ReDirection - Self Help Program for Minor Attracted Individuals

Pedophilia Clinical Trial

— ReDirection  

Official title:

A Multicenter, Waitlist Controlled, Randomized Clinical Trial of the Effectiveness of a Self Help Program Based on Cognitive Behavioral Therapy for Individuals With Sexual Urges Involving Minors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133569
• Other study ID #: 2023-02321-01
• Secondary ID: 101084355-BRIDGE
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 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 the ReDirection program for individuals with low or medium risk to commit child sexual abuse.

Primary question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?

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.

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 urges 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.

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

• concern about sexual urges regarding children*,

• CSAM use past six month

• Low to medium 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

• Pedophilia

Intervention

Behavioral:
• ReDirection
Self help program based on principles for cognitive behavioral therapy

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	Castelló
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

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Child sexual abuse material usage	Measured with Sexual Child Molestation Risk Assessment (SChiMRA+), part B, item 1 (self-reported time spent last week in hours watching CSAM) including 3 follow up questions (about time/day, severity, and of youngest child).	Pre-intervention, during the intervention, and immediately after the intervention.
Primary	Other behaviors related to sexual interest in children.	Time spent last week (hours), as self reported on the SChiMRA+ scale part B, item 4.	Pre-intervention, during the intervention, and immediately after the intervention.
Primary	Depressive symtoms	Scores on the PHQ-9 questionnaire (Patient Health Questionnaire; 0-27 points; higher scores indicate more severe depressive symptoms).	Pre-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	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, and immediately after the intervention.

External Links

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