Home » Trials » SLCTR/2017/032


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. -

SLCTR Registration Number

SLCTR/2017/032


Date of Registration

22 Sep 2017

The date of last modification

Sep 22, 2017



Application Summary


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 of Health Condition(s) Studied

Intimate partner violence


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1197-4078


Any other number(s) assigned to the trial and issuing authority

Protocol 2017/066 ANU Human Ethics Research Committee


Trial Details


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Health services research


Intervention(s) planned

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.

Intervention
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.


Inclusion criteria

  1. Volunteers
  2. Over 18 years of age
  3. Literate in Tamil, Sinhalese or English and
  4. Having at least one child attending the targeted preschool. [It is not essential for married couples to both participate. One parent (or a single parent) is welcome to volunteer.]

Exclusion criteria

No specific exclusion criteria identified



Primary outcome(s)

Difference in prevalence between the intervention and control groups of family violence experienced by preschool mothers.

  1. 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).

  2. Mental health and depression using the Sri Lankan specific Peradeniya Depression Scale (PDS).


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

10 months post post commencement of intervention


Secondary outcome

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.

  1. 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)

  2. Difference in prevalence of depression, in control and intervention groups, using the Sri Lankan PDS

  3. Satisfaction with the intervention

  4. Challenges or barriers to its implementation (from qualitative interviews)


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

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.

  1. 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)

  2. Difference in prevalence of depression, in control and intervention groups, using the Sri Lankan PDS

  3. Satisfaction with the intervention

  4. Challenges or barriers to its implementation (from qualitative interviews)



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

Sri Lanka


Anticipated start date

2018-01-15


Anticipated end date

2018-12-31


Recruitment status

Pending


State of ethics review approval

Approved by University of Peradeniya Institutional Ethical Review Committee (2017/EC/17) and Australian National University Human Ethics Research Committee (2017/066).


Funding source

Australian Commonwealth Department of Foreign Affairs and Trade, Peoples Policy Insititute, Sri Lanka, Peradeniya University



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr Kamalini Lokuge, MBBS, MA (IntLaw), PhD(Epi), FAFPHM, OAM
Lead investigator
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


Kamalini.Lokuge@anu.edu.au
http://nceph.anu.edu.au/research

Contact Person for Public Queries

Dr Thilini Rajapakse
Co- Investigator
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


gemba471@gmail.com
http://www.pdn.ac.lk/


Primary study sponsor/organization

Australian Commonwealth Department of Foreign Affairs and Trade
Lead investigator
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

www.dfat.gov.au

Secondary study sponsor (If any)

Mr. Tissa De Silva
Chair
Peoples Policy Institute 19 Wijeyamangalarama Road, Kohuwela, Colombo, Sri Lanka Mi Sevana, 288/42, Colombo Road, Galle Sri Lanka
Tel: +94774632907

kltsds@gmail.com