Fromberger Peter, Schröder Sonja, Bauer Louisa, Siegel Bruno, Tozdan Safiye, Briken Peer, Buntrock Claudia, Etzler Sonja, Rettenberger Martin, Leha Andreas, Müller Jürgen L
Clinic for Psychiatry and Psychotherapy-Forensic Psychiatry, University Medical Center Göttingen, Georg-August-University Göttingen, Göttingen, Germany.
Center for Psychosocial Medicine, Institute for Sex Research, Sexual Medicine & Forensic Psychiatry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Front Psychiatry. 2021 Jan 8;11:575464. doi: 10.3389/fpsyt.2020.575464. eCollection 2020.
There is a high demand for evidence-based and cost-effective treatment concepts for convicted individuals who sexually abused children (ISAC) and individuals who consumed child sexual exploitation material (ICCSEM) under community supervision (CS). The @myTabu-consortium developed a guided web-based intervention for convicted ISAC and ICCSEM under CS consisting of six online modules targeting psychological meaningful risk factors. The study aims to evaluate the effectiveness of this guided web-based intervention in reducing dynamic risk factors and the risk to re-offend compared to a placebo condition. Furthermore, these dynamic risk factors are measured before and after every module to evaluate their individual effectiveness to reduce the respective risk factor as well as risk to re-offend. This clinical trial protocol describes the planned methods as well as the intervention concept. The methodological design is a placebo controlled randomized add-on trial ( = 582) with follow-ups at 8 points in time. The placebo condition controls for attention and expectation effects and comprises the same amount of modules with a comparable temporal effort as the experimental intervention. The trial is conducted as an add-on to community supervision as usually done. Primary outcomes are dynamic risk factors assessed by self-report risk assessment tools and officially recorded re-offenses. To the best of our knowledge, the study is the first to compare the (cost-) effectiveness of a guided web-based intervention for convicted ISAC and ICCSEM under community supervision against a placebo condition. Methodological limitations (e.g., potential ceiling- or volunteers-effects) are discussed. : German Clinical Trial Register (DRKS 00021256). Prospectively registered: 24.04.2020.
对于在社区监管（CS）下性虐待儿童的罪犯（ISAC）以及消费儿童性剥削材料的个人（ICCSEM），对基于证据且具成本效益的治疗方案有着很高的需求。@myTabu联盟为在社区监管下的ISAC和ICCSEM罪犯开发了一种基于网络的引导式干预措施，该措施由六个针对具有心理意义的风险因素的在线模块组成。本研究旨在评估这种基于网络的引导式干预措施与安慰剂条件相比，在降低动态风险因素和再犯罪风险方面的有效性。此外，在每个模块前后都对这些动态风险因素进行测量，以评估其降低各自风险因素以及再犯罪风险的个体有效性。本临床试验方案描述了计划采用的方法以及干预概念。方法设计为安慰剂对照随机附加试验（n = 582），在8个时间点进行随访。安慰剂条件控制注意力和期望效应，包含与实验干预数量相同且时间投入相当的模块。该试验作为社区监管的附加措施按常规进行。主要结局是通过自我报告风险评估工具评估的动态风险因素以及官方记录的再次犯罪情况。据我们所知，本研究是首次比较在社区监管下针对ISAC和ICCSEM罪犯的基于网络的引导式干预措施与安慰剂条件的（成本）有效性。文中讨论了方法学局限性（例如，潜在的天花板效应或志愿者效应）。试验注册号：德国临床试验注册中心（DRKS 00021256）。前瞻性注册时间：2020年4月24日。
