MVP RCT: Mind and Voice Project Randomized Control Trial

Mental Health Clinical Trial

Official title:

MVP RCT: Mind and Voice Project Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018807
• Other study ID #: HUM00155614
• Secondary ID: 5K23AA022641-05
• Status: Completed
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: December 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Resource pamphlet
The pamphlet will list violence prevention, mental health, and substance abuse services.

Behavioral:
• Remote Therapy
Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.

Locations

Country	Name	City	State
United States	Hurley Medical Center	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, as Measured by Number of Sessions Completed	At least 80% of session content completed.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks