An interventional study of Behavioral: MiBridge in Child Sexual Abuse and Pedophilia, sponsored by Karolinska Institutet. Recruiting at 6 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
The overall aim of the study is to evaluate the effectiveness of Mi Bridge to motivate high risk participants to admit to treatment.
The main research question is:
Is Mi Bridge, an anonymous online program based on the principles for Motivational Interviewing, effective in making high risk individuals for committing child sexual abuse prone to seek treatment for problems related to sexual interest involving children at a health care facility?
The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with sexual interest in children, and that are using child sexual abuse material (CSAM), so that these people can access treatment according to their needs and level of risk, with the objective of reducing the risk for child sexual abuse and improving the health of the group.
The intervention will be available in seven languages and will be tested in six countries.
Primary research questions:
Does Mi Bridge increase the likelihood that individuals at high risk for committing child sexual abuse accept seeking treatment for problems related to sexual interest involving minors at a health care facility?
Does Mi Bridge increase participants motivation for change regarding sexual behaviors involving minors?
Secondary research questions:
Does Mi Bridge increase the intention to seek treatment in the coming month for problems related to sexual interest involving minors at a health care facility?
Does Mi Bridge decrease participants sexual interest involving children?
Does Mi Bridge significantly decreases participants past week sexual behaviors involving children?
Does Mi Bridge significantly decreases participants symptoms of depression?
Is Mi Bridge effective in reducing certain dynamic risk factors for committing child sexual abuse?
About the intervention. Mi Bridge is a series of up to five conversations between a practitioner and a study participant over three weeks to help the participants understand more about themselves and their willingness to change, and to help the participants connect with the care they need and want. The conversations are carried out as anonymous voice calls or anonymous text-based chat. Mi Bridge is based on the established and well-researched method of Motivational Interviewing, which has been shown to be effective in helping people achieve the desired changes for several lifestyle related problems.
Research subjects will be recruited through Darknet and Clearnet. Darknet refers to websites that are accessible via Tor or similar services. The intervention is provided by practitioners and researchers in the relevant countries.
Mi Bridge will be evaluated through an international multicenter study using randomized wait-list controlled design.
The research subjects will sign a written consent form on the Iterapi platform without disclosing personal data such as name or location. During the subsequent screening interview via chat or voice call on Iterapi, participation criteria are ensured, questions are answered, and the consent to participate is confirmed. The research subjects are thus admitted to the study.
After inclusion, participants answer the baseline survey which consists of validated self-assessment questionnaires with both multiple choice and free-text answers.
Weekly during, after the waitlist, and after the therapeutic intervention, research subjects answer questions to evaluate the effectiveness and safety of the interventions.
A Statistical Analysis Plan (SAP) based on pilot study is pre-registered at the OSF platform. The SAP describes sample size calculations, and planned analyses of outcome measures.
Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish
Exclusion Criteria:
MiBridge: A series of five conversations over three weeks to help participants understand more about themselves and their willingness to change, and to help participants connect with the care they need and want.
Behavioral: Behavioral: MiBridge
Participants are on a waitlist which means they have no active intervention, only weekly measurements with the same questionnaires as in the active arm
A series of five conversations over three weeks to help participants understand more about themselves and their willingness to change, and to help participants connect with the care they need and want.
Motivation to seek treatment
The Motivation to Seek Care questionnaire, item 1, which targets motivation to seek treatment for problems related to sexual interest involving children (Likert scale 1-7; higher scores indicates higher motivation).
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Motivation to make a change
Responses on the Change Questionnaire (3 items, ordinal from 0 - 10; 0 - 30 points in total; higher score indicates more readiness to make a change related to sexual behaviors involving children).
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Plan to seek treatment coming month
The Motivation to Seek Care questionnaire, item 2, which targets the intention to actually seek treatment during the coming month for problems related to sexual interest involving children (Y/N, coded as 1=YES, and 2=NO).
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Sexual interest involving children
Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more interest).
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Behaviors related to sexual interest in children
Time spent last week (hours), as self reported on the SChiMRA+ part B, item 1-4.
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Level of hypersexuality
Scores on the HBI-19 questionnaire (Hypersexual Behavior Inventory; 19-95 points; higher scores indicate higher level of sexuality; more than 52 points indicate hypersexuality).
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Dynamic risk for committing child sexual abuse
Scores on Acute-2007 (21 items; 0-42 points; higher scores indicate higher dynamic risk for committing child sexual abuse).
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Depressive symtoms
Scores on the PHQ-9 questionnaire (Patient Health Questionnaire; 0-27 points; higher scores indicate more severe depressive symptoms).
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Plan to share: No
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Pedophilia
Karolinska Institutet