Family Violence and Alcohol and Drug Misuse in Sri Lanka

July 1, 2019 updated by: Polly Wallace, Australian National University

Developing, Implementing and Evaluating Preschool Based Interventions to Address Family Violence and Alcohol and Drug Misuse in Sri Lanka

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2600
        • Australian National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Intervention preschools

Capacity building to support families affected by IPV & substance misuse will be provided to the intervention preschools.

Specifically, capacity building, training and support will be provided to

  • selected mothers on the provision of safe, confidential and relevant community-based referral and support services for women affected by IPV.
  • selected fathers on the provision of safe, confidential and relevant community-based referral and support to men seeking support for substance misuse problems.
  • intervention preschool teachers on provision of IPV and substance misuse prevention educational messages and referral pathways to services for these issues.
Training targeted groups (mothers, fathers, preschool teachers, community officers managing preschools) separately with the 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.
NO_INTERVENTION: Control preschool
No intervention or training will not be provided to the control group in order to assess the impact of the intervention between the control and intervention arms of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in prevalence between the intervention and control groups of family violence experienced by preschool mothers.
Time Frame: At least six months post intervention
Mothers from all participating preschools ( both intervention and control groups) will be surveyed to measure prevalence of family violence at 6 months after implementation of the intervention. The survey for mothers will include questions adapted from the World Health Organization Multi Country Survey of Violence against Women that will indicate prevalence of violence against them by their husband (or intimate partner). The survey will also include the Sri Lankan specific Peradeniya Depression Scale to measure mental health and depression in adults.
At least six months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in prevalence between the intervention and control groups of alcohol and drug misuse experienced by preschool fathers.
Time Frame: At least six months post intervention
Volunteer fathers from the preschool will be surveyed to measure the impact of the intervention on prevalence of alcohol and drug misuse. This survey will include locally validated versions of the Alcohol Used Disorders Identification Test (AUDIT), the Drug Abuse Screening Test (DAST) and the Sri Lankan specific Peradeniya Depression Scale to measure mental health and depression in adults.
At least six months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kamalini Lokuge, Dr, Humanitarian Research Project Leader

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 23, 2018

Primary Completion (ACTUAL)

December 30, 2018

Study Completion (ACTUAL)

February 28, 2019

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

November 11, 2017

First Posted (ACTUAL)

November 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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