CClinicalTrials.gg
CompletedNCT04018807Updated Dec 12, 2022

MVP RCT: Mind and Voice Project Randomized Control Trial

An interventional study of Resource pamphlet and Remote Therapy in Physical Health, Mental Health and Alcohol; Use, Problem, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-12.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Physical Health
  • Mental Health
  • Alcohol; Use, Problem
  • Interpersonal Violence

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03

In context

Alcohol Drinking

925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.

This study's enrollment of 26 is below the median of 108 across 802 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Prior Alcohol Use
  • Interpersonal Violence

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Other
    Resource Pamphlet

    Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level.

    Other: Resource pamphlet

  • Experimental
    Remote Therapy

    Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks.

    Behavioral: Remote Therapy

Interventions

  • OtherResource pamphlet

    The pamphlet will list violence prevention, mental health, and substance abuse services.

  • BehavioralRemote Therapy

    Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.

06

What researchers measure

Primary outcomes

  1. Feasibility, as Measured by Number of Sessions Completed

    At least 80% of session content completed.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Hurley Medical Center
    Flint, Michigan 48503, United States
08

References and documents

Study documents

  • Informed consent form · Oct 3, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04018807
Lead sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Quyen Ngo (Research Assistant Professor, University of Michigan) — Principal investigator
First posted
Jul 15, 2019
Start date
Jul 22, 2019
Primary completion
Jul 31, 2020
Completion
Jul 31, 2020
Last update
Dec 12, 2022

Study contacts

Quyen Ngo, PhD
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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