ReDirection - Self Help Program for Minor Attracted Individuals (ReDirection)

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.

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?

Study Overview

• Status: Recruiting
• Conditions: Pedophilia; Child Abuse Sexual
• Intervention / Treatment: Behavioral: ReDirection

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoffer Rahm, MD, PhD; Phone Number: +46793393723; Email: christoffer.rahm@ki.se
• Study Contact Backup: Name: Maria Breide; Phone Number: +46735563825; Email: maria.breide@ki.se

Study Locations

• Czechia
  • Klecany, Czechia
    • Recruiting
    • National Institute of Mental Health
    • Contact: Katerina Klapilova, Ass Professor
    • Principal Investigator: Katerina Klapilova, Ass Professor
• Finland
  • Helsinki, Finland
    • Recruiting
    • Protect Children NGO
    • Contact: Nina Vaarhanen-Valkonen
    • Principal Investigator: Nina Vaarhanen-Valkonen
• Germany
  • Hamburg, Germany
    • Recruiting
    • [University Medical Center Hamburg-Eppendorf
    • Contact: Peer Briken, Professor
    • Principal Investigator: Peer Briken, Professor
• Slovakia
  • Bratislava, Slovakia
    • Recruiting
    • Bratislava Police Academy
    • Contact: Josef Metenko, Professor
    • Principal Investigator: Josef Metenko, Professor
• Spain
  • Castelló, Spain
    • Recruiting
    • Universitat Jaume I
    • Contact: Rafael Ballester, Professor
    • Principal Investigator: Rafael Ballester, Professor
• Sweden
  • Stockholm, Sweden, 11842
    • Recruiting
    • Centre for psychiatry research, Region Stockholm
    • Contact: Christoffer Rahm, MD PhD; Phone Number: +46793393723; Email: christoffer.rahm@ki.se
    • Principal Investigator: Christoffer Rahm, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: ReDirection; Self help program based on principles for cognitive behavioral therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Universitätsklinikum Hamburg-Eppendorf; National Institute of Mental Health, Czech Republic; Linköping University, Sweden; Centre for Psychiatry Research, Region Stockholm, Sweden; Universitat Jaume I, Spain; Protect Children Organisation, Finland; Academy of the Police Force, Bratislava, Slovakia

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): April 21, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Child sexual abuse material; Internet based self-help program
• Additional Relevant MeSH Terms: Mental Disorders; Paraphilic Disorders; Pedophilia
• Other Study ID Numbers: 2023-02321-01; 101084355-BRIDGE-ISF-2021 (Other Identifier: European Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No