Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715426
Recruitment Status : Completed
First Posted : October 23, 2018
Results First Posted : July 16, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Michelle Munro-Kramer, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Sexual Violence
Primary Prevention
Intervention Behavioral: MKit
Enrollment 250
Recruitment Details 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).
Pre-assignment Details 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.
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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 133 117
1-Month Follow-Up Survey 113 97
4-Month Follow-Up Survey 112 92
Completed 112 92
Not Completed 21 25
Arm/Group Title MKit WebApp Intervention Standard of Care Total
Hide 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 Number of Baseline Participants 133 117 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 117 participants 250 participants
18.19  (0.617) 18.17  (0.460) 18.18  (0.548)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 117 participants 250 participants
Male
53
  39.8%
52
  44.4%
105
  42.0%
Female
75
  56.4%
64
  54.7%
139
  55.6%
Trans Female/Trans Woman
1
   0.8%
0
   0.0%
1
   0.4%
Trans Male/Trans Man
0
   0.0%
0
   0.0%
0
   0.0%
Genderqueer/Gender Nonconforming
1
   0.8%
0
   0.0%
1
   0.4%
Different Identity
2
   1.5%
0
   0.0%
2
   0.8%
Prefer Not to Disclose
1
   0.8%
1
   0.9%
2
   0.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 117 participants 250 participants
White/Caucasian
67
  50.4%
65
  55.6%
132
  52.8%
Black/African American
12
   9.0%
3
   2.6%
15
   6.0%
Hispanic/Latino/Spanish
5
   3.8%
7
   6.0%
12
   4.8%
Middle Eastern/North African
6
   4.5%
1
   0.9%
7
   2.8%
Asian
34
  25.6%
34
  29.1%
68
  27.2%
Native Hawaiian/Other Pacific Islander
1
   0.8%
0
   0.0%
1
   0.4%
Multiple Ethnicities/Other
8
   6.0%
7
   6.0%
15
   6.0%
Sexual Orientation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 117 participants 250 participants
Heterosexual or Straight
114
  85.7%
103
  88.0%
217
  86.8%
Gay or Lesbian
3
   2.3%
3
   2.6%
6
   2.4%
Bisexual
7
   5.3%
8
   6.8%
15
   6.0%
Something Else
3
   2.3%
2
   1.7%
5
   2.0%
Prefer not to disclose
6
   4.5%
1
   0.9%
7
   2.8%
Year in School  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 117 participants 250 participants
Freshman
123
  92.5%
111
  94.9%
234
  93.6%
Sophomore
6
   4.5%
4
   3.4%
10
   4.0%
Junior
4
   3.0%
2
   1.7%
6
   2.4%
1.Primary Outcome
Title Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale
Hide Description 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.
Time Frame 1-month
Hide Outcome Measure Data
Hide Analysis Population Description
Only intervention participants were asked the items on the System Usability Scale.
Arm/Group Title MKit WebApp Intervention
Hide 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.

Overall Number of Participants Analyzed 113
Mean (Standard Deviation)
Unit of Measure: score on a scale
64.36  (20.86)
2.Primary Outcome
Title Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale
Hide Description 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.
Time Frame 4-Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only intervention participants were asked the items on the System Usability Scale.
Arm/Group Title MKit WebApp Intervention
Hide 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.

Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on a scale
62.08  (20.94)
3.Primary Outcome
Title Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale
Hide 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 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.
Time Frame 1-Month
Hide Outcome Measure Data
Hide Analysis Population Description
Only intervention participants were asked the items on the System Acceptability Scale.
Arm/Group Title MKit WebApp Intervention
Hide 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.

Overall Number of Participants Analyzed 113
Mean (Standard Deviation)
Unit of Measure: score on a scale
16.00  (2.91)
4.Primary Outcome
Title Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale
Hide 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 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.
Time Frame 4-Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only intervention participants were asked the items on the System Acceptability Scale.
Arm/Group Title MKit WebApp Intervention
Hide 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.

Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on a scale
15.94  (3.32)
5.Secondary Outcome
Title 1-Month Retention
Hide 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 rate (those retained/those enrolled) will be computed based on interaction with the WebApp.
Time Frame 1-Month
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 133 117
Measure Type: Count of Participants
Unit of Measure: Participants
Completed 1-Month Survey
113
  85.0%
97
  82.9%
Did not complete 1-Month Survey
20
  15.0%
20
  17.1%
6.Secondary Outcome
Title 4-Month Retention
Hide 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 rate (those retained/those enrolled) will be computed based on interaction with the WebApp.
Time Frame 4-Month
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 133 117
Measure Type: Count of Participants
Unit of Measure: Participants
Completed 4-Month Survey
112
  84.2%
92
  78.6%
Did not complete 4-Month Survey
21
  15.8%
25
  21.4%
7.Other Pre-specified Outcome
Title 1-Month Sexual Victimization as Assessed by the 10-item Sexual Experiences Survey
Hide 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 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.
Time Frame 1-Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 113 97
Measure Type: Count of Participants
Unit of Measure: Participants
Victimization - Fondled, Kissed, or Rubbed Against Experienced
9
   8.0%
10
  10.3%
Did not experience
103
  91.2%
87
  89.7%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Oral Sex Experienced
3
   2.7%
1
   1.0%
Did not experience
109
  96.5%
96
  99.0%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Vaginal Sex Experienced
4
   3.5%
1
   1.0%
Did not experience
63
  55.8%
54
  55.7%
Not Applicable
45
  39.8%
41
  42.3%
Missing
1
   0.9%
1
   1.0%
Victimization - Anal Sex Experienced
1
   0.9%
0
   0.0%
Did not experience
111
  98.2%
97
 100.0%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Attempted Oral Sex Experienced
4
   3.5%
3
   3.1%
Did not experience
108
  95.6%
94
  96.9%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Attempted Vaginal Sex Experienced
4
   3.5%
0
   0.0%
Did not experience
63
  55.8%
55
  56.7%
Not Applicable
45
  39.8%
41
  42.3%
Missing
1
   0.9%
1
   1.0%
Victimization - Attempted Anal Sex Experienced
1
   0.9%
1
   1.0%
Did not experience
111
  98.2%
96
  99.0%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Rape Experienced
6
   5.3%
1
   1.0%
Did not experience
107
  94.7%
96
  99.0%
Not Applicable
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
8.Other Pre-specified Outcome
Title 4-Months Sexual Victimization as Assessed by the 10-item Sexual Experience Survey
Hide 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 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 4-Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 112 92
Measure Type: Count of Participants
Unit of Measure: Participants
Victimization - Fondled, Kissed, or Rubbed Against Experienced
7
   6.3%
9
   9.8%
Did not experience
104
  92.9%
83
  90.2%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Oral Sex Experienced
4
   3.6%
2
   2.2%
Did not experience
107
  95.5%
90
  97.8%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Vaginal Sex Experienced
1
   0.9%
3
   3.3%
Did not experience
67
  59.8%
49
  53.3%
Not Applicable
43
  38.4%
40
  43.5%
Missing
1
   0.9%
0
   0.0%
Victimization - Anal Sex Experienced
1
   0.9%
0
   0.0%
Did not experience
110
  98.2%
92
 100.0%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Attempted Oral Sex Experienced
3
   2.7%
1
   1.1%
Did not experience
108
  96.4%
91
  98.9%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Attempted Vaginal Sex Experienced
0
   0.0%
1
   1.1%
Did not experience
67
  59.8%
51
  55.4%
Not Applicable
43
  38.4%
40
  43.5%
Missing
2
   1.8%
0
   0.0%
Victimization - Attempted Anal Sex Experienced
0
   0.0%
0
   0.0%
Did not experience
111
  99.1%
92
 100.0%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
Victimization - Rape Experienced
6
   5.4%
1
   1.1%
Did not experience
105
  93.8%
91
  98.9%
Not Applicable
0
   0.0%
0
   0.0%
Missing
1
   0.9%
0
   0.0%
9.Other Pre-specified Outcome
Title 1-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey
Hide 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 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.
Time Frame 1-Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 113 97
Measure Type: Count of Participants
Unit of Measure: Participants
Perpetration - Fondled, Kissed, or Rubbed Against Perpetrated
4
   3.5%
0
   0.0%
Did not perpetrate
108
  95.6%
97
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Oral Sex Perpetrated
1
   0.9%
0
   0.0%
Did not perpetrate
111
  98.2%
97
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Vaginal Sex Perpetrated
1
   0.9%
0
   0.0%
Did not perpetrate
111
  98.2%
97
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Anal Sex Perpetrated
1
   0.9%
0
   0.0%
Did not perpetrate
111
  98.2%
97
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Attempted Oral Sex Perpetrated
1
   0.9%
0
   0.0%
Did not perpetrate
111
  98.2%
97
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Attempted Vaginal Sex Perpetrated
1
   0.9%
0
   0.0%
Did not perpetrate
111
  98.2%
97
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Attempted Anal Sex Perpetrated
1
   0.9%
0
   0.0%
Did not perpetrate
111
  98.2%
97
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Rape Perpetrated
1
   0.9%
0
   0.0%
Did not perpetrate
112
  99.1%
97
 100.0%
Missing
0
   0.0%
0
   0.0%
10.Other Pre-specified Outcome
Title 4-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey
Hide 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 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.
Time Frame 4-Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 112 92
Measure Type: Count of Participants
Unit of Measure: Participants
Perpetration - Fondled, Kissed, or Rubbed Against Perpetrated
2
   1.8%
1
   1.1%
Did not perpetrate
109
  97.3%
91
  98.9%
Missing
1
   0.9%
0
   0.0%
Perpetration - Oral Sex Perpetrated
0
   0.0%
0
   0.0%
Did not perpetrate
111
  99.1%
92
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Vaginal Sex Perpetrated
0
   0.0%
0
   0.0%
Did not perpetrate
111
  99.1%
92
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Anal Sex Perpetrated
0
   0.0%
0
   0.0%
Did not perpetrate
111
  99.1%
92
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Attempted Oral Sex Perpetrated
0
   0.0%
0
   0.0%
Did not perpetrate
111
  99.1%
92
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Attempted Vaginal Sex Perpetrated
0
   0.0%
0
   0.0%
Did not perpetrate
111
  99.1%
92
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Attempted Anal Sex Perpetrated
0
   0.0%
0
   0.0%
Did not perpetrate
111
  99.1%
92
 100.0%
Missing
1
   0.9%
0
   0.0%
Perpetration - Rape Perpetrated
1
   0.9%
0
   0.0%
Did not perpetrate
110
  98.2%
92
 100.0%
Missing
1
   0.9%
0
   0.0%
11.Other Pre-specified Outcome
Title 1-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form
Hide Description 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).
Time Frame 1-Month
Hide Outcome Measure Data
Hide Analysis Population Description
Data for the 1-Month Knowledge scale were missing from 1 participant in the Intervention group.
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 112 97
Mean (Standard Deviation)
Unit of Measure: score on a scale
85.63  (12.09) 82.77  (12.38)
12.Other Pre-specified Outcome
Title 4-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form
Hide Description 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).
Time Frame 4-Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 112 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
84.05  (12.76) 79.01  (14.09)
13.Other Pre-specified Outcome
Title Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items
Hide Description 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).
Time Frame 1-Month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 110 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
93.45  (10.88) 90.17  (11.50)
14.Other Pre-specified Outcome
Title Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items
Hide Description 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).
Time Frame 4-Months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for the 4-Month Self-Efficacy scale were missing for 2 participants in the Intervention group.
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 110 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
90.72  (13.07) 88.33  (13.91)
15.Other Pre-specified Outcome
Title 1-Month Consensual Sexual Activity With 2 Investigator Created Items
Hide Description 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.
Time Frame 1-Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 113 97
Measure Type: Count of Participants
Unit of Measure: Participants
Non-Consensual Sexual Intercourse Engaged in non-consensual sexual behavior
2
   1.8%
1
   1.0%
Did not engage in non-consensual sexual behavior
109
  96.5%
96
  99.0%
Missing
2
   1.8%
0
   0.0%
Non-Consensual Sexual Contact Engaged in non-consensual sexual behavior
2
   1.8%
2
   2.1%
Did not engage in non-consensual sexual behavior
111
  98.2%
95
  97.9%
Missing
0
   0.0%
0
   0.0%
16.Other Pre-specified Outcome
Title 4-Month Consensual Sexual Activity With 2 Investigator Created Items
Hide Description 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.
Time Frame 4-Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 112 92
Measure Type: Count of Participants
Unit of Measure: Participants
Non-Consensual Sexual Intercourse Engaged in non-consensual sexual behavior
2
   1.8%
2
   2.2%
Did not engage in non-consensual sexual behavior
109
  97.3%
90
  97.8%
Missing
1
   0.9%
0
   0.0%
Non-Consensual Sexual Contact Engaged in non-consensual sexual behavior
1
   0.9%
1
   1.1%
Did not engage in non-consensual sexual behavior
110
  98.2%
91
  98.9%
Missing
1
   0.9%
0
   0.0%
17.Other Pre-specified Outcome
Title 1-Month Universal Violence Prevention Screening Protocol
Hide Description 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.
Time Frame 1-Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 113 97
Measure Type: Count of Participants
Unit of Measure: Participants
Been in a relationship in past 1 month No
74
  65.5%
71
  73.2%
Yes
39
  34.5%
26
  26.8%
Not Asked
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
Slapped, kicked, pushed, choked, or punched No
37
  32.7%
23
  23.7%
Yes
1
   0.9%
3
   3.1%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Forced or coerced you to have sex No
37
  32.7%
25
  25.8%
Yes
1
   0.9%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Threatened you with a weapon or blackmailed you No
38
  33.6%
25
  25.8%
Yes
0
   0.0%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Made you afraid that you could be physically hurt No
38
  33.6%
25
  25.8%
Yes
0
   0.0%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Repeatedly used words, yelled, or screamed at you No
37
  32.7%
25
  25.8%
Yes
1
   0.9%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Controlled who/where you were allowed to see or go No
37
  32.7%
25
  25.8%
Yes
1
   0.9%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Minimized, denied, or normalized abusive behaviors No
38
  33.6%
25
  25.8%
Yes
0
   0.0%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Threatened or abused important people or things No
38
  33.6%
25
  25.8%
Yes
0
   0.0%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Used your identity to make you do something No
38
  33.6%
25
  25.8%
Yes
0
   0.0%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Used social media or texts to know where you are No
36
  31.9%
25
  25.8%
Yes
2
   1.8%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Monitored social media/required to share passwords No
37
  32.7%
25
  25.8%
Yes
1
   0.9%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
Sabotaged academic relationships/made feel unsmart No
38
  33.6%
25
  25.8%
Yes
0
   0.0%
1
   1.0%
Not Asked
74
  65.5%
71
  73.2%
Missing
1
   0.9%
0
   0.0%
18.Other Pre-specified Outcome
Title 4-Month Universal Violence Prevention Screening Protocol
Hide Description 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.
Time Frame 4-Month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 112 92
Measure Type: Count of Participants
Unit of Measure: Participants
Been in a relationship in past 4 months No
71
  63.4%
69
  75.0%
Yes
41
  36.6%
23
  25.0%
Not Asked
0
   0.0%
0
   0.0%
Slapped, kicked, pushed, choked, or punched No
38
  33.9%
23
  25.0%
Yes
3
   2.7%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Forced or coerced you to have sex No
37
  33.0%
23
  25.0%
Yes
4
   3.6%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Threatened you with a weapon or blackmailed you No
41
  36.6%
23
  25.0%
Yes
0
   0.0%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Made you afraid that you could be physically hurt No
41
  36.6%
23
  25.0%
Yes
0
   0.0%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Repeatedly used words, yelled, or screamed at you No
39
  34.8%
23
  25.0%
Yes
2
   1.8%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Controlled who/where you were allowed to see or go No
39
  34.8%
23
  25.0%
Yes
2
   1.8%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Minimized, denied, or normalized abusive behaviors No
37
  33.0%
23
  25.0%
Yes
4
   3.6%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Threatened or abused important people or things No
41
  36.6%
23
  25.0%
Yes
0
   0.0%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Used your identity to make you do something No
40
  35.7%
23
  25.0%
Yes
1
   0.9%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Used social media or texts to know where you are No
40
  35.7%
23
  25.0%
Yes
1
   0.9%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Monitored social media/required to share passwords No
40
  35.7%
23
  25.0%
Yes
1
   0.9%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
Sabotaged academic relationships/made feel unsmart No
40
  35.7%
23
  25.0%
Yes
1
   0.9%
0
   0.0%
Not Asked
71
  63.4%
69
  75.0%
19.Other Pre-specified Outcome
Title 1-Month Intimate Partner Violence Attitude Scale
Hide Description 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.
Time Frame 1-Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 113 97
Mean (Standard Deviation)
Unit of Measure: score on a scale
26.80  (9.05) 28.81  (9.72)
20.Other Pre-specified Outcome
Title 4-Month Intimate Partner Violence Attitude Scale
Hide Description 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.
Time Frame 4-Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MKit WebApp Intervention Standard of Care
Hide 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.
Overall Number of Participants Analyzed 112 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
27.70  (9.52) 28.60  (10.43)
Time Frame 4 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
Hide 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 (%) Affected / at Risk (%)
Total   0/133 (0.00%)   0/117 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
MKit WebApp Intervention Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/133 (0.00%)   0/117 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MKit WebApp Intervention Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/133 (0.00%)   0/117 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michelle Munro-Kramer
Organization: University of Michigan
Phone: 734-904-4600
EMail: mlmunro@umich.edu
Publications of Results:
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.
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
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
Layout table for additonal information
Responsible Party: Michelle Munro-Kramer, University of Michigan
ClinicalTrials.gov Identifier: NCT03715426     History of Changes
Other Study ID Numbers: HUM00133004-A
KL2TR000434 ( U.S. NIH Grant/Contract )
KL2TR002241 ( U.S. NIH Grant/Contract )
5R49CE002099-05 ( U.S. NIH Grant/Contract )
First Submitted: October 17, 2018
First Posted: October 23, 2018
Results First Submitted: June 24, 2019
Results First Posted: July 16, 2019
Last Update Posted: July 29, 2019