Clinical trial NCT06918106: Screening and Brief-Intervention of Post-war Alcohol Consumption in Public Hospital Outpatients
Official title: Screening and Brief-Intervention of Post-war Alcohol Consumption in Public Hospital Outpatients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Aksum University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: Rationale:

Evidence on the effectiveness of screening and brief-intervention of unhealthy alcohol consumption in conflict-affected population in countries like Ethiopia are insufficient. This can affect the development and implementation of effective alcohol policies and interventions unless more studies strive to fill such gaps.

By screening post-war alcohol consumption and examining the efficacy of brief-interventions, this research will address the gap on the effectiveness of Screening and Brief-Intervention on reduction of hazardous/harmful alcohol consumption among public hospital outpatients. Findings can lead policymakers and health professionals to develop initiatives that promote abstinence or low risk drinking behavior to improve alcohol related health outcomes among hospital outpatients. Findings of this study can assist the development of evidence-based policy and management programs to reduce risky alcohol consumptions among public hospital outpatients.

Therefore, post-war alcohol consumption in Tigray public hospital outpatients needs to be rigorously studied to formulate an appropriate and effective intervention mechanism to prevent and reduce risky alcohol consumption among outpatients.

General Objectives:

To screen post-war alcohol consumptions and test the effectiveness of Brief-Intervention in reducing risky alcohol consumption among Public Hospital outpatients in Tigray from 2024 to 2026.

Specific Objectives:

To assess rate of post-war alcohol consumption among public hospital outpatients in Tigray from 2024 to 2026.

To determine associated factors of post-war alcohol consumptions among public hospital outpatients in Tigray from 2024 to 2026.

To test the effectiveness of screening and Brief-Intervention of alcohol consumption among public hospital outpatients in Tigray.

Methodology:

The researchers want to study the effectiveness of screening and brief-intervention of post-war alcohol consumption among public hospital outpatients in Tigray. The study will have a continuous outcome (AUDIT score) and equal sample size in both intervention and control groups. Therefore, the researchers prefer to use the simplest established formula to calculate the sample size in each group as follows.

Assuming the mean difference in AUDIT score between intervention and control groups that this study will bring is 4.4, Standard Deviation is 10, alpha (α) is 0.05 at 95% confidence interval, beta (β) is 0.20 then the sample size in each group is calculated to be n=81 with a total required sample of 162. However, since evidence are reporting that there were 28% and 33% of loss of follow-up at 6 and 12 months respectively, the required sample size in each group will be inflated to 131 with a total required sample size of 262. All female and male outpatients aged 18 years and above with no serious medical or mental illnesses with an AUDIT score of 8-19 will be included in the intervention. While outpatients less than 18 years, those with serious illnesses and have an AUDIT score of less than 7 or ≥ 20 will be excluded from the intervention.

Intervention group will receive a single session of simple advice, brief-counseling and broacher with 6-and 12-months follow-up screening. Whereas outpatients in control group will only receive the 6- and 12-months follow-up screening to see their level of alcohol consumption.

Data management and analysis Data will be collected via face-to-face interview by trained data collectors. Collected data will be handled in a secured place and in a confidential way. The data will be coded, entered and analyzed to SPSS Vs 26. Means, standard deviations and percentage will be used for the descriptive statistics. Independent sample t-test or Mann-Whitney U test will be used to compare the mean of normally distributed or none-normally distributed AUDIT scores between intervention and control groups respectively. Repeated measure ANOVA will be used to test the effectiveness of Screening and Brief-Intervention of post-war alcohol consumption. However, non-parametric alternatives like Friedman test will be also used if assumptions for parametric statistics are failed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Screening and brief-intervention of post-war Alcohol Use among hospital outpatpatients
timeFrame: Time frame schedule: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: