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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR000434 | U.S. NIH Grant/Contract | View source | |
| KL2TR002241 | U.S. NIH Grant/Contract | View source | |
| 5R49CE002099-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This study utilizes implementation science principles to culturally adapt a pre-existing web-based application (WebApp) for use with college students. The ADAPT-ITT process will be utilized to adapt the WebApp to a diverse (race, ethnicity, gender/sexual identity) college population with a focus on life skills and holistic self-care as reinforcement to currently available primary prevention programming available to incoming students. The study hypothesis is that the adapted WebApp will be usable, acceptable, and students will be willing to use it as a reinforcement to current university primary prevention programming. The study team will also monitor retention of participants over the academic year. This is a repeat pilot test to evaluate changes implemented to the WebApp after the initial pilot during the 2017-2018 academic year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MKit WebApp Intervention | Experimental | The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas. |
|
| Standard of Care | No Intervention | The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MKit | Behavioral | MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale | Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 1) First, one is subtracted from the score of the odd items; 2) Second, the responses are subtracted from 5 for the even-numbered items; 3) Then the responses are summed and multiplied by 2.5 to get a range of 0-100. A score above 68 is considered above average for perceived usability. | 1-month |
| Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale | Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 1) First, one is subtracted from the score of the odd items; 2) Second, the responses are subtracted from 5 for the even-numbered items; 3) Then the responses are summed and multiplied by 2.5 to get a range of 0-100. A score above 68 is considered above average for perceived usability. | 4-Months |
| Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale | The 5-item System Acceptability Scale (investigator created) will be used to evaluate the acceptability of the WebApp in the intervention group only. An investigator-created acceptability scale with 5-items will be used to measure acceptability. Four items are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and will be reverse coded. One item assesses the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). All five items will be summed for a total score. Scores range from 5-25, with higher scores indicating greater acceptability. | 1-Month |
| Measure | Description | Time Frame |
|---|---|---|
| 1-Month Retention | The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp. | 1-Month |
| 4-Month Retention |
| Measure | Description | Time Frame |
|---|---|---|
| 1-Month Sexual Victimization as Assessed by the 10-item Sexual Experiences Survey | The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence victimization. The revised Sexual Experiences Survey - Short Form Victimization includes 10 items that are used to assess the frequency of seven victimization behaviors and then uses three questions to explore the sex of the perpetrator and if the participant believes they were raped. We will be items 1-7 to assess the number of times an individual has experienced victimization over the last 1 month from 0 to 3+ times. The results will be scored as a percentage of participants who have experienced each individual behavior and the percentage who report that they have experienced a rape. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle L Munro-Kramer, PhD,CNM,FNP | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18778162 | Result | Fincham FD, Cui M, Braithwaite S, Pasley K. Attitudes toward intimate partner violence in dating relationships. Psychol Assess. 2008 Sep;20(3):260-9. doi: 10.1037/1040-3590.20.3.260. | |
| 14520319 | Result | Heron SL, Thompson MP, Jackson E, Kaslow NJ. Do responses to an intimate partner violence screen predict scores on a comprehensive measure of intimate partner violence in low-income black women? Ann Emerg Med. 2003 Oct;42(4):483-91. doi: 10.1067/s0196-0644(03)00718-2. |
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In the MKit WebApp Intervention group, 1 potential participant did not complete the baseline survey. In the Standard of Care group, 4 potential participants did not complete the baseline survey. All of these potential participants were therefore not considered enrolled for the purposes of outcome analyses.
Participants were recruited from the mandatory primary prevention program, Relationship Remix, offered to all incoming students at the University of Michigan. We specifically recruited from October 21, 2018 - November 11, 2018 from Alice Lloyd Residence Hall (control) and Couzens and Fletcher Residence Halls (intervention).
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| ID | Title | Description |
|---|---|---|
| FG000 | MKit WebApp Intervention | The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas. MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources. |
| FG001 | Standard of Care | The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MKit WebApp Intervention | The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas. MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale | Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 1) First, one is subtracted from the score of the odd items; 2) Second, the responses are subtracted from 5 for the even-numbered items; 3) Then the responses are summed and multiplied by 2.5 to get a range of 0-100. A score above 68 is considered above average for perceived usability. | Only intervention participants were asked the items on the System Usability Scale. | Posted | Mean | Standard Deviation | score on a scale | 1-month |
|
4 months
Since this was an anonymous study, adverse events were defined as those reported to study staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MKit WebApp Intervention | The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas. MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Munro-Kramer | University of Michigan | 734-904-4600 | mlmunro@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2018 | Jun 24, 2019 | Prot_SAP_000.pdf |
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| Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale |
The 5-item System Acceptability Scale (investigator created) will be used to evaluate the acceptability of the WebApp in the intervention group only. An investigator-created acceptability scale with 5-items will be used to measure acceptability. Four items are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and will be reverse coded. One item assesses the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). All five items will be summed for a total score. Scores range from 5-25, with higher scores indicating greater acceptability. |
| 4-Months |
The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp. |
| 4-Month |
| 1-Month |
| 4-Months Sexual Victimization as Assessed by the 10-item Sexual Experience Survey | The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence victimization. The revised Sexual Experiences Survey - Short Form Victimization includes 10 items that are used to assess the frequency of seven victimization behaviors and then uses three questions to explore the sex of the perpetrator and if the participant believes they were raped. We will be items 1-7 to assess the number of times an individual has experienced victimization over the last 5 months from 0 to 3+ times. The results will be scored as a percentage of participants who have experienced each individual behavior and the percentage who report that they have experienced a rape. | 4-Months |
| 1-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey | The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence perpetration. The revised Sexual Experiences Survey - Short Form Perpetration includes seven items that are used to assess the frequency of perpetration of sexual violence behaviors and three questions that explore the sex of the victims and if the individual believes they have perpetrated a rape. We will be using these to assess the number of times an individual has perpetrated sexual violence over the last 1 month from 0 to 3+ times. The results will be scored as a percentage of participants who have perpetrated each individual behavior and the percentage who believe they have perpetrated a rape. | 1-Month |
| 4-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey | The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence perpetration. The revised Sexual Experiences Survey - Short Form Perpetration includes seven items that are used to assess the frequency of perpetration of sexual violence behaviors and three questions that explore the sex of the victims and if the individual believes they have perpetrated a rape. We will be using these to assess the number of times an individual has perpetrated sexual violence over the last 4 months from 0 to 3+ times. The results will be scored as a percentage of participants who have perpetrated each individual behavior and the percentage who believe they have perpetrated a rape. | 4-Months |
| 1-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form | Twenty knowledge questions about sexual and intimate partner violence adapted from the Texas Education Program Participant Response Form will be used to assess knowledge of healthy relationships, sexual violence, and intimate partner violence. The questions are scored from 1 (no knowledge) to 5 (a lot of knowledge) with higher scores indicating more knowledge. Possible sum scores range from 20 (no knowledge) to 100 (a lot of knowledge about all of the topics). | 1-Month |
| 4-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form | Twenty knowledge questions about sexual and intimate partner violence adapted from the Texas Education Program Participant Response Form will be used to assess knowledge of healthy relationships, sexual violence, and intimate partner violence. The questions are scored from 1 (no knowledge) to 5 (a lot of knowledge) with higher scores indicating more knowledge. Possible sum scores range from 20 (no knowledge) to 100 (a lot of knowledge about all of the topics). | 4-Months |
| Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items | Self-efficacy of protective behaviors related to sexual and intimate partner violence will be assessed using a questionnaire developed by the investigators. Participants will complete a 15 item questionnaire with responses ranging from 1 (not at all confident) to 7 (very confident) related to confidence in ability to handle situations related to sexual and intimate partner violence. The total score for each participant can range from 15 (not at all confident in any of the behaviors) to 105 (very confident in all behaviors). | 1-Month |
| Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items | Self-efficacy of protective behaviors related to sexual and intimate partner violence will be assessed using a questionnaire developed by the investigators. Participants will complete a 15 item questionnaire with responses ranging from 1 (not at all confident) to 7 (very confident) related to confidence in ability to handle situations related to sexual and intimate partner violence. The total score for each participant can range from 15 (not at all confident in any of the behaviors) to 105 (very confident in all behaviors). | 4-Months |
| 1-Month Consensual Sexual Activity With 2 Investigator Created Items | Two yes/no questions adopted from a colleague will be used to assess whether or not participants have ever engaged in sexual contact or intercourse that they found out was not consensual after the fact in the last 1 month. If they respond affirmatively then they will be asked an additional 14 descriptive questions about the event. Percent of students reporting ever engaging in sexual intercourse or contact that was not consensual will be reported. | 1-Month |
| 4-Month Consensual Sexual Activity With 2 Investigator Created Items | Two yes/no questions adopted from a colleague will be used to assess whether or not participants have ever engaged in sexual contact or intercourse that they found out was not consensual after the fact in the last 4 months. If they respond affirmatively then they will be asked an additional 14 descriptive questions about the event. Percent of students reporting ever engaging in sexual intercourse or contact that was not consensual will be reported. | 4-Months |
| 1-Month Universal Violence Prevention Screening Protocol | Thirteen yes/no questions from the Universal Violence Prevention Screening Protocol will be used to assess for personal experiences of intimate partner violence with the last 1 month. Each item will be evaluated individually and no total score will be computed. | 1-Month |
| 4-Month Universal Violence Prevention Screening Protocol | Thirteen yes/no questions from the Universal Violence Prevention Screening Protocol will be used to assess for personal experiences of intimate partner violence with the last 4 months. Each item will be evaluated individually and no total score will be computed. | 4-Month |
| 1-Month Intimate Partner Violence Attitude Scale | Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised will be used to assess for participant's attitudes related to intimate partner violence. Possible responses are on a Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree) with some items requiring reverse coding. Potential sum scores range from 17 to 85 with higher scores indicating a more favorable attitude towards intimate partner violence behaviors. | 1-Month |
| 4-Month Intimate Partner Violence Attitude Scale | Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised will be used to assess for participant's attitudes related to intimate partner violence. Possible responses are on a Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree) with some items requiring reverse coding. Potential sum scores range from 17 to 85 with higher scores indicating a more favorable attitude towards intimate partner violence behaviors. | 4-Months |
| Result | Brook J. SUS - A quick and dirty usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, McClelland (Eds.). Usability evaluation in industry. London: Taylor & Francis; 1996:189-194. |
| Result | Koss MP, Abbey A, Campbell R, Cook S, Norris J, Testa C, Ullman S, West C, White J. Revising the SES: A collaborative process to improve assessment of sexual aggression and victimization. Psychology Women Quarterly 31:357-370, 2007. doi:10.13072/midss.279 |
| Result | Busch NB. Outcome measures for sexual assault services in Texas. The University of Texas at Austin; 2003. Retrieved from https://s3.us-east-2.amazonaws.com/wcasa/old-website-resources/Evaluation-Selecting%2BIndicators-Measure%2BDatabase%2B15.%2BOutcome_Measures_Texas%2BManual.pdf |
| BG001 | Standard of Care | The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Year in School | Count of Participants | Participants |
|
The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.
MKit: MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources.
|
|
| Primary | Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale | Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 1) First, one is subtracted from the score of the odd items; 2) Second, the responses are subtracted from 5 for the even-numbered items; 3) Then the responses are summed and multiplied by 2.5 to get a range of 0-100. A score above 68 is considered above average for perceived usability. | Only intervention participants were asked the items on the System Usability Scale. | Posted | Mean | Standard Deviation | score on a scale | 4-Months |
|
|
|
| Primary | Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale | The 5-item System Acceptability Scale (investigator created) will be used to evaluate the acceptability of the WebApp in the intervention group only. An investigator-created acceptability scale with 5-items will be used to measure acceptability. Four items are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and will be reverse coded. One item assesses the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). All five items will be summed for a total score. Scores range from 5-25, with higher scores indicating greater acceptability. | Only intervention participants were asked the items on the System Acceptability Scale. | Posted | Mean | Standard Deviation | score on a scale | 1-Month |
|
|
|
| Primary | Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale | The 5-item System Acceptability Scale (investigator created) will be used to evaluate the acceptability of the WebApp in the intervention group only. An investigator-created acceptability scale with 5-items will be used to measure acceptability. Four items are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and will be reverse coded. One item assesses the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). All five items will be summed for a total score. Scores range from 5-25, with higher scores indicating greater acceptability. | Only intervention participants were asked the items on the System Acceptability Scale. | Posted | Mean | Standard Deviation | score on a scale | 4-Months |
|
|
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| Secondary | 1-Month Retention | The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp. | Retention was calculated based on the total number of participants that completed the Baseline survey. | Posted | Count of Participants | Participants | 1-Month |
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| Secondary | 4-Month Retention | The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp. | Retention was calculated based on the total number of participants that completed the Baseline survey. | Posted | Count of Participants | Participants | 4-Month |
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| Other Pre-specified | 1-Month Sexual Victimization as Assessed by the 10-item Sexual Experiences Survey | The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence victimization. The revised Sexual Experiences Survey - Short Form Victimization includes 10 items that are used to assess the frequency of seven victimization behaviors and then uses three questions to explore the sex of the perpetrator and if the participant believes they were raped. We will be items 1-7 to assess the number of times an individual has experienced victimization over the last 1 month from 0 to 3+ times. The results will be scored as a percentage of participants who have experienced each individual behavior and the percentage who report that they have experienced a rape. | Posted | Count of Participants | Participants | 1-Month |
|
|
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| Other Pre-specified | 4-Months Sexual Victimization as Assessed by the 10-item Sexual Experience Survey | The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence victimization. The revised Sexual Experiences Survey - Short Form Victimization includes 10 items that are used to assess the frequency of seven victimization behaviors and then uses three questions to explore the sex of the perpetrator and if the participant believes they were raped. We will be items 1-7 to assess the number of times an individual has experienced victimization over the last 5 months from 0 to 3+ times. The results will be scored as a percentage of participants who have experienced each individual behavior and the percentage who report that they have experienced a rape. | Posted | Count of Participants | Participants | 4-Months |
|
|
|
| Other Pre-specified | 1-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey | The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence perpetration. The revised Sexual Experiences Survey - Short Form Perpetration includes seven items that are used to assess the frequency of perpetration of sexual violence behaviors and three questions that explore the sex of the victims and if the individual believes they have perpetrated a rape. We will be using these to assess the number of times an individual has perpetrated sexual violence over the last 1 month from 0 to 3+ times. The results will be scored as a percentage of participants who have perpetrated each individual behavior and the percentage who believe they have perpetrated a rape. | Posted | Count of Participants | Participants | 1-Month |
|
|
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| Other Pre-specified | 4-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey | The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence perpetration. The revised Sexual Experiences Survey - Short Form Perpetration includes seven items that are used to assess the frequency of perpetration of sexual violence behaviors and three questions that explore the sex of the victims and if the individual believes they have perpetrated a rape. We will be using these to assess the number of times an individual has perpetrated sexual violence over the last 4 months from 0 to 3+ times. The results will be scored as a percentage of participants who have perpetrated each individual behavior and the percentage who believe they have perpetrated a rape. | Posted | Count of Participants | Participants | 4-Months |
|
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| Other Pre-specified | 1-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form | Twenty knowledge questions about sexual and intimate partner violence adapted from the Texas Education Program Participant Response Form will be used to assess knowledge of healthy relationships, sexual violence, and intimate partner violence. The questions are scored from 1 (no knowledge) to 5 (a lot of knowledge) with higher scores indicating more knowledge. Possible sum scores range from 20 (no knowledge) to 100 (a lot of knowledge about all of the topics). | Data for the 1-Month Knowledge scale were missing from 1 participant in the Intervention group. | Posted | Mean | Standard Deviation | score on a scale | 1-Month |
|
|
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| Other Pre-specified | 4-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form | Twenty knowledge questions about sexual and intimate partner violence adapted from the Texas Education Program Participant Response Form will be used to assess knowledge of healthy relationships, sexual violence, and intimate partner violence. The questions are scored from 1 (no knowledge) to 5 (a lot of knowledge) with higher scores indicating more knowledge. Possible sum scores range from 20 (no knowledge) to 100 (a lot of knowledge about all of the topics). | Posted | Mean | Standard Deviation | score on a scale | 4-Months |
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| Other Pre-specified | Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items | Self-efficacy of protective behaviors related to sexual and intimate partner violence will be assessed using a questionnaire developed by the investigators. Participants will complete a 15 item questionnaire with responses ranging from 1 (not at all confident) to 7 (very confident) related to confidence in ability to handle situations related to sexual and intimate partner violence. The total score for each participant can range from 15 (not at all confident in any of the behaviors) to 105 (very confident in all behaviors). | Data for the 1-Month Self-Efficacy scale were missing from 3 participants in the Intervention group and 5 participants in the Standard of Care group. | Posted | Mean | Standard Deviation | score on a scale | 1-Month |
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|
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| Other Pre-specified | Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items | Self-efficacy of protective behaviors related to sexual and intimate partner violence will be assessed using a questionnaire developed by the investigators. Participants will complete a 15 item questionnaire with responses ranging from 1 (not at all confident) to 7 (very confident) related to confidence in ability to handle situations related to sexual and intimate partner violence. The total score for each participant can range from 15 (not at all confident in any of the behaviors) to 105 (very confident in all behaviors). | Data for the 4-Month Self-Efficacy scale were missing for 2 participants in the Intervention group. | Posted | Mean | Standard Deviation | score on a scale | 4-Months |
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| Other Pre-specified | 1-Month Consensual Sexual Activity With 2 Investigator Created Items | Two yes/no questions adopted from a colleague will be used to assess whether or not participants have ever engaged in sexual contact or intercourse that they found out was not consensual after the fact in the last 1 month. If they respond affirmatively then they will be asked an additional 14 descriptive questions about the event. Percent of students reporting ever engaging in sexual intercourse or contact that was not consensual will be reported. | Posted | Count of Participants | Participants | 1-Month |
|
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| Other Pre-specified | 4-Month Consensual Sexual Activity With 2 Investigator Created Items | Two yes/no questions adopted from a colleague will be used to assess whether or not participants have ever engaged in sexual contact or intercourse that they found out was not consensual after the fact in the last 4 months. If they respond affirmatively then they will be asked an additional 14 descriptive questions about the event. Percent of students reporting ever engaging in sexual intercourse or contact that was not consensual will be reported. | Posted | Count of Participants | Participants | 4-Months |
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| Other Pre-specified | 1-Month Universal Violence Prevention Screening Protocol | Thirteen yes/no questions from the Universal Violence Prevention Screening Protocol will be used to assess for personal experiences of intimate partner violence with the last 1 month. Each item will be evaluated individually and no total score will be computed. | Posted | Count of Participants | Participants | 1-Month |
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| Other Pre-specified | 4-Month Universal Violence Prevention Screening Protocol | Thirteen yes/no questions from the Universal Violence Prevention Screening Protocol will be used to assess for personal experiences of intimate partner violence with the last 4 months. Each item will be evaluated individually and no total score will be computed. | All of the "Not Asked" individuals (following the first question) were those who reported that they were not in a relationship in the past 4 months in the first question. | Posted | Count of Participants | Participants | 4-Month |
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| Other Pre-specified | 1-Month Intimate Partner Violence Attitude Scale | Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised will be used to assess for participant's attitudes related to intimate partner violence. Possible responses are on a Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree) with some items requiring reverse coding. Potential sum scores range from 17 to 85 with higher scores indicating a more favorable attitude towards intimate partner violence behaviors. | Posted | Mean | Standard Deviation | score on a scale | 1-Month |
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| Other Pre-specified | 4-Month Intimate Partner Violence Attitude Scale | Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised will be used to assess for participant's attitudes related to intimate partner violence. Possible responses are on a Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree) with some items requiring reverse coding. Potential sum scores range from 17 to 85 with higher scores indicating a more favorable attitude towards intimate partner violence behaviors. | Posted | Mean | Standard Deviation | score on a scale | 4-Months |
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| 0 |
| 133 |
| 0 |
| 133 |
| 0 |
| 133 |
| EG001 | Standard of Care | The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. | 0 | 117 | 0 | 117 | 0 | 117 |
Not provided
Not provided
Not provided
| Not Applicable |
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| Missing |
|
| Victimization - Oral Sex |
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| Victimization - Vaginal Sex |
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| Victimization - Anal Sex |
|
| Victimization - Attempted Oral Sex |
|
| Victimization - Attempted Vaginal Sex |
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| Victimization - Attempted Anal Sex |
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| Victimization - Rape |
|
| Not Applicable |
|
| Missing |
|
| Victimization - Oral Sex |
|
| Victimization - Vaginal Sex |
|
| Victimization - Anal Sex |
|
| Victimization - Attempted Oral Sex |
|
| Victimization - Attempted Vaginal Sex |
|
| Victimization - Attempted Anal Sex |
|
| Victimization - Rape |
|
| Missing |
|
| Perpetration - Oral Sex |
|
| Perpetration - Vaginal Sex |
|
| Perpetration - Anal Sex |
|
| Perpetration - Attempted Oral Sex |
|
| Perpetration - Attempted Vaginal Sex |
|
| Perpetration - Attempted Anal Sex |
|
| Perpetration - Rape |
|
| Missing |
|
| Perpetration - Oral Sex |
|
| Perpetration - Vaginal Sex |
|
| Perpetration - Anal Sex |
|
| Perpetration - Attempted Oral Sex |
|
| Perpetration - Attempted Vaginal Sex |
|
| Perpetration - Attempted Anal Sex |
|
| Perpetration - Rape |
|
| Missing |
|
| Non-Consensual Sexual Contact |
|
| Missing |
|
| Non-Consensual Sexual Contact |
|
| Not Asked |
|
| Missing |
|
| Slapped, kicked, pushed, choked, or punched |
|
| Forced or coerced you to have sex |
|
| Threatened you with a weapon or blackmailed you |
|
| Made you afraid that you could be physically hurt |
|
| Repeatedly used words, yelled, or screamed at you |
|
| Controlled who/where you were allowed to see or go |
|
| Minimized, denied, or normalized abusive behaviors |
|
| Threatened or abused important people or things |
|
| Used your identity to make you do something |
|
| Used social media or texts to know where you are |
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| Monitored social media/required to share passwords |
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| Sabotaged academic relationships/made feel unsmart |
|
| Not Asked |
|
| Slapped, kicked, pushed, choked, or punched |
|
| Forced or coerced you to have sex |
|
| Threatened you with a weapon or blackmailed you |
|
| Made you afraid that you could be physically hurt |
|
| Repeatedly used words, yelled, or screamed at you |
|
| Controlled who/where you were allowed to see or go |
|
| Minimized, denied, or normalized abusive behaviors |
|
| Threatened or abused important people or things |
|
| Used your identity to make you do something |
|
| Used social media or texts to know where you are |
|
| Monitored social media/required to share passwords |
|
| Sabotaged academic relationships/made feel unsmart |
|