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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Behaviour - Liberty Program

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 -


Behaviour: Liberty Program
Intervention code [1] 0 0
Behaviour
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
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
Previous studies indicated high frequency of abuse in families and its consequences.
Considering the importance of interventions such as educational interventions, in order to
increase women's abilities to prevent abusive behaviors, the current research aims to
determine the impact of an Liberty program on prevention of violence against women and
propose solutions for less damages and consequences.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02437201
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02437201