MVP RCT: Mind and Voice Project Randomized Control Trial (NCT04018807) | Clinical Trial Compass
CompletedNot Applicable
MVP RCT: Mind and Voice Project Randomized Control Trial
United States26 participantsStarted 2019-07-22
Plain-language summary
The study seeks to learn more about the health behaviors of young adults. Health behaviors include relationships, physical and mental health, alcohol use, and conflicts with others. The purpose of this study is to improve prevention and intervention programs for young adults.
Who can participate
Age range
18 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Prior Alcohol Use
* Interpersonal Violence
Exclusion Criteria:
* Person does not understand/speak English
* Prisoner or person being taken into custody/under house arrest
* Person or parent/guardian unable to give consent due to insufficient cognitive orientation due to unknown reasons
* Person unable to give consent due to insufficient cognitive orientation due to drug or alcohol use/ accidental overdose; given pain medications (fails MMSE)
* Person diagnosed with schizophrenia
* Person is actively suicidal or being treated for self-harm (includes overdose with the intent to harm self - not accidental)
* Person being treated for child abuse situation
* Deaf or visually impaired/illiterate/can't speak
* Screened within last month or already in study
* Combative
* Patient died
* Too sick in emergency department to approach (e.g. - never stabilizes, in trauma bay, intubated, on ventilator, or a Level 1 trauma)
* Person has already refused 2 times
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility, as Measured by Number of Sessions Completed
Timeframe: 12 weeks
2
Acceptability, as Measured by Client Satisfaction
Timeframe: 12 weeks
3
Usability, as Measured by a Modified Systems Usability Scale