Child Sexual AbuseMi BridgeNCT06133595
Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Individuals with Sexual Interest in Children
A study testing Behavioral: MiBridge in people with Child Sexual Abuse and Pedophilia, run by Karolinska Institutet at 6 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Sexual Abuse, Pedophilia
- What is being tested?
- Behavioral: MiBridge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 18 Sep 2023to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Czechia1 site, 1 recruiting
- Recruiting
National Institute of Mental Health
Klecany
Katerina Klapilova, Ass Profes
Finland1 site, 1 recruiting
- Recruiting
Protect Children NGO
Helsinki
Nina Vaarhanen-Valkonen
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
Peer Briken, Professor
Slovakia1 site, 1 recruiting
- Recruiting
Bratislava Police Academy
Bratislava
Josef Metenko, Professor
Spain1 site, 1 recruiting
- Recruiting
Universitat Jaume I
Castellon
Rafael Ballester, Professor
Sweden1 site, 1 recruiting
- Recruiting
Centre for psychiatry research, Region Stockholm
Stockholm
Christoffer Rahm, MD PhD, +46793393723, christoffer.rahm@ki.se
Christoffer Rahm, MD PhD
About this study
Official title: A Multicenter, Waitlist Controlled, Randomized Clinical Trial of the Effectiveness of Mi Bridge, a Motivational Interviewing Intervention to Facilitate Help-seeking Among Individuals with Sexual Interest in Children
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?
Read the detailed description
The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with sexual interest in children, and that are using child sexual abuse material (CSAM), so that these people can access treatment according to their needs and level of risk, with the objective of reducing the risk for child sexual abuse and improving the health of the group.
The intervention will be available in seven languages and will be tested in six countries.
Primary research questions:
Does Mi Bridge increase the likelihood that individuals at high risk for committing child sexual abuse accept seeking treatment for problems related to sexual interest involving minors at a health care facility?
Does Mi Bridge increase participants motivation for change regarding sexual behaviors involving minors?
Secondary research questions:
Does Mi Bridge increase the intention to seek treatment in the coming month for problems related to sexual interest involving minors at a health care facility?
Does Mi Bridge decrease participants sexual interest involving children?
Does Mi Bridge significantly decreases participants past week sexual behaviors involving children?
Does Mi Bridge significantly decreases participants symptoms of depression?
Is Mi Bridge effective in reducing certain dynamic risk factors for committing child sexual abuse?
About the intervention. Mi Bridge is a series of up to five conversations between a practitioner and a study participant over three weeks to help the participants understand more about themselves and their willingness to change, and to help the participants connect with the care they need and want. The conversations are carried out as anonymous voice calls or anonymous text-based chat. Mi Bridge is based on the established and well-researched method of Motivational Interviewing, which has been shown to be effective in helping people achieve the desired changes for several lifestyle related problems.
Research subjects will be recruited through Darknet and Clearnet. Darknet refers to websites that are accessible via Tor or similar services. The intervention is provided by practitioners and researchers in the relevant countries.
Mi Bridge will be evaluated through an international multicenter study using randomized wait-list controlled design.
The research subjects will sign a written consent form on the Iterapi platform without disclosing personal data such as name or location. During the subsequent screening interview via chat or voice call on Iterapi, participation criteria are ensured, questions are answered, and the consent to participate is confirmed. The research subjects are thus admitted to the study.
After inclusion, participants answer the baseline survey which consists of validated self-assessment questionnaires with both multiple choice and free-text answers.
Weekly during, after the waitlist, and after the therapeutic intervention, research subjects answer questions to evaluate the effectiveness and safety of the interventions.
A Statistical Analysis Plan (SAP) based on pilot study is pre-registered at the OSF platform. The SAP describes sample size calculations, and planned analyses of outcome measures.
- Conditions
- Child Sexual Abuse, Pedophilia
- Being tested
- Behavioral: MiBridge
- Keywords
- Child sexual abuse material, Motivational Interviewing, Evidence based treatment, Individuals with sexual interest in children
- Medical subject headings
- Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: MiBridgeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Pre-intervention, during the intervention, and immediately after the intervention.
Secondary outcomes (6)
Plan to seek treatment coming month
The Motivation to Seek Care questionnaire, item 2, which targets the intention to actually seek treatment during the coming month for problems related to sexual interest involving children (Y/N, coded as 1=YES, and 2=NO).
Measured: Pre-intervention, during the intervention, and immediately after the intervention.
Sexual interest involving children
Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more interest).
Measured: Pre-intervention, during the intervention, and immediately after the intervention.
Behaviors related to sexual interest in children
Time spent last week (hours), as self reported on the SChiMRA+ part B, item 1-4.
Measured: Pre-intervention, during the intervention, and immediately after the intervention.
Level of hypersexuality
Scores on the HBI-19 questionnaire (Hypersexual Behavior Inventory; 19-95 points; higher scores indicate higher level of sexuality; more than 52 points indicate hypersexuality).
