ReDirection - Self Help Program for Individuals with Sexual Interest in Children

Karolinska Institute

Status: Enrolling

Conditions: Pedophilia; Child Abuse Sexual

Treatments: Behavioral: ReDirection

Study type: Interventional

Funder types: Other

Identifiers

NCT06133569

2023-02321-01

101084355-BRIDGE-ISF-2021 (Other Identifier)

Details and patient eligibility

About

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?

Full 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 interest 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 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish
• 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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

ReDirection

Experimental group

Description:

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.

Treatment:

Behavioral: ReDirection

Waitlist

No Intervention group

Description:

Participants are on a waitlist which means they have no active intervention, only weekly measurements with the same questionnaires as in the active arm.