Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MVP RCT: Mind and Voice Project Randomized Control Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04018807
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Quyen Ngo, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Physical Health Mental Health Alcohol; Use, Problem Interpersonal Violence Other: Resource pamphlet Behavioral: Remote Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MVP RCT: Mind and Voice Project Randomized Control Trial
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Feasibility, as Measured by Number of Sessions Completed [ Time Frame: 12 weeks ]
    At least 80% of session content completed.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018807


Contacts
Layout table for location contacts
Contact: Mandilyn Graham 773-301-3640 grmandil@med.umich.edu

Locations
Layout table for location information
United States, Michigan
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Mandilyn Graham    773-301-3640    grmandil@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Quyen Ngo, PhD University of Michigan

Layout table for additonal information
Responsible Party: Quyen Ngo, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04018807     History of Changes
Other Study ID Numbers: HUM00155614
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcohol Drinking
Drinking Behavior