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A pilot study to assess the feasibility and acceptability of culturally adapted brief intervention for risky drinkers, to outpatient setting in Sri Lankan context and the assessment tools to inform a future randomized control trial.

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SLCTR Registration Number

SLCTR/2024/018


Date of Registration

03 Jun 2024

The date of last modification

Jul 15, 2024



Application Summary


Scientific Title of Trial

A pilot study to assess the feasibility and acceptability of culturally adapted brief intervention for risky drinkers, to outpatient setting in Sri Lankan context and the assessment tools to inform a future randomized control trial.


Public Title of Trial

A pilot study to assess the feasibility and acceptability of a culturally adapted, ‘brief intervention’ vs ‘education about low risk drinking’ vs standard care for risky drinkers, in an outpatient setting in the Central Province, Sri Lanka.


Disease or Health Condition(s) Studied

Alcohol use disorders


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1302-6945


Any other number(s) assigned to the trial and issuing authority

2023/EC/83 - Ethics Review Committee, Faculty of Medicine, University of Peradeniya


Trial Details


What is the research question being addressed?

What is the feasibility and acceptability of testing an adapted brief intervention compared to either educating on low risk drinking or usual care in men with alcohol related problems presenting to the out-patient department of a tertiary care hospital?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Supportive care


Study Phase

Not Applicable


Intervention(s) planned

Brief intervention proposed by the WHO for hazardous and harmful alcohol use has been adapted by the principal investigator, to Sri Lanka to be used by the health care workers and by volunteers. This adapted brief intervention was tested in a previous pilot study (SLCTR/2022/027).

The pilot study will be done at Teaching Hospital Peradeniya (THP).

Block randomization will be used, where the patients will be allocated to a particular arm depending on the time of the day, they present to the OPD, and this will alternate. (e.g.: On the day of commencement of the data collection, the patients presenting to the OPD from 8 a.m.-12 noon will be allocated to CAU arm, 1 p.m.- 4 p.m. to UOA arm, 8 a.m.- 12 noon next day to ABI arm and 1-4 p.m. to CAU arm, and so on.) Therefore, the patients presenting to anytime of the day where OPD functions (i.e. from Monday to Friday from 8 a.m.to 4 p.m. and on Saturday from 8 a.m. to 12 noon) have equal chance of getting into any arm randomly.

There will be three arms. Two interventional arms and a control arm.

Interventional arms: the arm which receives improved version of the adapted intervention following the previous trial (ABI arm) and another arm receiving education about low risk drinking (UOA arm). The control arm will be 'Care as usual.'

The 2 intervention arms will be:

  1. Adapted Brief Intervention (ABI):

The Research Assistant (RA) responsible for this arm will carry out the ABI according to the instructions given in the manual (prepared by the principal investigator). The RAs who do the screening will do the intervention, so that they will have better rapport with the patients. It will take about 40-50 minutes for the screening, filling in the necessary questionnaires and the intervention. The intervention per se will take about 20-30 minutes. After the ABI the patients will receive the Alcohol information leaflet (AIL) as well. The same RA who does the intervention will approach a family member (FM) and Family member questionnaire FMQ will be filled. This will take about 15-20 minutes. This arm will receive a text message every 4 weeks after the intervention; ‘How are you going with your plan?’ to which the patient does not have to respond to, and this is just to remind them of the plan.

  1. Educating about the concept of ‘Unit of alcohol’ and instances where taking alcohol is risky (UOA arm):

Prepared information cards and diagrams which show what is meant by a ‘unit of alcohol’ and the volume of liquor (in glasses, cans, packets, bottles) in each type of commonly used alcoholic beverage containing a ‘unit of alcohol (UOA)’ will be used. The participant will be educated that he can take only 2 UOA for a day (emphasizing not per occasion) (expressing in the measure in the type of liquor he frequently takes) and about the things that he should avoid doing after taking even this amount of alcohol. They will also be educated that the risks will increase if he takes more than 4 UOA a day. The participants will receive the Alcohol information leaflet (AIL). It will take about 15-20 minutes for the screening, filling in the necessary questionnaires and the education. The intervention per se will take about 3-5 minutes. This group of participants will not get any follow-up messages. The same RA who talked to the patient will approach a family member (FM) and 'Short Questionnaire for Family Members' (SQFM) will be filled. This will take about 20-30 minutes. The patient is requested to present to the hospital with the same family member a RA had contacted at the recruitment, 4 weeks after the initial contact. It will take 15-20 minutes with the patient and 20-30 minutes with the FM.

Care as Usual Arm (CAU arm) (The control arm):

The participant will be told about their AUDIT score and that his consumption is likely to have caused problems already or is likely to cause him problems in the future. The alcohol information leaflet (AIL) will be given to him. It will take about 10-15 minutes for the screening, filling in the necessary questionnaires and informing about his AUDIT-C score and what it means. This group of participants will not get any follow-up calls. The same research assistants (RA) who talked to the patient will approach a family member (FM) and the Family Member Questionnaire (FMQ) will be filled. This will take about 15-20 minutes.

