Clinical trial NCT03341455: Family Violence and Alcohol and Drug Misuse in Sri Lanka
Official title: Developing, Implementing and Evaluating Preschool Based Interventions to Address Family Violence and Alcohol and Drug Misuse in Sri Lanka
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Domestic Abuse
Drug and Alcohol Abuse
Keywords: Sri Lanka
preschool
randomized control trial
Lead sponsor: Australian National University
Sponsor class: OTHER
Collaborators: name: University of Peradeniya
name: Department of Foregin Affairs and Trade, Australia
First posted: 2017-11-14
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be implemented using a randomised controlled trial design. Parents with children attending government-managed preschools in two study areas will be recruited to participate. Preschools will be randomly assigned to an intervention or control group. Preschool teachers in the intervention group will also be recruited to participate.
Primary purpose: PREVENTION

Brief summary: The investigators aim to implement a community-based support program delivered by preschool teachers and volunteer parents that will increase awareness, knowledge and uptake of available services for IPV and substance misuse, and of the link between these issues and poorer education outcomes in children. Through this, the aim is to decrease the prevalence of IPV and substance misuse.

The proposed method of implementation is to deliver targeted training to preschool teachers, mothers with children at the preschools, fathers with children at the preschools, and community development officers managing preschools. This project will target the most vulnerable sections of the community and will provide a sustainable and feasible strategy for scale up of the intervention.

By intervening through these preschools the investigators aim to identify and support high-risk families early enough to arrest the cycle of violence that results in children themselves becoming victims and perpetrators of such violence.

Detailed description: This project will be implemented as a cluster-randomised controlled trial (RCT) in preschools in 2 urban study areas. The unit of randomisation will be the preschool.

The intervention is a preschool-based capacity-building and support intervention addressing family violence and alcohol and drug misuse.

The study intervention will be delivered to preschool teachers, local government Community Development Department staff, other key government service providers, and selected mothers and fathers of children attending each preschool. Participants in data collection will be all teachers and parents of children in participating preschools.

Half the preschools in the study areas, selected at random, will receive the intervention initially. Those that do not will act as time-concurrent controls. If the intervention is demonstrated as being effective at the end of the study, these control preschools will subsequently receive the intervention.

This research will address important gaps in literature documented by other researchers by using multiple sources of data to assess the effectiveness of the intervention. Preschool communities have not previously been target populations when addressing domestic violence in Sri Lanka. Results will add to the evidence base for future interventions in Sri Lanka and have potential to contribute to national policy.

Study activities are listed in brief below, and will be subsequently expounded upon in the following sections.

1. A baseline survey at project outset will include mothers and fathers of children utilising these preschools, and will be conducted at the beginning of semester 1 of the project. This survey will include a series of self-report questionnaires, measuring: prevalence of family violence, prevalence of alcohol and drug misuse, depression, child psychological wellbeing, and gender attitudes to establish any baseline differences in prevalence of these factors between intervention and control groups.
2. Selected mothers and fathers from half of the preschools (the intervention group), along with preschool teachers, community development officers, and other government service providers, will receive training associated with the intervention before the end of semester 1.
3. Post intervention surveys with parents will be conducted near the end of the school year (at least 6 months post intervention) in all preschools in both study areas (both intervention and non-intervention groups).
4. Qualitative interviews will also be carried out with key informants associated with the project who received the intervention including teachers, community members, community development staff and other government sector service providers to determine their satisfaction with the intervention, and any challenges or barriers to its implementation.
5. If the intervention is deemed to have been effective, the non-intervention preschools will then receive the training intervention in 2019.

Eligibility criteria: Inclusion Criteria:

* parents must have at least one child attend the targeted preschool
* all participants must be literate in Tamil or Sinhalese or English

Exclusion Criteria:

- anyone with literacy difficulties (as the questionnaires are self-administered)

Primary outcomes:
measure: Difference in prevalence between the intervention and control groups of family violence experienced by preschool mothers.
timeFrame: At least six months post intervention
Secondary outcomes:
measure: Difference in prevalence between the intervention and control groups of alcohol and drug misuse experienced by preschool fathers.
timeFrame: At least six months post intervention
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Australian National University
state: Australian Capital Territory
Study officials:
affiliation: Humanitarian Research Project Leader
name: Kamalini Lokuge, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lokuge K, Wallace P, Subasinghe K, Thurber K, De Silva T, Clarke N, Waas D, Liyanage N, Attygalle U, Carron-Arthur B, Rodrigo K, Banks E, D'Este C, Rajapakse T. Protocol for a cluster-randomised controlled trial evaluating the impact of a preschool-based capacity building intervention on intimate partner violence and substance misuse in Sri Lanka. BMC Public Health. 2018 May 2;18(1):572. doi: 10.1186/s12889-018-5423-8.