PedophiliaNCT05831657
Prevent It 2.0/PRIORITY - An iCBT to Reduce the Risk of Committing Child Sexual Abuse
A study testing Prevent It 2.0 and Waitlist in people with Pedophilia, run by Karolinska Institutet at 3 sites in 3 countries.
Trial summary
Child sexual exploitation and abuse is a large-scale global issue that has been drastically rising since the advent of the internet that has brought about communication technologies enabling new ways to sexually abuse children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pedophilia
- What is being tested?
- Prevent It 2.0 and Waitlist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Feb 2023to 14 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Concerned about sexual urges regarding children
- Informed consent to participate
Who cannot join
- Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse)
- Participants that are judged to have a limited understanding of the languages that the treatment is delivered in (German, Swedish, and Portuguese)
- Lack serious intention to participate (assessed by the researcher/clinician during the intake interview, which lasts approximately one hour)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Portugal1 site
Universidade Do Porto
Porto, Praça de Gomes Teixeira, 4099-002
About this study
Official title: Prevent It 2.0/Prevention to Reduce Incidence of Sexual Abuse by Reaching Individuals Concerned About Their Risk to Young People - An Internet Mediated Cognitive Behavioral Therapy to Reduce the Risk of Committing Child Sexual Abuse
Child sexual exploitation and abuse is a large-scale global issue that has been drastically rising since the advent of the internet that has brought about communication technologies enabling new ways to sexually abuse children.
Prevent It is a free, anonymous, internet-delivered, and clinician-guided, cognitive behavioral therapy (CBT) intervention for adults who are concerned about their urges to engage in child sexual exploitation or abuse behaviors. It was developed based on many years of clinical experience from working with this patient group, as well as results from several previous research projects in the area of child sexual abuse.
Read more
Using a randomized controlled trial with waitlist control - a scientifically rigorous design - we will evaluate the effectiveness of the Swedish, German, and Portuguese versions of Prevent It 2.0 - an updated version of the initial Prevent It program. This evaluation is being funded by the European Commission and will consist of an international, multicentre, and academically initiated randomized controlled clinical trial for which those actively enrolled in Prevent It 2.0 will be compared to a waitlist control for each language version (Swedish, German, and Portuguese). Data will be collected across the three sites (Sweden, Germany, and Portugal), in their corresponding languages (Swedish, German, and Portuguese), over 18 months.
All data will be collected through the Iterapi platform that will be housed in a server by members of the Swedish subgroup located at Linköping University (LiU), Sweden. PRIORITY will provide intervention to 420 participants who will be recruited via multiple channels (darknet, Clearnet, police referral). Participation in the program will take place on both Darknet and Clearnet. All contact with participants, the treatment evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi. The Iterapi platform is designed specifically for clinical trials of internet-mediated CBT.
Read the detailed description
Child sexual exploitation and abuse is a large-scale global issue that has been drastically rising since the advent of the internet that has brought about communication technologies enabling new ways to sexually abuse children. In addition, existing programs for individuals concerned about their sexual urges and behavior toward children are generally sparse across the European Union (EU) and most have not been evaluated using rigorous scientific designs. Furthermore, those seeking to participate in prevention programs are often met with many internal and external barriers.
Therefore, to reduce the barriers often faced by those seeking help for their sexual urges to engage in child sexual exploitation or abuse, Prevent It was developed. Prevent It is a free, anonymous, internet-delivered, and clinician-guided, cognitive behavioral therapy (CBT) intervention for adults who are concerned about their urges to engage in child sexual exploitation or abuse behaviors. It was developed based on many years of clinical experience from working with this patient group, as well as results from several previous research projects in the area of child sexual abuse. Pilot results from a randomized clinical trial that assigned 160 child sexual abuse material (CSAM) users recruited from darknet forums to the intervention or placebo condition found that Prevent It significantly reduced CSAM use, that the program was safe from a negative side effects perspective, and well appreciated by the participants. However, the evaluation also revealed that participant attrition was high, particularly in the intervention condition, with almost half of the participants dropping out after the first two modules.
Prevent It was updated to Prevent It 2.0 based on feedback from participants and clinicians in the pilot study. It now contains 9 modules - with the first module focused on motivational engagement - that are completed over 9 weeks, with a 4 week follow up. The content of the therapy provided is classic CBT. Prevent It 2.0 will be provided in English, Swedish, German, and Portuguese. The Swedish, German, and Portuguese language versions are being evaluated within the framework of this project.
