Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300957
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-22
Brief Title:
Help Wanted Evaluating a Prevention Intervention for People With Sexual Interest in Children
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Help Wanted Evaluating a Prevention Intervention for People With Sexual Interest in Children
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
This project aims to evaluate the Help Wanted Prevention Intervention an online program to provide people with a sexual attraction to children the skills and resources to support their commitment to keep children safe and to improve the participants well-being In phase one ten men with a sexual attraction to children who have never had a contact offense with a child will be asked to go through an abbreviated version of the participant procedures that will be used in study phase two described next Specifically the ten participants will complete one of the online surveys review the Help Wanted program and participate in a 30-60 minute anonymous audio call with a member of the study team to provide feedback on the study procedures and materials eg consent form recruitment form Feedback from phase one will inform changes to study procedures for phase two Phase two consists of a large-scale evaluation of the Help Wanted program Three hundred men with a sexual attraction to children who have never had a contact offense with a child or accessed the Help Wanted Program will be randomly selected to be part of one of two groups the program group N 200 or the control group N 100 Both groups will be asked to complete an online survey before reviewing the Help Wanted Program provide feedback on the program over a one-month period and complete another online survey immediately after reviewing the program and three months after reviewing the program Participants in the control group will have a one month waiting period after the first online survey during which the participants will receive alternative resources and supports for mental health and sexual attraction to children After the one month waiting period participants in the control group will complete one additional online survey before reviewing the Help Wanted program and completing the two final online surveys one immediately after reviewing the program one three months after reviewing the program Survey questions will ask about participants thoughts feelings and behaviors including questions about the participants overall well-being and sexual attraction to children All study materials and resources are in English Resources provided to participants are also in English but provide services in over 30 countries to include participants who may reside in countries outside of the United States Participation is anonymous and all data will be kept confidential
Detailed Description:
The study seeks to conduct a randomized controlled trial RCT to evaluate the Help Wanted Prevention Intervention Help Wanted Help Wanted is a novel online self-paced intervention designed to support the needs of people with a sexual attraction to children who wish to keep children and themselves safe The intervention includes an introductory welcome place five training sessions that deliver core intervention content and a resources page that provides links to external sources of support
The RCT will be conducted in two phases to a evaluate the effects of Help Wanted on child sexual abuse offense behaviors grooming behaviors and proclivity to offend as well as the impact on targeted psychosocial stressors that are associated with child sexual abuse perpetration and b examine psychosocial stressors both as outcome measures and as potential mediators and moderators
In phase one the investigators will beta-test RCT study procedures with a sample of adults with a sexual attraction to children who have never abused a child N 10 Participants in this phase will be asked to
1 Provide a non-identifying email address to receive correspondence from the study team and verify the correspondence is working ie reminders to complete assessments a link to access study surveys and Help Wanted
2 Complete the pre-intervention survey approximately 20-30 minutes
3 Complete ie click through each of the five Help Wanted sessions and review the resources page
4 Complete the post-intervention survey approximately 20-30 minutes
5 Participate in a 30-60-minute anonymous audio call eg Zoom with a member of the study team to discuss their feedback on the study procedures These calls will be scheduled between the participant and a study staff using the participants non-identifying email address and will take place over an online platform such as Zoom that allows participants to take part in an audio-only meeting by only providing their non-identifying email address When using an online audio call platform anonymity of participants will be protected by disabling video and no personal identifiable information will be collected during the call Calls will be audio-recorded and transcribed to ensure that concerns are accurately captured and addressed as needed
The pre-intervention and post-intervention surveys contain all survey measures so the investigators will not require beta participants to complete the additional survey ie the 1-month post-intervention survey which includes only a portion of the measures in the pre- and post-intervention surveys Information gathered from beta participants will only inform changes to the study procedures before launching phase two of the RCT
In phase two the investigators will conduct a RCT to evaluate Help Wanted Three hundred men with a sexual attraction to children who have never harmed a child will be randomly assigned to the Help Wanted intervention condition HW n 200 or to a 1-month waitlist condition WL n 100 HW participants will be assessed at three timepoints recruitment baseline after reviewing the HW intervention for 1-month post-intervention and at 3-months post-intervention follow-up WL participants will be assessed at recruitment baseline after being provided alternative resources as a control for 1-month 2nd baseline after reviewing the HW intervention for 1 month post-intervention and at 3-months post-intervention follow-up Thus the RCT broadly follows a 2 interventions x 2 timepoints factorial design
The alternative resources provided to the waitlist control group will include suicide prevention mental health and CSA prevention helplines Specific resources for Australia Canada the United Kingdom and the US as well as a link to a list of suicide prevention mental health and emergency contact numbers in over 30 countries to provide additional resources for English speaking participants who may reside in these areas
Data include measures of offense-related outcomes internalizing problems social deficits sexual problems offense-supportive cognitions externalizing problems adverse childhood experiences as well as demographics
Recruitment The study team will design communications and plans to promote the study recruitment flyers for the beta test and RCT samples Recruitment flyers will be provided to organizations and people who provide resources and support for people with a sexual attraction to children These organizations will assist in recruitment by sharing the study recruitment flyer with people who utilize their services and for the RCT with others who may know people that may be eligible to participate in the study
Screening Procedures In order to monitor the number of participants in the study and ensure all study participants in each phase meet eligibility criteria study team members will manually screen participants using an audio only call before allowing the participants to enroll in the study Using approaches from a previous study with this population all interested people will be asked to fill out a scheduling form with a datetime the participants are available to speak to a study team member and a non-identifying email address that can be used to confirm the screening call and provide the potential participant with the audio call information Using a non-identifying email address will allow participants to remain anonymous throughout all study activities A link with instructions on how to create a non-identifying email address will be provided on the recruitment form and the scheduling page The scheduling form will also provide a link to a Portable Document Format PDF version of the appropriate Institutional Review Board-approved consent form so the participants are aware of the study details before scheduling a screening call When an interested person signs up for a time the participants will receive an email to their non-identifying email address with a Zoom link to complete the audio call A trained study team member will conduct these screening calls and any responses that are not easily determined as eligible or ineligible will be run by a study investigator for review before the interested person is invited to proceed to the consent stage of the study Screening calls are anticipated to last about 5 minutes People who do not respond to an asked question or are deemed to not meet the study eligibility criteria will not be enrolled in the study Ineligible people will be provided with a set of resources for general mental health suicide prevention and CSA prevention to the email address the participant provided People who meet eligibility requirements will be provided with a secure study link to access the online consent form which will be housed within the Quest system a data collections platform
People who are deemed eligible to participate based on their responses to the study screening questions will be provided with a secure study link to access an Institutional Review Board IRB approved consent document through the Quest system a data collections platform The secure study link will be provided by the recruitment team via an email to the non-identifying email address the potential participant provided Upon logging in to Quest each participant will be required to complete a consent form before participating in any study activities Consent documents will not ask for any identifying information eg name date of birth and both the screening questions and consent form will only ask for information to confirm the person is eligible to participate in the study eg age People who consent yes will automatically be provided with access to the baseline survey within Quest to begin participation in the study
RCT Data Analysis the investigators will assess the pre-post effects of Help Wanted on primary outcomes ie offense behaviors and proclivity to offend and targeted psychosocial stressors eg cognitionsattitudes coping skills self-image using analysis of covariance
In an analysis of covariance ANCOVA study in which means of the two groups with 21 allocation is to be compared the investigators estimated a total sample size of 150-300 to detect an effect size of 030-010 The total sample of 150-300 subjects achieves 80-90 power to detect differences among the means versus the alternative of equal means using an F test with a 005 significance level A target sample size of 300 participants should suffice if the investigators assume a dropout rate of 15
The investigators will also conduct a series of mediation and moderation analyses The mediation analyses will examine the potential mediating role of change in secondary outcomes ie psychosocial stressors in five dynamic risk domains in the association between change in primary outcomes and intervention status HW vs WL The estimated sample size of 300 in Aim 1 will have 90-100 power to detect a mediation effect of at least 040 regression coefficient of the mediator variable
To test for moderation the investigators will assess whether Adverse Childhood Experiences ACE a pre-randomization characteristic uncorrelated with the intervention condition moderates or buffers the association between change in primary outcomes and intervention status ie intervention outcome is conditional on the level of ACEs experienced
Data management The security and confidentiality of data is of the utmost concern and appropriate data management procedures have been established to ensure confidentiality The confidential nature of the data will be maintained by using study identifiersSIDs A limited number of study staff will have access to a linking document containing the only possible identifying information for participants the participants non-identifying email address This linking document will be destroyed once all data have been collected downloaded from the Quest system described below cleaned and analyzed
