NCT06133595

Brief Summary

The overall aim of the study is to evaluate the effectiveness of Mi Bridge to motivate high risk participants to admit to treatment. The main research question is: Is Mi Bridge, an anonymous online program based on the principles for Motivational Interviewing, effective in making high risk individuals for committing child sexual abuse prone to seek treatment for problems related to sexual interest involving children at a health care facility?

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 18, 2023

Completed
24 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 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

October 12, 2023

Last Update Submit

October 8, 2024

Conditions

Keywords

Child sexual abuse materialMotivational InterviewingEvidence based treatmentIndividuals with sexual interest in children

Outcome Measures

Primary Outcomes (2)

  • Motivation to seek treatment

    The Motivation to Seek Care questionnaire, item 1, which targets motivation to seek treatment for problems related to sexual interest involving children (Likert scale 1-7; higher scores indicates higher motivation).

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

  • Motivation to make a change

    Responses on the Change Questionnaire (3 items, ordinal from 0 - 10; 0 - 30 points in total; higher score indicates more readiness to make a change related to sexual behaviors involving children).

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

Secondary Outcomes (6)

  • Plan to seek treatment coming month

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

  • Sexual interest involving children

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

  • Behaviors related to sexual interest in children

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

  • Level of hypersexuality

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

  • Dynamic risk for committing child sexual abuse

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

  • +1 more secondary outcomes

Study Arms (2)

Experimental: MiBridge

EXPERIMENTAL

MiBridge: A series of five conversations over three weeks to help participants understand more about themselves and their willingness to change, and to help participants connect with the care they need and want.

Behavioral: Behavioral: MiBridge

No Intervention: 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

A series of five conversations over three weeks to help participants understand more about themselves and their willingness to change, and to help participants connect with the care they need and want.

Experimental: MiBridge

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
  • Concerns about sexual interest regarding children
  • CSAM use past six month
  • High 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

Castellon, Spain

RECRUITING

Centre for psychiatry research, Region Stockholm

Stockholm, Sweden

RECRUITING

Related Links

MeSH Terms

Conditions

Pedophilia

Condition Hierarchy (Ancestors)

Paraphilic DisordersMental Disorders

Central Study Contacts

Christoffer Rahm, MD, PhD

CONTACT

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 Mi Bridge intervention or waitlist during the initial phase of the study and those who receive waitlist receive Mi Bridge 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 18, 2023

Primary Completion

October 8, 2024

Study Completion

October 8, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations