Family Violence and Alcohol and Drug Misuse in Sri Lanka

NCT ID: NCT03341455

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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Intimate Partner Violence Domestic Abuse Drug and Alcohol Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type OTHER

Capacity building to support families affected by IPV & substance misuse

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Capacity building to support families affected by IPV & substance misuse

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Peradeniya

OTHER

Sponsor Role collaborator

Department of Foregin Affairs and Trade, Australia

OTHER_GOV

Sponsor Role collaborator

Australian National University

OTHER

Sponsor Role lead

Responsible Party

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Polly Wallace

Co-investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamalini Lokuge, Dr

Role: PRINCIPAL_INVESTIGATOR

Humanitarian Research Project Leader

Locations

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Australian National University

Canberra, Australian Capital Territory, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 29716553 (View on PubMed)

Other Identifiers

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2017/066

Identifier Type: -

Identifier Source: org_study_id

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