- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341455
Family Violence and Alcohol and Drug Misuse in Sri Lanka
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
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Australian Capital Territory
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Canberra, Australian Capital Territory, Australia, 2600
- Australian National University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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.
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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.
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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
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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
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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.
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At least six months post intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kamalini Lokuge, Dr, Humanitarian Research Project Leader
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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