SLCTR Registration Number
Date of Registration
The date of last modification
Sep 22, 2017
Scientific Title of Trial
Randomized control trial: preschool-based training and support programs to reduce intimate partner violence (IPV) by addressing alcohol and drug misuse in young families in Sri Lanka.
Public Title of Trial
Intimate partner violence and alcohol and drug misuse in Sri Lanka
Disease or Health Condition(s) Studied
Intimate partner violence
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
Protocol 2017/066 ANU Human Ethics Research Committee
What is the research question being addressed?
Are preschool-based training and support programs addressing alcohol and drug misuse effective in reducing intimate partner violence in young families in Sri Lanka?
Type of study
Randomized controlled trial
Masking not used
Health services research
Study setting: Government run preschools in Galle and Colombo municipalities.
Target population and specific participant groups: parents of children attending government preschools in two urban municipalities. Participants who volunteer will be grouped into mothers, fathers and teachers as part of the study protocol.
Randomization will be at the level of the preschool, stratified by the study area (municipality). Half of the preschools in each study area will be randomly allocated to receive the intervention at the beginning of the preschool year. Randomization will be undertaken by the study statistician based outside the study areas, blinded to study site and preschool, and using a computer generated randomization process. The allocation program will be archived for reproducible research compliance.
We aim to implement a community-based support program delivered by preschool teachers and volunteer parents that will increase awareness, knowledge and uptake of services for domestic violence, and substance misuse, and of the link between these issues and poorer education outcomes in children. Training and resource materials will be developed by the project team through workshops with local service providers, and with input from local and international experts. These materials will build on and adapt existing resources developed locally and internationally and shown to have value in multiple settings, including those with limited resources.Training will be delivered by local members of the study team (including psychiatrists and government officers).
Standard of care provided to the control arm
The control arm of the trial will not receive any intervention. However, services that address IPV are available in all study areas.
If the intervention is deemed to have been effective, the non-intervention preschools will then receive the training intervention in 2019.
Measures for appropriate referral if necessary (during intervention) All parents will be provided with an initial participant information sheet which will have information on how to access available support services related to family violence/IPV and alcohol or drug use at any time. Also, this information sheet will list various sources in the community (teachers, community workers) through which they can further access additional support and information. During data collection, survey supervisors will be onsite and any participant requiring immediate support can access these supervisors. Survey supervisors will be trained in the provision of safe, non-judgemental and appropriate support. Information related to family violence, alcohol and drug management services in the community will be provided to those participants who request it.
Teachers and the survey team will receive training on how to recognise and deal with a hostile person in this setting.
No specific exclusion criteria identified
Difference in prevalence between the intervention and control groups of family violence experienced by preschool mothers.
Prevalence of IPV, awareness and uptake of services, and gender attitudes including questions adapted from the World Health Organization (WHO) Multi Country Survey of Violence against Women (MCSVAW).
Mental health and depression using the Sri Lankan specific Peradeniya Depression Scale (PDS).
10 months post post commencement of intervention]
The secondary outcomes for the study will come from responses by fathers and from qualitative data collected from preschool teachers during face to face interviews post intervention.
Difference in prevalence of alcohol and drug misuse, in control and intervention groups, using locally validated versions of the Alcohol Used Disorders Identification Test (AUDIT), the Drug Abuse Screening Test (DAST)
Difference in prevalence of depression, in control and intervention groups, using the Sri Lankan PDS
Satisfaction with the intervention
Challenges or barriers to its implementation (from qualitative interviews)
10 months post commencement of intervention]
Target number/sample size
In total, 680 families (680 fathers and 680 mothers) with 340 families in each arm (340 mothers and 340 fathers)
Countries of recruitment
Anticipated start date
Anticipated end date
Date of first enrollment
Date of study completion
Australian Commonwealth Department of Foreign Affairs and Trade, Peoples Policy Insititute, Sri Lanka, Peradeniya University
Date of Approval
Details of Ethics Review Committee
Contact person for Scientific Queries/Principal Investigator
Dr Kamalini Lokuge, MBBS, MA (IntLaw), PhD(Epi), FAFPHM, OAM
National Centre for Epidemiology & Population Health Research School of Population Health College of Health & Medicine The Australian National University 62 Mills Road Acton ACT 2601, Australia
Tel: +61 2 61256303
Contact Person for Public Queries
Dr Thilini Rajapakse
Senior Lecturer in Psychiatry Department of Psychiatry Faculty of Medicine University of Peradeniya, Sri Lanka, and Consultant Psychiatrist Psychiatry Unit Teaching Hospital Peradeniya
Tel: +94 777 386232
Primary study sponsor/organization
Australian Commonwealth Department of Foreign Affairs and Trade
Department of Foreign Affairs and Trade R.G. Casey Building John McEwen Crescent Barton ACT 0221 Australia
Tel: +61 2 6261 1111
Fax: +61 2 6261 3111
Secondary study sponsor (If any)
Mr. Tissa De Silva
Peoples Policy Institute 19 Wijeyamangalarama Road, Kohuwela, Colombo, Sri Lanka Mi Sevana, 288/42, Colombo Road, Galle Sri Lanka
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Results summary available
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results