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
The date of last modification
Jul 21, 2026
Trial Status
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
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:
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.
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.
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
Exclusion criteria
Primary outcome(s)
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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. |
[ Baseline, 4 weeks ] |
Secondary outcome(s)
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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
2023-01-24
Date of study completion
2023-02-04
Recruitment status
Complete: follow up complete
Funding source
Australian National University
Regulatory approvals
N/A
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 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/
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
Yes
Date of posting results
Date of study completion
2023-02-04
Final sample size
48
Date of first publication
Link to results
Brief summary of results
Background Risky drinking (RD) is a major health hazard in Sri Lanka. Alcohol brief intervention (BI) has been proven effective in minimizing RD but has not been utilised in Sri Lanka. We therefore aimed to adapt the WHO alcohol BI and targeted educational material to Sri Lanka, assess their feasibility and acceptability and evaluate appropriateness of methodology and measures for a future RCT. Study design A three-arm parallel-group pilot RCT. Methods The BI was adapted based on expert feedback. The study included male inpatients (with AUDIT-C screening score ?5) of a tertiary hospital. The three study arms were: adapted brief intervention (ABI), education about unit of alcohol (UOA), and feedback on screening results (FOA). Trained research assistants (RAs) screened and implemented the interventions. We report on follow-up rates (feasibility), participant and RA feedback (acceptability), recruitment efficiency and data quality (methodological appropriateness), and appropriateness of outcome measures. Results The ABI included a structured training manual for implementers, an alcohol information leaflet, and a personal information sheet. Patient follow-up rates were 69 %, 40 % and 71 % for FOA, UOA and ABI arms respectively. Family member recruitment was 31 %. Patient and RA feedback for ABI was overwhelmingly positive. Many patients were abstinent at baseline (37.5 %) and follow-up (75.9 %), mainly due to health concerns. FMQ revealed high ‘total family burden’. Patients struggled with TLFB recall. High childhood adversity prevalence (95.7 %) and low alcohol knowledge were observed. Conclusions The ABI demonstrated high acceptability among patients and RAs. All three interventions could be trialled in a future RCT. All measures except TLFB proved appropriate. Our innovative approach of evaluating outcomes from family members' perspectives proved feasible and valuable. The inpatient setting was not appropriate, rather a setting where patients continue their day-to-day activities, including usual drinking, should be considered in a future RCT.
