Alcohol UseNCT06713304
A Community-Based Intervention to Reduce Alcohol Use in Vietnamese Men
A study testing A community-based Protective Behavioral Strategies program in people with Alcohol Use, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to evaluate the effectiveness of a community-based Protective Behavioral Strategies (PBS) program in reducing alcohol use, severity of alcohol-related problems, and intention to use alcohol among people with hazardous alcohol use (HAU) in Vietnam. Read more about this study
- Who is it for?
- Ages 35 to 44 years, men only
- Conditions the study is for
- Alcohol Use
- What is being tested?
- A community-based Protective Behavioral Strategies program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2025to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 44 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Having a total AUDIT score from 8 to 15
- Completing at least primary school
- Able to use the Vietnamese language
- Having a mobile phone
- Willing to participate in this study
Who cannot join
- Using alcohol and other illicit drugs at the same time
- Having any physical illness or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Community-Based Protective Behavioral Strategies Program on Alcohol Use Among Adult Men With Hazardous Alcohol Use in Vietnam
This study aims to evaluate the effectiveness of a community-based Protective Behavioral Strategies (PBS) program in reducing alcohol use, severity of alcohol-related problems, and intention to use alcohol among people with hazardous alcohol use (HAU) in Vietnam. In this randomized controlled trial, 104 men aged 35-44 years, identified as having HAU (Alcohol Use Disorders Identification Test score = 8-15), will be recruited from a rural area in Thai Nguyen province, Vietnam. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group using stratified blocked randomization. The intervention group will participate in a community-based PBS program, which includes five weekly 90-minute sessions, with Short Message Service (SMS) reminders sent three times weekly after each session to reinforce PBS practices. The control group will receive usual care only.
The primary outcome is alcohol use, assessing both the quantity and frequency of consumption, measured at 1 month and 3 months post-intervention. Secondary outcomes include the severity of alcohol-related problems and intention to use alcohol. These will be assessed at baseline and the 3-month follow-up. Two-way repeated measures Multivariate analysis of variance (MANOVA) and regression models will be conducted to evaluate the effects of the intervention on the primary and secondary outcomes.
Read the detailed description
- Background and significance: Hazardous alcohol use (HAU) represents a significant public health concern, particularly among adult men in Vietnam. Effective interventions are needed to reduce HAU and its associated health risks. Protective Behavioral Strategies (PBS) have shown promise in mitigating HAU behaviors by promoting safer drinking practices and enhancing self-regulation among individuals.
- Study objectives:
- To compare the differences in the primary outcome (alcohol use) between the intervention and control groups at 1 month and 3 months post-intervention, and the differences in the secondary outcomes (severity of alcohol-related problems and intention to use alcohol) at 3 months post-intervention.
- To compare the differences in the primary outcome (alcohol use) at 1 month and 3 months post-intervention, and the differences in the secondary outcomes (severity of alcohol-related problems and intention to use alcohol) at 3 months post-intervention, within the intervention group compared to the pre-test.
- Study design:
This study employs a randomized controlled design. Alcohol use will be measured at both 1 month and 3 months after the intervention, whereas the secondary outcomes will be measured at 3 months. The 1-month follow-up allows for the evaluation of immediate changes in drinking behavior, while the 3-month follow-up assesses whether these changes are sustained. By comparing outcomes across both time points, the study can track the trajectory of the intervention's impact and identify any patterns of relapse or continued improvement. These follow-up periods align with common practice in alcohol intervention research.
- Intervention: The intervention group will participate in a community-based PBS program, which is structured around PBS as its central framework, enhanced by Alcohol Brief Intervention (functioning as a motivating component), and Behavioral Skills Training model (enhancing the learning of each PBS skill through a structured approach: instruction, modeling, rehearsal, and feedback). The community-based PBS program consists of 5 weekly sessions including Setting safe drinking limits, Choosing non-alcoholic drinks, Planning Ahead, Slowing down drinking, and Avoiding Risky Drinking situations each lasting 90 minutes.
The sessions will be delivered by the researcher in an in-person group format (10-12 participants per group) at a healthcare facility. Each session is structured as follows: Part 1-30 minutes: Introduction, relationship-building, and reviewing previous content. This segment focuses on fostering a supportive environment and reinforcing participants' connection with the program. Part 2-60 minutes: Learning and practicing PBS. Participants will be introduced to specific strategies each week, followed by hands-on practice, group discussions, and scenario-based exercises that encourage the application of PBS in real-life situations.
After each session, participants will receive three Short Message Service (SMS) text messages per week (a random day, Friday, and Saturday). These messages encourage participants to apply the PBS learned in the group sessions. The main activities in each session are briefly summarized below.
