Violence Against WomenNCT02437201
Study of Liberty Program on Women's Health and Intimate Partner Violence
A study testing Liberty Program in people with Violence Against Women, run by Macmillan Research Group UK at 8 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence Against Women
- What is being tested?
- Liberty Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Jul 2015to Dec 2017
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be married,
- Be under the aegis of Foundation at least for a year,
- Have at least one child.
Who cannot join
- Not participating in two educational sessions,
- Not being interested in continuing the cooperation.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
India2 sites
Vinita Nursing Home
Hindaun, Rajasthan
Sonal Foundation
Mahesāna, Gujarat
About this study
Official title: Study of Liberty Program on Women's Health and Intimate Partner Violence: Multinational, Open, Randomised, Controlled Clinical Study
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.
- Conditions
- Violence Against Women
- Being tested
- Liberty Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberty ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Liberty Group | Experimental | Weekly intensive support group for women with children who have suffered or are still suffering from domestic abuse (DA). Receives: Behavioral: Liberty Program |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life measured by SF 36 Scale
Measured: Change from baseline in SF 36 Scale at 6 months
Secondary outcomes (1)
Self-Esteem measured by Rosenberg Self-Esteem Questionnaire
Measured: Change from Baseline in Rosenberg Self-Esteem Questionnaire at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence Against WomenStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Goldington Family Center, UK, Vinita Nursing Home, India, Sonal Foundation, India
- Responsible party
- Sponsor
- Investigators
- Bharat B Chaudhari, MA, Study director, Sonal Foundation, IndiaParamjeet S Makkar, MD, Study director, Vinita Nursing Home, IndiaMichael Howe, MA, Study chair, Goldington Family Centre, UKAvinash Mishra, MA, Study director, Shanghai University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437201
- Sponsor's protocol ID
- Mac/NMP 1121
- Status last verified
- Sep 2015
- First submitted
- 3 May 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Liberty Program on Women's Health and Intimate Partner Violence: Multinational, Open, Randomised, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02437201
- Acronym / sponsor ID
- Mac/NMP 1121
- Conditions
- Violence Against Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Collaborators
- Goldington Family Center, UK, Vinita Nursing Home, India, Sonal Foundation, India
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 May 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberty Group | Experimental | Behavioral: Liberty ProgramWeekly intensive support group for women with children who have suffered or are still suffering from domestic abuse (DA). |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be married,
- Be under the aegis of Foundation at least for a year,
- Have at least one child.
Key exclusion criteria (2 listed)
- Not participating in two educational sessions,
- Not being interested in continuing the cooperation.
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 |
|---|---|---|
| Liberty Program | Behavioural | Liberty Group |
Primary outcome
Quality of Life measured by SF 36 Scale
Time frame: Change from baseline in SF 36 Scale at 6 months
1 secondary outcome
Self-Esteem measured by Rosenberg Self-Esteem Questionnaire
Time frame: Change from Baseline in Rosenberg Self-Esteem Questionnaire at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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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.
Bharat B Chaudhari, MA study director
Sonal Foundation, India
Paramjeet S Makkar, MD study director
Vinita Nursing Home, India
Michael Howe, MA study chair
Goldington Family Centre, UK
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberty Program in people with Violence Against Women, run by Macmillan Research Group UK at 8 sites in 7 countries.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India, United States, Australia, China, Greece and 2 more countries. 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?
Results are not available in the source record.
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?
Quality of Life measured by SF 36 Scale (time frame: Change from baseline in SF 36 Scale at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2015.