Gender Based ViolencePhase 2NCT01337778
Dil Mil (Hearts Together)
A Phase 2 study testing Primary care for Daughters-in-Law and The Dil Mil Intervention in people with Gender Based Violence and Women's Health, run by RTI International at 1 site in India.
Trial summary
A growing body of research indicates that gender-based violence (GBV) is a major global public health challenge. Yet, there is a dearth of evidence to guide program planning and policy-making efforts to reduce GBV. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gender Based Violence, Women's Health
- What is being tested?
- Primary care for Daughters-in-Law and The Dil Mil Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 539 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2010to Oct 2013
- Phase
- Phase 2
- 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 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Daughters-in-Law:
- married
- age 18 years to 30 years
- have ever experienced physical, psychological, or sexual violence perpetrated by husbands, mothers-in-law, or other marital family members
- pregnant and in the first or second trimester
- Kannada or Tamil speaking
Show all 12Show fewer
- able and willing to provide consent
- able and willing to refer their mother-in-law for study participation
- Mothers-in-Law:
- Kannada or Tamil speaking
- able and willing to give informed consent to participate
- confirm that they are the mother-in-law of a daughter-in-law who is being recruited.
Who cannot join
- planning to move from the area before the daughter-in-law completes 6 months postpartum
- cognitively impaired
- major depression or dementia
Trial locations and contacts
1 site in 1 country.
India1 site
St. John's Research Institute, St. John's National Academy of Health Sciences
Kormangala, Bangalore, 560034
About this study
Official title: Empowering Daughters and Mother-in-laws to Mitigate Gender-based Violence and Promote Women's Health in India
A growing body of research indicates that gender-based violence (GBV) is a major global public health challenge. Yet, there is a dearth of evidence to guide program planning and policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and potential effectiveness of an innovative women's empowerment intervention to reduce GBV and related adverse health outcomes. It is expected that the study findings will provide evidence to determine if a phase 3 effectiveness trial is merited and advance the science underlying GBV prevention.
Read the detailed description
The prevalence of physical, psychological, and sexual gender-based violence (GBV) is staggeringly high among young, married women in India. However, few GBV prevention interventions have been implemented, and none of these interventions has been rigorously evaluated. The investigators aim to fill this gap by conducting exploratory research on an innovative women's empowerment-based GBV prevention intervention. The proposed study builds on our previous research in urban poor communities in Bangalore, India, which revealed that efforts to enhance young, married women's power and to mitigate GBV will be limited if the broader context of their lives, which is shaped mainly by the marital family, is unaddressed. Previous research suggests that mothers-in-law (MILs) are a strategic familial entry point and that it may be possible to redirect the power they wield in the family toward reducing GBV against daughters-in-law (DILs). Based on this evidence and women's empowerment approaches that have successfully reduced GBV elsewhere, the investigators developed the intervention Dil Mil (meaning "Hearts Together" in India's national language, Hindi).
Guided by the Social Cognitive Theory and Heise's social-ecological framework of GBV, Dil Mil aims to empower DIL-MIL dyads with knowledge, skills, and social support critical to the mitigation of GBV and related adverse health outcomes among DILs. The investigators chose antenatal care as the context for implementing this intervention because of women's nearly universal use of antenatal care in urban India. A phase 1 pilot study demonstrated that our approach is acceptable and likely to be safe. The aim of this R21 is to conduct a phase 2 trial to examine the feasibility, safety, and potential effectiveness of Dil Mil in order to determine if a phase 3 effectiveness trial is merited.
The proposed study is a randomized controlled trial with 140 dyads comprising pregnant DILs (aged 18 to 30 years, in their first or second trimester of pregnancy, with a history of GBV) and their MILs. Recruitment will take place at four primary health centers serving poor communities in Bangalore. Dyads will be offered standard care or standard care plus the Dil Mil intervention, and evaluations will be conducted at 3 months and 6 months postpartum. The investigators will characterize the study population using descriptive statistics and assess feasibility and safety of the intervention using qualitative and quantitative data (Aim 1). Data on the effect of the intervention on intermediary outcomes-the empowerment of DILs and MILs (Aim 2)-and on the incidence of GBV among DILs during the first 6 months postpartum, DILs' perceived quality of life and psychosocial status, and maternal and infant health outcomes (Aim 3) will be analyzed using the intention-to-treat principle. Based on this evidence, the investigators will determine if a phase 3 trial is merited. In conclusion, this study will generate important insights on a novel, urgently needed response to GBV in a high prevalence setting and is highly likely to have a significant public health impact.
- Conditions
- Gender Based Violence, Women's Health
- Being tested
- Primary care for Daughters-in-Law, The Dil Mil Intervention
- Keywords
- gender based violence, maternal and child health, women, India
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary care for Daughters-in-LawBehavioural
Primary care for DILs will be offered based on national and international standards and include access to critical support services for women who have experienced GBV.A comprehensive health examination for MILs will include a gynecological exam and screening for diabetes and hypertension, along with appropriate information, prescriptions, and/or referrals. We will routinely offer GBV-related resources, such as information, counseling, and referrals to all participants. Referrals will be documented using a Referral Care Form and reviewed on a routine basis to ensure that appropriate care is being provided and to detect any potential study-related risks.
