Clinical trial NCT06133595: Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Individuals with Sexual Interest in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Sexual Abuse
Pedophilia
Keywords: Child sexual abuse material
Motivational Interviewing
Evidence based treatment
Individuals with sexual interest in children
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Centre for Psychiatry Research, Region Stockholm, Sweden
name: Linkoeping University
name: Universitat Jaume I, Spain
name: Protect Children Organisation, Finland
name: National Institute of Mental Health, Czech Republic
name: Academy of the Police Force, Bratislava, Slovakia
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2023-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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 interest involving children at a health care facility?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Motivation to seek treatment
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Motivation to make a change
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
Secondary outcomes:
measure: Plan to seek treatment coming month
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Sexual interest involving children
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Behaviors related to sexual interest in children
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Level of hypersexuality
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Dynamic risk for committing child sexual abuse
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Depressive symtoms
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
Other outcomes:
Locations:
city: Klecany
country: Czechia
facility: National Institute of Mental Health
city: Helsinki
country: Finland
facility: Protect Children NGO
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Bratislava
country: Slovakia
facility: Bratislava Police Academy
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
city: Stockholm
country: Sweden
facility: Centre for psychiatry research, Region Stockholm
Study officials:
References: