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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03341455




Registration number
NCT03341455
Ethics application status
Date submitted
12/04/2017
Date registered
14/11/2017
Date last updated
5/07/2019

Titles & IDs
Public title
Family Violence and Alcohol and Drug Misuse in Sri Lanka
Scientific title
Developing, Implementing and Evaluating Preschool Based Interventions to Address Family Violence and Alcohol and Drug Misuse in Sri Lanka
Secondary ID [1] 0 0
2017/066
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intimate Partner Violence 0 0
Domestic Abuse 0 0
Drug and Alcohol Abuse 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Capacity building to support families affected by IPV & substance misuse

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

* 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: 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.


BEHAVIORAL: 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 code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in prevalence between the intervention and control groups of family violence experienced by preschool mothers.
Timepoint [1] 0 0
At least six months post intervention
Secondary outcome [1] 0 0
Difference in prevalence between the intervention and control groups of alcohol and drug misuse experienced by preschool fathers.
Timepoint [1] 0 0
At least six months post intervention

Eligibility
Key inclusion criteria
* parents must have at least one child attend the targeted preschool
* all participants must be literate in Tamil or Sinhalese or English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- anyone with literacy difficulties (as the questionnaires are self-administered)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2019
Sample size
Target
Accrual to date
Final
900
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
Australian National University - Canberra
Recruitment postcode(s) [1] 0 0
2600 - Canberra

Funding & Sponsors
Primary sponsor type
Other
Name
Australian National University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Peradeniya
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Department of Foregin Affairs and Trade, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT03341455
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Kamalini Lokuge, Dr
Address 0 0
Humanitarian Research Project Leader
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03341455