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Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men

Primary Purpose

Drinking Behavior, Drinking Excessive, Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBIRT
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Drinking Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: self-identify as Black aged 18 or older low income as defined by any indicator (e.g., Medicaid; Earned Income Tax Credit; Children's Health Insurance Plan; subsidized housing; child care subsidies; food stamps; low-income energy assistance; free/reduced lunch program; supplemental nutrition program; Head Start program). Exclusion Criteria: -

Sites / Locations

  • UAMSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SBIRT

Usual-care

Arm Description

Each intervention barbershop, will hold screening days, where a trained community health worker will be onsite to provide Screening, Brief Intervention, and Referral to Treatment (SBIRT).

Six months after completion of Time 1, barbershops in the usual-care arm will receive the intervention.

Outcomes

Primary Outcome Measures

Alcohol Use - total number of drinking days
At-risk drinking behavior measured as: number of drinking days
Alcohol Use - total number of drinking days
At-risk drinking behavior measured as: number of drinking days
Alcohol Use - total number of drinking days
At-risk drinking behavior measured as: number of drinking days
Alcohol Use - number of unhealthy drinking days
At-risk drinking behavior measured as: number of unhealthy drinking days
Alcohol Use - number of unhealthy drinking days
At-risk drinking behavior measured as: number of unhealthy drinking days
Alcohol Use - total number of unhealthy drinking days
At-risk drinking behavior measured as: number of unhealthy drinking days
Mental Health - depression
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Mental Health - depression
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Mental Health - depression
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Mental Health - Posttraumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Mental Health - Posttraumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Mental Health - Posttraumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Social Support
Family, friend, and partner support (number of people in support network)
Social Support
Family, friend, and partner support (number of people in support network)
Social Support
Family, friend, and partner support (number of people in support network)
Healthcare Utilization
Number of subjects who have utilized healthcare services
Healthcare Utilization
Number of subjects who have utilized healthcare services
Healthcare Utilization
Number of subjects who have utilized healthcare services

Secondary Outcome Measures

Full Information

First Posted
October 17, 2022
Last Updated
July 11, 2023
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT05609344
Brief Title
Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men
Official Title
Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Socially disadvantaged Black men are at increased risk for unhealthy drinking habits that may, in turn, increase preventable chronic disease. This project seeks to test the effectiveness of a Screening, Brief Intervention, and Referral to Treatment (SBIRT) intervention for use within barbershop settings to reduce average drinking days and the number of unhealthy drinking days. Data from this study will further our understanding of how to reduce the risk of alcohol-related morbidity and mortality among Black men. Data will also improve our understanding of strategies that can improve the implementation of evidence-based care models in non-clinical settings; thus, extending the reach of evidence-based care to communities with the highest need.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drinking Behavior, Drinking Excessive, Drinking

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBIRT
Arm Type
Experimental
Arm Description
Each intervention barbershop, will hold screening days, where a trained community health worker will be onsite to provide Screening, Brief Intervention, and Referral to Treatment (SBIRT).
Arm Title
Usual-care
Arm Type
Other
Arm Description
Six months after completion of Time 1, barbershops in the usual-care arm will receive the intervention.
Intervention Type
Behavioral
Intervention Name(s)
SBIRT
Intervention Description
Low risk individuals will receive an educational pamphlet about alcohol use and the impact on health. Moderate Risk individuals will receive a brief alcohol intervention. High risk individuals will receive the brief alcohol intervention and be referred to specialty treatment.
Primary Outcome Measure Information:
Title
Alcohol Use - total number of drinking days
Description
At-risk drinking behavior measured as: number of drinking days
Time Frame
Baseline
Title
Alcohol Use - total number of drinking days
Description
At-risk drinking behavior measured as: number of drinking days
Time Frame
3 months
Title
Alcohol Use - total number of drinking days
Description
At-risk drinking behavior measured as: number of drinking days
Time Frame
6 months
Title
Alcohol Use - number of unhealthy drinking days
Description
At-risk drinking behavior measured as: number of unhealthy drinking days
Time Frame
Baseline
Title
Alcohol Use - number of unhealthy drinking days
Description
At-risk drinking behavior measured as: number of unhealthy drinking days
Time Frame
3 months
Title
Alcohol Use - total number of unhealthy drinking days
Description
At-risk drinking behavior measured as: number of unhealthy drinking days
Time Frame
6 months
Title
Mental Health - depression
Description
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Time Frame
Baseline
Title
Mental Health - depression
Description
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Time Frame
3 months
Title
Mental Health - depression
Description
The PHQ-9 is the depression module of the Patient Health Questionnaire (a diagnostic instrument for common mental disorders), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ9 will be used for this outcome.
Time Frame
6 months
Title
Mental Health - Posttraumatic Stress Disorder (PTSD)
Description
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Time Frame
Baseline
Title
Mental Health - Posttraumatic Stress Disorder (PTSD)
Description
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Time Frame
3 months
Title
Mental Health - Posttraumatic Stress Disorder (PTSD)
Description
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
Time Frame
6 months
Title
Social Support
Description
Family, friend, and partner support (number of people in support network)
Time Frame
Baseline
Title
Social Support
Description
Family, friend, and partner support (number of people in support network)
Time Frame
3 months
Title
Social Support
Description
Family, friend, and partner support (number of people in support network)
Time Frame
6 months
Title
Healthcare Utilization
Description
Number of subjects who have utilized healthcare services
Time Frame
Baseline
Title
Healthcare Utilization
Description
Number of subjects who have utilized healthcare services
Time Frame
3 months
Title
Healthcare Utilization
Description
Number of subjects who have utilized healthcare services
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: self-identify as Black aged 18 or older low income as defined by any indicator (e.g., Medicaid; Earned Income Tax Credit; Children's Health Insurance Plan; subsidized housing; child care subsidies; food stamps; low-income energy assistance; free/reduced lunch program; supplemental nutrition program; Head Start program). Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille Hart, MPH
Phone
5015266076
Email
chart@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany F Haynes, PhD
Phone
(501) 526-6613
Email
TFHaynes@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany F Haynes, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAMS
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Hart
Phone
501-526-6076
Email
chart@uams.edu

12. IPD Sharing Statement

Learn more about this trial

Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men

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