跳至主要内容
临床试验/NCT05831657
NCT05831657已完成不适用

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

Karolinska Institutet3 个研究点 分布在 3 个国家目标入组 205 人开始时间: 2023年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
3
主要终点
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?

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years of age or older
  • •Concerned about sexual urges regarding children
  • •Informed consent to participate

排除标准

  • •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)

研究组 & 干预措施

Prevent It 2.0 Swedish

Experimental

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

干预措施: Prevent It 2.0 (Other)

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.

干预措施: Waitlist (Other)

Prevent It 2.0 German

Experimental

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

干预措施: Prevent It 2.0 (Other)

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

干预措施: Waitlist (Other)

Prevent It 2.0 Portuguese

Experimental

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

干预措施: Prevent It 2.0 (Other)

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

干预措施: Waitlist (Other)

结局指标

主要结局

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?

时间窗: 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

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

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoffer Rahm

MD, PhD, Associate Professor

Karolinska Institutet

研究点 (3)

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