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NCT04018807 Clinical Trial

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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