ReDirection - Self Help Program for Individuals with Sexual Interest in Children
NCT ID: NCT06133569
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
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-09-27
2024-10-10
Brief Summary
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Primary question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?
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Detailed Description
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More concretely, we aim to evaluate a revised version of an already available cognitive-behavioral self-help program, ReDirection, with the aim of testing whether this intervention can reduce sexual interest regarding children and CSAM use, in a group of people assessed as being at low or medium risk of committing sexual abuse of children. The intervention will be available in seven languages and will be tested in six countries.
Primary research question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?
Secondary research questions: Is ReDirection effective in reducing research subjects' overall risk of committing sexual acts involving children? Does ReDirection reduce specific dynamic risk factors for committing CSA?
ReDirection is based on cognitive behavioral therapy and consists of five modules. The program aims to help participants reduce their CSAM use by gaining a better understanding of, and skills to manage risky sexual thoughts, feelings, and behaviors. At the end of the program, participants are offered an anonymous follow-up chat and if needed during the program, participants can contact a practitioner via chat.
Research subjects will be recruited through Darknet and Clearnet. Darknet refers to websites that are accessible via TOR or similar services. The interventions are provided by practitioners and researchers in the relevant countries.
ReDirection 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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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ReDirection
ReDirection is a self help program based on cognitive behavioral therapy methodology and consists of five modules. The program aims to help participants reduce their CSAM use by gaining a better understanding of, and skills to manage risky sexual thoughts, feelings, and behaviors.
ReDirection
Self help program based on principles for cognitive behavioral therapy
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
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ReDirection
Self help program based on principles for cognitive behavioral therapy
Eligibility Criteria
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Inclusion Criteria
* concern about sexual interest regarding children\*,
* CSAM use past six month
* Low to medium risk for committing child sexual abuse according to the SChiMRA scale
Exclusion Criteria
18 Years
ALL
No
Sponsors
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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
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Christoffer Rahm
Principal Investigator
Locations
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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
Castelló, , Spain
Centre for psychiatry research, Region Stockholm
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Katerina Klapilova, Ass Professor
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
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Web page for the study
Other Identifiers
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101084355-BRIDGE-ISF-2021
Identifier Type: OTHER
Identifier Source: secondary_id
2023-02321-01
Identifier Type: -
Identifier Source: org_study_id
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