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Completed

NCT Number: NCT04018807

MVP RCT: Mind and Voice Project Randomized Control Trial

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.

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Key information

Conditions

Physical Health Alcohol-Related Disorders Alcohol; Use, Problem Alcoholism Behavior Chemically-Induced Disorders Interpersonal Violence Mental Disorders Mental Health Personal Satisfaction Psychological Well-Being Substance-Related Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hurley Medical Center

Flint, Michigan, 48503, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resource pamphlet

Other

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

Remote Therapy

Behavioral

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2019
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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