Domestic ViolenceNCT04107025
Effects of a Legal Support Program on Women Experiencing Domestic Violence
A study testing HELP in people with Domestic Violence and Anxiety, run by NMP Medical Research Institute at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Domestic Violence, Anxiety, Depression
- What is being tested?
- HELP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesIndia
- Study dates
- 28 Apr 2017to 12 Mar 2018
- Phase
- Interventional
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female survivors of Intimate Partner Violence
- 18 years old or older
- Gives informed consent
Who cannot join
- Diagnosed mental health condition
- Terminally ill
- Chronic condition
- On psychiatric medication
- Sexual assault
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Domestic Violence, Anxiety, Depression, Stress
- Being tested
- HELP
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HELP |
| Usual Care | No intervention | Participants were scheduled for legal consultancy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety symptoms were assessed using the Hospital Anxiety Depression Scale
Measured: Change from baseline anxiety symptoms at 4 weeks
Depression
Depression symptoms were assessed using the Hospital Anxiety Depression Scale
Measured: Change from baseline depression symptoms at 4 weeks
Stress
Perceived Stress Scale was used to assess stress symptoms
Measured: Change from baseline stress symptoms at 4 weeks
Secondary outcomes (1)
Self esteem
Rosenberg's Self-Esteem Scale was used to measure self esteem
Measured: Change from baseline self esteem at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start28 Apr 2017
- Primary completion30 Jan 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Study director, Warwick Research ServicesAnurag Sharma, MPhil, Study chair, Patan Girls CollegeRekha Khandelwal, PhD, Principal investigator, NMP Medical Research Institute, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107025
- Sponsor's protocol ID
- NMP/07845
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Legal Support Program on Women Experiencing Domestic Violence: Help Intervention Study
- ClinicalTrials.gov ID
- NCT04107025
- Acronym / sponsor ID
- NMP/07845
- Conditions
- Domestic Violence, Anxiety, Depression, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 27 Sep 2019 (actual)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: HELPAs 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. |
| Usual Care | No intervention | –Participants were scheduled for legal consultancy only. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female survivors of Intimate Partner Violence
- 18 years old or older
- Gives informed consent
Key exclusion criteria (5 listed)
- Diagnosed mental health condition
- Terminally ill
- Chronic condition
- On psychiatric medication
- Sexual assault
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 |
|---|---|---|
| HELPIndividual 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. | Other | Intervention |
Primary outcome
Anxiety
Time frame: Change from baseline anxiety symptoms at 4 weeks
Anxiety symptoms were assessed using the Hospital Anxiety Depression Scale
Depression
Time frame: Change from baseline depression symptoms at 4 weeks
Depression symptoms were assessed using the Hospital Anxiety Depression Scale
Stress
Time frame: Change from baseline stress symptoms at 4 weeks
Perceived Stress Scale was used to assess stress symptoms
1 secondary outcome
Self esteem
Time frame: Change from baseline self esteem at 4 weeks
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 25 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Domestic Violence
RecruitingObservational study
Self-Dehumanization and Hesitation to Report Domestic Violence
Domestic Violence
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Community Resiliency Collective Efficacy Intervention
Violence, Physical, Violence, Non-accidental
Enrolling by invitation
Evaluation of a Trauma-Informed Partner Violence Intervention Program
Domestic Violence, Post Traumatic Stress Disorder
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
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 study director
Warwick Research Services
Anurag Sharma, MPhil study chair
Patan Girls College
Rekha Khandelwal, PhD principal investigator
NMP Medical Research Institute, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HELP in people with Domestic Violence and Anxiety, run by NMP Medical Research Institute at 2 sites 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 5 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Anxiety (time frame: Change from baseline anxiety symptoms at 4 weeks). The study lists 3 primary outcomes in all. 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 25 Oct 2019.