Registration

Participant Information Sheet and Consent

Information for research subjects

We would like to ask you if you are interested in participating in a research project. This document provides information about the project and what it entails to take part.

What is this project and why do you want me to participate?

There is a great need for more knowledge on how to help people who are concerned about their sexual thoughts, feelings, or behaviors towards children. The overall aim of this research project is to reduce the risk of sexual violence against children by developing therapeutic interventions for persons with a sexual interest in children who view, share or otherwise use images or videos of children for sexual purposes, so called child sexual abuse material (CSAM). The research project evaluates two such interventions; one aims to help these people reduce their use of CSAM, the other aims to help these people connect with the care they need.

You are being asked to participate because you are concerned about your sexual thoughts, feelings, or behaviors regarding children, you have used CSAM in the past six months, you would like to get help with this, and you have expressed interest in participating in the study.

The research principal for the project is Region Stockholm. The research principal means the organization responsible for the project. Participating principal is Karolinska Institutet. The application has been approved by the Ethical Review Authority, case number 2023-02321-01.

How does the project work?

In this study two anonymous online interventions for people with concerns about their sexual urges towards children and who use CSAM are evaluated, (1) ReDirection, a self-help program based on cognitive behavioral therapy and (2) Mi Bridge, a series of conversations via text-based chat, based on Motivational Interviewing.

We also conduct anonymous chat interviews in which participants are asked about their own perceptions of their problem and how they feel about seeking help for problems related to their sexual interest in children.

It is possible to choose to only participate in certain parts of the study.

As a first step, you will receive the information about the research project on this page and you can give your consent to participate in the study. If you are interested in participating and give your consent, you will then make an appointment for an anonymous screening interview via text-based chat. The purpose of the interview is to give you the opportunity to ask questions about the study and for the researcher to see that you meet the criteria for participation. The interview takes about 45 minutes. If you meet the criteria, you will be asked to confirm your informed consent to participate in the research project Bridge, which means that you are accepted into the study.

Once you have been admitted to the study, at the end of the screening interview you will be offered to participate in the "Culture Formulation Interview" (CFI) where you will have the opportunity to talk about how you perceive your problem, and about your experience of seeking help and support to deal with problems related to your sexual interest in children and your use of CSAM. The chat interview takes about 60 minutes.

After the screening interview and the Cultural Formulation Interview, if you choose to participate in it, you will be asked to fill in some forms with questions about sexuality, mental health, social situation and about any previous convictions if applicable. The estimated time for this is about 30 minutes. Depending on how you respond to the forms, you will either be offered the opportunity to participate in the ReDirection self-help program or in the Mi Bridge conversational series.

If you are offered and accept ReDirection: Half of the study participants will have immediate access to the self-help program and half will be randomly assigned to be placed on a waiting list for five weeks before starting the program. While on the waiting list, participants are asked to answer questions about any ongoing problematic sexual behaviour.

ReDirection is based on cognitive behavioural therapy (CBT), it lasts five weeks and consists of five modules. Each module contains information and exercises that participants work with independently at their convenience. It takes about an hour a week to work on each module. The intervention ends with a chat session to follow up on your program efforts and goals. Participants also have the possibility to book a chat session with a practitioner if needed during the program.

After completion of the program, participants are asked to fill in some additional forms as a post-treatment measurement. Estimated time for this is about 20 minutes. After the treatment, we will ask the participants how they experienced the treatment and whether they perceive it as helpful. Then the participant is completely finished in the study. Total time for study participation if you receive the self-help treatment is about eight hours.

If you are offered and accept to participate in Mi Bridge: Half of the participants will directly access the Mi-Bridge intervention, and half will be randomly allocated to be placed on a waiting list for three weeks before they can start the intervention. While on the waiting list, participants are asked to answer questions about any ongoing problematic sexual behaviour.

The Mi Bridge intervention lasts three weeks and involves participants chatting anonymously with one of our practitioners on five occasions. Chat sessions are 30 minutes long and can be booked on our website. The chat sessions give participants the opportunity to explore what is important in their lives, their motivation to change, the type of help they want and what it would mean for them to seek treatment at a clinic that works with patients with a sexual interest in children. After completion of the Mi Bridge intervention, participants are asked to fill in some additional forms as a post-treatment measurement. Estimated time for this is about 20 minutes. Then the participant is completely finished in the study. Total time for study participation if you receive Motivational Interviewing is about six hours.

Other information that applies both in ReDirection and Mi Bridge

You will need a computer or a smartphone. Your participation is completely anonymous, and the platform is also available via onion links.

From time to time, we will ask you to report links to websites containing CSAM if you know of any, and to give us information if you know of any children or young people who you believe are at risk of abuse or harm in any way. The information you provide will be handled in accordance with Swedish law. You can also choose not to answer these questions.

If you consent to take part in the study, proceed to fill in the form but then say no to taking part in the help interventions, we will ask you why you do not want help. The reason for this is that we want to make care more accessible to people presenting with this problem. So, all views on care are interesting to us. At the end of the study, all participants will receive a list of clinics that work with patients with sexual interest in children and the online treatments available.

Possible consequences and risks of participating in the project

The forms, interviews and help interventions do not pose any obvious risks to your health. Some of the questions relate to private topics such as sexuality and mental health that may be uncomfortable to respond to. The treatments have no known serious negative side effects, but if you experience any, please contact any of us working in the project via email: projectbridge@protonmail.com. We will also ask you in detail about any side effects at the end of the study.

After working through your thoughts and feelings in the self-help program or chatting with a practitioner about your problems, you may feel relieved. Your sexual thoughts, feelings, or behaviors towards children and your use of CSAM may be reduced thanks to the interventions available to you in this research project.

The risk of integrity intrusion is low. The platform used has several security systems built in, and we have taken several measures to keep the participant safe, e.g., we do not collect any personal data, and we encourage you to use an anonymous email address that is used only for this study. The risk of identification from the stored data is very much within your control - you can avoid providing identifying information in chats.

What happens to my data?

All data collected is self-reported and you will remain completely anonymous throughout the whole research project. All data will be treated confidentially, stored in a way so no unauthorised person can access it, and all persons handling the data are bound by professional secrecy. Data will be handled in accordance with Karolinska Institutet's archiving rules for research documents and will be stored for at least ten years after the research results have been reported. The results of the study will be presented in articles in scientific journals, but no information can be linked to any individual.

Data can be shared with researchers in other countries to enable further research studies such as meta-analyses. All data shared is anonymous.

GDPR (The General Data Protection Regulation) is not applicable to anonymous data. If we receive information from a participant about a child at risk of harm, we may report it to social services but we will not share any information about the participant.

How do I get information about the results of the project?

If you are interested in the final research reports, please contact the responsible researcher, see below. As your participation is anonymous, it is not possible for you to request your individual data.

Insurance and compensation

Due to the anonymous nature of your participation, there will be no patient insurance to cover your participation and you will not be entitled to any financial compensation. Your participation is free of charge.

Participation is voluntary

Your participation is voluntary and you can choose to withdraw at any time. If you choose not to participate or wish to withdraw your participation, you do not need to state your reasons.

If you wish to withdraw your participation, please notify us by sending an email to projectbridge@protonmail.com or inform your practitioner if you are participating in a help intervention.


Responsible for the project

Principal Investigator for the project is Christoffer Rahm, MD PhD, specialist in Psychiatry, Region Stockholm, who can be reached at christoffer.rahm@regionstockholm.se or 070-001 14 57. Questions about the project can be sent to projectbridge@protonmail.com.


Registration

You can now start your registration for the study. After registering for the study and checking "I consent" below, the screening interview will follow, during which a practitioner will ensure that you meet the criteria required to be admitted to the study. If you are accepted, you will be asked to confirm your informed consent to participate in the research project and you will proceed to the next step.

By checking "I consent" below you consent to the following statements:

  • I have received oral and/or written information about the study and have had the opportunity to ask questions. I can keep the written information.
  • I agree to participate in: Bridge - Evaluation of two online interventions for linking individuals with sexual interest in minors to treatment, and investigations to assess cultural factors affecting the clinical encounter.
  • The data you report on the platform will be managed within the study and reviewed by members of the project team. The data will also be merged with data from other similar ethical research studies and, upon request, after publication, can be reviewed and used by researchers in other ethically reviewed research projects.

You are now given the choice to use an email address with your registered account.
An email address can be beneficial because this will be the main contact link used by the platform to inform you about various operations such as password recovery, new materials available, event reminders, new messages from us (only non- treatment specific information will be sent over email).
However, to leave an email might feel unsafe, which we respect. One thing to keep in mind is if you do not use an email account and forget your password there is no way to recover it.

(Required only if you choose to use an email address)

Important: Choose your desired language here because this will be the language in which the program content will be shown to you later

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(Required only if you choose not to use an email address)