NCT03341455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

April 12, 2017

Last Update Submit

July 1, 2019

Conditions

Keywords

Sri Lankapreschoolrandomized control trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    At least six months post intervention

Secondary Outcomes (1)

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

    At least six months post intervention

Study Arms (2)

Intervention preschools

OTHER

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.

Behavioral: Capacity building to support families affected by IPV & substance misuse

Control preschool

NO INTERVENTION

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.

Interventions

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 preschools

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Australian National University

Canberra, Australian Capital Territory, 2600, Australia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kamalini Lokuge, Dr

    Humanitarian Research Project Leader

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

April 12, 2017

First Posted

November 14, 2017

Study Start

January 23, 2018

Primary Completion

December 30, 2018

Study Completion

February 28, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be available to other researchers.

Locations