Primary Prevention Clinical Trial
— MKitOfficial title:
MKit: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
Verified date | May 2019 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 261 |
Est. completion date | April 28, 2018 |
Est. primary completion date | April 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Michigan Department of State Police, National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 3-Month Sexual Violence Victimization | 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 (Koss et al., 2007) 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 3 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-months | |
Other | 5-Month Sexual Violence Victimization | 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 (Koss et al., 2007) 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. | 5-months | |
Other | 3-Month Sexual Violence Perpetration | 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 (Koss et al., 2007) 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 3 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. | 3-months | |
Other | 5-Month Sexual Violence Perpetration | 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 (Koss et al., 2007) 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 5 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-months | |
Other | 3-Month Sexual Violence Knowledge | An 8-item (investigator created) scale will be used to measure participants' sexual violence knowledge at 3-months. The investigator-created sexual violence knowledge questions are scored from 1 (Strongly Agree) to 5 (Strongly Disagree) and the scores will be reverse-coded and summed for a total sexual violence knowledge score ranging from 8 - 40, with higher scores indicating more sexual violence knowledge. | 3-months | |
Other | 5-Month Sexual Violence Knowledge | An 8-item (investigator created) scale will be used to measure participants' sexual violence knowledge at 5-months. The investigator-created sexual violence knowledge questions are scored from 1 (Strongly Agree) to 5 (Strongly Disagree) and the scores will be reverse-coded and summed for a total sexual violence knowledge score ranging from 8 - 40, with higher scores indicating more sexual violence knowledge. | 5-months | |
Other | 3-Month Sexual Relationship Power | Fifteen items from the Relationship Control sub-scale of the Sexual Relationship Power Scale will be used to measure power dynamics within participants' sexual relationships at 3-months. The Relationship Control Sub-scale Items (Pulerwitz, Gortmaker, & DeJong, 2000) are scored from 1 (Strongly Agree) to 4 (Strongly Disagree). Scores are summed with total scores ranging from 15-60. Higher scores represent higher sexual relationship power. | 3-months | |
Other | 5-Month Sexual Relationship Power | Fifteen items from the Relationship Control sub-scale of the Sexual Relationship Power Scale will be used to measure power dynamics within participants' sexual relationships at 5-months. The Relationship Control Sub-scale Items (Pulerwitz, Gortmaker, & DeJong, 2000) are scored from 1 (Strongly Agree) to 4 (Strongly Disagree). Scores are summed with total scores ranging from 15-60. Higher scores represent higher sexual relationship power. | 5-months | |
Other | 3-Month Rape Myth Acceptance | The 22-item modified Illinois Rape Myth Acceptance scale will be used to measure attitudes endorsing rape myths at 3-months. The modified Illinois Rape Myth Acceptance Scale (McMahon & Farmer, 2011) is scored from 1 (Strongly Agree) to 5 (Strongly Disagree). It includes four sub-scales (She asked for it, He didn't mean to, It wasn't really rape, and She lied). The items in each sub-scale can be summed for a total score and the scores for the entire scale can be summed for a cumulative score. Scores on the full scale range from 22-110. Scores on the She Asked For It and He Didn't Mean To sub-scales range from 6-30. Scores on the It Wasn't Really Rape and the She Lied sub-scales range from 5-25. Higher scores indicate greater rejection of rape myths. | 3-months | |
Other | 5-Month Rape Myth Acceptance | The 22-item modified Illinois Rape Myth Acceptance scale will be used to measure attitudes endorsing rape myths at 5-months. The modified Illinois Rape Myth Acceptance Scale (McMahon & Farmer, 2011) is scored from 1 (Strongly Agree) to 5 (Strongly Disagree). It includes four sub-scales (She asked for it, He didn't mean to, It wasn't really rape, and She lied). The items in each sub-scale can be summed for a total score and the scores for the entire scale can be summed for a cumulative score. Scores on the full scale range from 22-110. Scores on the She Asked For It and He Didn't Mean To sub-scales range from 6-30. Scores on the It Wasn't Really Rape and the She Lied sub-scales range from 5-25. Higher scores indicate greater rejection of rape myths. | 5-months | |
Primary | 3-Month Usability | 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-months | |
Primary | 5-Month Usability | 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-months | |
Primary | 3-Month Acceptability | 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-months | |
Primary | 5-Month Acceptability | 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. | 5-months | |
Secondary | 3-Month Retention | 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-months | |
Secondary | 5-Month Retention | 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. | 5-months |
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