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

• 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: University of Michigan
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Michelle Munro-Kramer, University of Michigan

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
Sexual Violence; Primary Prevention	Behavioral: MKit	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: October 21, 2018
• Actual Primary Completion Date: April 1, 2019
• Actual Study Completion Date: April 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 :

1. Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale [ Time Frame: 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.
2. Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale [ Time Frame: 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.
3. Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale [ Time Frame: 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.
4. Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale [ Time Frame: 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. 1-Month Retention [ Time Frame: 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.
2. 4-Month Retention [ Time Frame: 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. 1-Month Sexual Victimization as Assessed by the 10-item Sexual Experiences Survey [ Time Frame: 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.
2. 4-Months Sexual Victimization as Assessed by the 10-item Sexual Experience Survey [ Time Frame: 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.
3. 1-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey [ Time Frame: 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. 4-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey [ Time Frame: 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.
5. 1-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form [ Time Frame: 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).
6. 4-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form [ Time Frame: 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).
7. Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items [ Time Frame: 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).
8. Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items [ Time Frame: 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).
9. 1-Month Consensual Sexual Activity With 2 Investigator Created Items [ Time Frame: 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.
10. 4-Month Consensual Sexual Activity With 2 Investigator Created Items [ Time Frame: 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.
11. 1-Month Universal Violence Prevention Screening Protocol [ Time Frame: 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.
12. 4-Month Universal Violence Prevention Screening Protocol [ Time Frame: 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.
13. 1-Month Intimate Partner Violence Attitude Scale [ Time Frame: 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.
14. 4-Month Intimate Partner Violence Attitude Scale [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

United States, Michigan

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)

Documents provided by Michelle Munro-Kramer, University of Michigan:

Study Protocol and Statistical Analysis Plan  [PDF] August 24, 2018

More Information

Publications of Results:

Fincham FD, Cui M, Braithwaite S, Pasley K. Attitudes toward intimate partner violence in dating relationships. Psychol Assess. 2008 Sep;20(3):260-9. doi: 10.1037/1040-3590.20.3.260.

Heron SL, Thompson MP, Jackson E, Kaslow NJ. Do responses to an intimate partner violence screen predict scores on a comprehensive measure of intimate partner violence in low-income black women? Ann Emerg Med. 2003 Oct;42(4):483-91.

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

• Responsible Party: Michelle Munro-Kramer, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT03715426
• 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 Posted: October 23, 2018
• Results First Posted: July 16, 2019
• Last Update Posted: July 29, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No