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

Child Sexual Abuse Clinical Trial

— Mi Bridge  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133595
• Other study ID #: 2023-02321-01-B
• Secondary ID: 101084355-BRIDGE
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Karolinska Institutet
• Contact: Christoffer Rahm, MD, PhD
• Phone: +46793393723
• Email: christoffer.rahm[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: April 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Child Sexual Abuse
• Pedophilia

Intervention

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.

Locations

Country	Name	City	State
Czechia	National Institute of Mental Health	Klecany
Finland	Protect Children NGO	Helsinki
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Slovakia	Bratislava Police Academy	Bratislava
Spain	Universitat Jaume I	Castellón De La Plana
Sweden	Centre for psychiatry research, Region Stockholm	Stockholm

Sponsors (8)

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

Countries where clinical trial is conducted

Czechia,  Finland,  Germany,  Slovakia,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

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