Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Individuals with Sexual Interest in Children (Mi Bridge)

A Multicenter, Waitlist Controlled, Randomized Clinical Trial of the Effectiveness of Mi Bridge, a Motivational Interviewing Intervention to Facilitate Help-seeking Among Individuals with Sexual Interest in Children

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?

Study Overview

• Status: Recruiting
• Conditions: Pedophilia; Child Sexual Abuse
• Intervention / Treatment: Behavioral: Behavioral: MiBridge

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoffer Rahm, MD, PhD; Phone Number: +46793393723; Email: christoffer.rahm@ki.se
• Study Contact Backup: Name: Maria Breide; Phone Number: +46735563825; Email: maria.breide@ki.se

Study Locations

• Czechia
  • Klecany, Czechia
    • Recruiting
    • National Institute of Mental Health
    • Contact: Katerina Klapilova, Ass Profes
• Finland
  • Helsinki, Finland
    • Recruiting
    • Protect Children NGO
    • Contact: Nina Vaarhanen-Valkonen
• Germany
  • Hamburg, Germany
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Peer Briken, Professor
• Slovakia
  • Bratislava, Slovakia
    • Recruiting
    • Bratislava Police Academy
    • Contact: Josef Metenko, Professor
• Spain
  • Castellón De La Plana, Spain
    • Recruiting
    • Universitat Jaume I
    • Contact: Rafael Ballester, Professor
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Centre for psychiatry research, Region Stockholm
    • Contact: Christoffer Rahm, MD PhD; Phone Number: +46793393723; Email: christoffer.rahm@ki.se
    • Contact: Christoffer Rahm, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish

  • Concerns about sexual interest 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: MiBridge; 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; 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.
No Intervention: No Intervention: Waitlist; 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?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).	Pre-intervention, during the intervention, and immediately after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).	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).	Pre-intervention, during the intervention, and immediately after the intervention.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Universitätsklinikum Hamburg-Eppendorf; National Institute of Mental Health, Czech Republic; Linköping University, Sweden; Centre for Psychiatry Research, Region Stockholm, Sweden; Universitat Jaume I, Spain; Protect Children Organisation, Finland; Academy of the Police Force, Bratislava, Slovakia

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): October 8, 2024
• Study Completion (Estimated): October 8, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Evidence based treatment; Child sexual abuse material; Individuals with sexual interest in children
• Additional Relevant MeSH Terms: Mental Disorders; Paraphilic Disorders; Pedophilia
• Other Study ID Numbers: 2023-02321-01-B; 101084355-BRIDGE-ISF-2021 (Other Identifier: European Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No