NCT04107025

Brief Summary

Intimate partner violence (IPV) is a major public health concern. Worldwide, 1 in 3 women have experienced domestic abuse/ violence in their lifetime. In most cases, family lawyers, advocates are first contact before the police. If the children are involved, finding the legal options become the priority for women before leaving the abuser. The purpose of this study was to compare the effectiveness of the HELP (Health, Education Legal Support Program) intervention among IPV survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

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

April 28, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
Last Updated

October 25, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

September 24, 2019

Last Update Submit

October 24, 2019

Conditions

Domestic ViolenceAnxietyDepressionStress

Outcome Measures

Primary Outcomes (3)

  • Anxiety

    Anxiety symptoms were assessed using the Hospital Anxiety Depression Scale

    Change from baseline anxiety symptoms at 4 weeks

  • Depression

    Depression symptoms were assessed using the Hospital Anxiety Depression Scale

    Change from baseline depression symptoms at 4 weeks

  • Stress

    Perceived Stress Scale was used to assess stress symptoms

    Change from baseline stress symptoms at 4 weeks

Secondary Outcomes (1)

  • Self esteem

    Change from baseline self esteem at 4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

As part of the intervention, along with legal opinions, advise and support, participants were provided counselling support during their time to help survivors with trauma of legal proceedings.

Other: HELP

Usual Care

NO INTERVENTION

Participants were scheduled for legal consultancy only.

Interventions

HELPOTHER

Individual counseling were given to each intervention group participant. They were assisted with safety, emotional and mental support and referrals for health and financial assistance. Participants were also given handout to manage anxiety and panic situations during the legal procedures.

Intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale survivors of domestic violence
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female survivors of Intimate Partner Violence
  • years old or older
  • Gives informed consent

You may not qualify if:

  • Diagnosed mental health condition
  • Terminally ill
  • Chronic condition
  • On psychiatric medication
  • Sexual assault

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gyansanjeevani

Būndi, Rajasthan, India

Location

Gyansanjeevani

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Neha Sharma, PhD

    Warwick Research Services

    STUDY DIRECTOR

  • Anurag Sharma, MPhil

    Patan Girls College

    STUDY CHAIR

  • Rekha Khandelwal, PhD

    NMP Medical Research Institute, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 27, 2019

Study Start

April 28, 2017

Primary Completion

January 30, 2018

Study Completion

March 12, 2018

Last Updated

October 25, 2019

Record last verified: 2019-09

Locations

IN(2)