Sexual BehaviorSTOP-CSAMNCT06764901
Scalable Technology for Online Prevention of Child Sexual Abuse (CSA) and CSA Materials
A study testing Online Therapy Chat Service (TCS) in people with Sexual Behavior and Child Sexual Abuse Material (CSAM) Consumption, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
Trial summary
1. Summary The STOP-CSAM Study is a two-armed randomized controlled trial of a non-pharmacological Therapy Chat Service for prevention of Child Sexual Abuse (CSA) and Child Sexual Abuse Materials (CSAM) in self-referred and self motivated patients with high frequent CSAM use and non-detected by the legal authorities. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sexual Behavior, Child Sexual Abuse Material (CSAM) Consumption, Behavioural Disorder
- What is being tested?
- Online Therapy Chat Service (TCS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Oct 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participant (≥18 years);
- use of CSAM in the previous 2 weeks;
- English, German, Czech, Spanish or Portuguese speaker;
- voluntary participation and agreement with the terms of the study.
Who cannot join
- Having severe neuropsychiatric comorbidities (unstable psychotic disorder, organic brain damage, diminished intellectual capabilities, untreated drug or alcohol addiction);
- current inpatient psychiatric stays and/or any other current treatment for CSAM behaviour;
- CSA perpetration history (past or present);
- currently under a criminal investigation, proceeding, punishment or probation status for committing online or offline CSA or CSAM use
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Scalable Technology for Online Prevention of Child Sexual Abuse (CSA) and CSA Materials - a Randomized Controlled Trial
- Summary The STOP-CSAM Study is a two-armed randomized controlled trial of a non-pharmacological Therapy Chat Service for prevention of Child Sexual Abuse (CSA) and Child Sexual Abuse Materials (CSAM) in self-referred and self motivated patients with high frequent CSAM use and non-detected by the legal authorities.
- Trial design This study is a prospective multicentred, stratified, parallel-group superiority study conducted in Germany, Czechia and Spain.
- Background There has been a significant increase in child sexual abuse material (CSAM) on the internet in recent years. The use of CSAM is problematic especially because it creates a demand for and maintains contact child sexual abuse. Unfortunately, despite the significant increase in the number of CSAM users, limited resources are available for investigation and prosecution. Consequently, many users remain in the community, with neither intervention from the criminal justice system, nor the health system. The proposed study will examine whether a therapy chat service (TCS) intervention reduces the demand for, circulation and spread of CSAM in undetected offenders, as compared to a control group.
- Methods The sample consists of individuals aged 18 years or older (expected N = 630), who have used CSAM in the prior two weeks and are seeking help voluntarily. Participants will be randomized to (1) a Therapy Chat Service (TCS) intervention or (2) a four-week waitlist (control group) followed by a TCS intervention. The TCS intervention group will receive four to six one-hour online therapy chat sessions over the period of four weeks, while the control group will remain on a waitlist for these four weeks before receiving the same TCS intervention. Assessments will be conducted at baseline (pre-intervention) and at 4-, 8-, 12- and 16-weeks post-intervention. The main objective of the study is to compare the effectiveness of TCS in the prevention of CSAM use within a sample of self-referred participants. The primary outcome is the significant decrease of CSAM consumption, which will be assessed by comparing self-reported severity and time spent using CSAM in the two weeks before the intervention and at four weeks following the intervention. Potential progress measures include time spent, severity and frequency of CSAM consumed. Psychological wellbeing and total sexual outlet will be also measured as secondary outcomes, other participant variables such as risk factors for CSAM consumption or sexual interests and therapeutic variables such as number of patient-therapist interactions, modules covered per session, common factors of psychotherapy, adverse effects of intervention and dropout rate will be also measured. Outcomes between groups will be compared following standard principles for RCTs.
- Results The study will open for recruitment in October 2023, and data collection is expected to be completed by November 2024. The results for the primary outcomes are planned to be analysed by December 2024 and submitted for publication by the end of the project in March 2025.
- Discussion The study will test whether the TCS intervention has a positive effect, not only in terms of reducing self-seeking potential sexual offenders' problematic sexual behaviours, but also on measures such as psychological wellbeing in CSAM users. Possible adverse effects of TCS intervention will also be assessed.
Recently, a similar trial called PRIOTAB-CBT, compared pre- and post-treatment outcome measures between a treatment group to a control group (Lätth et al., 2022). Results showed a significantly larger reduction in time spent using CSAM in the treatment group, in comparison to the control group. PRIOTAB-CBTh was a single-centre, single-blinded, psychological placebo-controlled RCT of an online cognitive behavioural psychotherapy. If the STOP-CSAM trial demonstrates that a TCS intervention reduces CSAM use, it could be an effective prevention strategy for sexual violence against children.
