Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention for High-risk Drinking University Students

September 24, 2019 updated by: Dr. Wang Man-Ping, The University of Hong Kong

A Pilot Study on the Feasibility of Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention to Reduce High-risk Drinking Among University Students in Hong Kong

The aims of this pilot study are:

  1. To examine the factors associated with alcohol drinking and alcohol use disorder
  2. To examine the effect of face-to-face alcohol brief intervention on drinking reduction
  3. To examine the effect of a continuous interactive chat-based intervention via "WhatsApp" on drinking reduction
  4. To explore the perception of face-to-face alcohol brief intervention
  5. To explore the perception of continuous interactive chat-based intervention via instant messaging mobile application "WhatsApp"

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

According to the Department of Health, majority of people in Hong Kong started to develop drinking habit at 18-21 years of age in 2014/2015. Amongst them, 16.8% had scored higher than 3 in the Alcohol Use Disorders Identification Test for Consumption (AUDIT-C) (an abbreviated version of the Alcohol Use Disorders Identification Test, or AUDIT, designed by the World Health Organization(WHO)), while 3.5% had even scored 8 or above in the test. With higher prevalence to begin drinking within 18 and 23 years old, university students could have established higher tendency of harmful drinking and alcohol dependence as compared with other age groups. Therefore, early interventions such as the evidence-based Alcohol Brief Intervention (ABI) suggested by the WHO are particularly needed to target university drinkers who are 5% more likely to develop higher frequency of drinking in later of their lives compared with other age groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • School of Nursing, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hong Kong resident aged 18 to 26 inclusive
  • Scored 5-19 inclusive in the Alcohol Use Disorder Identification Test (AUDIT)
  • Able to communicate in Chinese and read Chinese
  • Using a phone with instant messaging mobile application "WhatsApp" installed for communication

Exclusion Criteria:

  • Students with communication barrier (either physically or cognitively)
  • Currently participating in other alcohol treatment services or clinics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Alcohol brief intervention+mobile chat-based instant messages
Behavioral: Mobile chat-based instant messages
Subjects in the active arm study will receive continuous interactive chat-based intervention as an extension of alcohol brief intervention at baseline. The interactive mobile chat will be carried out on Friday night and Saturday before and during the period of "happy hour" and ask for drinking and giving personalized advises on drinking reduction using behavioral change techniques.
Behavioral: Alcohol brief intervention
Those in the control arm will be assigned to only receive the face-to-face ABI. The ABI consists of: (1) giving feedback and information about the screening result in phase I and hazard of drinking; (2) emphasizing the benefits of reduce drinking and informing about alcohol problems; (3) setting goal on reducing alcohol consumption; (4) reviewing advice and ;(5) giving encouragement.
Other Names:
  • ABI
Active Comparator: control group
Alcohol brief intervention
Behavioral: Alcohol brief intervention
Those in the control arm will be assigned to only receive the face-to-face ABI. The ABI consists of: (1) giving feedback and information about the screening result in phase I and hazard of drinking; (2) emphasizing the benefits of reduce drinking and informing about alcohol problems; (3) setting goal on reducing alcohol consumption; (4) reviewing advice and ;(5) giving encouragement.
Other Names:
  • ABI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in AUDIT score
Time Frame: 2 weeks after baseline
Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use)
2 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in number of standard drinks
Time Frame: 2 weeks after baseline
Defined by either increase or decrease in standard drinks number
2 weeks after baseline
Attempt to reduce drinking
Time Frame: 2 weeks after baseline
Have tried to reduce drinking either successful or not
2 weeks after baseline
Change in confidence to reduce drinking
Time Frame: 2 weeks after baseline
Defined by either increase or decrease confidence in reduce drinking
2 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pilot alcohol study (Unists)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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