- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06778044
ReDirection / Self-Guided ICBT to Reduce the Risk of Child Sexual Abuse Material (CSAM) Use
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carissa Augustyn, PhD
- Phone Number: 780-497-5003
- Email: redirectionprogram@proton.me
Study Contact Backup
- Name: Michael Seto, PhD
- Phone Number: 613-803-0792
- Email: michael.seto@theroyal.ca
Study Locations
-
-
-
Ottawa, Canada
- Recruiting
- University of Ottawa Integrated Mental Health Research at The Royal
-
Contact:
- Carissa Augustyn, PhD
- Phone Number: 780-497-5003
- Email: redirectionprogram@proton.me
-
-
-
-
-
Helsinki, Finland
- Recruiting
- Protect Children NGO
-
Contact:
- Nina Vaaranen-Valkonen, M.Soc.Sc
- Phone Number: +358 40 747 8829
- Email: nina.vaaranen-valkonen@protectchildren.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
A free, anonymous, online, self-guided cognitive behavioral therapy (CBT) intervention.
Consists of 6 modules.
|
|
Experimental: 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
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
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
Collaborators
Investigators
- Principal Investigator: Carissa Augustyn, PhD, The Royal Ottawa Mental Health Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0246
- OFIL-20-257 (Other Grant/Funding Number: Oak Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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