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Family Violence and Alcohol and Drug Misuse in Sri Lanka

Primary Purpose

Intimate Partner Violence, Domestic Abuse, Drug and Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Capacity building to support families affected by IPV & substance misuse
Sponsored by
Australian National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intimate Partner Violence focused on measuring Sri Lanka, preschool, randomized control trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Australian National University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention preschools

Control preschool

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in prevalence between the intervention and control groups of alcohol and drug misuse experienced by preschool fathers.
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.

Full Information

First Posted
April 12, 2017
Last Updated
July 1, 2019
Sponsor
Australian National University
Collaborators
University of Peradeniya, Department of Foregin Affairs and Trade, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT03341455
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Australian National University
Collaborators
University of Peradeniya, Department of Foregin Affairs and Trade, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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. 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. 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). 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. If the intervention is deemed to have been effective, the non-intervention preschools will then receive the training intervention in 2019.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intimate Partner Violence, Domestic Abuse, Drug and Alcohol Abuse
Keywords
Sri Lanka, preschool, randomized control trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Allocation of interventions cannot be concealed from either training staff or study participants once implementation occurs. All data collectors will be blinded to the intervention status of preschools. The study will be presented as a project related to family health and wellbeing, no specific study hypotheses will be presented to participants, and data collectors will not be involved in delivering the intervention. However, parents at preschools receiving the intervention will be aware of the training activities, and may still link the intervention to survey activities.
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention preschools
Arm Type
Other
Arm Description
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.
Arm Title
Control preschool
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Capacity building to support families affected by IPV & substance misuse
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in prevalence between the intervention and control groups of family violence experienced by preschool mothers.
Description
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.
Time Frame
At least six months post intervention
Secondary Outcome Measure Information:
Title
Difference in prevalence between the intervention and control groups of alcohol and drug misuse experienced by preschool fathers.
Description
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.
Time Frame
At least six months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamalini Lokuge, Dr
Organizational Affiliation
Humanitarian Research Project Leader
Official's Role
Principal Investigator
Facility Information:
Facility Name
Australian National University
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2600
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers.
Citations:
PubMed Identifier
29716553
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.
Results Reference
derived

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Family Violence and Alcohol and Drug Misuse in Sri Lanka

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