Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03715426
Collaborator
National Institutes of Health (NIH) (NIH)
250
1
2
5.9
42.5
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. This is a repeat pilot test to evaluate changes implemented to the WebApp after the initial pilot during the 2017-2018 academic year.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
250 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 21, 2018
Actual Primary Completion Date
:
Apr 1, 2019
Actual Study Completion Date
:
Apr 18, 2019
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
- Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale [1-month]
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.
- Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale [4-Months]
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.
- Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale [1-Month]
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.
- Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale [4-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 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.
Secondary Outcome Measures
- 1-Month Retention [1-Month]
The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp.
- 4-Month Retention [4-Month]
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.
Other Outcome Measures
- 1-Month Sexual Victimization as Assessed by the 10-item Sexual Experiences Survey [1-Month]
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.
- 4-Months Sexual Victimization as Assessed by the 10-item Sexual Experience Survey [4-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 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.
- 1-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey [1-Month]
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.
- 4-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey [4-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 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.
- 1-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form [1-Month]
Twenty knowledge questions about sexual and intimate partner violence adapted from the Texas Education Program Participant Response Form will be used to assess knowledge of healthy relationships, sexual violence, and intimate partner violence. The questions are scored from 1 (no knowledge) to 5 (a lot of knowledge) with higher scores indicating more knowledge. Possible sum scores range from 20 (no knowledge) to 100 (a lot of knowledge about all of the topics).
- 4-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form [4-Months]
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).
- Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items [1-Month]
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).
- Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items [4-Months]
Self-efficacy of protective behaviors related to sexual and intimate partner violence will be assessed using a questionnaire developed by the investigators. Participants will complete a 15 item questionnaire with responses ranging from 1 (not at all confident) to 7 (very confident) related to confidence in ability to handle situations related to sexual and intimate partner violence. The total score for each participant can range from 15 (not at all confident in any of the behaviors) to 105 (very confident in all behaviors).
- 1-Month Consensual Sexual Activity With 2 Investigator Created Items [1-Month]
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.
- 4-Month Consensual Sexual Activity With 2 Investigator Created Items [4-Months]
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.
- 1-Month Universal Violence Prevention Screening Protocol [1-Month]
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.
- 4-Month Universal Violence Prevention Screening Protocol [4-Month]
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.
- 1-Month Intimate Partner Violence Attitude Scale [1-Month]
Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised will be used to assess for participant's attitudes related to intimate partner violence. Possible responses are on a Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree) with some items requiring reverse coding. Potential sum scores range from 17 to 85 with higher scores indicating a more favorable attitude towards intimate partner violence behaviors.
- 4-Month Intimate Partner Violence Attitude Scale [4-Months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Currently enrolled as a student at the participating university (University of Michigan)
-
Age 18 or older
-
Willing to participate in the study
-
Able to speak and read English
-
Participated in Relationship Remix at the University of Michigan at residence halls during the Fall of 2018.
-
Enroll with your University of Michigan email.
Exclusion Criteria:
- 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)
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:
NCT03715426
Other Study ID Numbers:
- HUM00133004-A
- KL2TR000434
- KL2TR002241
- 5R49CE002099-05
First Posted:
Oct 23, 2018
Last Update Posted:
Jul 29, 2019
Last Verified:
Jul 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 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 Detail | 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 |
|---|---|---|
| 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 |
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 | 133 | 117 | 250 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
18.19
(0.617)
|
18.17
(0.460)
|
18.18
(0.548)
|
| Sex/Gender, Customized (Count of Participants) | |||
| Male |
53
39.8%
|
52
44.4%
|
105
42%
|
| Female |
75
56.4%
|
64
54.7%
|
139
55.6%
|
| Trans Female/Trans Woman |
1
0.8%
|
0
0%
|
1
0.4%
|
| Trans Male/Trans Man |
0
0%
|
0
0%
|
0
0%
|
| Genderqueer/Gender Nonconforming |
1
0.8%
|
0
0%
|
1
0.4%
|
| Different Identity |
2
1.5%
|
0
0%
|
2
0.8%
|
| Prefer Not to Disclose |
1
0.8%
|
1
0.9%
|
2
0.8%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White/Caucasian |
67
50.4%
|
65
55.6%
|
132
52.8%
|
| Black/African American |
12
9%
|
3
2.6%
|
15
6%
|
| Hispanic/Latino/Spanish |
5
3.8%
|
7
6%
|
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%
|
1
0.4%
|
| Multiple Ethnicities/Other |
8
6%
|
7
6%
|
15
6%
|
| Sexual Orientation (Count of Participants) | |||
| Heterosexual or Straight |
114
85.7%
|
103
88%
|
217
86.8%
|
| Gay or Lesbian |
3
2.3%
|
3
2.6%
|
6
2.4%
|
| Bisexual |
7
5.3%
|
8
6.8%
|
15
6%
|
| Something Else |
3
2.3%
|
2
1.7%
|
5
2%
|
| Prefer not to disclose |
6
4.5%
|
1
0.9%
|
7
2.8%
|
| Year in School (Count of Participants) | |||
| Freshman |
123
92.5%
|
111
94.9%
|
234
93.6%
|
| Sophomore |
6
4.5%
|
4
3.4%
|
10
4%
|
| Junior |
4
3%
|
2
1.7%
|
6
2.4%
|
Outcome Measures
| Title | Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale |
|---|---|
| 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 |
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 | 113 |
| Mean (Standard Deviation) [score on a scale] |
64.36
(20.86)
|
| Title | Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale |
|---|---|
| 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 |
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 | 112 |
| Mean (Standard Deviation) [score on a scale] |
62.08
(20.94)
|
| Title | Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale |
|---|---|
| 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 |
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 | 113 |
| Mean (Standard Deviation) [score on a scale] |
16.00
(2.91)
|
| Title | Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale |
|---|---|
| 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 |
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 | 112 |
| Mean (Standard Deviation) [score on a scale] |
15.94
(3.32)
|
| Title | 1-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 rate (those retained/those enrolled) will be computed based on interaction with the WebApp. |
| Time Frame | 1-Month |
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 | 133 | 117 |
| Completed 1-Month Survey |
113
85%
|
97
82.9%
|
| Did not complete 1-Month Survey |
20
15%
|
20
17.1%
|
| Title | 4-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 rate (those retained/those enrolled) will be computed based on interaction with the WebApp. |
| Time Frame | 4-Month |
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 | 133 | 117 |
| Completed 4-Month Survey |
112
84.2%
|
92
78.6%
|
| Did not complete 4-Month Survey |
21
15.8%
|
25
21.4%
|
| Title | 1-Month Sexual Victimization as Assessed by the 10-item Sexual Experiences Survey |
|---|---|
| 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 |
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 | 113 | 97 |
| Experienced |
9
6.8%
|
10
8.5%
|
| Did not experience |
103
77.4%
|
87
74.4%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
3
2.3%
|
1
0.9%
|
| Did not experience |
109
82%
|
96
82.1%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
4
3%
|
1
0.9%
|
| Did not experience |
63
47.4%
|
54
46.2%
|
| Not Applicable |
45
33.8%
|
41
35%
|
| Missing |
1
0.8%
|
1
0.9%
|
| Experienced |
1
0.8%
|
0
0%
|
| Did not experience |
111
83.5%
|
97
82.9%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
4
3%
|
3
2.6%
|
| Did not experience |
108
81.2%
|
94
80.3%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
4
3%
|
0
0%
|
| Did not experience |
63
47.4%
|
55
47%
|
| Not Applicable |
45
33.8%
|
41
35%
|
| Missing |
1
0.8%
|
1
0.9%
|
| Experienced |
1
0.8%
|
1
0.9%
|
| Did not experience |
111
83.5%
|
96
82.1%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
6
4.5%
