Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Individuals with Sexual Interest in Children
NCT ID: NCT06133595
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2023-09-18
2024-10-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment for Problematic Sexual Behavior of Preteen Children
NCT05514730
Tertiary Prevention of Child Sexual Abuse
NCT06126926
Prevent It 2.0/PRIORITY - An iCBT to Reduce the Risk of Committing Child Sexual Abuse
NCT05831657
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
NCT07001735
Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors
NCT03794986
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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: 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: 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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre for Psychiatry Research, Region Stockholm, Sweden
UNKNOWN
Linkoeping University
OTHER_GOV
Universitat Jaume I, Spain
UNKNOWN
Protect Children Organisation, Finland
UNKNOWN
National Institute of Mental Health, Czech Republic
OTHER
Academy of the Police Force, Bratislava, Slovakia
UNKNOWN
Universitätsklinikum Hamburg-Eppendorf
OTHER
Karolinska Institutet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christoffer Rahm
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Katerina Klapilova, Ass Profes
Role: primary
Nina Vaarhanen-Valkonen
Role: primary
Peer Briken, Professor
Role: primary
Josef Metenko, Professor
Role: primary
Rafael Ballester, Professor
Role: primary
Christoffer Rahm, MD PhD
Role: backup
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
101084355-BRIDGE-ISF-2021
Identifier Type: OTHER
Identifier Source: secondary_id
2023-02321-01-B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.