Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Minor Attracted Individuals

Study Overview
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Brief Summary
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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 urges involving minors at a health care facility?

Detailed Description
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The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with concerns about their sexual urges regarding 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 urges 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 urges involving minors at a health care facility? Does Mi Bridge decrease participants sexual urges 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.

Official Title
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A Multicenter, Waitlist Controlled, Randomized Clinical Trial of the Effectiveness of Mi Bridge, a Motivational Interviewing Intervention to Facilitate Help-seeking Among Minor Attracted Individuals

Conditions
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Child Sexual Abuse, Pedophilia

Intervention / Treatment
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* Behavioral: Behavioral: MiBridge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish Concerns about sexual urges regarding children CSAM use past six month High risk for committing child sexual abuse according to the SChiMRA scale Exclusion Criteria: Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse) will be excluded, or lack of serious intentions to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants are allocated to either the Mi Bridge intervention or waitlist during the initial phase of the study and those who receive waitlist receive Mi Bridge during the second phase of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: MiBridge<br>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<br>* 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.<br>|
| No Intervention: No Intervention: Waitlist<br>Participants are on a waitlist which means they have no active intervention, only weekly measurements with the same questionnaires as in the active arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation to seek treatment | The Motivation to Seek Care questionnaire, item 1, which targets motivation to seek treatment for problems related to sexual urges involving children (Likert scale 1-7; higher scores indicates higher motivation). | 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). | Pre-intervention, during the intervention, and immediately after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 urges involving children (Y/N, coded as 1=YES, and 2=NO). | Pre-intervention, during the intervention, and immediately after the intervention. | 
| Sexual urges involving children | Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more urges). | 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. | 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). | 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). | 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). | Pre-intervention, during the intervention, and immediately after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child sexual abuse material, Motivational Interviewing, Evidence based treatment