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

12 Nov 2018

The date of last modification

Feb 11, 2019



Application Summary


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)


Trial Details


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:

  1. Health clinic providing brief alcohol interventions. These interventions are based upon those used by NATA (Sri Lankan National Authority on Tobacco and Alcohol)

  2. 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

  3. 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



State of Ethics Review Approval


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 & Sponsor Information


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

Trial Completion details


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