Skip to main content
OpenTrials
Completed

NCT Number: NCT05663047

Prevent It 2.0/GPP -iCBT to Reduce the Risk of Committing Child Sexual Abuse

Child sexual abuse is a large-scale global problem, and with the internet and communication technologies enabling new ways to sexually abuse children, the problem is drastically increasing.

Prevent It is a free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention for individuals concerned about their sexual urges or behaviors involving children. The treatment program is based on many years of clinical experience from working with this patient group, results from several previous research projects.

Using the scientifically rigorous design of a randomized controlled trial with waitlist control, we want to evaluate Prevent It 2.0 - an updated cognitive behavioral therapy treatment for individuals who are concerned about their sexual urges regarding children.

The study design is an academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control. 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.

Recruitment will be carried out through multiple channels, and takes 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, designed specifically for clinical trials of Internet-mediated CBT.

The treatment contains nine modules over thirteen weeks and the content of the therapy is classic CBT.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pedophilia Mental Disorders Paraphilic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CPF - centrum för psykiatriforskning.

Stockholm, 113 64, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • concern about sexual urges regarding children
  • Informed consent to participate

Exclusion criteria

  • 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 (English)
  • Lack serious intention to participate (assessed by the researcher/therapist during the intake interview, which lasts approximately one hour)

Treatment and study plan

Prevent It 2.0

Other

A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention

Waitlist

Other

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.

Primary outcomes

  1. 1. Is Prevent It 2.0 effective in reducing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale)?involving children

    Time frame: Up to 13 weeks

    Sexual Symptom Assessment Scale, The range is 0 to 48, with 0 indicating no symptoms and 48 indicating severe symptoms.

Secondary outcomes

  1. Is Prevent It 2.0 effective in reducing participants' sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA+) Part B?

    Time frame: Up to 13 weeks

    The Sexual Child Molestation Risk Assessment, there's no scoring system at the moment. It's all item-by-item. But for all items, higher values are worse (e.g., more hours watching CSAM, more motivation to interact with children, etc).

Other outcomes

  1. Is Prevent It 2 safe from a negative side effects perspective, as measured by the Negative Effects Questionnaire (NEQ-20)?

    Time frame: Up to 13 weeks

    NEQ-20 taps the occurrence (binary, yes or no) and severity (on a 5-point Likert scale 0-4, ranging from not at all to extremely) of 20 statements regarding negative effects of psychological treatment and ends with one free-text question. For each statement answered with yes , the respondent also reports whether they believe the negative effect is caused by "the treatment I received" or "other circumstances". Maximum score = 80, Minimum score = 0.

  2. Comparisons of attrition rates in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?

    Time frame: Up to 13 weeks

  3. Comparisons of SChiMRA in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?

    Time frame: Up to 13 weeks

  4. Comparisons of NEQ-20 in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?

    Time frame: Up to 13 weeks

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • The Royal Ottawa Mental Health Centre

Registry information

Official study title

Prevent It 2.0/GPP - Internet Mediated Cognitive Behavioral Therapy to Reduce the Risk of Committing Child Sexual Abuse - Global Perpetrator Prevention Project

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Dec 23, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.