Drinking Behavior Clinical Trial
Official title:
Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men
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 |
Verified date | May 2024 |
Source | University of Arkansas |
Contact | Camille Hart, MPH |
Phone | 5015266076 |
chart[@]uams.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: - |
Country | Name | City | State |
---|---|---|---|
United States | UAMS | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
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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