MKit: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03316911
Collaborator
National Institutes of Health (NIH) (NIH), Michigan Department of State Police (Other)
261
1
2
6.2
42.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MKit
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
261 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
MKit: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
Actual Study Start Date :
Oct 22, 2017
Actual Primary Completion Date :
Apr 28, 2018
Actual Study Completion Date :
Apr 28, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. 3-Month Usability [3-months]

    The 10-item System Usability Scale will be used to evaluate the usability of WebApp in the intervention group only. The System Usability Scale (Brook, 1996) includes 10 items that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree). To get a final score the: 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.

  2. 5-Month Usability [5-months]

    The 10-item System Usability Scale will be used to evaluate the usability of WebApp in the intervention group only. The System Usability Scale (Brook, 1996) includes 10 items that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree). To get a final score the: 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.

  3. 3-Month Acceptability [3-months]

    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 assess 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. 5-Month Acceptability [5-months]

    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 assess 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.

Secondary Outcome Measures

  1. 3-Month Retention [3-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 score (those retained/those enrolled) will be computed based on interaction with the WebApp.

  2. 5-Month Retention [5-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 score (those retained/those enrolled) will be computed based on interaction with the WebApp.

Other Outcome Measures

  1. 3-Month Sexual Violence Victimization [3-months]

    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 (Koss et al., 2007) 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 3 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.

  2. 5-Month Sexual Violence Victimization [5-months]

    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 (Koss et al., 2007) 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.

  3. 3-Month Sexual Violence Perpetration [3-months]

    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 (Koss et al., 2007) 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 3 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. 5-Month Sexual Violence Perpetration [5-months]

    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 (Koss et al., 2007) 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 5 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.

  5. 3-Month Sexual Violence Knowledge [3-months]

    An 8-item (investigator created) scale will be used to measure participants' sexual violence knowledge at 3-months. The investigator-created sexual violence knowledge questions are scored from 1 (Strongly Agree) to 5 (Strongly Disagree) and the scores will be reverse-coded and summed for a total sexual violence knowledge score ranging from 8 - 40, with higher scores indicating more sexual violence knowledge.

  6. 5-Month Sexual Violence Knowledge [5-months]

    An 8-item (investigator created) scale will be used to measure participants' sexual violence knowledge at 5-months. The investigator-created sexual violence knowledge questions are scored from 1 (Strongly Agree) to 5 (Strongly Disagree) and the scores will be reverse-coded and summed for a total sexual violence knowledge score ranging from 8 - 40, with higher scores indicating more sexual violence knowledge.

  7. 3-Month Sexual Relationship Power [3-months]

    Fifteen items from the Relationship Control sub-scale of the Sexual Relationship Power Scale will be used to measure power dynamics within participants' sexual relationships at 3-months. The Relationship Control Sub-scale Items (Pulerwitz, Gortmaker, & DeJong, 2000) are scored from 1 (Strongly Agree) to 4 (Strongly Disagree). Scores are summed with total scores ranging from 15-60. Higher scores represent higher sexual relationship power.

  8. 5-Month Sexual Relationship Power [5-months]

    Fifteen items from the Relationship Control sub-scale of the Sexual Relationship Power Scale will be used to measure power dynamics within participants' sexual relationships at 5-months. The Relationship Control Sub-scale Items (Pulerwitz, Gortmaker, & DeJong, 2000) are scored from 1 (Strongly Agree) to 4 (Strongly Disagree). Scores are summed with total scores ranging from 15-60. Higher scores represent higher sexual relationship power.

  9. 3-Month Rape Myth Acceptance [3-months]

    The 22-item modified Illinois Rape Myth Acceptance scale will be used to measure attitudes endorsing rape myths at 3-months. The modified Illinois Rape Myth Acceptance Scale (McMahon & Farmer, 2011) is scored from 1 (Strongly Agree) to 5 (Strongly Disagree). It includes four sub-scales (She asked for it, He didn't mean to, It wasn't really rape, and She lied). The items in each sub-scale can be summed for a total score and the scores for the entire scale can be summed for a cumulative score. Scores on the full scale range from 22-110. Scores on the She Asked For It and He Didn't Mean To sub-scales range from 6-30. Scores on the It Wasn't Really Rape and the She Lied sub-scales range from 5-25. Higher scores indicate greater rejection of rape myths.

  10. 5-Month Rape Myth Acceptance [5-months]

    The 22-item modified Illinois Rape Myth Acceptance scale will be used to measure attitudes endorsing rape myths at 5-months. The modified Illinois Rape Myth Acceptance Scale (McMahon & Farmer, 2011) is scored from 1 (Strongly Agree) to 5 (Strongly Disagree). It includes four sub-scales (She asked for it, He didn't mean to, It wasn't really rape, and She lied). The items in each sub-scale can be summed for a total score and the scores for the entire scale can be summed for a cumulative score. Scores on the full scale range from 22-110. Scores on the She Asked For It and He Didn't Mean To sub-scales range from 6-30. Scores on the It Wasn't Really Rape and the She Lied sub-scales range from 5-25. Higher scores indicate greater rejection of rape myths.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Currently enrolled as a student at the participating university (University of Michigan)

  2. Age 18 or older

  3. Willing to participate in the study

  4. Able to speak and read English

  5. Participated in Relationship Remix at Alice Lloyd Hall or Mosher-Jordan Hall during the Fall of 2017. These residence halls were selected due to their similar sizes and demographic populations to allow for "approximate matching" between the control and intervention group.

Exclusion Criteria:
  1. Did not complete the Relationship Remix session

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • National Institutes of Health (NIH)
  • Michigan Department of State Police

Investigators

  • Principal Investigator: Michelle L Munro-Kramer, PhD,CNM,FNP, University of Michigan

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Michelle Munro-Kramer, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT03316911
Other Study ID Numbers:
  • HUM00133004
  • KL2TR000434
  • KL2TR002241
  • CSA-16-17
First Posted:
Oct 23, 2017
Last Update Posted:
May 10, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

Participant Flow

Recruitment Details Participants were recruited from the mandatory primary prevention training sessions, Relationship Remix, offered to all incoming students at the University of Michigan. We specifically recruited in October 22, 2017 - November 17, 2017 from Alice Lloyd Residence Hall (control) and Mosher Jordan Residence Hall (intervention).
Pre-assignment Detail
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Period Title: Overall Study
STARTED 122 139
3-Month Follow-up Survey 93 112
5-Month Follow-up Survey 89 110
COMPLETED 89 110
NOT COMPLETED 33 29

Baseline Characteristics

Arm/Group Title MKit WebApp Intervention Standard of Care Total
Arm/Group Description 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. 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. Total of all reporting groups
Overall Participants 122 139 261
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
18.13
(.545)
18.20
(.554)
18.17
(.550)
Sex/Gender, Customized (Count of Participants)
Male
40
32.8%
56
40.3%
96
36.8%
Female
81
66.4%
80
57.6%
161
61.7%
Genderqueer/Gender Nonconforming
1
0.8%
2
1.4%
3
1.1%
Trans Female/Trans Woman
0
0%
1
0.7%
1
0.4%
Trans Male/Trans Man
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Count of Participants)
White/Caucasian
72
59%
95
68.3%
167
64%
Black or African American
3
2.5%
4
2.9%
7
2.7%
Hispanic/Latino/Spanish
6
4.9%
6
4.3%
12
4.6%
American Indian/Alaska Native
1
0.8%
0
0%
1
0.4%
Asian
31
25.4%
26
18.7%
57
21.8%
Multiple Ethnicity/Other
9
7.4%
3
2.2%
12
4.6%
Middle East/North African
0
0%
4
2.9%
4
1.5%
Native Hawaiian/Other Pacific Islander
0
0%
1
0.7%
1
0.4%
Sexual Orientation (Count of Participants)
Heterosexual or Straight
102
83.6%
119
85.6%
221
84.7%
Gay or Lesbian
1
0.8%
7
5%
8
3.1%
Bisexual
8
6.6%
8
5.8%
16
6.1%
Something Else
4
3.3%
3
2.2%
7
2.7%
Prefer not to disclose
7
5.7%
2
1.4%
9
3.4%
Year in School (Count of Participants)
Freshman
115
94.3%
132
95%
247
94.6%
Sophomore
6
4.9%
5
3.6%
11
4.2%
Junior
0
0%
1
0.7%
1
0.4%
Senior
0
0%
1
0.7%
1
0.4%
Graduate or Professional Student
1
0.8%
0
0%
1
0.4%

Outcome Measures

1. Primary Outcome
Title 3-Month Usability
Description The 10-item System Usability Scale will be used to evaluate the usability of WebApp in the intervention group only. The System Usability Scale (Brook, 1996) includes 10 items that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree). To get a final score the: 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.
Time Frame 3-months

Outcome Measure Data

Analysis Population Description
Only intervention participants were asked the items on the System Usability Scale.
Arm/Group Title MKit WebApp Intervention
Arm/Group Description 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.
Measure Participants 93
Mean (Standard Deviation) [score on a scale]
67.66
(14.87)
2. Primary Outcome
Title 5-Month Usability
Description The 10-item System Usability Scale will be used to evaluate the usability of WebApp in the intervention group only. The System Usability Scale (Brook, 1996) includes 10 items that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree). To get a final score the: 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.
Time Frame 5-months

Outcome Measure Data

Analysis Population Description
Only intervention participants were asked the items on the System Usability Scale.
Arm/Group Title MKit WebApp Intervention
Arm/Group Description 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.
Measure Participants 89
Mean (Standard Deviation) [score on a scale]
68.88
(14.86)
3. Primary Outcome
Title 3-Month Acceptability
Description 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 assess 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.
Time Frame 3-months

Outcome Measure Data

Analysis Population Description
Only intervention participants were asked the items on the System Acceptability Scale.
Arm/Group Title MKit WebApp Intervention
Arm/Group Description 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.
Measure Participants 93
Mean (Standard Deviation) [score on a scale]
15.53
(3.14)
4. Primary Outcome
Title 5-Month Acceptability
Description 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 assess 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.
Time Frame 5-months

Outcome Measure Data

Analysis Population Description
Only intervention participants were asked the items on the System Acceptability Scale.
Arm/Group Title MKit WebApp Intervention
Arm/Group Description 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.
Measure Participants 89
Mean (Standard Deviation) [score on a scale]
15.55
(3.15)
5. Secondary Outcome
Title 3-Month Retention
Description The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention score (those retained/those enrolled) will be computed based on interaction with the WebApp.
Time Frame 3-months

Outcome Measure Data

Analysis Population Description
Retention was calculated based on the total number of participants that completed the Baseline survey.
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 122 139
Completed 3-Month Survey
93
76.2%
112
80.6%
Did not complete 3-Month Survey
29
23.8%
27
19.4%
6. Secondary Outcome
Title 5-Month Retention
Description The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention score (those retained/those enrolled) will be computed based on interaction with the WebApp.
Time Frame 5-months

Outcome Measure Data

Analysis Population Description
Retention was calculated based on the total number of participants that completed the Baseline survey.
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 122 139
Completed 5-Month Survey
89
73%
110
79.1%
Did not complete 5-Month Survey
33
27%
29
20.9%
7. Other Pre-specified Outcome
Title 3-Month Sexual Violence Victimization
Description 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 (Koss et al., 2007) 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 3 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.
Time Frame 3-months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 93 112
Experienced
7
5.7%
13
9.4%
Did not experience
86
70.5%
98
70.5%
Not Applicable
0
0%
0
0%
Missing
0
0%
1
0.7%
Experienced
2
1.6%
7
5%
Did not experience
91
74.6%
104
74.8%
Not Applicable
0
0%
0
0%
Missing
0
0%
1
0.7%
Experienced
1
0.8%
2
1.4%
Did not experience
66
54.1%
67
48.2%
Not Applicable
26
21.3%
41
29.5%
Missing
0
0%
2
1.4%
Experienced
1
0.8%
1
0.7%
Did not experience
92
75.4%
109
78.4%
Not Applicable
0
0%
0
0%
Missing
0
0%
2
1.4%
Experienced
1
0.8%
5
3.6%
Did not experience
92
75.4%
105
75.5%
Not Applicable
0
0%
0
0%
Missing
0
0%
2
1.4%
Experienced
3
2.5%
3
2.2%
Did not experience
64
52.5%
66
47.5%
Not Applicable
26
21.3%
41
29.5%
Missing
0
0%
2
1.4%
Experienced
1
0.8%
3
2.2%
Did not experience
92
75.4%
107
77%
Not Applicable
0
0%
0
0%
Missing
0
0%
2
1.4%
Experienced
2
1.6%
3
2.2%
Did not experience
91
74.6%
107
77%
Not Applicable
0
0%
0
0%
Missing
0
0%
2
1.4%
8. Other Pre-specified Outcome
Title 5-Month Sexual Violence Victimization
Description 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 (Koss et al., 2007) 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.
Time Frame 5-months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 89 110
Experienced
7
5.7%
10
7.2%
Did not experience
82
67.2%
99
71.2%
Not Applicable
0
0%
0
0%
Missing
0
0%
1
0.7%
Experienced
0
0%
0
0%
Did not experience
89
73%
109
78.4%
Not Applicable
0
0%
0
0%
Missing
0
0%
1
0.7%
Experienced
2
1.6%
0
0%
Did not experience
62
50.8%
68
48.9%
Not Applicable
25
20.5%
40
28.8%
Missing
0
0%
2
1.4%
Experienced
0
0%
0
0%
Did not experience
89
73%
108
77.7%
Not Applicable
0
0%
0
0%
Missing
0
0%
2
1.4%
Experienced
3
2.5%
5
3.6%
Did not experience
86
70.5%
103
74.1%
Not Applicable
0
0%
0
0%
Missing
0
0%
2
1.4%
Experienced
3
2.5%
3
2.2%
Did not experience
61
50%
65
46.8%
Not Applicable
25
20.5%
40
28.8%
Missing
0
0%
2
1.4%
Experienced
0
0%
0
0%
Did not experience
89
73%
108
77.7%
Not Applicable
0
0%
0
0%
Missing
0
0%
2
1.4%
Experienced
3
2.5%
2
1.4%
Did not experience
86
70.5%
106
76.3%
Not Applicable
0
0%
0
0%
Missing
0
0%
2
1.4%
9. Other Pre-specified Outcome
Title 3-Month Sexual Violence Perpetration
Description 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 (Koss et al., 2007) 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 3 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.
Time Frame 3-months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 93 112
Perpetrated
0
0%
3
2.2%
Did not perpetrate
93
76.2%
107
77%
Missing
0
0%
2
1.4%
Perpetrated
0
0%
0
0%
Did not perpetrate
93
76.2%
110
79.1%
Missing
0
0%
2
1.4%
Perpetrated
0
0%
0
0%
Did not perpetrate
93
76.2%
110
79.1%
Missing
0
0%
2
1.4%
Perpetrated
0
0%
1
0.7%
Did not perpetrate
93
76.2%
109
78.4%
Missing
0
0%
2
1.4%
Perpetrated
0
0%
1
0.7%
Did not perpetrate
93
76.2%
109
78.4%
Missing
0
0%
2
1.4%
Perpetrated
0
0%
0
0%
Did not perpetrate
93
76.2%
110
79.1%
Missing
0
0%
2
1.4%
Perpetrated
0
0%
0
0%
Did not perpetrate
93
76.2%
110
79.1%
Missing
0
0%
2
1.4%
Perpetrated
0
0%
0
0%
Did not perpetrate
93
76.2%
109
78.4%
Missing
0
0%
3
2.2%
10. Other Pre-specified Outcome
Title 5-Month Sexual Violence Perpetration
Description 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 (Koss et al., 2007) 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 5 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.
Time Frame 5-months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 89 110
Perpetrated
1
0.8%
1
0.7%
Did not perpetrate
88
72.1%
108
77.7%
Missing
0
0%
1
0.7%
Perpetrated
0
0%
1
0.7%
Did not perpetrate
89
73%
108
77.7%
Missing
0
0%
1
0.7%
Perpetrated
0
0%
0
0%
Did not perpetrate
89
73%
109
78.4%
Missing
0
0%
1
0.7%
Perpetrated
0
0%
0
0%
Did not perpetrate
89
73%
109
78.4%
Missing
0
0%
1
0.7%
Perpetrated
0
0%
0
0%
Did not perpetrate
89
73%
109
78.4%
Missing
0
0%
1
0.7%
Perpetrated
2
1.6%
0
0%
Did not perpetrate
87
71.3%
109
78.4%
Missing
0
0%
1
0.7%
Perpetrated
0
0%
0
0%
Did not perpetrate
89
73%
109
78.4%
Missing
0
0%
1
0.7%
Perpetrated
0
0%
0
0%
Did not perpetrate
89
73%
109
78.4%
Missing
0
0%
1
0.7%
11. Other Pre-specified Outcome
Title 3-Month Sexual Violence Knowledge
Description An 8-item (investigator created) scale will be used to measure participants' sexual violence knowledge at 3-months. The investigator-created sexual violence knowledge questions are scored from 1 (Strongly Agree) to 5 (Strongly Disagree) and the scores will be reverse-coded and summed for a total sexual violence knowledge score ranging from 8 - 40, with higher scores indicating more sexual violence knowledge.
Time Frame 3-months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 93 112
Mean (Standard Deviation) [score on a scale]
35.81
(3.67)
36.61
(4.64)
12. Other Pre-specified Outcome
Title 5-Month Sexual Violence Knowledge
Description An 8-item (investigator created) scale will be used to measure participants' sexual violence knowledge at 5-months. The investigator-created sexual violence knowledge questions are scored from 1 (Strongly Agree) to 5 (Strongly Disagree) and the scores will be reverse-coded and summed for a total sexual violence knowledge score ranging from 8 - 40, with higher scores indicating more sexual violence knowledge.
Time Frame 5-months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 89 110
Mean (Standard Deviation) [score on a scale]
35.72
(3.54)
36.67
(5.10)
13. Other Pre-specified Outcome
Title 3-Month Sexual Relationship Power
Description Fifteen items from the Relationship Control sub-scale of the Sexual Relationship Power Scale will be used to measure power dynamics within participants' sexual relationships at 3-months. The Relationship Control Sub-scale Items (Pulerwitz, Gortmaker, & DeJong, 2000) are scored from 1 (Strongly Agree) to 4 (Strongly Disagree). Scores are summed with total scores ranging from 15-60. Higher scores represent higher sexual relationship power.
Time Frame 3-months

