Effectiveness of Screening and Brief-InterventionNCT06918106
Screening and Brief-Intervention of Post-war Alcohol Consumption in Public Hospital Outpatients
A study testing Simple advice, Brief-counseling and brochure in people with Effectiveness of Screening and Brief-Intervention and Unhealthy Alcohol Use, run by Aksum University at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effectiveness of Screening and Brief-Intervention, Unhealthy Alcohol Use
- What is being tested?
- Simple advice, Brief-counseling and brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteEthiopia
- Study dates
- 3 Apr 2025to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age less than 18 years
- Outpatients with serious medical or mental illnesses
- Outpatients with AUDIT score of less than 7 and above 20
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abraha G Woldemariam, PhD in Health Science contact
Ethiopia1 site, 1 recruiting
- Recruiting
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
Abraha G Woldemariam, PhD in Health Science, +251934890415 ext. +251914776393, abrahagoshw@gmail.com
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Simple advice, Brief-counseling and brochure
- Keywords
- Post-war alcohol use, Screening and Brief-intervention, Harmful alcohol use, Hazardous alcohol use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple advice, Brief-counseling and brochureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Simple advice, Brief-counseling and brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- study subjects with 0-7 AUDIT score which is equivalent to "Low Risk Drink" and will be excluded from the intervention.
- study subjects with 8-19 AUDIT score which is equivalent to "Hazardous/ Harmful Drink" and will enter to the brief-intervention.
- 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.
Measured: Time frame schedule: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start3 Apr 2025
- Primary completion1 Jul 2026
- Study completion29 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Screening and Brief-InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aksum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abraha Gosh, Aksum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918106
- Sponsor's protocol ID
- AKU/CHS-CSH/MS/06/17
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Brief-Intervention of Post-war Alcohol Consumption in Public Hospital Outpatients
- ClinicalTrials.gov ID
- NCT06918106
- Acronym / sponsor ID
- AKU/CHS-CSH/MS/06/17
- Keywords
- Post-war alcohol use, Screening and Brief-intervention, Harmful alcohol use, Hazardous alcohol use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Aksum UniversityUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Behavioral: Simple advice, Brief-counseling and brochureParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age less than 18 years
- Outpatients with serious medical or mental illnesses
- Outpatients with AUDIT score of less than 7 and above 20
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple advice, Brief-counseling and brochureParticipants 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. | Behavioural | Control Group |
Primary outcome
Screening and brief-intervention of post-war Alcohol Use among hospital outpatpatients
Time frame: Time frame schedule: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abraha G Woldemariam, PhD in Health Science contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple advice, Brief-counseling and brochure in people with Effectiveness of Screening and Brief-Intervention and Unhealthy Alcohol Use, run by Aksum University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abraha G Woldemariam, PhD in Health Science (+251934890415 ext. +251914776393, abrahagoshw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening and brief-intervention of post-war Alcohol Use among hospital outpatpatients (time frame: Time frame schedule: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.