A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College

Not Applicable

Completed

• Conditions: Primary Prevention; Sexual Violence
• Interventions: Behavioral: MKit

• Registration Number: NCT03316911
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Study Start: 2017-10-22
• Study First Posted: 2017-10-23
• Primary Completion: 2018-04-28
• Study Completion: 2018-04-28
• Results First Submitted: 2019-04-11
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-09
• Last Update Submitted: 2019-05-09
• Results First Posted: 2019-05-10
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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.

Read More

Exclusion Criteria

1. Did not complete the Relationship Remix session

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MKit WebApp Intervention	MKit	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.

Primary Outcome Measures

Name	Time	Method
5-Month Usability	5-months	The 10-item System Usability Scale will be used to evaluate the usability of WebApp in the intervention group only. The System Usability Scale (Brook, 1996) includes 10 items that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree). To get a final score the: 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.
5-Month Acceptability	5-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 assess 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.
3-Month Usability	3-months	The 10-item System Usability Scale will be used to evaluate the usability of WebApp in the intervention group only. The System Usability Scale (Brook, 1996) includes 10 items that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree). To get a final score the: 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.
3-Month Acceptability	3-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 assess 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

Name	Time	Method
5-Month Retention	5-months	The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention score (those retained/those enrolled) will be computed based on interaction with the WebApp.
3-Month Retention	3-months	The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention score (those retained/those enrolled) will be computed based on interaction with the WebApp.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States