Abuse Physical Battered Woman SyndromePhase 2NCT01933555
Impact of Women's Empowerment Program for Abused Pregnant Women
A Phase 2 study testing Empowerment Program in people with Abuse Physical Battered Woman Syndrome, run by Macmillan Research Group UK at 1 site in India.
Trial summary
Although domestic violence is recognized as major threat in pregnancy, there is no intervention has been developed or test to support women in India. To evaluate the effect of women's empowerment program administered to abused women in order to reduce domestic abuse, improving health status and safety behavior. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abuse Physical Battered Woman Syndrome
- What is being tested?
- Empowerment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2013to Aug 2013
- Phase
- Phase 2
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 18 years of age,
- victims of intimate partner violence, and
- willing to participate
Who cannot join
- women whose abuser was not their intimate partner or
- who were unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Women's Empowerment Program for Abused Pregnant Women: A Randomized Controlled Trial
Although domestic violence is recognized as major threat in pregnancy, there is no intervention has been developed or test to support women in India. To evaluate the effect of women's empowerment program administered to abused women in order to reduce domestic abuse, improving health status and safety behavior.
- Conditions
- Abuse Physical Battered Woman Syndrome
- Being tested
- Empowerment Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Empowerment program | Experimental | The hour intervention, delivered over a 11-week period, consisted of an empowerment and additional components adapted from Freedom program run to support domestic abused women. Receives: Behavioral: Empowerment Program |
| Control group | No intervention | Standard care, which was routine check ups and care provided by health care professionals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life(Sf-36)
Measured: Five Months
Secondary outcomes (1)
Post natal depression
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse Physical Battered Woman SyndromeStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Macmillan research group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933555
- Sponsor's protocol ID
- Mac/NMP 0912
- Status last verified
- Aug 2013
- First submitted
- 28 Aug 2013
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Women's Empowerment Program for Abused Pregnant Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01933555
- Acronym / sponsor ID
- Mac/NMP 0912
- Conditions
- Abuse Physical Battered Woman Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Sep 2013 (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.
Although domestic violence is recognized as major threat in pregnancy, there is no intervention has been developed or test to support women in India. To evaluate the effect of women's empowerment program administered to abused women in order to reduce domestic abuse, improving health status and safety behavior.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowerment program | Experimental | Behavioral: Empowerment ProgramThe hour intervention, delivered over a 11-week period, consisted of an empowerment and additional components adapted from Freedom program run to support domestic abused women. |
| Control group | No intervention | –Standard care, which was routine check ups and care provided by health care professionals. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least 18 years of age,
- victims of intimate partner violence, and
- willing to participate
Key exclusion criteria (2 listed)
- women whose abuser was not their intimate partner or
- who were unable to consent
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 |
|---|---|---|
| Empowerment Program | Behavioural | Empowerment program |
Primary outcome
Quality of life(Sf-36)
Time frame: Five Months
1 secondary outcome
Post natal depression
Time frame: 5 months
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 2 Sep 2013.
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.
Neha Sharma, PhD principal investigator
Macmillan research group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empowerment Program in people with Abuse Physical Battered Woman Syndrome, run by Macmillan Research Group UK at 1 site in India.
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: finished, as of the sponsor's last update on 2 Sep 2013. 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 India. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of life(Sf-36) (time frame: Five 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 2 Sep 2013.