- Usual care: Usual care refers to the standard services provided by primary care nurses to people with HAU in the community, as per national guidelines. This typically includes educational sessions on the adverse effects of alcohol, guidance on relevant laws and health regulations, and referrals to healthcare services.
- Outcome measures:
- Alcohol use is measured by both the amount and frequency of alcohol consumption. The amount of alcohol use is quantified as the total grams of pure alcohol that participants consumed per week in the previous month measuring at baseline, 1 month, and 3 months post-intervention. This is calculated using the formula: Volume (ml) × Alcohol by Volume (%) × 0.79, where Alcohol by Volume is the alcohol by volume percentage and 0.79 is the conversion factor for the density of ethanol (Vietnamese Ministry of Health, 2020). Frequency of alcohol use is defined as the number of days per week in the previous month that participants consume alcohol measuring at baseline, 1 month, and 3 months post-intervention. These variables are measured using the Alcohol Timeline Follow back.
- The severity of alcohol-related problems refers to the participants' self-report of the extent and intensity of negative consequences resulting from alcohol use, measured at baseline and 3 months post-intervention. These consequences are categorized into physical, intrapersonal, interpersonal, social responsibility, and impulse control domains. This variable is measured using the Drinker Inventory of Consequences.
- Intention to use alcohol is operationally defined as participants' self-reported intention or willingness to consume alcohol within the next 30 days. This is measured using a 7-point Likert scale at baseline and 3 months post-intervention in response to the statement: "I intend to drink alcohol in the next 30 days" with responses ranging from 1 to 7.
- Data Analysis:
Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 28.0. Two-way repeated measures Multivariate analysis of variance (MANOVA) will be employed to assess changes in outcomes over time and between groups. Regression models will be utilized to explore the relationship between the intervention and changes in alcohol use and associated outcomes.
- Conditions
- Alcohol Use
- Being tested
- A community-based Protective Behavioral Strategies program
- Keywords
- Alcohol use, Protective Behavioral Strategies, Adult Men
- Medical subject headings
- Alcohol Drinking, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A community-based Protective Behavioral Strategies programBehavioural
A 5-week group program delivered in a healthcare setting to teach and practice protective behavioral strategies. The objectives of each session are:
Session 1: Setting Safe Drinking Limit: The participants can identify the risk related to their drinking behavior, calculate a standard drink, and set a safe drinking limit.
Session 2: Choosing Nonalcoholic Drinks: The participants can understand the benefits of using nonalcoholic beverages and identify and select nonalcoholic beverages.
Session 3: Planning Ahead: The participants can make a plan to stop using during drinking events and know how to say "no" to alcohol use.
Session 4: Slowing down drinking: The participants can understand the benefits of slowing down drinking and know how to slow down their drinks.
Session 5: Avoid Risky Drinking Situations: The participants can understand the negative effects of excessive drinking and know how to avoid excessive drinking.
| Study group | Role | What they receive |
|---|---|---|
| A Community-Based Protective Behavioral Strategies Program | Experimental | Participants receive the community-based Protective Behavioral Strategies program Receives: Behavioral: A community-based Protective Behavioral Strategies program |
| Control Group | No intervention | Participants receiving the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
Alcohol use is measured by both the amount and frequency of alcohol consumption. The amount of alcohol use is quantified as the total grams of pure alcohol that participants consumed per week in the previous month measuring at baseline, 1 month, and 3 months post-intervention. This is calculated using the formula: Volume (ml) × ABV(%) × 0.79, where ABV is the alcohol by volume percentage and 0.79 is the conversion factor for the density of ethanol. Frequency of alcohol use is defined as the number of days per week in the previous month that participants consume alcohol measuring at baseline, 1 month, and 3 months post-intervention. These variables are measured using the Alcohol Timeline Follow back (TLFB).
Measured: Baseline, 1 month and 3 months post-intervention
Secondary outcomes (2)
Severity of alcohol-related problems
The severity of alcohol-related problems refers to the participants' self-report of the extent and intensity of negative consequences resulting from alcohol use, measured at baseline and 3 months post-intervention. These consequences are categorized into physical, intrapersonal, interpersonal, social responsibility, and impulse control domains. This variable is measured using the Drinker Inventory of Consequences (DrInC).
Measured: Baseline and 3 months post-intervention
Intention to use alcohol
Intention to use alcohol is operationally defined as participants' self-reported intention or willingness to consume alcohol within the next 30 days. This is measured using a 7-point Likert scale at baseline and 3 months post-intervention in response to the statement: "I intend to drink alcohol in the next 30 days" with responses ranging from 1 to 7.
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Feb 2025
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713304
- Sponsor's protocol ID
- FONCU2601
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Van Nhat T, Stithyudhakarn S, Wang MP, Uthis P. A community-based protective behavioral strategies program for hazardous alcohol use among middle-aged men in rural Vietnam: A randomized controlled trial. Arch Psychiatr Nurs. 2026 Aug;63:152182. doi: 10.1016/j.apnu.2026.152182. Epub 2026 Jul 13.
PubMed 42608108
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Community-Based Protective Behavioral Strategies Program on Alcohol Use Among Adult Men With Hazardous Alcohol Use in Vietnam
- ClinicalTrials.gov ID
- NCT06713304
- Acronym / sponsor ID
- FONCU2601
- Conditions
- Alcohol Use
- Keywords
- Alcohol use, Protective Behavioral Strategies, Adult Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 3 Dec 2024 (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.
This study aims to evaluate the effectiveness of a community-based Protective Behavioral Strategies (PBS) program in reducing alcohol use, severity of alcohol-related problems, and intention to use alcohol among people with hazardous alcohol use (HAU) in Vietnam. In this randomized controlled trial, 104 men aged 35-44 years, identified as having HAU (Alcohol Use Disorders Identification Test score = 8-15), will be recruited from a rural area in Thai Nguyen province, Vietnam. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group using stratified blocked randomization. The intervention group will participate in a community-based PBS program, which includes five weekly 90-minute sessions, with Short Message Service (SMS) reminders sent three times weekly after each session to reinforce PBS practices. The control group will receive usual care only.
The primary outcome is alcohol use, assessing both the quantity and frequency of consumption, measured at 1 month and 3 months post-intervention. Secondary outcomes include the severity of alcohol-related problems and intention to use alcohol. These will be assessed at baseline and the 3-month follow-up. Two-way repeated measures Multivariate analysis of variance (MANOVA) and regression models will be conducted to evaluate the effects of the intervention on the primary and secondary outcomes.
Detailed description
- Background and significance: Hazardous alcohol use (HAU) represents a significant public health concern, particularly among adult men in Vietnam. Effective interventions are needed to reduce HAU and its associated health risks. Protective Behavioral Strategies (PBS) have shown promise in mitigating HAU behaviors by promoting safer drinking practices and enhancing self-regulation among individuals.
- Study objectives:
- To compare the differences in the primary outcome (alcohol use) between the intervention and control groups at 1 month and 3 months post-intervention, and the differences in the secondary outcomes (severity of alcohol-related problems and intention to use alcohol) at 3 months post-intervention.
- To compare the differences in the primary outcome (alcohol use) at 1 month and 3 months post-intervention, and the differences in the secondary outcomes (severity of alcohol-related problems and intention to use alcohol) at 3 months post-intervention, within the intervention group compared to the pre-test.
- Study design:
This study employs a randomized controlled design. Alcohol use will be measured at both 1 month and 3 months after the intervention, whereas the secondary outcomes will be measured at 3 months. The 1-month follow-up allows for the evaluation of immediate changes in drinking behavior, while the 3-month follow-up assesses whether these changes are sustained. By comparing outcomes across both time points, the study can track the trajectory of the intervention's impact and identify any patterns of relapse or continued improvement. These follow-up periods align with common practice in alcohol intervention research.
- Intervention: The intervention group will participate in a community-based PBS program, which is structured around PBS as its central framework, enhanced by Alcohol Brief Intervention (functioning as a motivating component), and Behavioral Skills Training model (enhancing the learning of each PBS skill through a structured approach: instruction, modeling, rehearsal, and feedback). The community-based PBS program consists of 5 weekly sessions including Setting safe drinking limits, Choosing non-alcoholic drinks, Planning Ahead, Slowing down drinking, and Avoiding Risky Drinking situations each lasting 90 minutes.
The sessions will be delivered by the researcher in an in-person group format (10-12 participants per group) at a healthcare facility. Each session is structured as follows: Part 1-30 minutes: Introduction, relationship-building, and reviewing previous content. This segment focuses on fostering a supportive environment and reinforcing participants' connection with the program. Part 2-60 minutes: Learning and practicing PBS. Participants will be introduced to specific strategies each week, followed by hands-on practice, group discussions, and scenario-based exercises that encourage the application of PBS in real-life situations.
After each session, participants will receive three Short Message Service (SMS) text messages per week (a random day, Friday, and Saturday). These messages encourage participants to apply the PBS learned in the group sessions. The main activities in each session are briefly summarized below.
- Usual care: Usual care refers to the standard services provided by primary care nurses to people with HAU in the community, as per national guidelines. This typically includes educational sessions on the adverse effects of alcohol, guidance on relevant laws and health regulations, and referrals to healthcare services.
