Home » Trials » SLCTR/2022/027


A Pilot Study To Inform A 3-Arm Parallel-Group RCT Of An Adapted Brief Intervention For Alcohol Use Disorders In Sri Lanka, And Assess Potential Correlates Of Effectiveness, Such As Early Childhood Trauma

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SLCTR Registration Number

SLCTR/2022/027


Date of Registration

22 Nov 2022

The date of last modification

Nov 24, 2022



Application Summary


Scientific Title of Trial

A Pilot Study To Inform A 3-Arm Parallel-Group RCT Of An Adapted Brief Intervention For Alcohol Use Disorders In Sri Lanka, And Assess Potential Correlates Of Effectiveness, Such As Early Childhood Trauma


Public Title of Trial

To see the feasibility and acceptability of an adapted talking therapy developed by using existent talking therapy of WHO, for excessive use of alcohol, compared with usual care and education about low risk drinking for men who get admitted with alcohol related problems to a tertiary care hospital in Central Province and see whether having subjected to childhood adversities affect the outcome of the intervention


Disease or Health Condition(s) Studied

Alcohol use disorders


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1280-2455


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

2022/EC/56


Trial Details


What is the research question being addressed?

Is adapted brief intervention more effective compared to either educating on low risk drinking or usual care in men admitted with alcohol related problems to a tertiary care hospital and does this outcome correlate with childhood adversities?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Data analysts, Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

Study setting: Teaching Hospital Peradeniya. Method of randomisation: Participants will be randomized according to ABC, BCA, CAB order. Intervention: Adapted Brief Intervention (ABI): The World Health Organization (WHO) has introduced a brief intervention to be used among those with alcohol used disorders. Brief interventions (BIs) are ‘short conversations aiming in a non-confrontational way to motivate individuals to think about and/or plan a change in their drinking behaviour in order to reduce their consumption and/or their risk of harm’. The manual given by the WHO is already adapted by the principal investigator, and comments from five experts were amalgamated. This was repeated until a desired outcome was reached. The adapted brief intervention has taken the cultural aspects of Sri Lanka to consideration, hoping that this will improve the acceptability and effectiveness of the intervention. The manual which the principal investigator has prepared gives guidance to the research assistant on how to proceed with the patient depending on his individual circumstances, level of motivation and what his choice is. The 3 arms are as follows:

  1. Care as usual (CAU arm) (The control arm): The participant will be told about their Alcohol Use Disorders Identification Test (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. 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 'Short Questionnaire for Family Members' (SQFM) will be filled. This will take about 20-30 minutes. The patient is requested to present to THP, with the same family member a RA had contacted with 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.

  2. Adapted Brief Intervention (ABI) arm The RA responsible to 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 60 minutes for the screening and the intervention. After the ABI the patients will receive the AIL as well. The same RA who does the intervention will approach a FM and SQFM will be filled. This will take about 20-30 minutes. The patient is requested to present to THP, with the same family member a RA had contacted with 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. This arm will receive a text message 2 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.

  3. Educating about the concept of ‘Unit of alcohol’ and instances where taking alcohol is risky (UOA arm): Prepared information cards and diagrams which shows 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 AIL. 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 SQFM will be filled. This will take about 20-30 minutes. The patient is requested to present to THP, with the same family member a RA had contacted with 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.


Inclusion criteria

  1. All consenting male patients who are 18 years or above admitted to wards 1,8,12,16 and 17 of Teaching Hospital Peradeniya
  2. All male patients who score 5 or more for Alcohol Use Disorders Identification Test-C (AUDIT-C) which is a screening tool.

Exclusion criteria

  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 in a previous admission
  5. Patients who are not able to communicate adequately in Sinhala


Primary outcome(s)

1.

Timeline Follow Back method will be used to compare alcohol consumption pre and post intervention. Timeline Follow Back, is a tool used to assess the number of drinks the patient consumed each day. The patient has to mark ‘0’ on days he did not consume alcohol. Consumption measured in this manner, four weeks prior to the initial assessment and four weeks of follow-up will be compared between the three arms and also of the same patient to see whether there is any change.

[

Baseline, 4 weeks

]
2.

The score of 'Short Questionnaire for Family Members' This is a questionnaire which assesses the impact of alcohol user on the family member under 4 areas. The outcome is assessed by comparing the sub-score to each area (since lowering of score indicates improvement in some areas while in others, increasing score means improvement), at the beginning of the study and follow up period. The 4 areas are as follows: Impact on the family member (worrying behaviour, active disturbance), symptoms experienced (psychological and physical), how the family member is coping (engaged coping emotional, engaged coping assertive, tolerant inactive coping, withdrawal coping) and available support to the family member (helpful informal support, helpful formal support, unhelpful informal support). Each component is assessed separately at the beginning of the trial and at all follow up encounters.

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Baseline, 4 weeks

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Secondary outcome(s)

1.

None

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Target number/sample size

45 (15 patients per arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2023-01-01


Anticipated end date

2023-04-30


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Australian National University


Regulatory approvals

N/A



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-10-25


Approval number

2022/EC/56


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:Senior Lecturer, Department of Psychiatry, Faculty of Medicine, University of Peradeniya
Telephone:+94718704480
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dewasmika Ariyasinghe
Senior Lecturer
Senior Lecturer, Department of Psychiatry, Faculty of Medicine, University of Peradeniya
+94812389445

+94812389106
dariyasinghe@pdn.ac.lk
https://med.pdn.ac.lk/departments/psychiatry/staff/dewasmika.html

Contact Person for Public Queries

Dewasmika Ariyasinghe
Senior Lecturer
Senior Lecturer, Department of Psychiatry, Faculty of Medicine, University of Peradeniya
+94812389445

+94812389106
dariyasinghe@pdn.ac.lk


Primary study sponsor/organization

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

Secondary study sponsor (If any)

Australian National University
PhD candidate
Mills Rd, Acton ACT 2601, Australia


cphdp.nceph@anu.edu.au
https://nceph.anu.edu.au/

Trial Completion details


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

Yes


IPD sharing plan description

The deidentified data of individual transcripts of the interviews with the participants of the intervention arm will be shared with the supervisory panel if needed. The deidentified results, tables, figures will be shared with the repository of the Australian National University for seven years after publication. This will be accessible only to the principal supervisor through a secure connection


Study protocol available

Yes


Protocol version and date


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