Data will be collected using Quest a data collection program Participants will access Quest using the participants non-identifying email address and a password the participants create All study data will be collected anonymously therefore no data will be connected to participant personal information The confidentiality and security of data files on staff computers will be maintained by ensuring password protection on all computer accounts and storage of all data on Johns Hopkins University JHU One Drive Electronic backup of all database files will occur daily per JHU backup procedures Access to all study forms will be password protected and available only to the study team
The use of an online consent form will allow participants to retain anonymity All audio data from phase 1 interviews will be encrypted and saved on JHU One Drive until it is transcribed and analyzed at which point audio files will be permanently destroyed Access to all data will be password protected and data will be backed up daily to a secure location on the Quest system for phase one and two survey data and on JHU One Drive for phase one audio data and linking document
Any study problems or concerns will be brought to the attention of the project manager and PI immediately and the IRB and Centers for Disease Control will be notified according to IRB policies when applicable Three experts selected for the ability to comprehend clinical research data understanding of the population under study or understanding of prevention interventions were selected to serve on a Data Safety Monitoring Board DSMB for this project The DSMB will meet bi-annually throughout the RCT
The RCT will be conducted in two phases to a evaluate the effects of Help Wanted on child sexual abuse offense behaviors grooming behaviors and proclivity to offend as well as the impact on targeted psychosocial stressors that are associated with child sexual abuse perpetration and b examine psychosocial stressors both as outcome measures and as potential mediators and moderators
In phase one the investigators will beta-test RCT study procedures with a sample of adults with a sexual attraction to children who have never abused a child N 10 Participants in this phase will be asked to
1 Provide a non-identifying email address to receive correspondence from the study team and verify the correspondence is working ie reminders to complete assessments a link to access study surveys and Help Wanted
2 Complete the pre-intervention survey approximately 20-30 minutes
3 Complete ie click through each of the five Help Wanted sessions and review the resources page
4 Complete the post-intervention survey approximately 20-30 minutes
5 Participate in a 30-60-minute anonymous audio call eg Zoom with a member of the study team to discuss their feedback on the study procedures These calls will be scheduled between the participant and a study staff using the participants non-identifying email address and will take place over an online platform such as Zoom that allows participants to take part in an audio-only meeting by only providing their non-identifying email address When using an online audio call platform anonymity of participants will be protected by disabling video and no personal identifiable information will be collected during the call Calls will be audio-recorded and transcribed to ensure that concerns are accurately captured and addressed as needed
The pre-intervention and post-intervention surveys contain all survey measures so the investigators will not require beta participants to complete the additional survey ie the 1-month post-intervention survey which includes only a portion of the measures in the pre- and post-intervention surveys Information gathered from beta participants will only inform changes to the study procedures before launching phase two of the RCT
In phase two the investigators will conduct a RCT to evaluate Help Wanted Three hundred men with a sexual attraction to children who have never harmed a child will be randomly assigned to the Help Wanted intervention condition HW n 200 or to a 1-month waitlist condition WL n 100 HW participants will be assessed at three timepoints recruitment baseline after reviewing the HW intervention for 1-month post-intervention and at 3-months post-intervention follow-up WL participants will be assessed at recruitment baseline after being provided alternative resources as a control for 1-month 2nd baseline after reviewing the HW intervention for 1 month post-intervention and at 3-months post-intervention follow-up Thus the RCT broadly follows a 2 interventions x 2 timepoints factorial design
The alternative resources provided to the waitlist control group will include suicide prevention mental health and CSA prevention helplines Specific resources for Australia Canada the United Kingdom and the US as well as a link to a list of suicide prevention mental health and emergency contact numbers in over 30 countries to provide additional resources for English speaking participants who may reside in these areas
Data include measures of offense-related outcomes internalizing problems social deficits sexual problems offense-supportive cognitions externalizing problems adverse childhood experiences as well as demographics
Recruitment The study team will design communications and plans to promote the study recruitment flyers for the beta test and RCT samples Recruitment flyers will be provided to organizations and people who provide resources and support for people with a sexual attraction to children These organizations will assist in recruitment by sharing the study recruitment flyer with people who utilize their services and for the RCT with others who may know people that may be eligible to participate in the study
Screening Procedures In order to monitor the number of participants in the study and ensure all study participants in each phase meet eligibility criteria study team members will manually screen participants using an audio only call before allowing the participants to enroll in the study Using approaches from a previous study with this population all interested people will be asked to fill out a scheduling form with a datetime the participants are available to speak to a study team member and a non-identifying email address that can be used to confirm the screening call and provide the potential participant with the audio call information Using a non-identifying email address will allow participants to remain anonymous throughout all study activities A link with instructions on how to create a non-identifying email address will be provided on the recruitment form and the scheduling page The scheduling form will also provide a link to a Portable Document Format PDF version of the appropriate Institutional Review Board-approved consent form so the participants are aware of the study details before scheduling a screening call When an interested person signs up for a time the participants will receive an email to their non-identifying email address with a Zoom link to complete the audio call A trained study team member will conduct these screening calls and any responses that are not easily determined as eligible or ineligible will be run by a study investigator for review before the interested person is invited to proceed to the consent stage of the study Screening calls are anticipated to last about 5 minutes People who do not respond to an asked question or are deemed to not meet the study eligibility criteria will not be enrolled in the study Ineligible people will be provided with a set of resources for general mental health suicide prevention and CSA prevention to the email address the participant provided People who meet eligibility requirements will be provided with a secure study link to access the online consent form which will be housed within the Quest system a data collections platform
People who are deemed eligible to participate based on their responses to the study screening questions will be provided with a secure study link to access an Institutional Review Board IRB approved consent document through the Quest system a data collections platform The secure study link will be provided by the recruitment team via an email to the non-identifying email address the potential participant provided Upon logging in to Quest each participant will be required to complete a consent form before participating in any study activities Consent documents will not ask for any identifying information eg name date of birth and both the screening questions and consent form will only ask for information to confirm the person is eligible to participate in the study eg age People who consent yes will automatically be provided with access to the baseline survey within Quest to begin participation in the study
RCT Data Analysis the investigators will assess the pre-post effects of Help Wanted on primary outcomes ie offense behaviors and proclivity to offend and targeted psychosocial stressors eg cognitionsattitudes coping skills self-image using analysis of covariance
In an analysis of covariance ANCOVA study in which means of the two groups with 21 allocation is to be compared the investigators estimated a total sample size of 150-300 to detect an effect size of 030-010 The total sample of 150-300 subjects achieves 80-90 power to detect differences among the means versus the alternative of equal means using an F test with a 005 significance level A target sample size of 300 participants should suffice if the investigators assume a dropout rate of 15
The investigators will also conduct a series of mediation and moderation analyses The mediation analyses will examine the potential mediating role of change in secondary outcomes ie psychosocial stressors in five dynamic risk domains in the association between change in primary outcomes and intervention status HW vs WL The estimated sample size of 300 in Aim 1 will have 90-100 power to detect a mediation effect of at least 040 regression coefficient of the mediator variable
To test for moderation the investigators will assess whether Adverse Childhood Experiences ACE a pre-randomization characteristic uncorrelated with the intervention condition moderates or buffers the association between change in primary outcomes and intervention status ie intervention outcome is conditional on the level of ACEs experienced
Data management The security and confidentiality of data is of the utmost concern and appropriate data management procedures have been established to ensure confidentiality The confidential nature of the data will be maintained by using study identifiersSIDs A limited number of study staff will have access to a linking document containing the only possible identifying information for participants the participants non-identifying email address This linking document will be destroyed once all data have been collected downloaded from the Quest system described below cleaned and analyzed
Data will be collected using Quest a data collection program Participants will access Quest using the participants non-identifying email address and a password the participants create All study data will be collected anonymously therefore no data will be connected to participant personal information The confidentiality and security of data files on staff computers will be maintained by ensuring password protection on all computer accounts and storage of all data on Johns Hopkins University JHU One Drive Electronic backup of all database files will occur daily per JHU backup procedures Access to all study forms will be password protected and available only to the study team
The use of an online consent form will allow participants to retain anonymity All audio data from phase 1 interviews will be encrypted and saved on JHU One Drive until it is transcribed and analyzed at which point audio files will be permanently destroyed Access to all data will be password protected and data will be backed up daily to a secure location on the Quest system for phase one and two survey data and on JHU One Drive for phase one audio data and linking document
Any study problems or concerns will be brought to the attention of the project manager and PI immediately and the IRB and Centers for Disease Control will be notified according to IRB policies when applicable Three experts selected for the ability to comprehend clinical research data understanding of the population under study or understanding of prevention interventions were selected to serve on a Data Safety Monitoring Board DSMB for this project The DSMB will meet bi-annually throughout the RCT
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 |
|---|---|---|---|
| CE003310 | OTHER_GRANT | None | None |
| OMB NO 0920-1301 | OTHER | OMB | None |