Using a randomized controlled trial with waitlist control - a scientifically rigorous design - we will evaluate the effectiveness of the Swedish, German, and Portuguese versions of Prevent It 2.0. This is part of a larger project (Prevention to Reduce Incidence of Sexual Abuse by Reaching Individuals Concerned About Their Risk to Young People; PRIORITY) funded by the European (EU) Commission aimed at translating and culturally adapting Prevent It 2.0 into German, Portuguese, and Swedish. Effectiveness of the program will be evaluated based on the impact of Prevent It 2.0 on participants sexual urges toward children.
Evaluating the efficacy of Prevent It 2.0 will consist of an international, multicentre, and academically initiated randomized controlled clinical trial for which those actively enrolled in Prevent It 2.0 will be compared to a waitlist control for each language version (Swedish, German, and Portuguese). Data will be collected across the three sites (Sweden, Germany, and Portugal), in their corresponding languages (Swedish, German, and Portuguese), over 18 months. All data will be collected through the Iterapi platform that will be housed in a server by members of the Swedish subgroup located at Linköping University (LiU), Sweden. PRIORITY will provide intervention to 420 participants who will be recruited via multiple channels (Darknet, Clearnet, police referral). Participation in the program will take place on both Darknet and Clearnet. All contact with participants, the treatment evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi. The Iterapi platform is designed specifically for clinical trials of internet-mediated CBT.
- Conditions
- Pedophilia
- Being tested
- Prevent It 2.0, Waitlist
- Keywords
- Child sexual abuse, Pedophilic disorder, Preventive psychiatry, Internet based intervention, Cognitive behavioral therapy, Waitlist
- Medical subject headings
- Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevent It 2.0Other
A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention
WaitlistOther
Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior.
| Study group | Role | What they receive |
|---|---|---|
| Prevent It 2.0 Swedish | Experimental | A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in Swedish. Receives: Other: Prevent It 2.0 |
| Waitlist Swedish | Active comparator | Waitlist Swedish Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior in Swedish. Receives: Other: Waitlist |
| Prevent It 2.0 German | Experimental | A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in German Receives: Other: Prevent It 2.0 |
| Waitlist German | Active comparator | Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior in German Receives: Other: Waitlist |
| Prevent It 2.0 Portuguese | Experimental | A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in Portuguese Receives: Other: Prevent It 2.0 |
| Waitlist Portuguese | Active comparator | Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior in Portuguese Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is Prevent It 2.0 effective in changing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale) across each language version?
SSAS; scores for each item range from 0 to 4; total scores range from 0 to 48; higher scores indicate a worse outcome [i.e., more sexual urges involving children]
Measured: At time of registration of the intervention, immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention
Secondary outcomes (2)
Is Prevent It 2.0 effective in changing participants' sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA+) Part B across each language version?
There's no scoring system at the moment. It's all item-by-item. But for all items, higher values indicate a worse outcome [e.g., more hours watching CSAM, etc.]
Measured: Immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention.]
Is Prevent It 2.0 effective in changing participants' likelihood of engaging in sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA +) Part A across each language version?
There's no scoring system at the moment. It's all item-by-item. But for all items, higher values indicate a worse outcome [e.g., more motivation to interact with children, etc.]
Measured: Immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start15 Feb 2023
- Primary completion15 Nov 2024
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PedophiliaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control across three language sites (i.e., Swedish, Portuguese, and German)
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Ottawa Mental Health Centre, Johns Hopkins Bloomberg School of Public Health, Universitätsklinikum Hamburg-Eppendorf, Universidade do Porto
- Responsible party
- Principal investigator, Christoffer Rahm, Karolinska Institutet
- Investigators
- Peer Briken, MD, Principal investigator, Co-investigator, Universitaetsklinikum Hamburg-EppendorfJoana Carvalho, PhD, Principal investigator, Co-investigator, Universidade Do PortoMichael Seto, PhD, Principal investigator, Co-investigator, The Royal Ottawa Health Care GroupElizabeth J Letourneau, PhD, Principal investigator, Co-investigator, Moore Center for the Prevention of Child Sexual Abuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831657
- Sponsor's protocol ID
- Prevent It 2.0/PRIORITY
- Status last verified
- Oct 2024
- First submitted
- 31 Jan 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in each respective article, after deidentification (text, tables, figures, and appendices). Fully deidentified participant data will be shared in a public repository without demographic information. Data with demographic information will be shared with an approved data access agreement.
Publications
Latth J, Landgren V, McMahan A, Sparre C, Eriksson J, Malki K, Soderquist E, Oberg KG, Rozental A, Andersson G, Kaldo V, Langstrom N, Rahm C. Effects of internet-delivered cognitive behavioral therapy on use of child sexual abuse material: A randomized placebo-controlled trial on the Darknet. Internet Interv. 2022 Nov 15;30:100590. doi: 10.1016/j.invent.2022.100590. eCollection 2022 Dec.
