Effects of a Legal Support Program on Women Experiencing Domestic Violence

Effects of a Legal Support Program on Women Experiencing Domestic Violence: Help Intervention Study

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stress; Anxiety; Domestic Violence
• Intervention / Treatment: Other: HELP

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Bundi, Rajasthan, India
      • Gyansanjeevani
    • Jaipur, Rajasthan, India
      • Gyansanjeevani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Usual Care; Participants were scheduled for legal consultancy only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self esteem	Rosenberg's Self-Esteem Scale was used to measure self esteem	Change from baseline self esteem at 4 weeks

Collaborators and Investigators

• Sponsor: NMP Medical Research Institute
• Collaborators: Warwick Research Services
• Investigators: Study Chair: Anurag Sharma, MPhil, Patan Girls College; Principal Investigator: Rekha Khandelwal, PhD, NMP Medical Research Institute, India

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): March 12, 2018

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: NMP/07845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No