A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
9 мая 2019 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
261
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- University of Michigan
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Вмешательство MKit в веб-приложение
Подразделение по вмешательству получит стандартный пакет обучения по уходу для поступающих в Мичиганский университет студентов, который включает: 1) Haven, онлайн-модуль о здоровых отношениях и сексуальном насилии, завершенный до прибытия в кампус; 2) «Relationship Remix» — интерактивная программа для равных, посвященная здоровым отношениям и сексуальному насилию; и 3) Change it Up, образовательный театральный спектакль с участием свидетелей, поставленный студентами-актёрами.
Кроме того, они получат доступ к MKit WebApp, что даст им доступ к контенту, постановке целей и ресурсам для 14 тематических областей.
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MKit — это веб-приложение, которое использует подход, основанный на жизненных навыках, для решения проблемы здоровых отношений и сексуального насилия.
Он включает в себя 14 плиток, которые содержат информацию, постановку целей и ресурсы.
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Без вмешательства: Стандарт заботы
Контрольная группа получит стандартный пакет обучения по уходу для поступающих в Мичиганский университет студентов, который включает: 1) Haven, онлайн-модуль о здоровых отношениях и сексуальном насилии, завершенный до прибытия в кампус; 2) «Relationship Remix» — интерактивная программа для равных, посвященная здоровым отношениям и сексуальному насилию; и 3) Change it Up, образовательный театральный спектакль с участием свидетелей, поставленный студентами-актёрами.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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3-Month Usability
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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3-Month Retention
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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3-Month Sexual Violence Victimization
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Michelle L Munro-Kramer, PhD,CNM,FNP, University of Michigan
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
22 октября 2017 г.
Первичное завершение (Действительный)
28 апреля 2018 г.
Завершение исследования (Действительный)
28 апреля 2018 г.
Даты регистрации исследования
Первый отправленный
17 октября 2017 г.
Впервые представлено, что соответствует критериям контроля качества
17 октября 2017 г.
Первый опубликованный (Действительный)
23 октября 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
10 мая 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 мая 2019 г.
Последняя проверка
1 мая 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- HUM00133004
- KL2TR000434 (Грант/контракт NIH США)
- KL2TR002241 (Грант/контракт NIH США)
- CSA-16-17 (Другой идентификатор: Michigan Department of State Police, Grants and Community Services Division)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .