Clinical trial NCT06778044: ReDirection / Self-Guided ICBT to Reduce the Risk of Child Sexual Abuse Material (CSAM) Use
Official title: Evaluation of an Online Self-Help Program for CSAM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pedophilia
Keywords: Child Sexual Abuse Material
Paraphilic Disorders
Waitlist
Child sexual abuse
Cognitive behavioural therapy
Self-help intervention
Internet based intervention
Prevention
Pedophilic disorder
Lead sponsor: The Royal Ottawa Mental Health Centre
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Bloomberg School of Public Health
name: Protect Children Organisation, Finland
First posted: 2025-01-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-arm randomized controlled trial where two treatment arms (ReDirection 1.0 and ReDirection 2.0) are compared to a waitlist control.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Do ReDirection 1.0 and ReDirection 2.0 reduce participants' urges to use CSAM?
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Do ReDirection 1.0 and ReDirection 2.0 reduce participants' proclivity to offend?
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Integrated Mental Health Research at The Royal
city: Helsinki
country: Finland
facility: Protect Children NGO
Study officials:
affiliation: The Royal Ottawa Mental Health Centre
name: Carissa Augustyn, PhD
role: PRINCIPAL_INVESTIGATOR
References: