Clinical trial NCT03715426: Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
Official title: MKit: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Violence
Primary Prevention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-10-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale
timeFrame: 1-month
measure: Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale
timeFrame: 4-Months
measure: Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale
timeFrame: 1-Month
measure: Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale
timeFrame: 4-Months
Secondary outcomes:
measure: 1-Month Retention
timeFrame: 1-Month
measure: 4-Month Retention
timeFrame: 4-Month
Other outcomes:
measure: 1-Month Sexual Victimization as Assessed by the 10-item Sexual Experiences Survey
timeFrame: 1-Month
measure: 4-Months Sexual Victimization as Assessed by the 10-item Sexual Experience Survey
timeFrame: 4-Months
measure: 1-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey
timeFrame: 1-Month
measure: 4-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey
timeFrame: 4-Months
measure: 1-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form
timeFrame: 1-Month
measure: 4-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form
timeFrame: 4-Months
measure: Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items
timeFrame: 1-Month
measure: Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items
timeFrame: 4-Months
measure: 1-Month Consensual Sexual Activity With 2 Investigator Created Items
timeFrame: 1-Month
measure: 4-Month Consensual Sexual Activity With 2 Investigator Created Items
timeFrame: 4-Months
measure: 1-Month Universal Violence Prevention Screening Protocol
timeFrame: 1-Month
measure: 4-Month Universal Violence Prevention Screening Protocol
timeFrame: 4-Month
measure: 1-Month Intimate Partner Violence Attitude Scale
timeFrame: 1-Month
measure: 4-Month Intimate Partner Violence Attitude Scale
timeFrame: 4-Months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michelle L Munro-Kramer, PhD,CNM,FNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Heron SL, Thompson MP, Jackson E, Kaslow NJ. Do responses to an intimate partner violence screen predict scores on a comprehensive measure of intimate partner violence in low-income black women? Ann Emerg Med. 2003 Oct;42(4):483-91. doi: 10.1067/s0196-0644(03)00718-2.
citation: 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.
citation: 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
citation: 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