Clinical trial NCT05831657: Prevent It 2.0/PRIORITY - An iCBT to Reduce the Risk of Committing Child Sexual Abuse
Official title: Prevent It 2.0/Prevention to Reduce Incidence of Sexual Abuse by Reaching Individuals Concerned About Their Risk to Young People - An Internet Mediated Cognitive Behavioral Therapy to Reduce the Risk of Committing Child Sexual Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pedophilia
Keywords: Child sexual abuse
Pedophilic disorder
Preventive psychiatry
Internet based intervention
Cognitive behavioral therapy
Waitlist
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Royal Ottawa Mental Health Centre
name: Johns Hopkins Bloomberg School of Public Health
name: Universitätsklinikum Hamburg-Eppendorf
name: Universidade do Porto
First posted: 2023-04-26
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Detailed description: 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. In addition, existing programs for individuals concerned about their sexual urges and behavior toward children are generally sparse across the European Union (EU) and most have not been evaluated using rigorous scientific designs. Furthermore, those seeking to participate in prevention programs are often met with many internal and external barriers.

Therefore, to reduce the barriers often faced by those seeking help for their sexual urges to engage in child sexual exploitation or abuse, Prevent It was developed. 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. Pilot results from a randomized clinical trial that assigned 160 child sexual abuse material (CSAM) users recruited from darknet forums to the intervention or placebo condition found that Prevent It significantly reduced CSAM use, that the program was safe from a negative side effects perspective, and well appreciated by the participants. However, the evaluation also revealed that participant attrition was high, particularly in the intervention condition, with almost half of the participants dropping out after the first two modules.

Prevent It was updated to Prevent It 2.0 based on feedback from participants and clinicians in the pilot study. It now contains 9 modules - with the first module focused on motivational engagement - that are completed over 9 weeks, with a 4 week follow up. The content of the therapy provided is classic CBT. Prevent It 2.0 will be provided in English, Swedish, German, and Portuguese. The Swedish, German, and Portuguese language versions are being evaluated within the framework of this project.

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. This is part of a larger project (Prevention to Reduce Incidence of Sexual Abuse by Reaching Individuals Concerned About Their Risk to Young People; PRIORITY) funded by the European (EU) Commission aimed at translating and culturally adapting Prevent It 2.0 into German, Portuguese, and Swedish. Effectiveness of the program will be evaluated based on the impact of Prevent It 2.0 on participants sexual urges toward children.

Evaluating the efficacy of Prevent It 2.0 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Concerned 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 (German, Swedish, and Portuguese)
* Lack serious intention to participate (assessed by the researcher/clinician during the intake interview, which lasts approximately one hour)

Primary outcomes:
measure: 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?
timeFrame: 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:
measure: 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?
timeFrame: Immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention.]
measure: 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?
timeFrame: 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:
measure: 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?
timeFrame: During the intervention up to 8 weeks, and immediately after the intervention
measure: 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?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: 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?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 effective in changing participants' sexualized coping, as measured by the Hypersexual Behavior Inventory (HBI-19) - coping items across each language version?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 effective in changing participants' emotional identification with children, as measured by the Child-like Sense of Self subscale of the Cognitive and Emotional Congruence with Children (C-ECWC) scale across each language version?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 effective in changing participants' offense-supportive cognitions, as measured by the Sex With Children (SWCH) scale, across each language version?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 effective in changing participants' alcohol use, as measured by the Quantity-Frequency measure, across each language version?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 effective in changing participants' negative affect, as measured by the Patient Health Questionnaire, across each language version?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 effective in changing participants' motivation for change, as measured by the Readiness to Change Questionnaire, across each language version?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 effective in changing how participants spend their leisure and recreation time, measured by having participants self-report to how they usually spend their leisure/recreation time, across each language version?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 effective in changing participants' social connection/loneliness, as measured by the Perceived Social Support Questionnaire, across each language version?
timeFrame: Immediately before the intervention/pre-intervention, immediately after the intervention, and four weeks after the intervention
measure: Is Prevent It 2.0 safe from a negative side effects perspective, as measured by the Negative Effects Questionnaire, across language version?
timeFrame: Immediately after the intervention
measure: Comparisons on participants' paraphilic interests, as measured by the Self-rating Sexual Interests (LASSIE) scale - version 2.1, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on participants' criminal history, measured by self-reported prior charges related to violent, sexual, or non-violent criminal offences, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on participants' history of relationship instability, measured by self-reported items assessing historical relationship instability, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on participants' history of employment/education instability, measured by participants' self-report to items assessing this, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on participants' history of alcohol abuse, as measured by the Alcohol Use Disorders Identification Test - Consumption items, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on religiosity/spirituality, measured by having participants' self-report to items assessing religious/ spiritual practices, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on participants' adverse childhood experiences, as measured by the Adverse Childhood Experiences (ACEs) Questionnaire, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on autism, as measured by the Ritvo Autism and Asperger Diagnostic Scale - 14-item Screener, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on participants' engagement in prior child sexual abuse behaviors, as measured by the Sexual Behavior Involving Minor Scale (SBIMS) - Part B, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
measure: Comparisons on participants' static risk in relation to sexual abuse, as measured by self-reported items created out of the Static-99R, between active arm and waitlist in Prevent It 2.0 and between language versions will be conducted
timeFrame: At time of registration of the intervention
Locations:
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Porto
country: Portugal
facility: Universidade Do Porto
state: Praça de Gomes Teixeira
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Co-investigator, Universitaetsklinikum Hamburg-Eppendorf
name: Peer Briken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-investigator, Universidade Do Porto
name: Joana Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-investigator, The Royal Ottawa Health Care Group
name: Michael Seto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-investigator, Moore Center for the Prevention of Child Sexual Abuse
name: Elizabeth J Letourneau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.