NCT06133569

Brief Summary

The overall aim of the study is to evaluate the effectiveness of the ReDirection program for individuals with low or medium risk to commit child sexual abuse. Primary question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
6 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 12, 2023

Last Update Submit

October 8, 2024

Conditions

Child Abuse SexualPedophilia

Keywords

Child sexual abuse materialCognitive behavioral therapyInternet based self-help programIndividuals with sexual interest in children

Outcome Measures

Primary Outcomes (4)

  • Sexual interest involving children

    Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more interest).

    Pre-intervention, during the intervention, and immediately after the intervention.

  • Child sexual abuse material usage

    Measured with Sexual Child Molestation Risk Assessment (SChiMRA+), part B, item 1 (self-reported time spent last week in hours watching CSAM) including 3 follow up questions (about time/day, severity, and of youngest child).

    Pre-intervention, during the intervention, and immediately after the intervention.

  • Other behaviors related to sexual interest in children.

    Time spent last week (hours), as self reported on the SChiMRA+ scale part B, item 4.

    Pre-intervention, during the intervention, and immediately after the intervention.

  • Depressive symtoms

    Scores on the PHQ-9 questionnaire (Patient Health Questionnaire; 0-27 points; higher scores indicate more severe depressive symptoms).

    Pre-intervention, and immediately after the intervention.

Secondary Outcomes (2)

  • Dynamic risk for committing child sexual abuse

    Pre-intervention, during the intervention,and immediately after the intervention.

  • Level of hypersexuality

    Pre-intervention, and immediately after the intervention.

Study Arms (2)

ReDirection

EXPERIMENTAL

ReDirection is a self help program based on cognitive behavioral therapy methodology and consists of five modules. The program aims to help participants reduce their CSAM use by gaining a better understanding of, and skills to manage risky sexual thoughts, feelings, and behaviors.

Behavioral: ReDirection

Waitlist

NO INTERVENTION

Participants are on a waitlist which means they have no active intervention, only weekly measurements with the same questionnaires as in the active arm.

Interventions

ReDirectionBEHAVIORAL

Self help program based on principles for cognitive behavioral therapy

ReDirection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish
  • concern about sexual interest regarding children\*,
  • CSAM use past six month
  • Low to medium risk for committing child sexual abuse according to the SChiMRA scale

You may not qualify if:

  • \- Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse) will be excluded, or lack of serious intentions to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

National Institute of Mental Health

Klecany, Czechia

RECRUITING

Protect Children NGO

Helsinki, Finland

RECRUITING

[University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Bratislava Police Academy

Bratislava, Slovakia

RECRUITING

Universitat Jaume I

Castelló, Spain

RECRUITING

Centre for psychiatry research, Region Stockholm

Stockholm, 11842, Sweden

RECRUITING

Related Links

MeSH Terms

Conditions

Pedophilia

Condition Hierarchy (Ancestors)

Paraphilic DisordersMental Disorders

Central Study Contacts

Christoffer Rahm, MD, PhD

CONTACT

+46793393723christoffer.rahm@ki.se

Maria Breide

CONTACT

+46735563825maria.breide@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants are allocated to either the ReDirection intervention or waitlist during the initial phase of the study and those who receive waitlist receive ReDirection during the second phase of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2023

First Posted

November 15, 2023

Study Start

September 27, 2023

Primary Completion

October 10, 2024

Study Completion

October 10, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations

SE(1)FI(1)CZ(1)SL(1)DE(1)ES(1)