MVP RCT: Mind and Voice Project Randomized Control Trial

NCT04018807 | Completed

• 2 other identifiers: HUM001556145K23AA022641-05
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Feasibility, as Measured by Number of Sessions Completed

  At least 80% of session content completed.

  12 weeks

• 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

• 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

Study Arms (2)

Resource Pamphlet

OTHER

Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level.

Other: Resource pamphlet

Remote Therapy

EXPERIMENTAL

Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks.

Behavioral: Remote Therapy

Interventions

Resource pamphlet OTHER

The pamphlet will list violence prevention, mental health, and substance abuse services.

Resource Pamphlet

Remote Therapy BEHAVIORAL

Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.

Remote Therapy

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Prior Alcohol Use
• Interpersonal Violence

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

MeSH Terms

Conditions

Psychological Well-Being; Alcoholism

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Quyen Ngo, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 15, 2019
• Study Start: July 22, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)