Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial

Melissa Pearson; Andrew Dawson; Jacques Raubenheimer; Lalith Senerathna; Katherine Conigrave; K S Kylie Lee; Thilini Rajapakse; Pahala Hangidi Gedara Janaka Pushpakumara; Sisira Siribaddana; Jane Brandt Soerensen; Flemming Konradsen; Stephen Jan; Angela J Dawson; Nicholas Buckley; Ranil Abeysinghe; Prabash Siriwardhana; Chamil Priyadarshana; Paul S Haber; Monika Dzidowska; Palitha Abeykoon; Nick Glozier

doi:10.1136/bmjopen-2022-064722

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial

BMJ Open. 2023 Jun 15;13(6):e064722. doi: 10.1136/bmjopen-2022-064722.

Authors

Melissa Pearson^{1

2

3}, Andrew Dawson^{2

3}, Jacques Raubenheimer⁴, Lalith Senerathna^{3

5}, Katherine Conigrave^{6

7

8}, K S Kylie Lee^{7

8}, Thilini Rajapakse^{3

9}, Pahala Hangidi Gedara Janaka Pushpakumara^{3

10}, Sisira Siribaddana¹¹, Jane Brandt Soerensen¹², Flemming Konradsen¹², Stephen Jan¹³, Angela J Dawson¹⁴, Nicholas Buckley^{3

4}, Ranil Abeysinghe⁹, Prabash Siriwardhana^{3

5}, Chamil Priyadarshana³, Paul S Haber^{6

7

8}, Monika Dzidowska⁷, Palitha Abeykoon¹⁵, Nick Glozier¹⁶

Affiliations

¹ Centre for Pesticide Suicide Prevention, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK Melissa.Pearson@ed.ac.uk.
² Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
³ South Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka.
⁴ Biomedical Informatics and Digital Health, University of Sydney, Sydney, New South Wales, Australia.
⁵ Department of Health Promotion, Faculty of Applied Sciences, Rajarata University of Sri Lanka, Mihintale, Sri Lanka.
⁶ Sydney Medical School, Royal Prince Albert Hospital, Camperdown, New South Wales, Australia.
⁷ NHMRC Centre of Research Excellence in Indigenous Health and Alcohol, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
⁸ The Edith Collins Centre (Translational Research in Alcohol Drugs and Toxicology), Sydney Local Health District, Camperdown, New South Wales, Australia.
⁹ Department of Psychiatry, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
¹⁰ Department of Family Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Peradeniya, Sri Lanka.
¹¹ Department of Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka.
¹² Global Health Section, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
¹³ The George Institute for Global Health, Sydney, New South Wales, Australia.
¹⁴ Faculty of Health, World Health Collaborating Centre, University of Technology, Sydney, Sydney, New South Wales, Australia.
¹⁵ National Authority on Tobacco and Alcohol, Colombo, Sri Lanka.
¹⁶ Brain and Mind Research Institute, University of Sydney, Sydney, New South Wales, Australia.

Abstract

Introduction: Alcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19.

Methods and analysis: We aimed to recruit 20 villages (approximately n=4000) in rural Sri Lanka. The proposed intervention consisted of health screening clinics, alcohol brief intervention, participatory drama, film, and public health promotion materials to be delivered over 12 weeks.Following disruptions to the trial resulting from the Easter bombings in 2019, COVID-19 and a national financial crisis, we adapted the study in two main ways. First, the interventions were reconfigured for hybrid delivery. Second, a rolling pre-post study evaluating changes in alcohol use, mental health, social capital and financial stress as the primary outcome and implementation and ex-ante economic analysis as secondary outcomes.

Ethics and dissemination: The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and February 2022) and the University of Sydney (2019/006). Findings will be disseminated locally in collaboration with the community and stakeholders.The new hybrid approach may be more adaptable, scalable and generalisable than the planned intervention. The changes will allow a closer assessment of individual interventions while enabling the evaluation of this discontinuous event through a naturalistic trial design. This may assist other researchers facing similar disruptions to community-based studies.

Trial registration: The trial is registered with the Sri Lanka Clinical Trials Registry; https://slctr.lk/trials/slctr-2018-037.

Keywords: Depression & mood disorders; PREVENTIVE MEDICINE; PUBLIC HEALTH; Substance misuse.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Alcohol Drinking / prevention & control
COVID-19* / epidemiology
COVID-19* / prevention & control
Counseling / methods
Health Education
Humans
Sri Lanka / epidemiology