All the participants in three arms are requested to present to THP at 4 weeks, 12 weeks and 26 weeks after the initial contact. The family members will be requested to come 26 weeks after the initial assessment. It will take 15-20 minutes with the patient and 15-20 minutes with the FM.

For the Pilot study the follow up period will be 26 weeks.

Alcohol Information Leaflet (AIL): The AIL consists of simple illustrations and text to provide a basic understanding of; the effects of alcohol on the body, what constitutes a standard drink or 'UOA’ and ‘binge drinking’ for commonly consumed liquor types in Sri Lanka, what is meant by risky drinking and information on how to seek help. The leaflet includes basic information which will help people to make an informed choice whether or not to use alcohol, how to take alcohol (if one wants to) with minimal risk, emphasizing ‘zero alcohol’ is the best.


Inclusion criteria

The male patients who are =/> 18 years presenting to the out-patient department of Teaching Hospital Peradeniya, who score >4 for AUDIT-C will be eligible to participate in the study.


Exclusion criteria

If a patient has at least one of the following criteria, he will be For the Pilot study the follow up period will be 26 weeks. excluded from the study.

  1. The patients who have ongoing serious physical or mental illness, making them incapable of following the directions given
  2. The patients who are already on therapy/ intervention to reduce alcohol related harms.
  3. The patients who choose to go for specialized psychiatry care due to the severity of their ARPs (Others in this category will be chosen since BI could be helpful in some such patients (WHO, 2017)
  4. If the patient has been recruited in the current study on a previous occasion
  5. Patients who are not able to communicate adequately in Sinhala.


Primary outcome(s)

1.

Measuring acceptability of the ABI to the patient:

  1. The questionnaire which was used in the previous pilot study (SLCTR/2022/027) by the investigators of the current study to assess participant satisfaction and acceptability of the ABI using several domains; content, setting, qualities of the individual who delivers the intervention, attitude and perceived effectiveness towards ABI will be used (Attached in the email).
[

At the recruitment and at 4, 12 and 26 weeks

]
2.

Measuring acceptability of the ABI to the RAs: The questionnaire used in the previous pilot study (SLCTR/2022/027) by the investigators of the current study to get the feedback from the RAs will be used. It assesses the training they received on alcohol and the study before the commencement of the study, their perception of how the patient receives the brief intervention, how confident they felt when talking to the patient, length of the session, what they like/ dislike about the brief intervention and comments to improve (Attached in the email).

[

At the recruitment and at 4, 12 and 26 weeks

]
3.

Measuring feasibility of the study: This will be determined by the rate at which the patients can be recruited into the study as well as from the rates at which the patients and the family members would attend the follow-up visits

[

At the recruitment and at 4, 12 and 26 weeks

]

Secondary outcome(s)

1.

None

[]

Target number/sample size

150 (50 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2024-06-04


Anticipated end date

2025-02-28


Date of first enrollment

2024-06-14


Date of study completion


Recruitment status

Recruiting


Funding source

Australian National University


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2024-03-07


Approval number

2023/EC/83


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:Faculty of Medicine, University of Peradeniya
Telephone:+94-812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dewasmika Ariyasinghe
Professor in Psychiatry
Department of Psychiatry, Faculty of Medicine, University of Peradeniya
+94812389445
+94718704480
+94812389106
dewasmika.ariyasinghe@med.pdn.ac.lk
https://med.pdn.ac.lk/departments/psychiatry/staff/dewasmika.html

Contact Person for Public Queries

Dewasmika Ariyasinghe
Professor in Psychiatry
Department of Psychiatry, Faculty of Medicine, University of Peradeniya
+94812389445
+94718704480
+94812389106
dewasmika.ariyasinghe@med.pdn.ac.lk
https://med.pdn.ac.lk/departments/psychiatry/staff/dewasmika.html


Primary study sponsor/organization

Department of Psychiatry, Faculty of Medicine, University of Peradeniya

Department of Psychiatry, Faculty of Medicine, University of Peradeniya
+94812389445
+94812389106
dewasmika.ariyasinghe@med.pdn.ac.lk
https://med.pdn.ac.lk/departments/psychiatry/staff/dewasmika.html

Secondary study sponsor (If any)

Australian National University

Australian National University Mills Rd, Acton ACT 2601, Australia


u7087000@anu.edu.au
https://nceph.anu.edu.au/people/students/dr-dewasmika-ariyasinghe

Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

1. All individual participant data collected during the trial, after deidentification, if requested by other researchers 2. Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices)


Study protocol available

Yes


Protocol version and date

Version 2.0


Protocol URL


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results