MVP RCT: Mind and Voice Project Randomized Control Trial

NCT ID: NCT04018807

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Health Mental Health Alcohol; Use, Problem Interpersonal Violence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resource Pamphlet

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

Group Type OTHER

Resource pamphlet

Intervention Type OTHER

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

Remote Therapy

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

Group Type EXPERIMENTAL

Remote Therapy

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resource pamphlet

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

Intervention Type OTHER

Remote Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Quyen Ngo

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Quyen Ngo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hurley Medical Center

Flint, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5K23AA022641-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00155614

Identifier Type: -

Identifier Source: org_study_id