Prevent It 2.0/GPP -iCBT to Reduce the Risk of Committing Child Sexual Abuse

Study Overview
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Brief Summary
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Child sexual abuse is a large-scale global problem, and with the internet and communication technologies enabling new ways to sexually abuse children, the problem is drastically increasing. Prevent It is a free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention for individuals concerned about their sexual urges or behaviors involving children. The treatment program is based on many years of clinical experience from working with this patient group, results from several previous research projects. Using the scientifically rigorous design of a randomized controlled trial with waitlist control, we want to evaluate Prevent It 2.0 - an updated cognitive behavioral therapy treatment for individuals who are concerned about their sexual urges regarding children. The study design is an academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control. Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior. Recruitment will be carried out through multiple channels, and takes place on both Darknet and Clearnet. All contact with participants, the treatment, evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi, designed specifically for clinical trials of Internet-mediated CBT. The treatment contains nine modules over thirteen weeks and the content of the therapy is classic CBT.

Official Title
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Prevent It 2.0/GPP - Internet Mediated Cognitive Behavioral Therapy to Reduce the Risk of Committing Child Sexual Abuse - Global Perpetrator Prevention Project

Conditions
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Pedophilia

Intervention / Treatment
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* Other: Prevent It 2.0
* Other: Waitlist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: concern about sexual urges regarding children Informed consent to participate Exclusion Criteria: Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse) Participants that are judged to have a limited understanding of the languages that the treatment is delivered in (English) Lack serious intention to participate (assessed by the researcher/therapist during the intake interview, which lasts approximately one hour)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevent It 2.0<br> | Other: Prevent It 2.0<br>* A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention<br>|
| Active Comparator: Waitlist<br> | Other: Waitlist<br>* Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Is Prevent It 2.0 effective in reducing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale)?involving children | Sexual Symptom Assessment Scale, The range is 0 to 48, with 0 indicating no symptoms and 48 indicating severe symptoms. | Up to 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is Prevent It 2.0 effective in reducing participants' sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA+) Part B? | The Sexual Child Molestation Risk Assessment, there's no scoring system at the moment. It's all item-by-item. But for all items, higher values are worse (e.g., more hours watching CSAM, more motivation to interact with children, etc). | Up to 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventive psychiatry, Child sexual abuse, Pedophilic disorder, Internet based intervention, Cognitive behavioral therapy, Waitlist