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

October 8, 2024 updated by: Christoffer Rahm, Karolinska Institutet

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.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child sexual abuse material usage
Time Frame: Pre-intervention, during the intervention, and immediately after the intervention.
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 Frame: Pre-intervention, during the intervention, and immediately after the intervention.
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
Time Frame: Pre-intervention, and immediately after the intervention.
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.
Sexual interest involving children
Time Frame: Pre-intervention, during the intervention, and immediately after the intervention.
Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more interest).
Pre-intervention, during the intervention, and immediately after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dynamic risk for committing child sexual abuse
Time Frame: Pre-intervention, during the intervention,and immediately after the intervention.
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
Time Frame: Pre-intervention, and immediately after the intervention.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings