Home » Trials » SLCTR/2018/037
A stepped wedge trial of the scaling up of a community-based alcohol education program in rural Sri Lankan villages and its effects on alcohol use, and associated harms, depression and social capital.
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SLCTR Registration Number
SLCTR/2018/037
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A stepped wedge trial of the scaling up of a community-based alcohol education program in rural Sri Lankan villages and its effects on alcohol use, and associated harms, depression and social capital.
Public Title of Trial
The effects of a community based alcohol education program in rural Sri Lankan villages on alcohol use, social dynamics and mental health outcomes
Disease or Health Condition(s) Studied
Alcohol misuse
Scientific Acronym
THEATRE
Public Acronym
THEATRE
Brief title
None
Universal Trial Number
U1111-1220-5732
Any other number(s) assigned to the trial and issuing authority
ERC/2018/21 (ERC- Rajarata University of Sri Lanka)
What is the research question being addressed?
Does a community-based alcohol education program reduce alcohol use and associated harms in villages in rural Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Historical
Assignment
Other
Purpose
Prevention
Study Phase
Phase 2
Intervention(s) planned
All adults over 18 years living in 20 “at risk” villages (defined as being in the highest tertile of villages with problematic drinking patterns from previous surveys) in the North Central Province.
Each village will receive interventions over a period of 12 weeks.
As the intervention is rolled out to villages at different times this allows both comparisons between villages randomised to control time versus intervention time, as well as pre and post intervention comparisons within each village.
The interventions are multi-modal comprising of:
Health clinic providing brief alcohol interventions. These interventions are based upon those used by NATA (Sri Lankan National Authority on Tobacco and Alcohol)
Four ‘village based forum’ dramas over 11 weeks. These dramas contain various health messages and encourage audience participation. The dramas are delivered by students trained by the Faculty of Fine Arts, University of Peradeniya
Community health promotion materials including Posters/DVDs/Information pamphlets previously used in the pilot program
Inclusion criteria
Cluster inclusion criteria:
• Village identified with harmful drinking or conflicts related to alcohol
Participant inclusion criteria:
• Be a permanent resident of the village
• Be aged 18 and over
Exclusion criteria
• Children (persons under 18 years of age)
• Cognitively impaired people
Primary outcome(s)
|
1.
To determine whether the intervention sustainably reduces alcohol use in males in at risk Sri Lankan villages using the Alcohol Use Disorders Identification Test (AUDIT) questionnaire. |
[ Baseline, Pre-intervention, 6 months and 24 months after the intervention is delivered ] |
Secondary outcome(s)
|
1.
The level of depression as measured by patient health questionnaire -9 |
[ Baseline, Pre-intervention, 6 months and 24 months after the intervention is delivered ] |
|
2.
Hospital Records: Alcohol associated injury; Deliberate Self-harm, Road accidents, hospital presentations with domestic and interpersonal violence, Sexual assault, alcohol withdrawal |
[ Baseline, Pre-intervention, 6 months and 24 months after the intervention is delivered ] |
|
3.
Police records; Public drunkenness, Suicide, Road accidents, Domestic and interpersonal violence, Sexual assault |
[ Baseline, Pre-intervention, 6 months and 24 months after the intervention is delivered ] |
|
4.
Child growth outcomes by linking routine data of repeated measures of children’s height and weight which is collected by provincial |
[ Baseline, Pre-intervention, 6 months and 24 months after the intervention is delivered ] |
Target number/sample size
20 cluster villages
Countries of recruitment
Sri Lanka
Anticipated start date
2018-12-01
Anticipated end date
2022-06-30
Date of first enrollment
2018-12-11
Date of study completion
Recruitment status
Recruiting
Funding source
NHMRC Global Alliance for Chronic Diseases. APP1146354
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-07-03
Approval number
ERC/2018/21
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka |
| Institutional Address: | 2nd Floor, Para-clinical Building Faculty of Medicine and Allied Sciences Rajarata University of Sri Lanka Saliyapura, Sri Lanka |
| Telephone: | +94 252053633 |
| Email: | ethicsreviewcommittee@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Andrew Dawson
Clinical Professor of Medicine
The University of Sydney,
1-3 Ross St (K06),
Glebe NSW 2006
Tel: +61 2 9351 6131
Andrew.Dawson@sydney.edu.au
Contact Person for Public Queries
Dr Lalith Senarathna
Health Promotion Division,
Faculty of Applied Sciences,
Rajarata University
Tel: 025 2266131
l_senarathna@hotmail.com
Primary study sponsor/organization
The University of Sydney
1-3 Ross St (K06),
Glebe NSW 2006
Tel: +61 2 9351 6131
Andrew.Dawson@sydney.edu.au
Secondary study sponsor (If any)
South Asian Clinical Toxicology Research Collaboration
Faculty of Medicine,
University of Peradeniya
Tel: 0814479822
Fax: 0814479822
enquiry@sactrc.org
www.sactrc.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
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