PubMed 36573073
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevent It 2.0/Prevention to Reduce Incidence of Sexual Abuse by Reaching Individuals Concerned About Their Risk to Young People - An Internet Mediated Cognitive Behavioral Therapy to Reduce the Risk of Committing Child Sexual Abuse
- ClinicalTrials.gov ID
- NCT05831657
- Acronym / sponsor ID
- Prevent It 2.0/PRIORITY
- Conditions
- Pedophilia
- Keywords
- Child sexual abuse, Pedophilic disorder, Preventive psychiatry, Internet based intervention, Cognitive behavioral therapy, Waitlist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Royal Ottawa Mental Health Centre, Johns Hopkins Bloomberg School of Public Health, Universitätsklinikum Hamburg-Eppendorf, Universidade do Porto
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 26 Apr 2023 (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.
Child sexual exploitation and abuse is a large-scale global issue that has been drastically rising since the advent of the internet that has brought about communication technologies enabling new ways to sexually abuse children.
Prevent It is a free, anonymous, internet-delivered, and clinician-guided, cognitive behavioral therapy (CBT) intervention for adults who are concerned about their urges to engage in child sexual exploitation or abuse behaviors. It was developed based on many years of clinical experience from working with this patient group, as well as results from several previous research projects in the area of child sexual abuse.
Using a randomized controlled trial with waitlist control - a scientifically rigorous design - we will evaluate the effectiveness of the Swedish, German, and Portuguese versions of Prevent It 2.0 - an updated version of the initial Prevent It program. This evaluation is being funded by the European Commission and will consist of an international, multicentre, and academically initiated randomized controlled clinical trial for which those actively enrolled in Prevent It 2.0 will be compared to a waitlist control for each language version (Swedish, German, and Portuguese). Data will be collected across the three sites (Sweden, Germany, and Portugal), in their corresponding languages (Swedish, German, and Portuguese), over 18 months.
All data will be collected through the Iterapi platform that will be housed in a server by members of the Swedish subgroup located at Linköping University (LiU), Sweden. PRIORITY will provide intervention to 420 participants who will be recruited via multiple channels (darknet, Clearnet, police referral). Participation in the program will take place on both Darknet and Clearnet. All contact with participants, the treatment evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi. The Iterapi platform is designed specifically for clinical trials of internet-mediated CBT.
Detailed description
Child sexual exploitation and abuse is a large-scale global issue that has been drastically rising since the advent of the internet that has brought about communication technologies enabling new ways to sexually abuse children. In addition, existing programs for individuals concerned about their sexual urges and behavior toward children are generally sparse across the European Union (EU) and most have not been evaluated using rigorous scientific designs. Furthermore, those seeking to participate in prevention programs are often met with many internal and external barriers.
Therefore, to reduce the barriers often faced by those seeking help for their sexual urges to engage in child sexual exploitation or abuse, Prevent It was developed. Prevent It is a free, anonymous, internet-delivered, and clinician-guided, cognitive behavioral therapy (CBT) intervention for adults who are concerned about their urges to engage in child sexual exploitation or abuse behaviors. It was developed based on many years of clinical experience from working with this patient group, as well as results from several previous research projects in the area of child sexual abuse. Pilot results from a randomized clinical trial that assigned 160 child sexual abuse material (CSAM) users recruited from darknet forums to the intervention or placebo condition found that Prevent It significantly reduced CSAM use, that the program was safe from a negative side effects perspective, and well appreciated by the participants. However, the evaluation also revealed that participant attrition was high, particularly in the intervention condition, with almost half of the participants dropping out after the first two modules.
Prevent It was updated to Prevent It 2.0 based on feedback from participants and clinicians in the pilot study. It now contains 9 modules - with the first module focused on motivational engagement - that are completed over 9 weeks, with a 4 week follow up. The content of the therapy provided is classic CBT. Prevent It 2.0 will be provided in English, Swedish, German, and Portuguese. The Swedish, German, and Portuguese language versions are being evaluated within the framework of this project.
Using a randomized controlled trial with waitlist control - a scientifically rigorous design - we will evaluate the effectiveness of the Swedish, German, and Portuguese versions of Prevent It 2.0. This is part of a larger project (Prevention to Reduce Incidence of Sexual Abuse by Reaching Individuals Concerned About Their Risk to Young People; PRIORITY) funded by the European (EU) Commission aimed at translating and culturally adapting Prevent It 2.0 into German, Portuguese, and Swedish. Effectiveness of the program will be evaluated based on the impact of Prevent It 2.0 on participants sexual urges toward children.
