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.

Pearson, M; Dawson, A; Raubenheimer, J; Senerathna, L; Conigrave, K; Lee, KSK; Rajapakse, T; Pushpakumara, PHGJ; Siribaddana, S; Soerensen, JB; Konradsen, F; Jan, S; Dawson, AJ; Buckley, N; Abeysinghe, R; Siriwardhana, P; Priyadarshana, C; Haber, PS; Dzidowska, M; Abeykoon, P; Glozier, N

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.

Pearson, M Dawson, A

Raubenheimer, J Senerathna, L Conigrave, K Lee, KSK Rajapakse, T Pushpakumara, PHGJ Siribaddana, S Soerensen, JB Konradsen, F Jan, S Dawson, AJ Buckley, N Abeysinghe, R Siriwardhana, P Priyadarshana, C Haber, PS Dzidowska, M Abeykoon, P Glozier, N

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Publisher:: BMJ
Publication Type:: Journal Article
Citation:: BMJ Open, 2023, 13, (6), pp. e064722
Issue Date:: 2023-06-15

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Field	Value	Language
dc.contributor.author	Pearson, M
dc.contributor.author	Dawson, A https://orcid.org/0000-0003-0926-2202
dc.contributor.author	Raubenheimer, J
dc.contributor.author	Senerathna, L
dc.contributor.author	Conigrave, K
dc.contributor.author	Lee, KSK
dc.contributor.author	Rajapakse, T
dc.contributor.author	Pushpakumara, PHGJ
dc.contributor.author	Siribaddana, S
dc.contributor.author	Soerensen, JB
dc.contributor.author	Konradsen, F
dc.contributor.author	Jan, S
dc.contributor.author	Dawson, AJ
dc.contributor.author	Buckley, N
dc.contributor.author	Abeysinghe, R
dc.contributor.author	Siriwardhana, P
dc.contributor.author	Priyadarshana, C
dc.contributor.author	Haber, PS
dc.contributor.author	Dzidowska, M
dc.contributor.author	Abeykoon, P
dc.contributor.author	Glozier, N
dc.date.accessioned	2023-09-25T23:44:30Z
dc.date.available	2023-09-25T23:44:30Z
dc.date.issued	2023-06-15
dc.identifier.citation	BMJ Open, 2023, 13, (6), pp. e064722
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/172290
dc.description.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.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ
dc.relation.ispartof	BMJ Open
dc.relation.isbasedon	10.1136/bmjopen-2022-064722
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
dc.subject.classification	32 Biomedical and clinical sciences
dc.subject.classification	42 Health sciences
dc.subject.classification	52 Psychology
dc.subject.mesh	Humans
dc.subject.mesh	Sri Lanka
dc.subject.mesh	COVID-19
dc.subject.mesh	Health Education
dc.subject.mesh	Counseling
dc.subject.mesh	Alcohol Drinking
dc.subject.mesh	Humans
dc.subject.mesh	Alcohol Drinking
dc.subject.mesh	Counseling
dc.subject.mesh	Health Education
dc.subject.mesh	Sri Lanka
dc.subject.mesh	COVID-19
dc.subject.mesh	Humans
dc.subject.mesh	Sri Lanka
dc.subject.mesh	COVID-19
dc.subject.mesh	Health Education
dc.subject.mesh	Counseling
dc.subject.mesh	Alcohol Drinking
dc.title	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.
dc.type	Journal Article
utslib.citation.volume	13
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
utslib.for	1199 Other Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - WHO CC
utslib.copyright.status	open_access	*
dc.date.updated	2023-09-25T23:44:24Z
pubs.issue	6
pubs.publication-status	Published online
pubs.volume	13
utslib.citation.issue	6

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.

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http://hdl.handle.net/10453/172290