Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133595
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-10-12
Brief Title:
Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Individuals with Sexual Interest in Children
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mi Bridge
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 101084355-BRIDGE-ISF-2021 | OTHER | European Commission | None |