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

NCT05663047 | Completed

• 1 other identifier: Prevent It 2.0/GPP
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pedophilia

Keywords

Child sexual abuse; Pedophilic disorder; Preventive psychiatry; Internet based intervention; Cognitive behavioral therapy; Waitlist

Outcome Measures

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

  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 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?

  Up to 13 weeks

Other Outcomes (4)

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

  Up to 13 weeks

• 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

Study Arms (2)

Prevent It 2.0

EXPERIMENTAL

Other: Prevent It 2.0

Waitlist

ACTIVE COMPARATOR

Other: Waitlist

Interventions

Prevent It 2.0 OTHER

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

Prevent It 2.0

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.

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Royal Ottawa Mental Health Centre: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

CPF - centrum för psykiatriforskning.

Stockholm, 113 64, Sweden

Location

MeSH Terms

Conditions

Pedophilia

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Paraphilic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Christoffer Rahm, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 23, 2022
• Study Start: November 25, 2022
• Primary Completion: October 2, 2024
• Study Completion: February 11, 2025
• Last Updated: March 5, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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).

Locations

SE (1)