Clinical trial NCT03316911: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
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)
name: Michigan Department of State Police
First posted: 2017-10-23
Enrollment: 261
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.


Eligibility criteria: Inclusion Criteria:

1. Currently enrolled as a student at the participating university (University of Michigan)
2. Age 18 or older
3. Willing to participate in the study
4. Able to speak and read English
5. Participated in Relationship Remix at Alice Lloyd Hall or Mosher-Jordan Hall during the Fall of 2017. These residence halls were selected due to their similar sizes and demographic populations to allow for "approximate matching" between the control and intervention group.

Exclusion Criteria:

1. Did not complete the Relationship Remix session

Primary outcomes:
measure: 3-Month Usability
timeFrame: 3-months
measure: 5-Month Usability
timeFrame: 5-months
measure: 3-Month Acceptability
timeFrame: 3-months
measure: 5-Month Acceptability
timeFrame: 5-months
Secondary outcomes:
measure: 3-Month Retention
timeFrame: 3-months
measure: 5-Month Retention
timeFrame: 5-months
Other outcomes:
measure: 3-Month Sexual Violence Victimization
timeFrame: 3-months
measure: 5-Month Sexual Violence Victimization
timeFrame: 5-months
measure: 3-Month Sexual Violence Perpetration
timeFrame: 3-months
measure: 5-Month Sexual Violence Perpetration
timeFrame: 5-months
measure: 3-Month Sexual Violence Knowledge
timeFrame: 3-months
measure: 5-Month Sexual Violence Knowledge
timeFrame: 5-months
measure: 3-Month Sexual Relationship Power
timeFrame: 3-months
measure: 5-Month Sexual Relationship Power
timeFrame: 5-months
measure: 3-Month Rape Myth Acceptance
timeFrame: 3-months
measure: 5-Month Rape Myth Acceptance
timeFrame: 5-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: