MVP RCT: Mind and Voice Project Randomized Control Trial

Not Applicable

Completed

• Conditions: Mental Health; Physical Health; Alcohol; Use, Problem; Interpersonal Violence
• Interventions: Other: Resource pamphlet; Behavioral: Remote Therapy

• Registration Number: NCT04018807
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-15
• Study Start: 2019-07-22
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Prior Alcohol Use
• Interpersonal Violence

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resource Pamphlet	Resource pamphlet	Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level.
Remote Therapy	Remote Therapy	Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks.

Primary Outcome Measures

Name	Time	Method
Feasibility, as Measured by Number of Sessions Completed	12 weeks	At least 80% of session content completed.
Acceptability, as Measured by Client Satisfaction	12 weeks	Client satisfaction is measured by the Client Satisfaction Questionnaire Exit-8, an 8 question survey where a high score indicates client satisfaction.
Usability, as Measured by a Modified Systems Usability Scale	12 weeks	System usability is measured by an adapted version of the Systems Usability Scale for the platform used.

Trial Locations

Locations (1)

Hurley Medical Center; 🇺🇸 Flint, Michigan, United States