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- Essai clinique NCT03316911
A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
9 mai 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
261
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Intervention sur l'application Web MKit
Le bras d'intervention recevra le programme de formation habituel sur les normes de soins pour les étudiants entrants à l'Université du Michigan, qui comprend : 1) Haven, un module en ligne sur les relations saines et la violence sexuelle complété avant de venir sur le campus ; 2) Relationship Remix, un programme interactif offert par des pairs sur les relations saines et la violence sexuelle; et 3) Change it Up, une représentation théâtrale éducative d'intervention de spectateurs présentée par des acteurs étudiants.
De plus, ils auront accès à l'application Web MKit, qui leur donnera accès au contenu, à la définition d'objectifs et aux ressources pour 14 domaines thématiques.
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MKit est une application Web qui utilise une approche axée sur les compétences de vie pour aborder les relations saines et la violence sexuelle.
Il comprend 14 tuiles qui intègrent des informations, la définition d'objectifs et des ressources.
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Aucune intervention: Norme de soins
Le bras de contrôle recevra le programme de formation habituel sur les normes de soins pour les étudiants entrants à l'Université du Michigan, qui comprend : 1) Haven, un module en ligne sur les relations saines et la violence sexuelle complété avant de venir sur le campus ; 2) Relationship Remix, un programme interactif offert par des pairs sur les relations saines et la violence sexuelle; et 3) Change it Up, une représentation théâtrale éducative d'intervention de spectateurs présentée par des acteurs étudiants.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
3-Month Usability
Délai: 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.
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3-months
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5-Month Usability
Délai: 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.
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5-months
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3-Month Acceptability
Délai: 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.
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3-months
|
5-Month Acceptability
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
3-Month Retention
Délai: 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.
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3-months
|
5-Month Retention
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
3-Month Sexual Violence Victimization
Délai: 3-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 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
Délai: 5-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 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
Délai: 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
|
5-Month Sexual Violence Perpetration
Délai: 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
|
3-Month Sexual Violence Knowledge
Délai: 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
|
5-Month Sexual Violence Knowledge
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 5-months
|
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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Michelle L Munro-Kramer, PhD,CNM,FNP, University of Michigan
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
22 octobre 2017
Achèvement primaire (Réel)
28 avril 2018
Achèvement de l'étude (Réel)
28 avril 2018
Dates d'inscription aux études
Première soumission
17 octobre 2017
Première soumission répondant aux critères de contrôle qualité
17 octobre 2017
Première publication (Réel)
23 octobre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 mai 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 mai 2019
Dernière vérification
1 mai 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HUM00133004
- KL2TR000434 (Subvention/contrat des NIH des États-Unis)
- KL2TR002241 (Subvention/contrat des NIH des États-Unis)
- CSA-16-17 (Autre identifiant: Michigan Department of State Police, Grants and Community Services Division)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur MKit
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University of MichiganNational Institutes of Health (NIH)ComplétéViolence sexuelle | Prévention primaireÉtats-Unis