- Outcome measures:
- Alcohol use is measured by both the amount and frequency of alcohol consumption. The amount of alcohol use is quantified as the total grams of pure alcohol that participants consumed per week in the previous month measuring at baseline, 1 month, and 3 months post-intervention. This is calculated using the formula: Volume (ml) × Alcohol by Volume (%) × 0.79, where Alcohol by Volume is the alcohol by volume percentage and 0.79 is the conversion factor for the density of ethanol (Vietnamese Ministry of Health, 2020). Frequency of alcohol use is defined as the number of days per week in the previous month that participants consume alcohol measuring at baseline, 1 month, and 3 months post-intervention. These variables are measured using the Alcohol Timeline Follow back.
- The severity of alcohol-related problems refers to the participants' self-report of the extent and intensity of negative consequences resulting from alcohol use, measured at baseline and 3 months post-intervention. These consequences are categorized into physical, intrapersonal, interpersonal, social responsibility, and impulse control domains. This variable is measured using the Drinker Inventory of Consequences.
- Intention to use alcohol is operationally defined as participants' self-reported intention or willingness to consume alcohol within the next 30 days. This is measured using a 7-point Likert scale at baseline and 3 months post-intervention in response to the statement: "I intend to drink alcohol in the next 30 days" with responses ranging from 1 to 7.
- Data Analysis:
Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 28.0. Two-way repeated measures Multivariate analysis of variance (MANOVA) will be employed to assess changes in outcomes over time and between groups. Regression models will be utilized to explore the relationship between the intervention and changes in alcohol use and associated outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Community-Based Protective Behavioral Strategies Program | Experimental | Behavioral: A community-based Protective Behavioral Strategies programParticipants receive the community-based Protective Behavioral Strategies program |
| Control Group | No intervention | –Participants receiving the usual care |
Who may qualify
- Ages
- 35 to 44 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having a total AUDIT score from 8 to 15
- Completing at least primary school
- Able to use the Vietnamese language
- Having a mobile phone
- Willing to participate in this study
Key exclusion criteria (2 listed)
- Using alcohol and other illicit drugs at the same time
- Having any physical illness or psychiatric disorders
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 |
|---|---|---|
| A community-based Protective Behavioral Strategies programA 5-week group program delivered in a healthcare setting to teach and practice protective behavioral strategies. The objectives of each session are: Session 1: Setting Safe Drinking Limit: The participants can identify the risk related to their drinking behavior, calculate a standard drink, and set a safe drinking limit. Session 2: Choosing Nonalcoholic Drinks: The participants can understand the benefits of using nonalcoholic beverages and identify and select nonalcoholic beverages. Session 3: Planning Ahead: The participants can make a plan to stop using during drinking events and know how to say "no" to alcohol use. Session 4: Slowing down drinking: The participants can understand the benefits of slowing down drinking and know how to slow down their drinks. Session 5: Avoid Risky Drinking Situations: The participants can understand the negative effects of excessive drinking and know how to avoid excessive drinking. | Behavioural | A Community-Based Protective Behavioral Strategies Program |
Primary outcome
Alcohol use
Time frame: Baseline, 1 month and 3 months post-intervention
Alcohol use is measured by both the amount and frequency of alcohol consumption. The amount of alcohol use is quantified as the total grams of pure alcohol that participants consumed per week in the previous month measuring at baseline, 1 month, and 3 months post-intervention. This is calculated using the formula: Volume (ml) × ABV(%) × 0.79, where ABV is the alcohol by volume percentage and 0.79 is the conversion factor for the density of ethanol. Frequency of alcohol use is defined as the number of days per week in the previous month that participants consume alcohol measuring at baseline, 1 month, and 3 months post-intervention. These variables are measured using the Alcohol Timeline Follow back (TLFB).
2 secondary outcomes
Severity of alcohol-related problems
Time frame: Baseline and 3 months post-intervention
Intention to use alcohol
Time frame: Baseline and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 42608108Van Nhat T, Stithyudhakarn S, Wang MP, Uthis P. A community-based protective behavioral strategies program for hazardous alcohol use among middle-aged men in rural Vietnam: A randomized controlled trial. Arch Psychiatr Nurs. 2026 Aug;63:152182. doi: 10.1016/j.apnu.2026.152182. Epub 2026 Jul 13.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A community-based Protective Behavioral Strategies program in people with Alcohol Use, run by Chulalongkorn University at 1 site in Thailand.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jun 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use (time frame: Baseline, 1 month and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713304, which also lists 1 linked publication.
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 30 Jun 2026.