ONLINE PARTICIPANT INFORMATION AND CONSENT FORM

An open trial of the self-guided Inroads intervention to reduce anxiety and alcohol use among young people

 

1. What is this study about?

You are invited to take part in an open trial of an innovative, effective online program (‘Inroads’) for young people who want to build skills to manage their anxiety and reduce or control their drinking.

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 drinking more often/more than you would like, alcohol can initially help you relax. However, once these effects wear off, alcohol actually makes your feelings of anxiety worse. The Inroads program provides strategies to help young people reduce reliance on alcohol and develop skills to cope with anxiety and life stressors. 

This Participant Information Statement tells you about the research study. Knowing what is involved will help you decide if you want to take part in the research. Please read this sheet carefully and ask questions about anything that you don’t understand or want to know more about. 

Please read this sheet carefully and email us on info@inroads.org.au if there is anything that you don’t understand or want to know more about. At the end of the Consent Form, if you are interested in being part of this research and gaining access to the Inroads program, please press the ‘I agree’ button. If you are not interested in participating in this research and do not want access to the Inroads program, please press the ‘I do not agree’ button (Note. You will not be able to receive access to the program without participating in this research).

Participation in this research study is voluntary. Your decisions will not affect your relationship with The University of Sydney.

By giving your consent to take part in this study you are telling us that you:

  • Understand what you have read.
  • Agree to take part in the research study as outlined below.
  • Agree to the use of your personal information as described.

You can download a copy of this form to keep from the ‘information & consent’ tab on the Inroads website. 

2. Who is running the study?

The research study is being carried out by the following researchers: 

  • Chief investigator Dr Lexine Stapinski, from the University of Sydney
  • Co-investigators:
    • Dr Katrina Prior, from the University of Sydney
    • Professor Andrew Baillie, from the University of Sydney
    • Associate Professor Nicola Newton, from the University of Sydney
    • Dr Mark Deady, from the Black Dog Institute, UNSW
    • Professor Maree Teesson, from the University of Sydney
    • Dr Erin Kelly, from the University of Sydney
    • Dr Annalese Bolton, from the University of Sydney
    • Ms Briana Lees, from the University of Sydney
    • Ms Siobhan Lawler, from the University of Sydney

3. What will the study involve for me?

Step 1: If you provide your consent after reading this Participation Information Statement, you will first complete a brief 15-minute survey which contains 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 the study is suitable for you, you will be asked to complete an additional survey about your experiences with anxiety and other mental health concerns, as well as your experiences with drinking alcohol and use of illicit drugs (i.e., cannabis, non-prescribed benzodiazepines and other illicit drugs such as methamphetamines). Questions on illicit drug use will not ask specific details such as time and place, therefore, there is no risk of legal consequences or other harm from disclosure of this information by you. 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 2-months and 6-months after the survey.

Once the survey is completed, you will be given immediate access to the Inroads program. The program involves 5 online modules which focus on developing skills to help you manage your anxiety and alcohol use. A new module will be available each week, and in addition, you will also receive a weekly email to provide you feedback on your progress and motivation to continue with the modules. 

Step 3: You will be asked to complete an online survey 2-months and 6-months after the initial survey. These surveys will take approximately 45 minutes to complete and will allow us to assess your progress and any benefits of the program. We will also ask for your feedback about the Inroads program.

4. How much of my time will the study take?

Each of the three Inroads surveys will take approximately 45 minutes each to complete. The Inroads program consists of five 30-minute modules, designed to be completed one week apart over a 5-week period. You will also be encouraged to complete homework forms to reinforce the skills you learn each week and reflect on your progress. You can spend as little or as much time as you like on these forms and applying the skills in your everyday life, however, we find the more time you spend, the more likely you are to see positive effects on your anxiety and drinking.

5. Do I have to be in the study? Can I withdraw from the study once I've started?

Being in this study is completely voluntary and you do not have to take part. Your decision whether to participate will not affect your relationship with the researchers, the funders, members of your treatment service or anyone else at the University of Sydney or other institutions conducting this research. 

If you decide to take part in the study and then change your mind later, you are free to withdraw at any time without giving a reason. Should you decide you would like to stop being involved in the study at any time, you may fill in the Withdrawal of Consent form, accessible from the ‘information & consent’ tab on the Inroads website (www.inroads.org.au/). After you withdraw, the researchers will not collect additional personal information from you. However, personal information already collected before you withdrew will be retained and will form part of the research results. If you do not want your data to be included, you must tell the researchers when you withdraw from the project. 

There are also some exceptional circumstances in which the researchers 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.

6. Are there any risks or costs associated with being in the study?

Some people may find it distressing to talk about or confront mental health 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 reducing your alcohol use will be associated with withdrawal symptoms and an increase in 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 info@inroads.org.au 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.

There are no costs to you by participating in this research study. If you choose to participate you also have the right to stop completing the survey(s) and/or Inroads program at any time and withdraw from the study.

7. Are there any benefits associated with being in the study?

If you complete the 2-month and 6-month follow-up surveys, you will be entered into a prize draw to win an AUD$150 Prezzee Swap e-gift voucher at each follow-up occasion (i.e., one will be available after the 2-month survey and the other after the 6-month survey). If you are the winner of the prize draw, you will be able to redeem your e-gift voucher at a list of popular stores, such as JB Hi-Fi, Netflix, Coles, Myer, David Jones, Hoyts, and Red Balloon. If you withdraw prior to the completion of the surveys, you will not be entered into the prize draws.

