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

Conditions

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

  • United States
    • 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.
Other: Resource pamphlet
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.
Behavioral: Remote Therapy
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

University of Michigan

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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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