A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
9 maggio 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
261
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intervento MKit WebApp
Il braccio di intervento riceverà il consueto pacchetto di formazione standard per gli studenti in arrivo presso l'Università del Michigan che include: 1) Haven, un modulo online sulle relazioni sane e la violenza sessuale completato prima di entrare nel campus; 2) Relationship Remix, un programma interattivo distribuito tra pari su relazioni sane e violenza sessuale; e 3) Change it Up, uno spettacolo teatrale educativo di intervento dello spettatore fornito da attori studenti.
Inoltre, riceveranno l'accesso alla MKit WebApp, che darà loro accesso a contenuti, definizione degli obiettivi e risorse per 14 aree tematiche.
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MKit è un'applicazione basata sul Web che utilizza un approccio basato sulle abilità della vita per affrontare relazioni sane e violenza sessuale.
Include 14 tessere che incorporano informazioni, impostazione degli obiettivi e risorse.
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Nessun intervento: Standard di sicurezza
Il braccio di controllo riceverà il consueto pacchetto di formazione standard per gli studenti in arrivo presso l'Università del Michigan che include: 1) Haven, un modulo online sulle relazioni sane e la violenza sessuale completato prima di entrare nel campus; 2) Relationship Remix, un programma interattivo distribuito tra pari su relazioni sane e violenza sessuale; e 3) Change it Up, uno spettacolo teatrale educativo di intervento dello spettatore fornito da attori studenti.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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3-Month Usability
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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3-Month Retention
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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3-Month Sexual Violence Victimization
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 3-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 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
|
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5-Month Sexual Violence Perpetration
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 5-months
|
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
Lasso di tempo: 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
Lasso di tempo: 5-months
|
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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Michelle L Munro-Kramer, PhD,CNM,FNP, University of Michigan
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
22 ottobre 2017
Completamento primario (Effettivo)
28 aprile 2018
Completamento dello studio (Effettivo)
28 aprile 2018
Date di iscrizione allo studio
Primo inviato
17 ottobre 2017
Primo inviato che soddisfa i criteri di controllo qualità
17 ottobre 2017
Primo Inserito (Effettivo)
23 ottobre 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 maggio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 maggio 2019
Ultimo verificato
1 maggio 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HUM00133004
- KL2TR000434 (Sovvenzione/contratto NIH degli Stati Uniti)
- KL2TR002241 (Sovvenzione/contratto NIH degli Stati Uniti)
- CSA-16-17 (Altro identificatore: Michigan Department of State Police, Grants and Community Services Division)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su MKit
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University of MichiganNational Institutes of Health (NIH)CompletatoViolenza sessuale | Prevenzione primariaStati Uniti