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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pedophilia
• Intervention / Treatment: Other: Prevent It 2.0; Other: Waitlist

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoffer Rahm, MD; Phone Number: +46-8-123 700 00; Email: Christoffer.rahm@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 113 64
    • Recruiting
    • CPF - centrum för psykiatriforskning.
    • Contact: Allison McMahan, PhDstudent; Email: allison.mcmahan@ki.se
    • Principal Investigator: Christoffer Rahm, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevent It 2.0	Other: Prevent It 2.0; A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention
Active Comparator: Waitlist	Other: Waitlist; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Sexual Symptom Assessment Scale, The range is 0 to 48, with 0 indicating no symptoms and 48 indicating severe symptoms.	Up to 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	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).	Up to 13 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparisons of attrition rates in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?		Up to 13 weeks
Comparisons of SChiMRA in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?		Up to 13 weeks
Comparisons of NEQ-20 in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?		Up to 13 weeks
Is Prevent It 2 safe from a negative side effects perspective, as measured by the Negative Effects Questionnaire (NEQ-20)?	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.	Up to 13 weeks

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Johns Hopkins Bloomberg School of Public Health; The Royal Ottawa Mental Health Centre
• Investigators: Principal Investigator: Christoffer Rahm, MD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Child sexual abuse; Pedophilic disorder; Preventive psychiatry; Internet based intervention; Waitlist
• Additional Relevant MeSH Terms: Mental Disorders; Paraphilic Disorders; Pedophilia
• Other Study ID Numbers: Prevent It 2.0/GPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For data shared through a data access agreement, beginning 3 months and ending 5 years following each article publication. Data shared in a public repository will be available immediately following each article publication and will be available for at least 5 years.

IPD Sharing Access Criteria

For data that contain demographic information, investigators who provide a methodologically sound proposal, and whose proposed use of the data has been approved by an independent review committee identified for this purpose. Any researcher may access the version of the data available in a public repository.

• For what types of analyses? To achieve aims in the approved proposal and for meta-analysis
• By what mechanism will data be made available? Proposals should be directed to Christoffer.rahm@ki.se. To gain access to the data with demographic information, data requesters will need to sign a data access agreement. Data will be made available digitally via a secure data transfer facility provided by Karolinska Institute. Fully deidentified data without demographics will be made available on the Open Science Framework (osf.io).

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No