Intimate Partner ViolenceNCT03341455
Family Violence and Alcohol and Drug Misuse in Sri Lanka
A study testing Capacity building to support families affected by IPV & substance misuse in people with Intimate Partner Violence and Domestic Abuse, run by Australian National University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence, Domestic Abuse, Drug and Alcohol Abuse
- What is being tested?
- Capacity building to support families affected by IPV & substance misuse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Jan 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- parents must have at least one child attend the targeted preschool
- all participants must be literate in Tamil or Sinhalese or English
Who cannot join
- anyone with literacy difficulties (as the questionnaires are self-administered)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Australian National University
Canberra, Australian Capital Territory, 2600
About this study
Official title: 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.
Read the 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.
- Being tested
- Capacity building to support families affected by IPV & substance misuse
- Keywords
- Sri Lanka, preschool, randomized control trial
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacity building to support families affected by IPV & substance misuseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: At least six months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start23 Jan 2018
- Primary completion30 Dec 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian National University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Peradeniya, Department of Foregin Affairs and Trade, Australia
- Responsible party
- Principal investigator, Polly Wallace, Australian National University
- Investigators
- Kamalini Lokuge, Dr, Principal investigator, Humanitarian Research Project Leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341455
- Sponsor's protocol ID
- 2017/066
- Status last verified
- Jul 2019
- First submitted
- 12 Apr 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Publications
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.
PubMed 29716553
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing, Implementing and Evaluating Preschool Based Interventions to Address Family Violence and Alcohol and Drug Misuse in Sri Lanka
- ClinicalTrials.gov ID
- NCT03341455
- Acronym / sponsor ID
- 2017/066
- Keywords
- Sri Lanka, preschool, randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Australian National UniversityUniversity, hospital or other
- Collaborators
- University of Peradeniya, Department of Foregin Affairs and Trade, Australia
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention preschools | Other | Behavioral: Capacity building to support families affected by IPV & substance misuseCapacity 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- parents must have at least one child attend the targeted preschool
- all participants must be literate in Tamil or Sinhalese or English
Key exclusion criteria (1 listed)
- anyone with literacy difficulties (as the questionnaires are self-administered)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capacity building to support families affected by IPV & substance misuseTraining 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. | Behavioural | Intervention preschools |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 29716553Lokuge 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.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamalini Lokuge, Dr principal investigator
Humanitarian Research Project Leader
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capacity building to support families affected by IPV & substance misuse in people with Intimate Partner Violence and Domestic Abuse, run by Australian National University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in prevalence between the intervention and control groups of family violence experienced by preschool mothers. (time frame: At least six months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03341455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.