- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018807
MVP RCT: Mind and Voice Project Randomized Control Trial
December 7, 2022 updated by: Quyen Ngo, University of Michigan
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Flint, Michigan, United States, 48503
- Hurley Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Resource Pamphlet
Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level.
|
The pamphlet will list violence prevention, mental health, and substance abuse services.
|
Experimental: Remote Therapy
Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks.
|
Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility, as Measured by Number of Sessions Completed
Time Frame: 12 weeks
|
At least 80% of session content completed.
|
12 weeks
|
Acceptability, as Measured by Client Satisfaction
Time Frame: 12 weeks
|
Client satisfaction is measured by the Client Satisfaction Questionnaire Exit-8, an 8 question survey where a high score indicates client satisfaction.
|
12 weeks
|
Usability, as Measured by a Modified Systems Usability Scale
Time Frame: 12 weeks
|
System usability is measured by an adapted version of the Systems Usability Scale for the platform used.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Quyen Ngo, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2019
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
July 31, 2020
Study Registration Dates
First Submitted
July 9, 2019
First Submitted That Met QC Criteria
July 9, 2019
First Posted (Actual)
July 15, 2019
Study Record Updates
Last Update Posted (Estimate)
December 12, 2022
Last Update Submitted That Met QC Criteria
December 7, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00155614
- 5K23AA022641-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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