Troubled Desire & Therapeutic Chat for Reduction of CSAM Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Reduction in Child Sexual Abuse Material (RCSAM) severity
研究概览
简要总结
The goal of this prospective multicentred, stratified, parallel-group superiority study is to prevent and reduce the usage of Child Sexual Abuse Material (CSAM) by a Therapist Chat Service (TCS) and Selfhelp Platform for Self-Referred Patients, mostly men with a sexual interest in children. The interventions are based on Cognitive Behavioral Therapy (CBT) principles and designed to treat the sexual behavioral disorder related with CSAM consumption.
- Participants in the Selfhelp modules group will show a statistically significantly higher proportion of reduction in CSAM behaviours four weeks after baseline, as compared to participants in the waitlist control group.
- Participants in the Selfhelp modules followed by TCS group will show a statistically significantly higher reduction of CSAM behaviours compared to participants in the Selfhelp-only and TCS-only groups, post-intervention.
Researchers will compare TCS-only-, Selfhelp-only-, Selfhelp + TCS- and Waiting group to see if if the interventions decrease CSAM use and improve mental well-being.
Participants will get web based selfhelp-modules and/or text-based chat intervention operated by trained therapists.
详细描述
The study will evaluate whether the TCS intervention and Selfhelp modules, independently or combined, effectively reduce CSAM use or risk of CSAM consumption and improve mental well-being among self-referred participants.
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Objectives 1.1 Primary objectives
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To compare the effectiveness in reducing CSAM behaviours between the TD only group and the waitlist group four weeks after the baseline assessment.
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To compare the post-intervention effectiveness in reducing CSAM behaviours of the Selfhelp modules versus TCS alone and Selfhelp modules followed by TCS.
1.2 Secondary objectives
- To assess the reduction in severity, time and self-rated risk of CSAM consumption among participants in the intervention groups (Selfhelp modules, TCS, or Selfhelp + TCS) compared to the waitlist control group, at post-intervention.
- To compare the impact of the interventions (Selfhelp modules, TCS, or Selfhelp + TCS) on mental wellbeing, in contrast to the control group, at the end of the intervention period.
- To evaluate the effect of the interventions (Selfhelp modules, TCS, or Selfhelp + TCS) on total sexual outlet compared with the waitlist control group after the intervention period.
- To identify any adverse effects associated with the interventions (Selfhelp modules, TCS, or Selfhelp + TCS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participant (≥18 years);
- •recent (last 2 weeks) CSAM use or past CSAM use and self-reported risk;
- •proficiency in English, German or Spanish;
- •voluntary participation and agreement to the terms of the study.
排除标准
- •Severe neuropsychiatric comorbidities (unstable psychotic disorder, organic brain damage, diminished intellectual functioning, untreated drug or alcohol addiction);
- •history of contact CSA perpetration (past or present);
- •ongoing criminal investigation, trial, punishment, or probation status for online or offline CSA or CSAM use;
- •current inpatient psychiatric treatment or other concurrent treatment targeting CSAM behaviours
结局指标
主要结局
Reduction in Child Sexual Abuse Material (RCSAM) severity
时间窗: every 2 weeks for 12 weeks after onboarding
A) Reduction in Child Sexual Abuse Material severity (RCSAM severity): A reduction in CSAM severity in the last 2 weeks, defined as the pre-post difference in highest "Combating Paedophile Information Networks in Europe" (COPINE) scale scores, with a reduction from severity levels 4 or higher to levels 3 or lower after the intervention.
Reduction in Child Sexual Abuse Material (RCSAM) time
时间窗: every 2 weeks for 12 weeks after onboarding
B) Reduction in Child Sexual Abuse Material time (RCSAM time): A 50% or greater decrease in CSAM consumption time (minutes) over the past 2 weeks. CSAM time is measured as the time (in minutes) spent consuming CSAM materials over the past 2 weeks.
Reduction in Child Sexual Abuse Material (RCSAM) risk
时间窗: every 2 weeks for 12 weeks after onboarding
C) Reduction in self-reported risk of Child Sexual Abuse Material use (RCSAM risk): A reduction in self-reported risk of CSAM use (RCSAM risk): A decrease in the risk of CSAM consumption over the last 2 weeks, defined as a pre-post decrease in self-reported risk, as measured using an adapted version of the "Sexual Child Molestation Risk Assessment" (SChiMRA+) Part A.
次要结局
- Risk of Child Sexual Abuse Material (CSAM) consumption(baseline and 12 weeks after onboarding)
- Frequency of Child Sexual Abuse Material (CSAM) consumption(baseline and every 2 weeks for 12 weeks after onboarding)
- Total Sexual Outlet(baseline and every 2 weeks during 12 weeks after onboarding)
- Mental Wellbeing(baseline and every 2 weeks during 12 weeks after onboarding)
研究者
Hannes Gieseler
Dipl.Des.
Charite University, Berlin, Germany