- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609344
Barbershop Talk: Reducing Excessive Alcohol Consumption Among Black Men
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Camille Hart, MPH
- Phone Number: 5015266076
- Email: chart@uams.edu
Study Contact Backup
- Name: Tiffany F Haynes, PhD
- Phone Number: (501) 526-6613
- Email: TFHaynes@uams.edu
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- UAMS
-
Contact:
- Camille Hart
- Phone Number: 501-526-6076
- Email: chart@uams.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SBIRT
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).
|
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.
|
Other: Usual-care
Six months after completion of Time 1, barbershops in the usual-care arm will receive the intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Use - total number of drinking days
Time Frame: Baseline
|
At-risk drinking behavior measured as: number of drinking days |
Baseline
|
Alcohol Use - total number of drinking days
Time Frame: 3 months
|
At-risk drinking behavior measured as: number of drinking days |
3 months
|
Alcohol Use - total number of drinking days
Time Frame: 6 months
|
At-risk drinking behavior measured as: number of drinking days |
6 months
|
Alcohol Use - number of unhealthy drinking days
Time Frame: Baseline
|
At-risk drinking behavior measured as: number of unhealthy drinking days |
Baseline
|
Alcohol Use - number of unhealthy drinking days
Time Frame: 3 months
|
At-risk drinking behavior measured as: number of unhealthy drinking days |
3 months
|
Alcohol Use - total number of unhealthy drinking days
Time Frame: 6 months
|
At-risk drinking behavior measured as: number of unhealthy drinking days |
6 months
|
Mental Health - depression
Time Frame: Baseline
|
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
|
Mental Health - depression
Time Frame: 3 months
|
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
|
Mental Health - depression
Time Frame: 6 months
|
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
|
Mental Health - Posttraumatic Stress Disorder (PTSD)
Time Frame: Baseline
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
|
Baseline
|
Mental Health - Posttraumatic Stress Disorder (PTSD)
Time Frame: 3 months
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
|
3 months
|
Mental Health - Posttraumatic Stress Disorder (PTSD)
Time Frame: 6 months
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL5)
|
6 months
|
Social Support
Time Frame: Baseline
|
Family, friend, and partner support (number of people in support network)
|
Baseline
|
Social Support
Time Frame: 3 months
|
Family, friend, and partner support (number of people in support network)
|
3 months
|
Social Support
Time Frame: 6 months
|
Family, friend, and partner support (number of people in support network)
|
6 months
|
Healthcare Utilization
Time Frame: Baseline
|
Number of subjects who have utilized healthcare services
|
Baseline
|
Healthcare Utilization
Time Frame: 3 months
|
Number of subjects who have utilized healthcare services
|
3 months
|
Healthcare Utilization
Time Frame: 6 months
|
Number of subjects who have utilized healthcare services
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tiffany F Haynes, PhD, University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 273439
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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