Participant Information Sheet for 16+

Version 3.0 17/02/2022

You are being invited to take part in a research study to see whether an app that we have developed helps young people who have had unwanted sexual experiences online or online sexual experiences that have gone wrong.

Please take the time to read the following information carefully before deciding whether to take part. Please get in touch with the research team if you would like more information or want to discuss anything.

Summary

Who: The i-Minds study is for people who have had unwanted sexual experiences online or online sexual experiences that have gone wrong. These can involve a wide range of experiences and everyone’s experience will be different. For example, they could involve receiving unwanted sexual materials of other young people (e.g., photos, videos), inappropriate sexual talk or requests online, and/or engaging in physical sexual activities online or in person after being in contact with someone online.

What: In collaboration with young people, parents and professionals, we have been busy designing and developing an app to help young people to better understand their own thoughts and feelings and the thoughts and feelings of others. We hope the app could improve difficult thoughts and feelings linked to their past unwanted online experiences. In this study, we want to test whether the app is helpful and if young people like using it.

How: If you read the information sheet and decide you would like to take part in the study, you will be asked to use the app for 6 weeks. Before and after using the app, we will ask you to complete some questionnaires about your wellbeing and internet use. We will also invite you to take part in an interview so that we can find out what you thought about the app, for example, what you liked or did not like about it and whether it helped you or not.

Thank you for taking the time to read this! 

About the research

Why have I been invited to take part?

You are being invited to take part in this study as you are a young person aged 16-18 years who is accessing support from an NHS service for young people and you have had unwanted sexual experiences online or a sexual experience online that has gone wrong.

We are inviting young people to use the app and tell us what they think about it. This is to help us understand whether young people find the app useful or not. We will invite around 60 young people to take part in the study.

Who is sponsoring and conducting the research?

This research is sponsored by Greater Manchester Mental Health NHS Foundation Trust (GMMH). The research will be conducted by researchers and clinicians based at The University of Manchester, GMMH, Pennine Care NHS Foundation Trust (PCFT), The University of Edinburgh and NHS Lothian.

The i-Minds Research Team

The University of Manchester

Prof Sandra Bucci         Dr Filippo Varese          Mr Matthew Machin      Dr Pauline Whelan

The University of Edinburgh

Prof Matthias Schwannauer             Prof Ethel Quayle

NHS Lothian

Prof Cathy Richards                  Mr Will Hewins

GMMH

Dr Kim Cartwright               Ms Cindy Chan                Ms Alice Newton                  Dr Amanda Larkin          Ms Marina Sandys

PCFT

Prof Prathiba Chitsabesan

Marie Collins Foundation

Mrs Victoria Green

What is the purpose of the research (why are we doing this research)?

The number of young people who have had unwanted sexual online or sexual experiences online that have gone wrong has increased in recent years. These online sexual experiences can have a negative effect on young people’s mental health and wellbeing. Even though these experiences happen a lot to many young people, there is not much tried and tested support available. Our aim is to improve the wellbeing of young people who have had unwanted or problematic online sexual experiences and protect them from future risk of harm.

Over the last 12 months, we have been working with young people, parents / caregivers and professionals to develop an app that we hope is easy to use, will improve the wellbeing of young people who use it and help keep young people safe online. In this study, we want to test the app to see whether young people like it, and if they find it helpful, easy and safe to use. We also want to know what changes need to be made to the app to make it better.

What will I be asked to do if I take part in the study?

If you think you might like to take part in the study, the first step will be you giving your care / key worker permission for us to contact you. We will then contact you to check you have read the information sheet and to see if you want more information. We will be happy to answer any questions you might have.

If you decide you do not want to take part, you do not need to take any further action.

If you decide you would like to take part, we will arrange a time to meet with you. This could be over the phone, online (e.g. Microsoft Teams/Zoom/NEARME) or in person, whichever you prefer.

When you meet us, we will asked you to confirm that you have had enough information about the study and that you consent to take part in the research. To give consent, you will need to complete a consent form in person (if we meet you face-to-face) or remotely (e.g. phone / Microsoft Teams/Zoom/NEARME). If you provide consent remotely, we may need to audio-record this using  safe (encrypted) recording device unless you complete the consent form and email it back to us. To give consent you will be asked questions and you will be asked to confirm that you agree. For example, we will ask you “Do you give consent to take part in the study?”

Following consent and provided you feel comfortable to begin, you will be asked to complete some questionnaires about how you are feeling, how your relationships are, and how you use the internet. There are no ‘right’ or ‘wrong’ answers. This will take around 50 minutes to complete.

After you have filled out the questionnaires, you will then be able to use the app for 6 weeks. We will help you download and set up the app. If you don’t have a smartphone don’t worry, we will give you one. We will also pay your data costs over the 6 weeks you use the app.

After you have used the app for 6 weeks, we will ask you to fill out the same questionnaires you did when you first took part. This is so we can see how things might have changed for you since you started using the app. We will also ask you to give us some feedback about the app (whether you liked using it or not). This will take place in the form of an optional audio-recorded interview (30-60 minutes) with a researcher. If you decide to stop using the app before 6 weeks, we might still ask you to fill out some questionnaires and tell us how you found using the app as your feedback is important to us.

What will using the app involve?

We have developed an app that we will ask you to use over a period of 6 weeks alongside the support you already receive from the NHS. The app is not intended to replace any care or support that you already receive. The app uses strategies taken from a type of talking therapy called “mentalisation therapy” (don’t worry it’s not as complicated as it sounds!). This talking therapy has been shown to help young people better manage their thoughts and feelings. The strategies used in the app are designed to help you better understand your own thoughts and feelings, as well as the thoughts and feelings of others. Sometimes it can be hard to understand your own feelings and the feelings of those around you, especially when you are communicating with others online. In this app, we will give you information and offer tips and strategies to help you understand how to keep yourself safe from unwanted sexual experiences online. We hope this will help you learn about how to manage your feelings and stay safe online.

A range of topics are covered in the app, including information about unwanted or problematic sexual experiences online, how we see ourselves and others, taking risks, understanding emotions, emotional and mental health, and the effect of difficult life experiences. There are also loads of videos and activities to use in the app.

You don’t need to worry about setting up the app, a researcher will help you do this. If you decide to take part, you can spend as little or as long as you like on the app.

Can I use the app if I don’t have access to a smartphone?

Yes. If you don’t have a smartphone (an iPhone or Android phone) we will give you one to use while you are taking part in the study. We will also pay for your data costs for the 6 weeks you are using the app.

Are there any risks in taking part?

There are no major risks in taking part in this study. It will take a bit of time and some of the questions asked are related to your mental health, your wellbeing and the experiences you have had online. It is possible that you might find some of those questions upsetting. If you do, you will be able to discuss this with a member of our team or with an NHS professional you already know.

Are there any benefits in taking part?

The information you give us will help us to develop new ways of helping young people. We hope our interviews will provide an open and comfortable space in which you can feel free to share your thoughts, feelings, and opinions. You will be reimbursed up to £60 for your time (£20 after completing for the first time the questionnaires with the researcher, £20 after the second meeting with the researcher after 6 weeks, and £20 if you decide to complete the feedback interview about the app [using vouchers, in cash or via a bank payment]. If you don’t have a smartphone, we will lend you one for the time you are using the app. If you have a smartphone, we can pay for your network costs for the time you are using the app.

Will the findings of the research be published?

Once all the information has been collected and we have looked over it all, we can send you an email summarising the findings of the research (if you agree to this when filling out the consent form).

The findings will be published in scientific journals and on our team’s website. We will also share the findings with the people who are advising and guiding us on the project (e.g. other young people who have had unwanted online sexual experiences, healthcare professionals, experts on this topic).

Although the research will be published and shared in a variety of ways, no one will know that the data (information) belongs to you; your name will not be used in anything that is shared.

Who has reviewed the research project?

The project has been reviewed by the West of Scotland REC 4 NHS Research Ethics Committee and the Health Research Authority (HRA). It has also been reviewed by the Sponsor and all participating partners.

Who is funding the research project?

A research organisation called the National Institute for Health Research (NIHR) Health Services and Delivery Research (HS&DR) Programme have funded this research.