Measured: Pre-intervention, during the intervention, and immediately after the intervention.
Dynamic risk for committing child sexual abuse
Scores on Acute-2007 (21 items; 0-42 points; higher scores indicate higher dynamic risk for committing child sexual abuse).
Measured: 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).
Measured: Pre-intervention, during the intervention, and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start18 Sep 2023
- Primary completion8 Oct 2024 (estimated)
- Study completion8 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Sexual AbuseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Linkoeping University, Universitat Jaume I, Spain, Protect Children Organisation, Finland, National Institute of Mental Health, Czech Republic, Academy of the Police Force, Bratislava, Slovakia, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Christoffer Rahm, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133595
- Sponsor's protocol ID
- 2023-02321-01-B
- Other IDs
- 101084355-BRIDGE-ISF-2021, 2023
- Acronym
- Mi Bridge
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Waitlist Controlled, Randomized Clinical Trial of the Effectiveness of Mi Bridge, a Motivational Interviewing Intervention to Facilitate Help-seeking Among Individuals with Sexual Interest in Children
- ClinicalTrials.gov ID
- NCT06133595
- Acronym / sponsor ID
- Mi Bridge / 2023-02321-01-B
- Conditions
- Child Sexual Abuse, Pedophilia
- Keywords
- Child sexual abuse material, Motivational Interviewing, Evidence based treatment, Individuals with sexual interest in children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Linkoeping University, Universitat Jaume I, Spain, Protect Children Organisation, Finland, National Institute of Mental Health, Czech Republic, Academy of the Police Force, Bratislava, Slovakia, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 8 Oct 2024 (estimated)
- Study completion
- 8 Oct 2024 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with sexual interest in children, and that are using child sexual abuse material (CSAM), so that these people can access treatment according to their needs and level of risk, with the objective of reducing the risk for child sexual abuse and improving the health of the group.
The intervention will be available in seven languages and will be tested in six countries.
Primary research questions:
Does Mi Bridge increase the likelihood that individuals at high risk for committing child sexual abuse accept seeking treatment for problems related to sexual interest involving minors at a health care facility?
Does Mi Bridge increase participants motivation for change regarding sexual behaviors involving minors?
Secondary research questions:
Does Mi Bridge increase the intention to seek treatment in the coming month for problems related to sexual interest involving minors at a health care facility?
Does Mi Bridge decrease participants sexual interest involving children?
Does Mi Bridge significantly decreases participants past week sexual behaviors involving children?
Does Mi Bridge significantly decreases participants symptoms of depression?
Is Mi Bridge effective in reducing certain dynamic risk factors for committing child sexual abuse?
About the intervention. Mi Bridge is a series of up to five conversations between a practitioner and a study participant over three weeks to help the participants understand more about themselves and their willingness to change, and to help the participants connect with the care they need and want. The conversations are carried out as anonymous voice calls or anonymous text-based chat. Mi Bridge is based on the established and well-researched method of Motivational Interviewing, which has been shown to be effective in helping people achieve the desired changes for several lifestyle related problems.
Research subjects will be recruited through Darknet and Clearnet. Darknet refers to websites that are accessible via Tor or similar services. The intervention is provided by practitioners and researchers in the relevant countries.
Mi Bridge will be evaluated through an international multicenter study using randomized wait-list controlled design.
The research subjects will sign a written consent form on the Iterapi platform without disclosing personal data such as name or location. During the subsequent screening interview via chat or voice call on Iterapi, participation criteria are ensured, questions are answered, and the consent to participate is confirmed. The research subjects are thus admitted to the study.
After inclusion, participants answer the baseline survey which consists of validated self-assessment questionnaires with both multiple choice and free-text answers.
Weekly during, after the waitlist, and after the therapeutic intervention, research subjects answer questions to evaluate the effectiveness and safety of the interventions.
A Statistical Analysis Plan (SAP) based on pilot study is pre-registered at the OSF platform. The SAP describes sample size calculations, and planned analyses of outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: MiBridge | Experimental | Behavioral: Behavioral: MiBridgeMiBridge: 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: MiBridgeA 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. | Behavioural | Experimental: MiBridge |
Primary outcome
Motivation to seek treatment
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
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).
Motivation to make a change
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
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).
6 secondary outcomes
Plan to seek treatment coming month
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Sexual interest involving children
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Behaviors related to sexual interest in children
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Level of hypersexuality
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Dynamic risk for committing child sexual abuse
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Depressive symtoms
Time frame: Pre-intervention, during the intervention, and immediately after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Partner
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: MiBridge in people with Child Sexual Abuse and Pedophilia, run by Karolinska Institutet at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia, Finland, Germany, Slovakia, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoffer Rahm, MD, PhD (+46793393723, christoffer.rahm@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation to seek treatment (time frame: Pre-intervention, during the intervention, and immediately after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.