A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
2019년 5월 9일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
261
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: MKit 웹앱 개입
개입 부문은 다음을 포함하는 University of Michigan의 신입생을 위한 일반적인 표준 치료 교육 패키지를 받게 됩니다. 1) Haven, 캠퍼스에 오기 전에 완료된 건강한 관계 및 성폭력에 관한 온라인 모듈; 2) Relationship Remix, 건강한 관계 및 성폭력에 대한 상호작용 동료 제공 프로그램; 3) Change it Up, 학생 배우가 제공하는 방관자 개입 교육 연극 공연.
또한 그들은 14개 주제 영역에 대한 콘텐츠, 목표 설정 및 리소스에 대한 액세스를 제공하는 MKit WebApp에 액세스할 수 있습니다.
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MKit은 건강한 관계와 성폭력을 다루기 위해 생명 기술 접근 방식을 사용하는 웹 기반 애플리케이션입니다.
여기에는 정보, 목표 설정 및 리소스가 포함된 14개의 타일이 포함되어 있습니다.
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간섭 없음: 치료의 표준
컨트롤 암은 다음을 포함하는 University of Michigan의 신입생을 위한 일반적인 관리 교육 패키지를 받게 됩니다. 1) Haven, 캠퍼스에 오기 전에 완료된 건강한 관계 및 성폭력에 관한 온라인 모듈; 2) Relationship Remix, 건강한 관계 및 성폭력에 대한 상호작용 동료 제공 프로그램; 3) Change it Up, 학생 배우가 제공하는 방관자 개입 교육 연극 공연.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-Month Usability
기간: 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
기간: 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
기간: 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
기간: 5-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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5-months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-Month Retention
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-Month Sexual Violence Victimization
기간: 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
기간: 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
기간: 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
기간: 5-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 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michelle L Munro-Kramer, PhD,CNM,FNP, University of Michigan
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 10월 22일
기본 완료 (실제)
2018년 4월 28일
연구 완료 (실제)
2018년 4월 28일
연구 등록 날짜
최초 제출
2017년 10월 17일
QC 기준을 충족하는 최초 제출
2017년 10월 17일
처음 게시됨 (실제)
2017년 10월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 5월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 5월 9일
마지막으로 확인됨
2019년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HUM00133004
- KL2TR000434 (미국 NIH 보조금/계약)
- KL2TR002241 (미국 NIH 보조금/계약)
- CSA-16-17 (기타 식별자: Michigan Department of State Police, Grants and Community Services Division)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
MKit에 대한 임상 시험
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University of MichiganNational Institutes of Health (NIH)완전한