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

NCT05831657 | Completed DMC

• 1 other identifier: Prevent It 2.0/PRIORITY
• Study Type: interventional
• Target: 205
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Child sexual abuse; Pedophilic disorder; Preventive psychiatry; Internet based intervention; Cognitive behavioral therapy; Waitlist

Outcome Measures

Primary Outcomes (1)

• Is Prevent It 2.0 effective in changing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale) across each language version?

  SSAS; scores for each item range from 0 to 4; total scores range from 0 to 48; higher scores indicate a worse outcome \[i.e., more sexual urges involving children\]

  At time of registration of the intervention, immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention

Secondary Outcomes (2)

• Is Prevent It 2.0 effective in changing participants' sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA+) Part B across each language version?

  Immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention.]

• Is Prevent It 2.0 effective in changing participants' likelihood of engaging in sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA +) Part A across each language version?

  Immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention.

Other Outcomes (22)

• Is Prevent It 2.0 effective in changing participants' acute dynamic risk of engaging in sexual behaviors involving children as measured by the Acute-2007-SR, across each language version?

  During the intervention up to 8 weeks, and immediately after the intervention

• Is Prevent It 2.0 effective in changing participants' sexual preoccupation, as measured by the Sexual Behavior Involving Minors Scale (SBIMS) - Part A across each language version?

  Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention

• Is Prevent It 2.0 effective in changing participants' sexual self-control, as measured by the Hypersexual Behavior Inventory (HBI-19) - control and consequences items across each language version?

  Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention

Study Arms (6)

Prevent It 2.0 Swedish

EXPERIMENTAL

A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in Swedish.

Other: Prevent It 2.0

Waitlist Swedish

ACTIVE COMPARATOR

Waitlist Swedish 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 in Swedish.

Other: Waitlist

Prevent It 2.0 German

EXPERIMENTAL

A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in German

Other: Prevent It 2.0

Waitlist German

ACTIVE COMPARATOR

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 in German

Other: Waitlist

Prevent It 2.0 Portuguese

EXPERIMENTAL

A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in Portuguese

Other: Prevent It 2.0

Waitlist Portuguese

ACTIVE COMPARATOR

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 in Portuguese

Other: Waitlist

Interventions

Prevent It 2.0 OTHER

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

Prevent It 2.0 German; Prevent It 2.0 Portuguese; Prevent It 2.0 Swedish

Waitlist OTHER

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.

Waitlist German; Waitlist Portuguese; Waitlist Swedish

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
• Concerned about sexual urges regarding children
• Informed consent to participate

You may not qualify if:

• 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 (German, Swedish, and Portuguese)
• Lack serious intention to participate (assessed by the researcher/clinician during the intake interview, which lasts approximately one hour)

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Royal Ottawa Mental Health Centre: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Universidade do Porto: collaborator

Study Sites (3)

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany, 20246, Germany

Location

Universidade Do Porto

Porto, Praça de Gomes Teixeira, 4099-002, Portugal

Location

Karolinska Institutet

Stockholm, Stockholm County, 113 64, Sweden

Location

Related Publications (1)

• Latth J, Landgren V, McMahan A, Sparre C, Eriksson J, Malki K, Soderquist E, Oberg KG, Rozental A, Andersson G, Kaldo V, Langstrom N, Rahm C. Effects of internet-delivered cognitive behavioral therapy on use of child sexual abuse material: A randomized placebo-controlled trial on the Darknet. Internet Interv. 2022 Nov 15;30:100590. doi: 10.1016/j.invent.2022.100590. eCollection 2022 Dec.

  PMID: 36573073 BACKGROUND

MeSH Terms

Conditions

Pedophilia

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Paraphilic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Peer Briken, MD

  Co-investigator, Universitaetsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Joana Carvalho, PhD

  Co-investigator, Universidade Do Porto

  PRINCIPAL INVESTIGATOR

• Michael Seto, PhD

  Co-investigator, The Royal Ottawa Health Care Group

  PRINCIPAL INVESTIGATOR

• Elizabeth J Letourneau, PhD

  Co-investigator, Moore Center for the Prevention of Child Sexual Abuse

  PRINCIPAL INVESTIGATOR

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: MD, PhD, Associate Professor

Model Details: An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control across three language sites (i.e., Swedish, Portuguese, and German)

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: April 26, 2023
• Study Start: February 15, 2023
• Primary Completion: November 15, 2024
• Study Completion: January 14, 2025
• Last Updated: March 5, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For data shared through a data access agreement, beginning 3 months and ending 5 years following each article publication. Data shared in a public repository will be available immediately following each article publication and will be available for at least 5 years.
• Access Criteria: For data that contain demographic information, 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. Any researcher may access the version of the data available in a public repository. * For what types of analyses? To achieve aims in the approved proposal and for meta-analysis * By what mechanism will data be made available? Proposals should be directed to Christoffer.rahm@ki.se. To gain access to the data with demographic information, data requesters will need to sign a data access agreement. Data will be made available digitally via a secure data transfer facility provided by Karolinska Institute. Fully deidentified data without demographics will be made available on the Open Science Framework (osf.io).

Locations

SE (1); DE (1); PT (1)