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临床试验/NCT06133569
NCT06133569招募中不适用

A Multicenter, Waitlist Controlled, Randomized Clinical Trial of the Effectiveness of a Self Help Program Based on Cognitive Behavioral Therapy for Individuals with Sexual Interest in Children.

Karolinska Institutet7 个研究点 分布在 6 个国家目标入组 60 人开始时间: 2023年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
7
主要终点
Sexual interest involving children

研究概览

简要总结

The overall aim of the study is to evaluate the effectiveness of the ReDirection program for individuals with low or medium risk to commit child sexual abuse.

Primary question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?

详细描述

The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with concerns about their sexual interest regarding children, and that are using child sexual abuse material (CSAM), so that these people can access treatment according to their needs and level of risk, with the objective of reducing the risk for child sexual abuse and improving the health of the group.

More concretely, we aim to evaluate a revised version of an already available cognitive-behavioral self-help program, ReDirection, with the aim of testing whether this intervention can reduce sexual interest regarding children and CSAM use, in a group of people assessed as being at low or medium risk of committing sexual abuse of children. The intervention will be available in seven languages and will be tested in six countries.

Primary research question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?

Secondary research questions: Is ReDirection effective in reducing research subjects' overall risk of committing sexual acts involving children? Does ReDirection reduce specific dynamic risk factors for committing CSA?

ReDirection is based on cognitive behavioral therapy and consists of five modules. The program aims to help participants reduce their CSAM use by gaining a better understanding of, and skills to manage risky sexual thoughts, feelings, and behaviors. At the end of the program, participants are offered an anonymous follow-up chat and if needed during the program, participants can contact a practitioner via chat.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish
  • concern about sexual interest regarding children*,
  • CSAM use past six month
  • Low to medium risk for committing child sexual abuse according to the SChiMRA scale

排除标准

  • Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse) will be excluded, or lack of serious intentions to participate.

结局指标

主要结局

Sexual interest involving children

时间窗: Pre-intervention, during the intervention, and immediately after the intervention.

Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more interest).

Child sexual abuse material usage

时间窗: Pre-intervention, during the intervention, and immediately after the intervention.

Measured with Sexual Child Molestation Risk Assessment (SChiMRA+), part B, item 1 (self-reported time spent last week in hours watching CSAM) including 3 follow up questions (about time/day, severity, and of youngest child).

Other behaviors related to sexual interest in children.

时间窗: Pre-intervention, during the intervention, and immediately after the intervention.

Time spent last week (hours), as self reported on the SChiMRA+ scale part B, item 4.

Depressive symtoms

时间窗: Pre-intervention, and immediately after the intervention.

Scores on the PHQ-9 questionnaire (Patient Health Questionnaire; 0-27 points; higher scores indicate more severe depressive symptoms).

次要结局

  • Dynamic risk for committing child sexual abuse(Pre-intervention, during the intervention,and immediately after the intervention.)
  • Level of hypersexuality(Pre-intervention, and immediately after the intervention.)

研究者

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

Christoffer Rahm

Principal Investigator

Karolinska Institutet

研究点 (7)

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