MVP RCT: Mind and Voice Project Randomized Control Trial

Study Overview
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Brief Summary
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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.

Official Title
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MVP RCT: Mind and Voice Project Randomized Control Trial

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

Intervention / Treatment
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* Other: Resource pamphlet
* Behavioral: Remote Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |