Sexual ViolenceNCT03715426

Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)

A study testing MKit in people with Sexual Violence and Primary Prevention, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Sexual Violence, Primary Prevention
What is being tested?: MKit
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 1 siteUnited States
Study dates: 21 Oct 2018to 18 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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 the University of Michigan at residence halls during the Fall of 2018.
Enroll with your University of Michigan email.

Who cannot join

Did not complete the Relationship Remix session.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: 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. This is a repeat pilot test to evaluate changes implemented to the WebApp after the initial pilot during the 2017-2018 academic year.

Conditions: Sexual Violence, Primary Prevention
Being tested: MKit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MKitBehavioural
MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources.

Study groups in NCT03715426
Study group	Role	What they receive
MKit WebApp Intervention	Experimental	The intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas. Receives: Behavioral: MKit
Standard of Care	No intervention	The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.

What is being measured

The primary outcome is the main question the study is designed to answer.

Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale
Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 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 for perceived usability.
Measured: 1-month
Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale
Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 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 for perceived usability.
Measured: 4-Months
Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale
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 assesses 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.
Measured: 1-Month
Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale
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 assesses 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.
Measured: 4-Months

Secondary outcomes (2)

1-Month Retention
The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp.
Measured: 1-Month
4-Month Retention
The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp.
Measured: 4-Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 201818 Apr 2019

First posted23 Oct 2018
Study start21 Oct 2018
Primary completion1 Apr 2019
Study completion18 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Sexual ViolenceStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03715426
Sponsor's protocol ID: HUM00133004-A
Other IDs: KL2TR000434, KL2TR002241, 5R49CE002099-05
Status last verified: Jul 2019
First submitted: 17 Oct 2018
Last updated: 29 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fincham FD, Cui M, Braithwaite S, Pasley K. Attitudes toward intimate partner violence in dating relationships. Psychol Assess. 2008 Sep;20(3):260-9. doi: 10.1037/1040-3590.20.3.260.
PubMed 18778162
Heron SL, Thompson MP, Jackson E, Kaslow NJ. Do responses to an intimate partner violence screen predict scores on a comprehensive measure of intimate partner violence in low-income black women? Ann Emerg Med. 2003 Oct;42(4):483-91. doi: 10.1067/s0196-0644(03)00718-2.
PubMed 14520319
Brook J. SUS - A quick and dirty usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, McClelland (Eds.). Usability evaluation in industry. London: Taylor & Francis; 1996:189-194.
Koss MP, Abbey A, Campbell R, Cook S, Norris J, Testa C, Ullman S, West C, White J. Revising the SES: A collaborative process to improve assessment of sexual aggression and victimization. Psychology Women Quarterly 31:357-370, 2007. doi:10.13072/midss.279
Busch NB. Outcome measures for sexual assault services in Texas. The University of Texas at Austin; 2003. Retrieved from https://s3.us-east-2.amazonaws.com/wcasa/old-website-resources/Evaluation-Selecting%2BIndicators-Measure%2BDatabase%2B15.%2BOutcome_Measures_Texas%2BManual.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Enrolling by invitation
The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
Acute Stress Symptoms, Sexual Violence
Recruiting
Centering Gender Affirming Resources in Higher Education
Sexual Violence, Drinking Heavy
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)

All Sexual Violence trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MKit: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
ClinicalTrials.gov ID: NCT03715426
Acronym / sponsor ID: HUM00133004-A
Conditions: Sexual Violence, Primary Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 21 Oct 2018 (actual)
Primary completion: 1 Apr 2019 (actual)
Study completion: 18 Apr 2019 (actual)
First posted: 23 Oct 2018 (actual)
Results: Posted 16 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MKit WebApp Intervention	Experimental	Behavioral: MKitThe intervention arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors. In addition, they will receive access the MKit WebApp, which will give them access to content, goal setting, and resources for 14 topic areas.
Standard of Care	No intervention	–The control arm will receive the usual standard of care training package for incoming students at the University of Michigan which includes: 1) Haven, an online module about healthy relationships and sexual violence completed before coming to campus; 2) Relationship Remix, an interactive peer-delivered program on healthy relationships and sexual violence; and 3) Change it Up, a bystander intervention educational theater performance delivered by student actors.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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 the University of Michigan at residence halls during the Fall of 2018.

Key exclusion criteria (1 listed)

Did not complete the Relationship Remix session.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MKitMKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources.	Behavioural	MKit WebApp Intervention

Primary outcome

Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale
Time frame: 1-month
Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 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 for perceived usability.
Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale
Time frame: 4-Months
Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 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 for perceived usability.
Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale
Time frame: 1-Month
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 assesses 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.
Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale
Time frame: 4-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 assesses 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.

2 secondary outcomes

1-Month Retention
Time frame: 1-Month
4-Month Retention
Time frame: 4-Month

Results and safety

Results posted to the registry on 16 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MKit WebApp Intervention	133	112
Standard of Care	117	92

Primary outcome: Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale

Time frame: 1-month. Mean (Standard Deviation). Unit: score on a scale

Measure	MKit WebApp Intervention n = 113
Value	64.36 (20.86)

Population analysed: Only intervention participants were asked the items on the System Usability Scale.

Primary outcome: Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale

Time frame: 4-Months. Mean (Standard Deviation). Unit: score on a scale

Measure	MKit WebApp Intervention n = 112
Value	62.08 (20.94)

Population analysed: Only intervention participants were asked the items on the System Usability Scale.

Primary outcome: Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale

Time frame: 1-Month. Mean (Standard Deviation). Unit: score on a scale

Measure	MKit WebApp Intervention n = 113
Value	16.00 (2.91)

Population analysed: Only intervention participants were asked the items on the System Acceptability Scale.

Primary outcome: Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale

Time frame: 4-Months. Mean (Standard Deviation). Unit: score on a scale

Measure	MKit WebApp Intervention n = 112
Value	15.94 (3.32)

Population analysed: Only intervention participants were asked the items on the System Acceptability Scale.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MKit WebApp Intervention	0 of 133 (0%)	0 of 133 (0%)	0 of 133
Standard of Care	0 of 117 (0%)	0 of 117 (0%)	0 of 117

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 18778162Fincham FD, Cui M, Braithwaite S, Pasley K. Attitudes toward intimate partner violence in dating relationships. Psychol Assess. 2008 Sep;20(3):260-9. doi: 10.1037/1040-3590.20.3.260.
Results publication: PubMed 14520319Heron SL, Thompson MP, Jackson E, Kaslow NJ. Do responses to an intimate partner violence screen predict scores on a comprehensive measure of intimate partner violence in low-income black women? Ann Emerg Med. 2003 Oct;42(4):483-91. doi: 10.1067/s0196-0644(03)00718-2.
Results publicationBrook J. SUS - A quick and dirty usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, McClelland (Eds.). Usability evaluation in industry. London: Taylor & Francis; 1996:189-194.
Results publicationKoss MP, Abbey A, Campbell R, Cook S, Norris J, Testa C, Ullman S, West C, White J. Revising the SES: A collaborative process to improve assessment of sexual aggression and victimization. Psychology Women Quarterly 31:357-370, 2007. doi:10.13072/midss.279
Results publicationBusch NB. Outcome measures for sexual assault services in Texas. The University of Texas at Austin; 2003. Retrieved from https://s3.us-east-2.amazonaws.com/wcasa/old-website-resources/Evaluation-Selecting%2BIndicators-Measure%2BDatabase%2B15.%2BOutcome_Measures_Texas%2BManual.pdf
Individual participant dataSharing planned: No

Related trials for Sexual Violence

Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Enrolling by invitation
The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
Acute Stress Symptoms, Sexual Violence
Recruiting
Centering Gender Affirming Resources in Higher Education
Sexual Violence, Drinking Heavy
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michelle L Munro-Kramer, PhD,CNM,FNP principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MKit in people with Sexual Violence and Primary Prevention, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale (time frame: 1-month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03715426, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.