Outcome Measure Data

Analysis Population Description
Only participants who chose a relationship status other than "Single" were asked the SRPS questions.
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 29 34
Mean (Standard Deviation) [score on a scale]
49.34
(6.03)
50.53
(6.16)
14. Other Pre-specified Outcome
Title 5-Month Sexual Relationship Power
Description Fifteen items from the Relationship Control sub-scale of the Sexual Relationship Power Scale will be used to measure power dynamics within participants' sexual relationships at 5-months. The Relationship Control Sub-scale Items (Pulerwitz, Gortmaker, & DeJong, 2000) are scored from 1 (Strongly Agree) to 4 (Strongly Disagree). Scores are summed with total scores ranging from 15-60. Higher scores represent higher sexual relationship power.
Time Frame 5-months

Outcome Measure Data

Analysis Population Description
Only participants who chose a relationship status other than "Single" were asked the SRPS questions.
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 27 42
Mean (Standard Deviation) [score on a scale]
50.56
(6.20)
51.55
(5.62)
15. Other Pre-specified Outcome
Title 3-Month Rape Myth Acceptance
Description The 22-item modified Illinois Rape Myth Acceptance scale will be used to measure attitudes endorsing rape myths at 3-months. The modified Illinois Rape Myth Acceptance Scale (McMahon & Farmer, 2011) is scored from 1 (Strongly Agree) to 5 (Strongly Disagree). It includes four sub-scales (She asked for it, He didn't mean to, It wasn't really rape, and She lied). The items in each sub-scale can be summed for a total score and the scores for the entire scale can be summed for a cumulative score. Scores on the full scale range from 22-110. Scores on the She Asked For It and He Didn't Mean To sub-scales range from 6-30. Scores on the It Wasn't Really Rape and the She Lied sub-scales range from 5-25. Higher scores indicate greater rejection of rape myths.
Time Frame 3-months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 93 112
Full Scale
95.33
(12.57)
93.98
(15.48)
She Asked for It Sub-scale
26.17
(3.98)
26.49
(4.51)
He Didn't Mean To Sub-scale
24.06
(4.27)
23.66
(5.02)
It Wasn't Really Rape Sub-scale
23.45
(2.76)
22.88
(3.73)
She Lied Sub-scale
21.65
(3.72)
20.95
(4.56)
16. Other Pre-specified Outcome
Title 5-Month Rape Myth Acceptance
Description The 22-item modified Illinois Rape Myth Acceptance scale will be used to measure attitudes endorsing rape myths at 5-months. The modified Illinois Rape Myth Acceptance Scale (McMahon & Farmer, 2011) is scored from 1 (Strongly Agree) to 5 (Strongly Disagree). It includes four sub-scales (She asked for it, He didn't mean to, It wasn't really rape, and She lied). The items in each sub-scale can be summed for a total score and the scores for the entire scale can be summed for a cumulative score. Scores on the full scale range from 22-110. Scores on the She Asked For It and He Didn't Mean To sub-scales range from 6-30. Scores on the It Wasn't Really Rape and the She Lied sub-scales range from 5-25. Higher scores indicate greater rejection of rape myths.
Time Frame 5-months

Outcome Measure Data

Analysis Population Description
One participant from the Control group had missing data and was not included in data analysis for the Rape Myth Acceptance measures.
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
Measure Participants 89 109
Full Scale
96.08
(10.20)
96.30
(12.86)
She Asked for It Sub-scale
26.60
(3.80)
26.80
(3.94)
He Didn't Mean To Sub-scale
24.00
(3.98)
24.69
(4.50)
It Wasn't Really Rape Sub-scale
23.58
(2.09)
23.29
(2.70)
She Lied Sub-scale
21.90
(3.35)
21.52
(3.77)

Adverse Events

Time Frame 5 months
Adverse Event Reporting Description Since this was an anonymous study, adverse events were defined as those reported to study staff.
Arm/Group Title MKit WebApp Intervention Standard of Care
Arm/Group Description 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. 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.
All Cause Mortality
MKit WebApp Intervention Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/122 (0%) 0/139 (0%)
Serious Adverse Events
MKit WebApp Intervention Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/122 (0%) 0/139 (0%)
Other (Not Including Serious) Adverse Events
MKit WebApp Intervention Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/122 (0%) 0/139 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Michelle Munro-Kramer
Organization University of Michigan
Phone 734-904-4600
Email mlmunro@umich.edu
Responsible Party:
Michelle Munro-Kramer, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT03316911
Other Study ID Numbers:
  • HUM00133004
  • KL2TR000434
  • KL2TR002241
  • CSA-16-17
First Posted:
Oct 23, 2017
Last Update Posted:
May 10, 2019
Last Verified:
May 1, 2019