MVP RCT: Mind and Voice Project Randomized Control Trial

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT04018807

Collaborator

(none)

Enrollment

Location

Arms

12.3

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Health Mental Health Alcohol; Use, Problem Interpersonal Violence	Other: Resource pamphlet Behavioral: Remote Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

MVP RCT: Mind and Voice Project Randomized Control Trial

Actual Study Start Date :

Jul 22, 2019

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Resource Pamphlet Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level.	Other: Resource pamphlet The pamphlet will list violence prevention, mental health, and substance abuse services.
Experimental: Remote Therapy Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks.	Behavioral: Remote Therapy Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.

Arm

Intervention/Treatment

Other: Resource Pamphlet

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

Other: Resource pamphlet

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

Experimental: Remote Therapy

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

Behavioral: Remote Therapy

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hurley Medical Center	Flint	Michigan	United States	48503

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Quyen Ngo, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Quyen Ngo, Research Assistant Professor, University of Michigan

ClinicalTrials.gov Identifier:

NCT04018807

Other Study ID Numbers:

HUM00155614

First Posted:

Jul 15, 2019

Last Update Posted:

Aug 7, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alcohol Drinking

Study Results

No Results Posted as of Aug 7, 2020