PedophiliaNCT06778044
ReDirection / Self-Guided ICBT to Reduce the Risk of Child Sexual Abuse Material (CSAM) Use
A study testing ReDirection 1.0, ReDirection 2.0 and Waitlist in people with Pedophilia, run by The Royal Ottawa Mental Health Centre at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pedophilia
- What is being tested?
- ReDirection 1.0, ReDirection 2.0 and Waitlist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jan 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Integrated Mental Health Research at The Royal
Ottawa
Carissa Augustyn, PhD, 780-497-5003, redirectionprogram@proton.me
Finland1 site, 1 recruiting
- Recruiting
Protect Children NGO
Helsinki
Nina Vaaranen-Valkonen, M.Soc.Sc, +358 40 747 8829, nina.vaaranen-valkonen@protectchildren.fi
About this study
Official title: 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.
Read more
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
- Being tested
- ReDirection 1.0, ReDirection 2.0, Waitlist
- Keywords
- Child Sexual Abuse Material, Paraphilic Disorders, Waitlist, Child sexual abuse, Cognitive behavioural therapy, Self-help intervention, Internet based intervention, Prevention, Pedophilic disorder
- Medical subject headings
- Pedophilia, Paraphilic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReDirection 1.0Other
A free, anonymous, online, self-guided cognitive behavioral therapy (CBT) intervention. Consists of 6 modules.
ReDirection 2.0Other
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.
WaitlistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ReDirection 1.0 | Experimental | Not described Receives: Other: ReDirection 1.0 |
| ReDirection 2.0 | Experimental | Not described Receives: Other: ReDirection 2.0 |
| Waitlist | Active comparator | Not described Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks
Secondary outcomes (1)
Do ReDirection 1.0 and ReDirection 2.0 reduce participants' proclivity to offend?
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'
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Jan 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PedophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, Protect Children Organisation, Finland
- Responsible party
- Principal investigator, Carissa Augustyn, The Royal Ottawa Mental Health Centre
- Investigators
- Carissa Augustyn, PhD, Principal investigator, The Royal Ottawa Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778044
- Sponsor's protocol ID
- 0246
- Other IDs
- OFIL-20-257
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Self-Help Program for CSAM
- ClinicalTrials.gov ID
- NCT06778044
- Acronym / sponsor ID
- 0246
- Conditions
- Pedophilia
- Keywords
- Child Sexual Abuse Material, Paraphilic Disorders, Waitlist, Child sexual abuse, Cognitive behavioural therapy, Self-help intervention, Internet based intervention, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, Protect Children Organisation, Finland
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| ReDirection 1.0 | Experimental | Other: ReDirection 1.0 |
| ReDirection 2.0 | Experimental | Other: ReDirection 2.0 |
| Waitlist | Active comparator | Other: Waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReDirection 1.0A free, anonymous, online, self-guided cognitive behavioral therapy (CBT) intervention. Consists of 6 modules. | Other | ReDirection 1.0 |
| ReDirection 2.0A free, anonymous, online, self-guided, cognitive behavioural therapy (CBT) intervention. Consists of 5 modules and the option for asynchronous messaging with a ReDirection specialist. | Other | ReDirection 2.0 |
| WaitlistParticipants 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. | Other | Waitlist |
Primary outcome
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.
1 secondary outcome
Do ReDirection 1.0 and ReDirection 2.0 reduce participants' proclivity to offend?
Time frame: Up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Pedophilia
Recruiting
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
Partner
Recruiting
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Pedophilia, Hebephilia
Recruiting
Troubled-Desire & Therapeutic Chat for Reduction of CSAM Use (TD-CHAT)
Prevention, Well Being
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carissa Augustyn, PhD principal investigator
The Royal Ottawa Mental Health Centre
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReDirection 1.0, ReDirection 2.0 and Waitlist in people with Pedophilia, run by The Royal Ottawa Mental Health Centre at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carissa Augustyn, PhD (780-497-5003, redirectionprogram@proton.me), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Do ReDirection 1.0 and ReDirection 2.0 reduce participants' urges to use CSAM? (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.