Measures taken due to COVID-19

We will make sure that everyone feels safe in this research with the ongoing COVID-19 pandemic. For example, when meetings are being held face-to-face, we will be very careful to make sure that:

• meetings take place in rooms where we can keep a safe distance apart.
• researchers will wear PPE (e.g., facemasks) whenever possible.
• workspaces and equipment will be disinfected (free from germs) frequently.

If you do not feel comfortable meeting face-to-face you don’t have to, we can meet either over the phone or online (e.g. Microsoft Teams/Zoom/NEARME).

Do I have to take part?

No, you do not have to take part. It is completely up to you; it is okay to say no and you do not have to explain why. This will not affect any care or support you currently receive.

Please contact Marina Sandys via email if you would like to take part: marina.sandys@gmmh.nhs.uk .

If you do decide to take part, you will be given this information sheet to keep and you will be asked to give consent.

What happens if I start using the app and then I change my mind?

If you decide to take part, you are still free to stop at any time without giving a reason and this won’t affect the care you receive and nothing negative will happen. However, it will not be possible to remove your information (data) from the project once it has been anonymised (when we cannot identify who you are) as we will not be able to know exactly which information belongs to you. This does not affect your data protection rights. If you decide not to take part, you do not need to do anything further.

If you take part and start using the app and then decide you don’t want to anymore, we would like to ask you about why you decided to stop taking part. This is mainly for our own learning, but we will only ask you about this if you consent to the interview. It is completely your choice.

What happens if I become distressed or upset while using the app?

The app includes a helpful contacts section so that if you feel upset while using the app, you can contact someone for help and support. The contact list will include information to out-of-hours emergency contacts (for example, A&E services; NHS contacts; charity helplines; and websites). Some examples of emergency contacts are:

Emergency contact	Number	When are they available?	What support they provide?
NHS 111 (England) NHS 24 (Scotland)	111	24 hours, and  you can contact when your GP is                     not available	Clinical health and mental health support
Edinburgh Crisis Centre	080 8010414	24 hours	Mental health support in an emergency or crisis
The Samaritans	116 123	24 hours	Mental health support in an emergency or crisis
Mental Health  Assessment Service	0131 537 6000	24 hours	Mental health support in an emergency or crisis
ChildLine	0800 1111	Anytime	Mental health support in an emergency or crisis
Breathing Space	0800 83 85 87	6pm – 2am Monday to Thursday 6pm – 6am Friday  to Monday morning	Help if you are experiencing low mood and depression or need someone to talk to
Campaign Against Living Miserably	0800 58 58 58	5pm-midnight	Provides listening services, information and support for anyone who needs it.

 

What if I become unable to consent?

If at any point in the study you lose the ability to give informed consent – for example, if you find it difficult to understand, remember or communicate information about taking part – you will no longer be able to take part in the research study. However, we may still use data that was collected before you lost the ability to consent and may also access data from your medical records.

Data Protection and Confidentiality

What information will you collect about me?

We will need to collect information from you, your medical records and your care team for this research project. This information will include, for example:

• Name
• Date of Birth
• Education Level
• Gender
• Experience with using the internet
• Name/Address of GP/support worker/care coordinator
• Treatment or support you are receiving from services

People will use this information to do the research or to check your records to make sure that the research is being done properly. We will need to add to your clinical notes that you are taking part in the so that there is a record of your participation in research activities. If we feel that you or someone else is at risk of being hurt in any way, we will also add this to your clinical notes so that we can keep you and others safe.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. We will be keeping a record of which parts of the app all the participants use, using secure software. At the end of the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

We will also ask to audio (voice) record any interviews that you might take part in. We will only record your voice using either the telephone or a digital platform like Microsoft Teams, Zoom, or NEARME. We will not ask to video record the interview. After we have recorded the interviews, they will be transferred from the audio-recording device to a secure computer. The recording will then be deleted from the audio-recording device. The interview recording will be typed up into written text (transcribed) by a member of the research team or by an approved person or organisation outside of the research team. You will not be able to be identified in the typed-up written note.

If you decide to take part in the study, your contact details will be used:

• to arrange and carry out appointments for you to complete questionnaires.
• to arrange and carry out an appointment to get you set up on the app.
• to arrange and carry out an interview (if you consent to being interviewed).
• if you have indicated on the Consent Form (Version 2 14/02/2022) that you would like to be sent a summary of the findings of the study.
• if you have indicated on the Consent Form (Version 2 14/02/2022) that you are happy to be contacted about other related studies in the future.

If you decide to change your mind about participating in the study, being contacted during the study or would like your details to be destroyed you can contact the research team.

What are my choices about how my information is used?

• You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
• We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
• If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study. With your consent, your anonymised data might be shared with other researchers and/or students carrying out research.

If you want to know more about your information (data) and how it is used, you can view this website www.hra.nhs.uk/information-about-patients

You can view GMMH’s General Data Protection Regulations information here-  https://www.gmmh.nhs.uk/gdpr-in-research.

You can also contact a member of the research team if there is anything you want to ask about. There are contact details at the bottom of this information sheet.

Will my participation in the study be confidential (private) and will my information be kept safe?

The NHS will manage your identifiable information (your “personal data”) as you are participating in a study conducted by a research team working at both Greater Manchester Mental Health NHS Foundation Trust and The University of Manchester. We will ask for your consent to let your GP know that you are participating in this study. We will also ask if we can let your care-coordinator/support worker/keyworker know.

We will keep your answers private. Your data will be identified by a unique code number rather than by name. Your data will be only viewed by the research team. We store all of the data we collect on secure password-protected computers at either the university or the NHS site. Your consent form, contact details and your answers to questionnaires and the interview will be kept for 5 years on the NHS Trusts’ secure web servers and / or the Universities’ Research Data Storage system. All the information we collect about you will be stored separately from each other and will be stored securely (encrypted/put into a code); only the research team will have access to this information.

If you tell us anything that makes us think that you or someone else is at risk of harm, we will share confidential information you gave us with others – this could be your GP, care worker or could involve other services, such as, the police. This is to make sure that you are safe and those around you are safe. If this does happen and we do need to speak to someone outside of the research team, we will always try to let you know first.

Sometimes people from the University, the NHS or regulatory bodies might also look at the data you give us. This is to make sure that we are carrying out the research properly and in a way that is safe.

If there is anything that you feel you don’t understand about how we store, collect, or use your data, please find out more by asking one of the research team, or sending an email to researchoffice@gmmh.nhs.uk or by ringing us on 0161 271 0084.

Indemnity (protection)

The study is sponsored by the GMMH NHS Trust. As such, standard NHS indemnity (protection) will apply for the study participants participation.

What if I have a complaint?

Contact details for complaints

If you want to make a complaint to the research team, please contact: Dr Amanda Larkin, the Project Manager, via email amanda.larkin@gmmh.nhs.uk. 

OR Professor Sandra Bucci, the Principal Investigator, via email sandra.bucci@manchester.ac.uk. 

If you wish to make a formal complaint to someone who is not part of the research team or if you are not satisfied with how we have dealt with your complaint, then please contact:

For Manchester

The Research Ethics Manager, Research Office, Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, by emailing: research.complaints@manchester.ac.uk  or by telephoning 0161 306 8089.

If you wish to contact us about your data (information) protection rights:

For Manchester:

Please email dataprotection@manchester.ac.uk or write to The Information Governance Office, Christie Building, The University of Manchester, Oxford Road, M13 9PL at the University and we will guide you through the process of exercising your rights.

You can also make a complaint via the NHS Complaints Procedure by contacting the Greater Manchester Mental Health NHS Foundation Trust Customer Care Team Manager on:

(0161) 358 0600 or (0800) 587 4793.

You will also be able to contact the Patient Advice and Liaison Service (PALS) in the first instance Tel: 0800 587 4793 Email: customercare@gmmh.nhs.uk

Contact Details

If you have any queries about the study or if you are interested in taking part, please let you care team know and, with your permission, they will pass on your contact details to us. One of the researchers will then contact you to discuss the study.  

Please contact Marina Sandys via email if you would like to take part: marina.sandys@gmmh.nhs.uk