given a unique participant login. You will use this login to access the program modules and complete all surveys. Your answers to survey questions and any information you provide will be transmitted over a secure connection If you agree to participate in this study, the responses you provide to the questionnaire will be stored on a secure server in Australia. Your contact details will be stored separately to your survey information. Your survey information will not be individually identifiable. After a period of 7 years, the online data will be deleted.
For all participants, the research team will be able to access survey data, cognitive task data, and will be able to see the completion status of each of the three surveys and the program modules. If you are allocated to the Inroads program, the clinical psychologists and Project Coordinator will have additional access to data contained within the program in order to review content and, reflect on progress and prepare clinical reports, as well as to provide suggestions and motivation, and trouble shoot any problems that arise. For research results and reporting, data from the treatment modules (e.g. confidence rating for weekly goals, score on module quizzes) will be aggregated and participants will not be identifiable. For practice forms, you will have option to tick ‘Private’ if you wish to complete content privately. In these cases, your psychologists will be unable to access your information.
9. How and when will I find out what the results of the research study are?
You have the right to receive feedback about the overall results of this study. After the study has been completed and results have been published, a one page summary of the research findings will be made available via a link on the study website.
10. What if I want to withdraw from the research study?
Your decision to not take part in this study will not affect your relationship with the University of New South Wales or the Macquarie University. If you do decide to take part in this project, you can withdraw from the study at any time without giving a reason. Should you decide to discontinue your participation in the project at any time, you may fill in the Revocation of Consent form, accessible from the ‘information & consent’ tab on the Inroads project website (www.inroads.org.au/).
If you decide to withdraw from the study, it will not affect your future relationship with the University of New South Wales or Macquarie University. If you decide to withdraw from the project, you have the option of also withdrawing all data relating to you. There are, however, some exceptional circumstances in which the researchers and therapists involved in the study have an obligation to retain and disclose confidential information, for example, if it is ordered by a court of law or if disclosing the information is considered necessary to prevent serious harm to you, another person, or the wider community.
We cannot and do not promise that you will receive any benefits from this project. You can download a copy of this form to keep from the ‘information & consent’ tab on the Inroads website.
11. What should I do if I have any further questions about my involvement in the research study?
If you want any further information concerning this project or if you have any problems which may be related to your involvement in the project, you can contact the research team by email (email@example.com).
12. What if I have a complaint or any concerns about the research study?
If you have any complaints about any aspect of the project, the way it is being conducted, then you may contact the Human Research Ethics Coordinator on:
SUPPORT AND CRISIS SERVICES
If you are in a crisis situation, are concerned about feelings or thoughts of suicide, or need immediate assistance:
Mental health issues, low mood, anxiety and stress
- NSW Rape Crisis (1800 424 017)
- 1800 RESPECT (1800 737 73)
- Child Abuse Prevention Service (1800 688 009)
Drug and alcohol concerns
National help lines:
State-based Services: Alcohol & Drug Information Service:
- NSW: 1800 422 599 or 02 9361 8000
- ACT: 02 6207 9977
- QLD: 1800 177 833 or 07 3837 5989
- SA: 1300 131 340 or 08 8363 8618
- WA: 1800 198 024 or 08 9442 5000
- NT: 1800 629 683 or 08 8922 8399 (Darwin)
- VIC: Directline (1800 888 236)
- TAS: 1800 811 994 or 03 6233 6722