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

NCT06778044 | Recruiting

• 2 other identifiers: 0246OFIL-20-257
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Do ReDirection 1.0 and ReDirection 2.0 reduce participants' urges to use CSAM?

  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 Outcomes (1)

• Do ReDirection 1.0 and ReDirection 2.0 reduce participants' proclivity to offend?

  Up to 8 weeks

Study Arms (3)

ReDirection 1.0

EXPERIMENTAL

Other: ReDirection 1.0

ReDirection 2.0

EXPERIMENTAL

Other: ReDirection 2.0

Waitlist

ACTIVE COMPARATOR

Other: Waitlist

Interventions

ReDirection 1.0 OTHER

A free, anonymous, online, self-guided cognitive behavioral therapy (CBT) intervention. Consists of 6 modules.

ReDirection 1.0

ReDirection 2.0 OTHER

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.

ReDirection 2.0

Waitlist OTHER

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.

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Protect Children Organisation, Finland: collaborator

Study Sites (2)

University of Ottawa Integrated Mental Health Research at The Royal

Ottawa, Canada

RECRUITING

Protect Children NGO

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Pedophilia; Paraphilic Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Carissa Augustyn, PhD

  The Royal Ottawa Mental Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carissa Augustyn, PhD

CONTACT

780-497-5003; redirectionprogram@proton.me

Michael Seto, PhD

CONTACT

613-803-0792; michael.seto@theroyal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A three-arm randomized controlled trial where two treatment arms (ReDirection 1.0 and ReDirection 2.0) are compared to a waitlist control.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: January 15, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following each article publication.
• 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.

Locations

CA (1); FI (1)