ReDirection / Self-Guided ICBT to Reduce the Risk of Child Sexual Abuse Material (CSAM) Use

January 23, 2025 updated by: Carissa Augustyn, The Royal Ottawa Mental Health Centre

Evaluation of an Online Self-Help Program for CSAM

The creation and distribution of child sexual abuse material (CSAM) is a large-scale global problem. CSAM is sometimes referred to as child pornography. It includes images, videos, live-streaming, and any other material that depicts sexual acts with a child or adolescent (i.e., a person under the age of 18). It also includes material that shows a child or adolescent in a sexually suggestive or explicit manner partially clothed, or nude, and can include material that does or does not illustrate sexual activity.

CSAM use is a problem that continues to drastically increase in size despite the numerous political, police, and technological initiatives that have been put forth as solutions. Previous research also suggests that many active CSAM users desire help to stop their use, but have experienced difficulties finding support that is anonymous. Thus, there is a great need for anonymous intervention programs that assist active and at-risk CSAM users in developing skills to manage their thoughts, feelings, and behaviours related to CSAM.

ReDirection is a free, anonymous, online, self-guided, cognitive behavioural therapy (CBT)-based program for individuals concerned about their use or risk to use CSAM. The treatment program is based on many years of clinical experience working with patients who have committed sexual offences, and the results of several previous research projects.

This study will implement a scientifically rigorous design (a three-armed randomized waitlist-controlled trial) to evaluate two versions of this intervention (ReDirection 1.0 and ReDirection 2.0). The primary difference between the two versions of ReDirection is the length of the program and whether it includes the option for asynchronous messaging with a ReDirection specialist. The study design compares ReDirection 1.0 and ReDirection 2.0 with a waitlist control group. Participants in the waitlist control will wait six weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing about sexual urges and behaviours.

Participants will be recruited directly from the ReDirection website, where they will be directed to a secure platform designed specifically for clinical trials of internet-mediated CBT. This platform is called Iterapi. Potential participants learn about the ReDirection program through advertisements on both the "Clearnet" and "Darknet." All trial activities, including participant registration, random assignment, intervention, and evaluation will be conducted via Iterapi.

Treatment includes five-to-six modules over five-to-six weeks and the content includes CBT-based psychoeducation and exercises that aim to help participants gain greater understanding of, and skills to manage risky sexual thoughts, feelings, and behaviours.

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.

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.
300

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

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:

  • 18 years of age or older
  • Able to read and understand English or Spanish
  • Have used or experienced urges to use CSAM within the last six months

Exclusion Criteria:

  • Younger than 18 years of age
  • Unable to read and understand English or Spanish
  • Have not used or experienced urges to use CSAM within the last six months

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: Parallel 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.
Active Comparator: Waitlist
Other: Waitlist
Participants in the waitlist control will wait six weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing sexual urges and behaviour.
Experimental: ReDirection 1.0
Other: ReDirection 1.0
A free, anonymous, online, self-guided cognitive behavioral therapy (CBT) intervention. Consists of 6 modules.
Experimental: ReDirection 2.0
Other: ReDirection 2.0
A free, anonymous, online, self-guided, cognitive behavioural therapy (CBT) intervention. Consists of 5 modules and the option for asynchronous messaging with a ReDirection specialist.

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
Do ReDirection 1.0 and ReDirection 2.0 reduce participants' urges to use CSAM?
Time Frame: Up to 8 weeks

Urges to use CSAM is measured using a modified version of the SSAS (Sexual Symptom Assessment Scale), which is a self-rated measure originally developed to assess general sexual compulsive behaviour. This measure was adapted to include language specific to CSAM use, and response options were altered to permit more precise measurement.

There's no scoring system at the moment. It's all item-by-item. But for all items, higher values indicated a greater frequency, intensity, and/or duration of urges.
Up to 8 weeks

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
Do ReDirection 1.0 and ReDirection 2.0 reduce participants' proclivity to offend?
Time Frame: Up to 8 weeks
Proclivity to offend is defined as likelihood to engage in offending behaviour if no one were to ever find out and the individual could not be punished. This is assessed using two separate items created for this study: one for likelihood of CSAM use and one for likelihood of sexual contact with a person 15 years of age or younger. These are each measured as a likelihood from 0 [minimum] to 100 [maximum]. A 0 indicates 'no chance' whereas 100 indicates 'guaranteed'
Up to 8 weeks

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.
The Royal Ottawa Mental Health Centre

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.
Johns Hopkins Bloomberg School of Public Health
Protect Children Organisation, Finland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carissa Augustyn, PhD, The Royal Ottawa Mental Health Centre

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.
January 15, 2025

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.
November 1, 2025

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.
November 1, 2025

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).
January 10, 2025

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.
January 10, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
January 23, 2025

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.
January 1, 2025

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.
  • 0246
  • OFIL-20-257 (Other Grant/Funding Number: Oak Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in each respective article (text, tables, figures and appendices). Data will be shared with an approved data access agreement.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following each article publication.

IPD Sharing Access Criteria

Investigators who provide a methodologically sound proposal, and whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Proposals should be directed to carissa.augustyn@theroyal.ca. To gain access to the data , data requesters will need to sign a data access agreement. Data will be made available digitally via a secure data transfer.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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.

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