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| Name | Class |
|---|---|
| Universitat Internacional de Catalunya | OTHER |
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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.
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.
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.
1. Objectives 1.1 Primary objectives
1.2 Secondary objectives
2. Hypotheses
2.1 Primary hypothesis
2.2 Secondary hypothesis
3.Trial design
This is a prospective, randomised, multicentre, open-label, parallel-group, superiority trial designed to compare stratified, pair-matched CSAM users across three intervention groups and one wait-list control group, with an allocation ratio of 1:1:1:1. Following participant agreement to the terms of the study, demographic information, measures for stratified randomization, and baseline outcome data will be collected. Additionally, data collected from the four groups Selfhelp modules, TCS, Selfhelp + TCS, and waitlist) of the TD-CHAT study will be compared with data from a fifth group (waitlist + TCS) sourced from the "Scalable Technology for Online Prevention of Child Sexual Abuse and Child Sexual Abuse Materials" (STOP-CSAM) project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selfhelp+TCS | Experimental | Selfhelp modules followed by Therapist Chat Service |
|
| Selfhelp modules | Active Comparator | Selfhelp modules only |
|
| TCS only | Active Comparator | 4-6 Sessions text message-based Therapist Chat Service only |
|
| Waitlist | No Intervention | Participants will remain on a waitlist for the first two weeks without receiving any kind of intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selfhelp modules | Behavioral | 16 web-based structured selfhelp modules, based on CBT techniques from the Berlin Dissexuality Therapy (Beier, K. M. (2021). Pedophilia, hebephilia and sexual offending against children. The Berlin Dissexuality Therapy (BEDIT). Springer) |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Child Sexual Abuse Material (RCSAM) severity | 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. | every 2 weeks for 12 weeks after onboarding |
| Reduction in Child Sexual Abuse Material (RCSAM) time | 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. | every 2 weeks for 12 weeks after onboarding |
| Reduction in Child Sexual Abuse Material (RCSAM) risk | 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. | every 2 weeks for 12 weeks after onboarding |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Child Sexual Abuse Material (CSAM) consumption | Risk of CSAM consumption: Sexual Child Molestation Risk Assessment (SchiMRA+ part A) at baseline and follow-up. | baseline and 12 weeks after onboarding |
| Frequency of Child Sexual Abuse Material (CSAM) consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlion | Recruiting | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32347899 | Background | Landgren V, Malki K, Bottai M, Arver S, Rahm C. Effect of Gonadotropin-Releasing Hormone Antagonist on Risk of Committing Child Sexual Abuse in Men With Pedophilic Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):897-905. doi: 10.1001/jamapsychiatry.2020.0440. | |
| 27052851 | Background |
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| Therapist Chat Service | Behavioral | Online Therapy Chat Service (TCS) based on CBT techniques from the Berlin Dissexuality Therapy (Beier, K. M. (2021). Pedophilia, hebephilia and sexual offending against children. The Berlin Dissexuality Therapy (BEDIT). Springer) |
|
Frequency of Child Sexual Abuse Material (CSAM) consumption: Self-reported every two weeks, at baseline and follow-up. |
| baseline and every 2 weeks for 12 weeks after onboarding |
| Mental Wellbeing | Mental wellbeing: The Warwick-Edinburgh Mental Wellbeing Scale (WEMBWS; Tennant et al., 2007). The total score is obtained by summing the score for each of the 14 items. The scoring range for each item is from 1 - 5 and the total score is from 14-70. Higher scores mean a better outcome. Mental wellbeing is measured over the past 2 weeks. | baseline and every 2 weeks during 12 weeks after onboarding |
| Total Sexual Outlet |
This outcome is measured at baseline and follow-up. | baseline and every 2 weeks during 12 weeks after onboarding |
| Universitat Internacional de Catalunya (UIC), Catalonia, Spain | Not yet recruiting | Barcelona | Spain |
|
| Merdian HL, Moghaddam N, Boer DP, Wilson N, Thakker J, Curtis C, Dawson D. Fantasy-Driven Versus Contact-Driven Users of Child Sexual Exploitation Material: Offender Classification and Implications for Their Risk Assessment. Sex Abuse. 2018 Apr;30(3):230-253. doi: 10.1177/1079063216641109. Epub 2016 Apr 6. |
| 18042300 | Background | Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. |
| Background | Quayle, E. (2008). The COPINE project. Irish Probation Journal, 5(9), 65-83. |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001523 | Mental Disorders |
| D010378 | Pedophilia |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010262 | Paraphilic Disorders |
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