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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. -

SLCTR Registration Number

SLCTR/2018/037


Date of Registration

12 Nov 2018

The date of last modification

Nov 12, 2018



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 of 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


Purpose

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)

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.


Primary outcome(s) - Time of assessment(s)

Baseline, Pre-intervention, 6 months and 24 months after the intervention is delivered


Secondary outcome

  1. The level of depression as measured by patient health questionnaire -9

  2. Hospital Records: Alcohol associated injury; Deliberate Self-harm, Road accidents, hospital presentations with domestic and interpersonal violence, Sexual assault, alcohol withdrawal

  3. Police records; Public drunkenness, Suicide, Road accidents, Domestic and interpersonal violence, Sexual assault

  4. Child growth outcomes by linking routine data of repeated measures of children’s height and weight which is collected by provincial


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by Ethics Review Committee, Faculty of Medicine& Allied Sciences, Rajarata University of Sri Lanka on 3rd July 2018 (Ref. No:ERC/2018/21)


Funding source

NHMRC Global Alliance for Chronic Diseases. APP1146354



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