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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 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?
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
National Institute of Mental Health
Klecany, Czechia
Protect Children NGO
Helsinki, Finland
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Bratislava Police Academy
Bratislava, Slovakia
Universitat Jaume I
Castellon, Spain
Centre for psychiatry research, Region Stockholm
Stockholm, Sweden
Start Date
September 18, 2023
Primary Completion Date
October 8, 2024
Completion Date
October 8, 2024
Last Updated
October 10, 2024
60
ESTIMATED participants
Behavioral: MiBridge
BEHAVIORAL
Lead Sponsor
Karolinska Institutet
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05663047