PMID- 33488416 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210126 IS - 1664-0640 (Print) IS - 1664-0640 (Electronic) IS - 1664-0640 (Linking) VI - 11 DP - 2020 TI - @myTabu-A Placebo Controlled Randomized Trial of a Guided Web-Based Intervention for Individuals Who Sexually Abused Children and Individuals Who Consumed Child Sexual Exploitation Material: A Clinical Study Protocol. PG - 575464 LID - 10.3389/fpsyt.2020.575464 [doi] LID - 575464 AB - Background: 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. Methods: The methodological design is a placebo controlled randomized add-on trial (N = 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. Discussion: 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. Clinical Trial Registration: German Clinical Trial Register (DRKS 00021256). Prospectively registered: 24.04.2020. CI - Copyright (c) 2021 Fromberger, Schroder, Bauer, Siegel, Tozdan, Briken, Buntrock, Etzler, Rettenberger, Leha and Muller. FAU - Fromberger, Peter AU - Fromberger P AD - Clinic for Psychiatry and Psychotherapy-Forensic Psychiatry, University Medical Center Gottingen, Georg-August-University Gottingen, Gottingen, Germany. FAU - Schroder, Sonja AU - Schroder S AD - Clinic for Psychiatry and Psychotherapy-Forensic Psychiatry, University Medical Center Gottingen, Georg-August-University Gottingen, Gottingen, Germany. FAU - Bauer, Louisa AU - Bauer L AD - Clinic for Psychiatry and Psychotherapy-Forensic Psychiatry, University Medical Center Gottingen, Georg-August-University Gottingen, Gottingen, Germany. FAU - Siegel, Bruno AU - Siegel B AD - Clinic for Psychiatry and Psychotherapy-Forensic Psychiatry, University Medical Center Gottingen, Georg-August-University Gottingen, Gottingen, Germany. FAU - Tozdan, Safiye AU - Tozdan S AD - Center for Psychosocial Medicine, Institute for Sex Research, Sexual Medicine & Forensic Psychiatry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Briken, Peer AU - Briken P AD - Center for Psychosocial Medicine, Institute for Sex Research, Sexual Medicine & Forensic Psychiatry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Buntrock, Claudia AU - Buntrock C AD - Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. FAU - Etzler, Sonja AU - Etzler S AD - Centre for Criminology, Wiesbaden, Germany. FAU - Rettenberger, Martin AU - Rettenberger M AD - Centre for Criminology, Wiesbaden, Germany. FAU - Leha, Andreas AU - Leha A AD - Department of Medical Statistics, University Medical Center Gottingen, Georg-August-University Gottingen, Gottingen, Germany. FAU - Muller, Jurgen L AU - Muller JL AD - Clinic for Psychiatry and Psychotherapy-Forensic Psychiatry, University Medical Center Gottingen, Georg-August-University Gottingen, Gottingen, Germany. LA - eng PT - Journal Article DEP - 20210108 PL - Switzerland TA - Front Psychiatry JT - Frontiers in psychiatry JID - 101545006 PMC - PMC7820175 OTO - NOTNLM OT - child exploitation material offenders OT - child sexual abuse (CSA) OT - eHealth OT - randomized placebo controlled trial OT - web-based intervention COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Access to the final trial data-set for investigators is not limited, e.g., by contractual agreements. EDAT- 2021/01/26 06:00 MHDA- 2021/01/26 06:01 PMCR- 2021/01/08 CRDT- 2021/01/25 05:38 PHST- 2020/06/23 00:00 [received] PHST- 2020/12/01 00:00 [accepted] PHST- 2021/01/25 05:38 [entrez] PHST- 2021/01/26 06:00 [pubmed] PHST- 2021/01/26 06:01 [medline] PHST- 2021/01/08 00:00 [pmc-release] AID - 10.3389/fpsyt.2020.575464 [doi] PST - epublish SO - Front Psychiatry. 2021 Jan 8;11:575464. doi: 10.3389/fpsyt.2020.575464. eCollection 2020.