Clinical trial NCT06133569: ReDirection - Self Help Program for Individuals with Sexual Interest in Children
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 Interest in Children.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Abuse Sexual
Pedophilia
Keywords: Child sexual abuse material
Cognitive behavioral therapy
Internet based self-help program
Individuals with sexual interest in children
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Centre for Psychiatry Research, Region Stockholm, Sweden
name: Linkoeping University
name: Universitat Jaume I, Spain
name: Protect Children Organisation, Finland
name: National Institute of Mental Health, Czech Republic
name: Academy of the Police Force, Bratislava, Slovakia
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2023-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants are allocated to either the ReDirection intervention or waitlist during the initial phase of the study and those who receive waitlist receive ReDirection during the second phase of the study.
Primary purpose: TREATMENT

Brief 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?

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sexual interest involving children
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Child sexual abuse material usage
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Other behaviors related to sexual interest in children.
timeFrame: Pre-intervention, during the intervention, and immediately after the intervention.
measure: Depressive symtoms
timeFrame: Pre-intervention, and immediately after the intervention.
Secondary outcomes:
measure: Dynamic risk for committing child sexual abuse
timeFrame: Pre-intervention, during the intervention,and immediately after the intervention.
measure: Level of hypersexuality
timeFrame: Pre-intervention, and immediately after the intervention.
Other outcomes:
Locations:
city: Klecany
country: Czechia
facility: National Institute of Mental Health
city: Helsinki
country: Finland
facility: Protect Children NGO
city: Hamburg
country: Germany
facility: [University Medical Center Hamburg-Eppendorf
city: Bratislava
country: Slovakia
facility: Bratislava Police Academy
city: Castelló
country: Spain
facility: Universitat Jaume I
city: Stockholm
country: Sweden
facility: Centre for psychiatry research, Region Stockholm
Study officials:
References: