NCT02437201

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 Health

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
7 countries

8 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

May 3, 2015

Last Update Submit

September 27, 2015

Conditions

Violence Against Women

Outcome Measures

Primary Outcomes (1)

  • Quality of Life measured by SF 36 Scale

    Change from baseline in SF 36 Scale at 6 months

Secondary Outcomes (1)

  • Self-Esteem measured by Rosenberg Self-Esteem Questionnaire

    Change from Baseline in Rosenberg Self-Esteem Questionnaire at 6 months

Study Arms (2)

Liberty Group

EXPERIMENTAL

Weekly intensive support group for women with children who have suffered or are still suffering from domestic abuse (DA).

Behavioral: Liberty Program

Control group

NO INTERVENTION

Interventions

Liberty ProgramBEHAVIORAL
Liberty Group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be married,
  • Be under the aegis of Foundation at least for a year,
  • Have at least one child.

You may not qualify if:

  • Not participating in two educational sessions,
  • Not being interested in continuing the cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Liberty USA

Boston, Massachusetts, United States

Location

Liberty Australia

Melbourne, Australia

Location

Liberty China

Shanghai, Shanghai Municipality, China

Location

Liberty Europe

Athens, Greece

Location

Sonal Foundation

Mahesāna, Gujarat, India

Location

Vinita Nursing Home

Hindaun, Rajasthan, India

Location

Liberty Pakistan

Lahore, Punjaab, Pakistan

Location

Liberty Africa

Johannesburg, South Africa

Location

Study Officials

  • Bharat B Chaudhari, MA

    Sonal Foundation, India

    STUDY DIRECTOR

  • Paramjeet S Makkar, MD

    Vinita Nursing Home, India

    STUDY DIRECTOR

  • Michael Howe, MA

    Goldington Family Centre, UK

    STUDY CHAIR

  • Avinash Mishra, MA

    Shanghai University, China

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2015

First Posted

May 7, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

IN(2)US(1)ZA(1)PA(1)AU(1)GR(1)CN(1)