Back to resultsMVP RCT: Mind and Voice Project Randomized Control Trial
Primary Purpose
Physical Health, Mental Health, Alcohol; Use, Problem
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resource pamphlet
Remote Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Physical Health
Eligibility Criteria
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
Sites / Locations
- Hurley Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Resource Pamphlet
Remote Therapy
Arm Description
Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level.
Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks.
Outcomes
Primary Outcome Measures
Feasibility, as Measured by Number of Sessions Completed
At least 80% of session content completed.
Acceptability, as Measured by Client Satisfaction
Client satisfaction is measured by the Client Satisfaction Questionnaire Exit-8, an 8 question survey where a high score indicates client satisfaction.
Usability, as Measured by a Modified Systems Usability Scale
System usability is measured by an adapted version of the Systems Usability Scale for the platform used.
Secondary Outcome Measures
Full Information
NCT ID
NCT04018807
First Posted
July 9, 2019
Last Updated
December 7, 2022
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04018807
Brief Title
MVP RCT: Mind and Voice Project Randomized Control Trial
Official Title
MVP RCT: Mind and Voice Project Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Health, Mental Health, Alcohol; Use, Problem, Interpersonal Violence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resource Pamphlet
Arm Type
Other
Arm Description
Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level.
Arm Title
Remote Therapy
Arm Type
Experimental
Arm Description
Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks.
Intervention Type
Other
Intervention Name(s)
Resource pamphlet
Intervention Description
The pamphlet will list violence prevention, mental health, and substance abuse services.
Intervention Type
Behavioral
Intervention Name(s)
Remote Therapy
Intervention Description
Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.
Primary Outcome Measure Information:
Title
Feasibility, as Measured by Number of Sessions Completed
Description
At least 80% of session content completed.
Time Frame
12 weeks
Title
Acceptability, as Measured by Client Satisfaction
Description
Client satisfaction is measured by the Client Satisfaction Questionnaire Exit-8, an 8 question survey where a high score indicates client satisfaction.
Time Frame
12 weeks
Title
Usability, as Measured by a Modified Systems Usability Scale
Description
System usability is measured by an adapted version of the Systems Usability Scale for the platform used.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quyen Ngo, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MVP RCT: Mind and Voice Project Randomized Control Trial
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