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

NCT05831657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2025-03-05

No results posted yet for this study

Summary

Child sexual exploitation and abuse is a large-scale global issue that has been drastically rising since the advent of the internet that has brought about communication technologies enabling new ways to sexually abuse children.

Prevent It is a free, anonymous, internet-delivered, and clinician-guided, cognitive behavioral therapy (CBT) intervention for adults who are concerned about their urges to engage in child sexual exploitation or abuse behaviors. It was developed based on many years of clinical experience from working with this patient group, as well as results from several previous research projects in the area of child sexual abuse.

Using a randomized controlled trial with waitlist control - a scientifically rigorous design - we will evaluate the effectiveness of the Swedish, German, and Portuguese versions of Prevent It 2.0 - an updated version of the initial Prevent It program. This evaluation is being funded by the European Commission and will consist of an international, multicentre, and academically initiated randomized controlled clinical trial for which those actively enrolled in Prevent It 2.0 will be compared to a waitlist control for each language version (Swedish, German, and Portuguese). Data will be collected across the three sites (Sweden, Germany, and Portugal), in their corresponding languages (Swedish, German, and Portuguese), over 18 months.

All data will be collected through the Iterapi platform that will be housed in a server by members of the Swedish subgroup located at Linköping University (LiU), Sweden. PRIORITY will provide intervention to 420 participants who will be recruited via multiple channels (darknet, Clearnet, police referral). Participation in the program will take 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. The Iterapi platform is designed specifically for clinical trials of internet-mediated CBT.

Conditions

  • Pedophilia

Interventions

OTHER

Prevent It 2.0

A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention

OTHER

Waitlist

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.

Sponsors & Collaborators

  • The Royal Ottawa Mental Health Centre

    collaborator OTHER
  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER
  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER
  • Universidade do Porto

    collaborator OTHER
  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Peer Briken, MD · Co-investigator, Universitaetsklinikum Hamburg-Eppendorf

  • Joana Carvalho, PhD · Co-investigator, Universidade Do Porto

  • Michael Seto, PhD · Co-investigator, The Royal Ottawa Health Care Group

  • Elizabeth J Letourneau, PhD · Co-investigator, Moore Center for the Prevention of Child Sexual Abuse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2024-11-15
Completion
2025-01-14

Countries

  • Germany
  • Portugal
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831657 on ClinicalTrials.gov