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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Michelle Munro-Kramer, University of Michigan

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 23, 2018
Results First Submitted Date  ICMJE June 24, 2019
Results First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE October 21, 2018
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Usability of the MKit WebApp [ 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 (Brook, 1996), 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.
  • Usability of the MKit WebApp [ Time Frame: 5-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 (Brook, 1996), 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.
  • Acceptability of the MKit WebApp [ Time Frame: 1-Month ]
    Acceptability of the MKit WebApp will be measured using a 5-item System Acceptability Scale created by the investigator. Participants in the experimental group will complete a System Acceptability Scale, which is a 5 item questionnaire regarding participants use of the MKit WebApp with four items that are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and one item that assess the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). Each item will be evaluated individually and no total score will be computed.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 one item assess the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). Each item will be evaluated individually and no total score will be computed.
  • Acceptability of the MKit WebApp [ Time Frame: 5-Months ]
    Acceptability of the MKit WebApp will be measured using a 5-item System Acceptability Scale created by the investigator. Participants in the experimental group will complete a System Acceptability Scale, which is a 5 item questionnaire regarding participants use of the MKit WebApp with four items that are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and one item that assess the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). Each item will be evaluated individually and no total score will be computed.
Change History Complete list of historical versions of study NCT03715426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • 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.
  • 5-Months Retention [ Time Frame: 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 rate (those retained/those enrolled) will be computed based on interaction with the WebApp.
Current Other Pre-specified Outcome Measures
 (submitted: July 15, 2019)
  • 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.
  • 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.
  • 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-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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: October 18, 2018)
  • 1-Month Sexual Victimization [ 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 (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 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.
  • 5-Months Sexual Victimization [ Time Frame: 5-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 (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.
  • 1-Month Sexual Violence Perpetration [ 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 (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 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.
  • 5-Month Sexual Violence Perpetration [ Time Frame: 5-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 (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.
  • 1-Month Sexual and Intimate Partner Violence Knowledge Questions [ Time Frame: 1-Month ]
    Twenty knowledge questions about sexual and intimate partner violence adapted from teh Texas Education Program Participant Response Form; https://www.wcasa.org/file_open.php?id=787) 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).
  • 5-Month Sexual and Intimate Partner Violence Knowledge Questions [ Time Frame: 5-Months ]
    Twenty knowledge questions about sexual and intimate partner violence adapted from teh Texas Education Program Participant Response Form; https://www.wcasa.org/file_open.php?id=787) 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).
  • Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence [ 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).
  • Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence [ Time Frame: 5-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).
  • 1-Month Consensual Sexual Activity [ 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 penetration 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. Each item will be evaluated individually and no total score will be computed.
  • 5-Month Consensual Sexual Activity [ Time Frame: 5-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 penetration 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. Each item will be evaluated individually and no total score will be computed.
  • 1-Month Universal Violence Prevention Screening Protocol [ Time Frame: 1-Month ]
    Thirteen yes/no questions from the Universal Violence Prevention Screening Protocol (Heron, Thompson, Jackson, & Kaslow, 2003) 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.
  • 5-Month Universal Violence Prevention Screening Protocol [ Time Frame: 5-Month ]
    Thirteen yes/no questions from the Universal Violence Prevention Screening Protocol -(Heron, Thompson, Jackson, & Kaslow, 2003) will be used to assess for personal experiences of intimate partner violence with the last 5 months. Each item will be evaluated individually and no total score will be computed.
  • 1-Month Intimate Partner Violence Attitude Scale [ Time Frame: 1-Month ]
    Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised (Finchman, Cuit, Braithwaite, & Pasley, 2008) 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.
  • 5-Month Intimate Partner Violence Attitude Scale [ Time Frame: 5-Months ]
    Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised (Finchman, Cuit, Braithwaite, & Pasley, 2008) 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.
 
Descriptive Information
Brief Title  ICMJE Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
Official Title  ICMJE MKit: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Sexual Violence
  • Primary Prevention
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: MKit
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2019)
250
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
300
Actual Study Completion Date  ICMJE April 18, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03715426
Other Study ID Numbers  ICMJE HUM00133004-A
KL2TR000434 ( U.S. NIH Grant/Contract )
KL2TR002241 ( U.S. NIH Grant/Contract )
5R49CE002099-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michelle Munro-Kramer, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Michelle L Munro-Kramer, PhD,CNM,FNP University of Michigan
PRS Account University of Michigan
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP