A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
9. Mai 2019 aktualisiert von: Michelle Munro-Kramer, University of Michigan
MKit: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
261
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- University of Michigan
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: MKit WebApp-Intervention
Der Interventionsarm erhält das übliche Behandlungsstandard-Schulungspaket für ankommende Studenten an der University of Michigan, das Folgendes umfasst: 1) Haven, ein Online-Modul über gesunde Beziehungen und sexuelle Gewalt, das abgeschlossen wird, bevor es auf den Campus kommt; 2) Relationship Remix, ein interaktives, von Gleichaltrigen bereitgestelltes Programm über gesunde Beziehungen und sexuelle Gewalt; und 3) Change it Up, eine Zuschauer-Interventions-Theateraufführung, die von studentischen Schauspielern aufgeführt wird.
Darüber hinaus erhalten sie Zugriff auf die MKit WebApp, die ihnen Zugriff auf Inhalte, Zielsetzungen und Ressourcen für 14 Themenbereiche bietet.
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MKit ist eine webbasierte Anwendung, die einen Life-Skills-Ansatz verwendet, um gesunde Beziehungen und sexuelle Gewalt anzugehen.
Es enthält 14 Kacheln, die Informationen, Zielsetzungen und Ressourcen enthalten.
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Kein Eingriff: Pflegestandard
Der Kontrollarm erhält das übliche Standard-Schulungspaket für ankommende Studenten an der University of Michigan, das Folgendes umfasst: 1) Haven, ein Online-Modul über gesunde Beziehungen und sexuelle Gewalt, das abgeschlossen wird, bevor er auf den Campus kommt; 2) Relationship Remix, ein interaktives, von Gleichaltrigen bereitgestelltes Programm über gesunde Beziehungen und sexuelle Gewalt; und 3) Change it Up, eine Zuschauer-Interventions-Theateraufführung, die von studentischen Schauspielern aufgeführt wird.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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3-Month Usability
Zeitfenster: 3-months
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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.
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3-months
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5-Month Usability
Zeitfenster: 5-months
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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.
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5-months
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3-Month Acceptability
Zeitfenster: 3-months
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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.
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3-months
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5-Month Acceptability
Zeitfenster: 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.
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5-months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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3-Month Retention
Zeitfenster: 3-months
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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.
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3-months
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5-Month Retention
Zeitfenster: 5-months
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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.
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5-months
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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3-Month Sexual Violence Victimization
Zeitfenster: 3-months
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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.
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3-months
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5-Month Sexual Violence Victimization
Zeitfenster: 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.
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5-months
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3-Month Sexual Violence Perpetration
Zeitfenster: 3-months
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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.
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3-months
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5-Month Sexual Violence Perpetration
Zeitfenster: 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.
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5-months
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3-Month Sexual Violence Knowledge
Zeitfenster: 3-months
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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.
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3-months
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5-Month Sexual Violence Knowledge
Zeitfenster: 5-months
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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.
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5-months
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3-Month Sexual Relationship Power
Zeitfenster: 3-months
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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.
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3-months
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5-Month Sexual Relationship Power
Zeitfenster: 5-months
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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.
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5-months
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3-Month Rape Myth Acceptance
Zeitfenster: 3-months
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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.
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3-months
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5-Month Rape Myth Acceptance
Zeitfenster: 5-months
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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.
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5-months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Michelle L Munro-Kramer, PhD,CNM,FNP, University of Michigan
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
22. Oktober 2017
Primärer Abschluss (Tatsächlich)
28. April 2018
Studienabschluss (Tatsächlich)
28. April 2018
Studienanmeldedaten
Zuerst eingereicht
17. Oktober 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. Oktober 2017
Zuerst gepostet (Tatsächlich)
23. Oktober 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. Mai 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Mai 2019
Zuletzt verifiziert
1. Mai 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- HUM00133004
- KL2TR000434 (US NIH Stipendium/Vertrag)
- KL2TR002241 (US NIH Stipendium/Vertrag)
- CSA-16-17 (Andere Kennung: Michigan Department of State Police, Grants and Community Services Division)
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Klinische Studien zur MKit
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University of MichiganNational Institutes of Health (NIH)AbgeschlossenSexuelle Gewalt | PrimärpräventionVereinigte Staaten