NCT01933555

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

August 28, 2013

Last Update Submit

August 28, 2013

Conditions

Abuse Physical Battered Woman Syndrome

Outcome Measures

Primary Outcomes (1)

  • Quality of life(Sf-36)

    Five Months

Secondary Outcomes (1)

  • Post natal depression

    5 months

Other Outcomes (1)

  • Domestic Violence Inventory and safety seeking behavior

    5 months

Study Arms (2)

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.

Behavioral: Empowerment Program

Control group

NO INTERVENTION

Standard care, which was routine check ups and care provided by health care professionals.

Interventions

Empowerment ProgramBEHAVIORAL
Empowerment program

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • at least 18 years of age,
  • victims of intimate partner violence, and
  • willing to participate

You may not qualify if:

  • women whose abuser was not their intimate partner or
  • who were unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP medical research institute

Jaipur, Rajasthan, 302019, India

Location

Study Officials

  • Neha Sharma, PhD

    Macmillan research group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 2, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations

IN(1)