- Funding European Commission - Internal Security Fund (ISF-2021).
- Conditions
- Sexual Behavior, Child Sexual Abuse Material (CSAM) Consumption, Behavioural Disorder, Behavior Problems, Online Behaviour
- Being tested
- Online Therapy Chat Service (TCS)
- Keywords
- Child Sexual Abuse Material (CSAM) consumption, CSAM, CSA, Pedophilia, Digital online intervention, CBT, Cognitive Behavioural Therapy, AI Assistant
- Medical subject headings
- Sexual Behavior, Mental Disorders, Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Therapy Chat Service (TCS)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Waitlist | No intervention | Control group: Waitlist. |
| TCS Intervention | Experimental | Not described Receives: Behavioral: Online Therapy Chat Service (TCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with a reduction in the severity or duration of CSAM use
- Diminished severity or time spent in CSAM consumption:
- Dichotomous outcome defined by a decrease of either a 50% or greater in time spent or of one level or greater of severity of the consumed materials, comparing week 1 and week 4.
- Primary outcome assessment:
- Severity (self-reported):
- Adapted version of COPINE scale (Merdian et al., 2013):
- Time (self-reported):
- How much time did you spend in total using these materials during the last two weeks? (hh:mm)
Measured: At the end of waiting period and/or intervention, usually 4 to 6 weeks after onboarding and following up every two weeks up to 16 weeks after onboarding
Secondary outcomes (3)
Frequency of CSAM consumption (self-reported)
How often have you used these materials during the last two weeks?
- Never
- Once
- Once/twice a week (2/4 times during last two weeks)
- Several times a week (more than four times during last two weeks)
- Every day
Measured: every 2 weeks for 16 weeks after onboarding
Increased mental wellbeing (composite)
Dichotomous outcome defined by an increase of a 10% or greater in mental wellbeing
- Mental wellbeing (self-reported):
● Measured with the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS; Tennant et al., 2007).
Measured: comparing week 1 and week 4
Total sexual outlet (self-reported)
- How many orgasms did you achieve during the last week?
- How many of these by masturbation?
- How many of these by sexual interaction with other people?
Measured: every 2 weeks for 16 weeks after onboarding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start24 Oct 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- * Randomized * Multi-centre * Open label * Parallel assignment * Superiority
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya, National Institute of Mental Health (NIMH), University of Trás-os-Montes and Alto Douro
- Responsible party
- Principal investigator, Klaus Michael Beier, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764901
- Sponsor's protocol ID
- 8000186001
- Other IDs
- 101084719
- Acronym
- STOP-CSAM
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalable Technology for Online Prevention of Child Sexual Abuse (CSA) and CSA Materials - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06764901
- Acronym / sponsor ID
- STOP-CSAM / 8000186001
- Conditions
- Sexual Behavior, Child Sexual Abuse Material (CSAM) Consumption, Behavioural Disorder, Behavior Problems, Online Behaviour
- Keywords
- Child Sexual Abuse Material (CSAM) consumption, CSAM, CSA, Pedophilia, Digital online intervention, CBT, Cognitive Behavioural Therapy, AI Assistant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya, National Institute of Mental Health (NIMH), University of Trás-os-Montes and Alto Douro
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Summary The STOP-CSAM Study is a two-armed randomized controlled trial of a non-pharmacological Therapy Chat Service for prevention of Child Sexual Abuse (CSA) and Child Sexual Abuse Materials (CSAM) in self-referred and self motivated patients with high frequent CSAM use and non-detected by the legal authorities.
- Trial design This study is a prospective multicentred, stratified, parallel-group superiority study conducted in Germany, Czechia and Spain.
- Background There has been a significant increase in child sexual abuse material (CSAM) on the internet in recent years. The use of CSAM is problematic especially because it creates a demand for and maintains contact child sexual abuse. Unfortunately, despite the significant increase in the number of CSAM users, limited resources are available for investigation and prosecution. Consequently, many users remain in the community, with neither intervention from the criminal justice system, nor the health system. The proposed study will examine whether a therapy chat service (TCS) intervention reduces the demand for, circulation and spread of CSAM in undetected offenders, as compared to a control group.