Evaluating the efficacy of Prevent It 2.0 will consist of an international, multicentre, and academically initiated randomized controlled clinical trial for which those actively enrolled in Prevent It 2.0 will be compared to a waitlist control for each language version (Swedish, German, and Portuguese). Data will be collected across the three sites (Sweden, Germany, and Portugal), in their corresponding languages (Swedish, German, and Portuguese), over 18 months. All data will be collected through the Iterapi platform that will be housed in a server by members of the Swedish subgroup located at Linköping University (LiU), Sweden. PRIORITY will provide intervention to 420 participants who will be recruited via multiple channels (Darknet, Clearnet, police referral). Participation in the program will take place on both Darknet and Clearnet. All contact with participants, the treatment evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi. The Iterapi platform is designed specifically for clinical trials of internet-mediated CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control across three language sites (i.e., Swedish, Portuguese, and German)
| Arm | Type | Receives |
|---|---|---|
| Prevent It 2.0 Swedish | Experimental | Other: Prevent It 2.0A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in Swedish. |
| Waitlist Swedish | Active comparator | Other: WaitlistWaitlist Swedish Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior in Swedish. |
| Prevent It 2.0 German | Experimental | Other: Prevent It 2.0A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in German |
| Waitlist German | Active comparator | Other: WaitlistParticipants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior in German |
| Prevent It 2.0 Portuguese | Experimental | Other: Prevent It 2.0A free, anonymous, internet-delivered, clinician-guided, cognitive behavioral therapy (CBT) intervention delivered in Portuguese |
| Waitlist Portuguese | Active comparator | Other: WaitlistParticipants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior in Portuguese |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Concerned about sexual urges regarding children
- Informed consent to participate
Key exclusion criteria (3 listed)
- Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse)
- Participants that are judged to have a limited understanding of the languages that the treatment is delivered in (German, Swedish, and Portuguese)
- Lack serious intention to participate (assessed by the researcher/clinician during the intake interview, which lasts approximately one hour)
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 |
|---|---|---|
| Prevent It 2.0A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention | Other | Prevent It 2.0 German, Prevent It 2.0 Portuguese, Prevent It 2.0 Swedish |
| WaitlistParticipants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior. | Other | Waitlist German, Waitlist Portuguese, Waitlist Swedish |
Primary outcome
Is Prevent It 2.0 effective in changing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale) across each language version?
Time frame: At time of registration of the intervention, immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention
SSAS; scores for each item range from 0 to 4; total scores range from 0 to 48; higher scores indicate a worse outcome [i.e., more sexual urges involving children]
2 secondary outcomes
Is Prevent It 2.0 effective in changing participants' sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA+) Part B across each language version?
Time frame: Immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention.]
Is Prevent It 2.0 effective in changing participants' likelihood of engaging in sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA +) Part A across each language version?
Time frame: Immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention.
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 5 Mar 2025.
- Background: PubMed 36573073Latth J, Landgren V, McMahan A, Sparre C, Eriksson J, Malki K, Soderquist E, Oberg KG, Rozental A, Andersson G, Kaldo V, Langstrom N, Rahm C. Effects of internet-delivered cognitive behavioral therapy on use of child sexual abuse material: A randomized placebo-controlled trial on the Darknet. Internet Interv. 2022 Nov 15;30:100590. doi: 10.1016/j.invent.2022.100590. eCollection 2022 Dec.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in each respective article, after deidentification (text, tables, figures, and appendices). Fully deidentified participant data will be shared in a public repository without demographic information. Data with demographic information will be shared with an approved data access agreement.
Related trials for Pedophilia
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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.
Peer Briken, MD principal investigator
Co-investigator, Universitaetsklinikum Hamburg-Eppendorf
Joana Carvalho, PhD principal investigator
Co-investigator, Universidade Do Porto
Michael Seto, PhD principal investigator
Co-investigator, The Royal Ottawa Health Care Group
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevent It 2.0 and Waitlist in people with Pedophilia, run by Karolinska Institutet at 3 sites in 3 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 3 inclusion and 3 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Portugal, Sweden. 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?
Is Prevent It 2.0 effective in changing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale) across each language version? (time frame: At time of registration of the intervention, immediately before the intervention/pre-intervention, during the intervention up to 8 weeks, immediately after the intervention, and four weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05831657, which also lists 1 linked publication.
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 5 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.