Screening and Brief-Intervention of Post-war Alcohol Consumption in Public Hospital Outpatients

NCT06918106 | Recruiting DMC

• 1 other identifier: AKU/CHS-CSH/MS/06/17
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

Background: High prevalence of alcohol-consumption among conflict-affected population has been reported in some low-and-middle income countries. However, studies that assess the effectiveness of screening and brief-intervention (SBI) in the reduction of unhealthy alcohol consumptions among conflict-affected hospital outpatients in Tigray are insufficient. Objective: This study aims to test the effectiveness of Screening and Brief-Intervention (SBI) in the reduction of unhealthy alcohol consumptions among conflict-affected hospital outpatients in Tigray. Method: About 1260 outpatients will be screened for alcohol consumption using Alcohol Use Disorder Identification Test (AUDIT). Those who will have "8-19" scores in the AUDIT will be allocated to "Intervention" and "Control" groups using block randomization and they will be followed at 6 and 12 months of follow - up. The Intervention group will receive simple advice, brief-counseling and 6-and 12-months follow-up screening of alcohol consumptions. However, outpatients in control group will only receive 6- and 12-months follow-up screening of alcohol consumptions. Data will be entered to and will be analyzed using SPSS V 26. Means, standard deviations and percentages will be used for descriptive statistics. Bivariate and multivariate logistic regression, at 95% of confidence interval and p-value of \<0.05, will be used to identify correlates of alcohol consumption. Independent sample t-test and Mann-Whitney U test will be used to compare AUDIT mean scores of normally and none-normally distributed continuous variables between intervention and control groups respectively.

Conditions

Effectiveness of Screening and Brief-Intervention; Unhealthy Alcohol Use

Keywords

Post-war alcohol use; Screening and Brief-intervention; Harmful alcohol use; Hazardous alcohol use

Outcome Measures

Primary Outcomes (1)

• Screening and brief-intervention of post-war Alcohol Use among hospital outpatpatients

  Time one (T1) screening using Alcohol use disorders identification test (AUDIT) will identify 1. study subjects with 0-7 AUDIT score which is equivalent to "Low Risk Drink" and will be excluded from the intervention. 2. study subjects with 8-19 AUDIT score which is equivalent to "Hazardous/ Harmful Drink" and will enter to the brief-intervention. 3. study subjects with 20 or more AUDIT score is equivalent to "Posible Alcohol dependency" and will be excluded from the study but referred for diagnostic evaluation and treatment.

  Time frame schedule: 12 months

Study Arms (1)

Control Group

OTHER

Participants in this group will not receive the intervention (Simple advice, Brief-counseling and broacher) except the screening for alcohol consumptions that will take at baseline (T1) and at 6 months (T2) and 12 months (T3) of follow-ups.

Behavioral: Simple advice, Brief-counseling and brochure

Interventions

Simple advice, Brief-counseling and brochure BEHAVIORAL

Participants assigned to the intervention group will receive "simple advice" plus "brief counseling" and "health broacher" and then they will be screened for alcohol consumption at 6 months and 12 months of follow-ups.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All gender (Female \& Male patients)
• Outpatients aged 18 years and above
• Outpatients with no serious medical or mental illnesses
• Outpatients who will be identified to have AUDIT score of 8-19

You may not qualify if:

• Age less than 18 years
• Outpatients with serious medical or mental illnesses
• Outpatients with AUDIT score of less than 7 and above 20

Sponsors & Collaborators

• Aksum University: lead

Study Sites (1)

Suhul General Hospital: is a general hospital located in Shire Endasilassie town, Northwest Tigray. Suhul Hospital provides a wide range of medical services for more than 18,000 people every month and has a psychiatry outpatient department

Shirē, Tigray, 1010, Ethiopia

RECRUITING

Central Study Contacts

Abraha G Woldemariam, PhD in Health Science

CONTACT

+251934890415; abrahagoshw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD (Assistant Professor)

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: April 9, 2025
• Study Start: April 3, 2025
• Primary Completion: April 3, 2026
• Study Completion: April 3, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)