Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02437201




Registration number
NCT02437201
Ethics application status
Date submitted
3/05/2015
Date registered
7/05/2015
Date last updated
29/09/2015

Titles & IDs
Public title
Study of Liberty Program on Women's Health and Intimate Partner Violence
Scientific title
Study of Liberty Program on Women's Health and Intimate Partner Violence: Multinational, Open, Randomised, Controlled Clinical Study
Secondary ID [1] 0 0
Mac/NMP 1121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Violence Against Women 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Liberty Group - Weekly intensive support group for women with children who have suffered or are still suffering from domestic abuse (DA).

No intervention: Control group -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quality of Life measured by SF 36 Scale
Timepoint [1] 0 0
Change from baseline in SF 36 Scale at 6 months
Secondary outcome [1] 0 0
Self-Esteem measured by Rosenberg Self-Esteem Questionnaire
Timepoint [1] 0 0
Change from Baseline in Rosenberg Self-Esteem Questionnaire at 6 months

Eligibility
Key inclusion criteria
* Be married,
* Be under the aegis of Foundation at least for a year,
* Have at least one child.
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Not participating in two educational sessions,
* Not being interested in continuing the cooperation.

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2017
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liberty Australia - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
China
State/province [2] 0 0
Shanghai
Country [3] 0 0
Greece
State/province [3] 0 0
Athens
Country [4] 0 0
India
State/province [4] 0 0
Gujarat
Country [5] 0 0
India
State/province [5] 0 0
Rajasthan
Country [6] 0 0
Pakistan
State/province [6] 0 0
Punjaab
Country [7] 0 0
South Africa
State/province [7] 0 0
Johannesburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Macmillan Research Group UK
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Goldington Family Center, UK
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Vinita Nursing Home, India
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sonal Foundation, India
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bharat B Chaudhari, MA
Address 0 0
Sonal Foundation, India
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02437201