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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05609344
Other study ID # 273439
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 26, 2023
Est. completion date July 31, 2027

Study information

Verified date May 2024
Source University of Arkansas
Contact Camille Hart, MPH
Phone 5015266076
Email chart@uams.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date July 31, 2027
Est. primary completion date July 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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: -

Study Design


Intervention

Behavioral:
SBIRT
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.

Locations

Country Name City State
United States UAMS Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol Use - total number of drinking days At-risk drinking behavior measured as:
number of drinking days
Baseline
Primary Alcohol Use - total number of drinking days At-risk drinking behavior measured as:
number of drinking days
3 months
Primary Alcohol Use - total number of drinking days At-risk drinking behavior measured as:
number of drinking days
6 months
Primary Alcohol Use - number of unhealthy drinking days At-risk drinking behavior measured as:
number of unhealthy drinking days
Baseline
Primary Alcohol Use - number of unhealthy drinking days At-risk drinking behavior measured as:
number of unhealthy drinking days
3 months
Primary Alcohol Use - total number of unhealthy drinking days At-risk drinking behavior measured as:
number of unhealthy drinking days
6 months
Primary 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. Baseline
Primary 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. 3 months
Primary 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. 6 months
Primary Mental Health - Posttraumatic Stress Disorder (PTSD) Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5) Baseline
Primary Mental Health - Posttraumatic Stress Disorder (PTSD) Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5) 3 months
Primary Mental Health - Posttraumatic Stress Disorder (PTSD) Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5) 6 months
Primary Social Support Family, friend, and partner support (number of people in support network) Baseline
Primary Social Support Family, friend, and partner support (number of people in support network) 3 months
Primary Social Support Family, friend, and partner support (number of people in support network) 6 months
Primary Healthcare Utilization Number of subjects who have utilized healthcare services Baseline
Primary Healthcare Utilization Number of subjects who have utilized healthcare services 3 months
Primary Healthcare Utilization Number of subjects who have utilized healthcare services 6 months
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