- Methods The sample consists of individuals aged 18 years or older (expected N = 630), who have used CSAM in the prior two weeks and are seeking help voluntarily. Participants will be randomized to (1) a Therapy Chat Service (TCS) intervention or (2) a four-week waitlist (control group) followed by a TCS intervention. The TCS intervention group will receive four to six one-hour online therapy chat sessions over the period of four weeks, while the control group will remain on a waitlist for these four weeks before receiving the same TCS intervention. Assessments will be conducted at baseline (pre-intervention) and at 4-, 8-, 12- and 16-weeks post-intervention. The main objective of the study is to compare the effectiveness of TCS in the prevention of CSAM use within a sample of self-referred participants. The primary outcome is the significant decrease of CSAM consumption, which will be assessed by comparing self-reported severity and time spent using CSAM in the two weeks before the intervention and at four weeks following the intervention. Potential progress measures include time spent, severity and frequency of CSAM consumed. Psychological wellbeing and total sexual outlet will be also measured as secondary outcomes, other participant variables such as risk factors for CSAM consumption or sexual interests and therapeutic variables such as number of patient-therapist interactions, modules covered per session, common factors of psychotherapy, adverse effects of intervention and dropout rate will be also measured. Outcomes between groups will be compared following standard principles for RCTs.
- Results The study will open for recruitment in October 2023, and data collection is expected to be completed by November 2024. The results for the primary outcomes are planned to be analysed by December 2024 and submitted for publication by the end of the project in March 2025.
- Discussion The study will test whether the TCS intervention has a positive effect, not only in terms of reducing self-seeking potential sexual offenders' problematic sexual behaviours, but also on measures such as psychological wellbeing in CSAM users. Possible adverse effects of TCS intervention will also be assessed.
Recently, a similar trial called PRIOTAB-CBT, compared pre- and post-treatment outcome measures between a treatment group to a control group (Lätth et al., 2022). Results showed a significantly larger reduction in time spent using CSAM in the treatment group, in comparison to the control group. PRIOTAB-CBTh was a single-centre, single-blinded, psychological placebo-controlled RCT of an online cognitive behavioural psychotherapy. If the STOP-CSAM trial demonstrates that a TCS intervention reduces CSAM use, it could be an effective prevention strategy for sexual violence against children.
- Funding European Commission - Internal Security Fund (ISF-2021).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Randomized * Multi-centre * Open label * Parallel assignment * Superiority
| Arm | Type | Receives |
|---|---|---|
| Waitlist | No intervention | –Control group: Waitlist. |
| TCS Intervention | Experimental | Behavioral: Online Therapy Chat Service (TCS) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participant (≥18 years);
- use of CSAM in the previous 2 weeks;
- English, German, Czech, Spanish or Portuguese speaker;
- voluntary participation and agreement with the terms of the study.
Key exclusion criteria (4 listed)
- Having severe neuropsychiatric comorbidities (unstable psychotic disorder, organic brain damage, diminished intellectual capabilities, untreated drug or alcohol addiction);
- current inpatient psychiatric stays and/or any other current treatment for CSAM behaviour;
- CSA perpetration history (past or present);
- currently under a criminal investigation, proceeding, punishment or probation status for committing online or offline CSA or CSAM use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Therapy Chat Service (TCS)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). | Behavioural | TCS Intervention |
Primary outcome
proportion of patients with a reduction in the severity or duration of CSAM use
Time frame: At the end of waiting period and/or intervention, usually 4 to 6 weeks after onboarding and following up every two weeks up to 16 weeks after onboarding
* Diminished severity or time spent in CSAM consumption: * Dichotomous outcome defined by a decrease of either a 50% or greater in time spent or of one level or greater of severity of the consumed materials, comparing week 1 and week 4. * Primary outcome assessment: * Severity (self-reported): o Adapted version of COPINE scale (Merdian et al., 2013): * Time (self-reported): * How much time did you spend in total using these materials during the last two weeks? (hh:mm)
3 secondary outcomes
Frequency of CSAM consumption (self-reported)
Time frame: every 2 weeks for 16 weeks after onboarding
Increased mental wellbeing (composite)
Time frame: comparing week 1 and week 4
Total sexual outlet (self-reported)
Time frame: every 2 weeks for 16 weeks after onboarding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Yes
Related trials for Sexual Behavior
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Therapy Chat Service (TCS) in people with Sexual Behavior and Child Sexual Abuse Material (CSAM) Consumption, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with a reduction in the severity or duration of CSAM use (time frame: At the end of waiting period and/or intervention, usually 4 to 6 weeks after onboarding and following up every two weeks up to 16 weeks after onboarding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.