We cannot guarantee or promise that you will receive any benefits from this research. However, based on our previous research showing the efficacy of the Inroads program in helping young people reduce their anxiety and use alcohol more safely (compared to an alcohol psychoeducation control group), you can reasonably expect some direct benefit from the program on your anxiety and drinking. 

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 program modules offered as part of the study. 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. The responses provided in the surveys and modules will be stored in computerised format stored on a secure server in Australia. Once we have completed our data collection, we will import the data and store it securely and confidentially on a secure server at the University of Sydney. Data will only be stored in password protected files, that can only be accessed by research staff. Your contact details will be stored separately to your survey information, so that you cannot be identified in your survey data.

Your identity/information will be kept strictly confidential, except as required by law or when there is an immediate risk of harm that can only be prevented by disclosing this information. For, example, if you disclose to us information that indicates a serious or immediate risk of harm or injury to you or another person. A serious and immediate threat to harm yourself or others may need to be reported to a third person. Any information concerning the protective safety of children is subject to reporting to relevant authorities. We will keep your data for 20 years before disposing of it in a confidential manner. 

We intend to publish the findings of this study in scientific journals and to present the findings at scientific conferences. In any publication or presentation of this study, information will be provided in such a way that you cannot be identified. Publicly presented data will only include numerical data and statistical analyses. They will not include descriptions of your personal history or any other information which may identify you. We also intend to compare the results of this study regarding the effectiveness of the Inroads program with the findings obtained in a previous study. Results will be published in scientific journals and presented at conferences, workshops and webinars. No information that can identify you will be provided in these publications or presentations. 

We will keep the information we collect for this study, and we may use it in future projects. By providing your consent you are allowing us to use your information in future projects. We don’t know at this stage what these other projects will involve. We will seek ethical approval before using the information in these future projects. By providing your consent, you are agreeing to us collecting personal information about you for the purposes of this research study. Your information will only be used for the purposes outlined in this Participant Information Statement, unless you consent otherwise.

9. Can I tell other people about the study?

Yes, you are more than welcome to tell other people about the study.

10. What if I would like further information about the 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 (info@inroads.org.au). 

11. Will I be told the results of the study?

You have the right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by contacting the research team on info@inroads.org.au. After the study has been completed and results have been published, a one-page summary of the research findings can be emailed or posted to you.

12. What if I have a complaint or any concerns about the research study?

Research involving humans in Australia is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this study have been approved by the HREC of the University of Sydney [2020/391]. As part of this process, we have agreed to carry out the study according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect people who agree to take part in research studies.

If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number. 

The Manager, Ethics Administration, University of Sydney:

SUPPORT SERVICES

If you become distressed or require additional support from someone not involved in the research at any stage during the study, please call one of the following services.

If you are in a crisis situation, are concerned about feelings or thoughts of suicide, or need immediate assistance:

  • Call 000 and request an ambulance. Stay on the line, speak clearly, and be ready to answer the operator's questions
  • Visit your local hospital's emergency department
  • Lifeline (13 11 14); online chat www.lifeline.org.au/get-help/online-services/crisis-chat
  • Headspace (1800 650 890); website www.headspace.org.au or online chat www.eheadspace.org.au
  • Counselling Online (1800 888 236); www.counsellingonline.org.au
  • Suicide call back service (1300 659 467); online counselling www.suicidecallbackservice.org.au
  • Mental Health Access Line:
    • ACT (1800 629 354) – Mental Health Triage Service
    • NSW (1800 011 511) – Mental Health Line
    • QLD (1300 64 22 55) - 24-hour specialist mental healthcare
    • SA (13 14 65) – Mental Health Triage Service
    • TAS (1800 332 388) – Mental Health Services Helpline
    • VIC (1300 363 746) – Psychiatric triage (information, assessment and referral) 24 hours a day, 7 days a week
    • WA (1800 676 822) – Mental Health Emergency Response Line
    • NT (1800 682 288) – Northern Territory Crisis Assessment Telephone Triage Service

Mental health issues, low mood, anxiety and stress

Rape/Trauma

  • NSW Rape Crisis (1800 424 017)
  • 1800 RESPECT (1800 737 732)
  • Child Abuse Prevention Service (02 9176 8000)

Drug and alcohol concerns

National help lines:

State-based health services: Alcohol & Drug Information Service:

  • NSW: 1800 422 599 for regional NSW or 02 9361 8000  for metropolitan NSW
  • ACT community health service: 02 6207 9977
  • QLD: 1800 177 833 for regional QLD or 07 3837 5989 for metropolitan QLD
  • SA: 1300 131 340 or 08 8363 8618
  • WA: 1800 198 024 for regional WA or 08 9442 5000 for metropolitan WA
  • NT: 1800 629 683 or call 08 8922 8399 (Darwin) to book an appointment to seek help for alcohol withdrawal
  • VIC: Directline (1800 888 236)
  • TAS: 1800 811 994

 

This information sheet is for you to keep by downloading it from ‘information & consent’ tab on the Inroads website (www.inroads.org.au).

Withdrawal of Participation

I hereby wish to WITHDRAW my consent to participate in the Inroads study, and understand that such withdrawal WILL NOT jeopardise any current/future treatment or relationship with any health care provider, the University of Sydney, the University of New South Wales, or Macquarie University.

I give permission for the Inroads project team to retain any data collection as part of my participation to date, and to include it in analyses conducted as part of the overall study.

4/12/2020