|
1
0.9%
|
| Did not experience |
107
80.5%
|
96
82.1%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
0
0%
|
0
0%
|
| Title | 4-Months Sexual Victimization as Assessed by the 10-item Sexual Experience Survey |
|---|---|
| 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 |
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 | 112 | 92 |
| Experienced |
7
5.3%
|
9
7.7%
|
| Did not experience |
104
78.2%
|
83
70.9%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
4
3%
|
2
1.7%
|
| Did not experience |
107
80.5%
|
90
76.9%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
1
0.8%
|
3
2.6%
|
| Did not experience |
67
50.4%
|
49
41.9%
|
| Not Applicable |
43
32.3%
|
40
34.2%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
1
0.8%
|
0
0%
|
| Did not experience |
110
82.7%
|
92
78.6%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
3
2.3%
|
1
0.9%
|
| Did not experience |
108
81.2%
|
91
77.8%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
0
0%
|
1
0.9%
|
| Did not experience |
67
50.4%
|
51
43.6%
|
| Not Applicable |
43
32.3%
|
40
34.2%
|
| Missing |
2
1.5%
|
0
0%
|
| Experienced |
0
0%
|
0
0%
|
| Did not experience |
111
83.5%
|
92
78.6%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Experienced |
6
4.5%
|
1
0.9%
|
| Did not experience |
105
78.9%
|
91
77.8%
|
| Not Applicable |
0
0%
|
0
0%
|
| Missing |
1
0.8%
|
0
0%
|
| Title | 1-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey |
|---|---|
| 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 |
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 | 113 | 97 |
| Perpetrated |
4
3%
|
0
0%
|
| Did not perpetrate |
108
81.2%
|
97
82.9%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
1
0.8%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
97
82.9%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
1
0.8%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
97
82.9%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
1
0.8%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
97
82.9%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
1
0.8%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
97
82.9%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
1
0.8%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
97
82.9%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
1
0.8%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
97
82.9%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
1
0.8%
|
0
0%
|
| Did not perpetrate |
112
84.2%
|
97
82.9%
|
| Missing |
0
0%
|
0
0%
|
| Title | 4-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey |
|---|---|
| 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 |
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 | 112 | 92 |
| Perpetrated |
2
1.5%
|
1
0.9%
|
| Did not perpetrate |
109
82%
|
91
77.8%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
0
0%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
92
78.6%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
0
0%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
92
78.6%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
0
0%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
92
78.6%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
0
0%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
92
78.6%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
0
0%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
92
78.6%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
0
0%
|
0
0%
|
| Did not perpetrate |
111
83.5%
|
92
78.6%
|
| Missing |
1
0.8%
|
0
0%
|
| Perpetrated |
1
0.8%
|
0
0%
|
| Did not perpetrate |
110
82.7%
|
92
78.6%
|
| Missing |
1
0.8%
|
0
0%
|
| Title | 1-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 | 112 | 97 |
| Mean (Standard Deviation) [score on a scale] |
85.63
(12.09)
|
82.77
(12.38)
|
| Title | 4-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form |
|---|---|
| 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 |
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 | 112 | 92 |
| Mean (Standard Deviation) [score on a scale] |
84.05
(12.76)
|
79.01
(14.09)
|
| Title | Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 | 110 | 92 |
| Mean (Standard Deviation) [score on a scale] |
93.45
(10.88)
|
90.17
(11.50)
|
| Title | Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 | 110 | 92 |
| Mean (Standard Deviation) [score on a scale] |
90.72
(13.07)
|
88.33
(13.91)
|
| Title | 1-Month Consensual Sexual Activity With 2 Investigator Created Items |
|---|---|
| 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 |
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 | 113 | 97 |
| Engaged in non-consensual sexual behavior |
2
1.5%
|
1
0.9%
|
| Did not engage in non-consensual sexual behavior |
109
82%
|
96
82.1%
|
| Missing |
2
1.5%
|
0
0%
|
| Engaged in non-consensual sexual behavior |
2
1.5%
|
2
1.7%
|
| Did not engage in non-consensual sexual behavior |
111
83.5%
|
95
81.2%
|
| Missing |
0
0%
|
0
0%
|
| Title | 4-Month Consensual Sexual Activity With 2 Investigator Created Items |
|---|---|
| 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 |
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 | 112 | 92 |
| Engaged in non-consensual sexual behavior |
2
1.5%
|
2
1.7%
|
| Did not engage in non-consensual sexual behavior |
109
82%
|
90
76.9%
|
| Missing |
1
0.8%
|
0
0%
|
| Engaged in non-consensual sexual behavior |
1
0.8%
|
1
0.9%
|
| Did not engage in non-consensual sexual behavior |
110
82.7%
|
91
77.8%
|
| Missing |
1
0.8%
|
0
0%
|
| Title | 1-Month Universal Violence Prevention Screening Protocol |
|---|---|
| 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 |
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 | 113 | 97 |
| No |
74
55.6%
|
71
60.7%
|
| Yes |
39
29.3%
|
26
22.2%
|
| Not Asked |
0
0%
|
0
0%
|
| Missing |
0
0%
|
0
0%
|
| No |
37
27.8%
|
23
19.7%
|
| Yes |
1
0.8%
|
3
2.6%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
37
27.8%
|
25
21.4%
|
| Yes |
1
0.8%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
38
28.6%
|
25
21.4%
|
| Yes |
0
0%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
38
28.6%
|
25
21.4%
|
| Yes |
0
0%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
37
27.8%
|
25
21.4%
|
| Yes |
1
0.8%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
37
27.8%
|
25
21.4%
|
| Yes |
1
0.8%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
38
28.6%
|
25
21.4%
|
| Yes |
0
0%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
38
28.6%
|
25
21.4%
|
| Yes |
0
0%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
38
28.6%
|
25
21.4%
|
| Yes |
0
0%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
36
27.1%
|
25
21.4%
|
| Yes |
2
1.5%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
37
27.8%
|
25
21.4%
|
| Yes |
1
0.8%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| No |
38
28.6%
|
25
21.4%
|
| Yes |
0
0%
|
1
0.9%
|
| Not Asked |
74
55.6%
|
71
60.7%
|
| Missing |
1
0.8%
|
0
0%
|
| Title | 4-Month Universal Violence Prevention Screening Protocol |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 | 112 | 92 |
| No |
71
53.4%
|
69
59%
|
| Yes |
41
30.8%
|
23
19.7%
|
| Not Asked |
0
0%
|
0
0%
|
| No |
38
28.6%
|
23
19.7%
|
| Yes |
3
2.3%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
37
27.8%
|
23
19.7%
|
| Yes |
4
3%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
41
30.8%
|
23
19.7%
|
| Yes |
0
0%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
41
30.8%
|
23
19.7%
|
| Yes |
0
0%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
39
29.3%
|
23
19.7%
|
| Yes |
2
1.5%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
39
29.3%
|
23
19.7%
|
| Yes |
2
1.5%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
37
27.8%
|
23
19.7%
|
| Yes |
4
3%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
41
30.8%
|
23
19.7%
|
| Yes |
0
0%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
40
30.1%
|
23
19.7%
|
| Yes |
1
0.8%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
40
30.1%
|
23
19.7%
|
| Yes |
1
0.8%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
40
30.1%
|
23
19.7%
|
| Yes |
1
0.8%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| No |
40
30.1%
|
23
19.7%
|
| Yes |
1
0.8%
|
0
0%
|
| Not Asked |
71
53.4%
|
69
59%
|
| Title | 1-Month Intimate Partner Violence Attitude Scale |
|---|---|
| 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 |
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 | 113 | 97 |
| Mean (Standard Deviation) [score on a scale] |
26.80
(9.05)
|
28.81
(9.72)
|
| Title | 4-Month Intimate Partner Violence Attitude Scale |
|---|---|
| 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 |
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 | 112 | 92 |
| Mean (Standard Deviation) [score on a scale] |
27.70
(9.52)
|
28.60
(10.43)
|
Adverse Events
| 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 | ||
| 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 | 0/133 (0%) | 0/117 (0%) | ||
Serious Adverse Events |
||||
| MKit WebApp Intervention | Standard of Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/133 (0%) | 0/117 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| MKit WebApp Intervention | Standard of Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/133 (0%) | 0/117 (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 |
| mlmunro@umich.edu |
Responsible Party:
Michelle Munro-Kramer,
Assistant Professor,
University of Michigan
ClinicalTrials.gov Identifier:
NCT03715426
Other Study ID Numbers:
- HUM00133004-A
- KL2TR000434
- KL2TR002241
- 5R49CE002099-05
First Posted:
Oct 23, 2018
Last Update Posted:
Jul 29, 2019
Last Verified:
Jul 1, 2019