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

Not Applicable

Completed

• Conditions: Pedophilia
• Interventions: Other: Waitlist; Other: Prevent It 2.0

• Registration Number: NCT05663047
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-25
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-23
• Status Verified: 2024-10
• Primary Completion: 2024-10-02
• Study Completion: 2025-02-11
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist	Waitlist	-
Prevent It 2.0	Prevent It 2.0	-

Primary Outcome Measures

Name	Time	Method
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	Up to 13 weeks	Sexual Symptom Assessment Scale, The range is 0 to 48, with 0 indicating no symptoms and 48 indicating severe symptoms.

Secondary Outcome Measures

Name	Time	Method
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?	Up to 13 weeks	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).

Trial Locations

Locations (1)

CPF - centrum för psykiatriforskning.; 🇸🇪 Stockholm, Sweden