The Dil Mil InterventionBehavioural
The Dil Mil intervention will be implemented during the second and third trimesters of the DILs' pregnancy. It consists of 2 half-day group sessions with DILs, 5 half-day group sessions with MILs, and one joint half-day session with DILs and MILs. The sessions are based on participatory learning and action principles and use stories, role-play, and discussion to enhance participants' knowledge, skills, and social support. Participants are encouraged to critically analyze their relationships and to develop and implement responses appropriate to their families and communities. The DIL-MIL joint session ends in a short celebration (based on a traditional ritual) in which MILs bless their DILs, and the MIL sessions culminate in a ceremony in which MILs' position in the family and community is recognized and celebrated. MILs draw up a family health action plan and take a pledge to reduce GBV and protect and promote their family's health.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care for DILs | Active comparator | Primary care for DILs will be offered based on national and international standards and include access to critical support services for women who have experienced gender-based violence. A comprehensive health examination for mothers-in-law will include a gynecological exam and screening for diabetes and hypertension, along with appropriate information, prescriptions, and/or referrals. We will routinely offer GBV-related resources, such as information, counseling, and referrals to all participants. Referrals will be documented using a Referral Care Form and reviewed on a routine basis to ensure that appropriate care is being provided and to detect any potential study-related risks. Receives: Behavioral: Primary care for Daughters-in-Law |
| Standard Care plus Dil Mil Intervention | Experimental | The Dil Mil intervention will be implemented during the second and third trimesters of the daughter-in-law's (DILs) pregnancy. It consists of 2 half-day group sessions with DILs, 5 half-day group sessions with mothers-in-law (MILs), and one joint half-day session with DILs and MILs. The sessions are based on participatory learning and action principles and use stories, role-play, and discussion to enhance participants' knowledge, skills, and social support. The DIL-MIL joint session ends in a short celebration (based on a traditional ritual) in which MILs bless their DILs, and the MIL sessions culminate in a ceremony in which MILs' position in the family and community is recognized and celebrated. MILs draw up a family health action plan and take a pledge to reduce gender-based violence (GBV) and protect and promote their family's health. Receives: Behavioral: The Dil Mil Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Gender-Based Violence (GBV)
Measured in terms of any physical, psychological, or sexual violence perpetrated by husbands, MILs, or other family members
Measured: 3 months postpartum
Incident GBV
Measured in terms of any physical, psychological, or sexual violence perpetrated by husbands, MILs, or other family members
Measured: 6 months postpartum
Secondary outcomes (8)
Safety
Measured by the frequency of safety alerts and adverse events at enrollment and during the course of the study.
Measured: 3 months postpartum
Safety
Measured by the frequency of safety alerts and adverse events at enrollment and during the course of the study.
Measured: 6 months postpartum
Feasibility
Data on recruitment, adherence (in the intervention arm) and attrition rates will be examined
Measured: 3 months postpartum
Feasibility
Data on recruitment, adherence (in the intervention arm) and attrition rates will be examined
Measured: 6 months postpartum
Daughter-in-Laws' (DILs') Knowledge
DILs' knowledge about safety and the links between GBV and health, their gender-equitable attitudes, and their decision-making skills
Measured: 3 months postpartum
DILs' Knowledge
DILs' knowledge about safety and the links between GBV and health, their gender-equitable attitudes, and their decision-making skills
Measured: 6 months postpartum
Mother-in-Laws' Knowledge
MILs' knowledge about the links between GBV and health and their gender-equitable attitudes; and improved relationships between MILS and DILs measured in terms of enhanced social support and communication.
Measured: 3 months postpartum
MILs' Knowledge
MILs' knowledge about the links between GBV and health and their gender-equitable attitudes; and improved relationships between MILS and DILs measured in terms of enhanced social support and communication.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gender Based 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- St. John's Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Suneeta Krishnan, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337778
- Sponsor's protocol ID
- 1R21HD062821-01A1
- Other IDs
- 1R21HD062821-01A1
- Status last verified
- Nov 2013
- First submitted
- 15 Apr 2011
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krishnan S, Subbiah K, Chandra P, Srinivasan K. Minimizing risks and monitoring safety of an antenatal care intervention to mitigate domestic violence among young Indian women: The Dil Mil trial. BMC Public Health. 2012 Nov 1;12:943. doi: 10.1186/1471-2458-12-943.
PubMed 23116189
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Daughters and Mother-in-laws to Mitigate Gender-based Violence and Promote Women's Health in India
- ClinicalTrials.gov ID
- NCT01337778
- Acronym / sponsor ID
- 1R21HD062821-01A1
- Conditions
- Gender Based Violence, Women's Health
- Keywords
- gender based violence, maternal and child health, women, India
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- St. John's Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Apr 2011 (estimated)
- 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.
A growing body of research indicates that gender-based violence (GBV) is a major global public health challenge. Yet, there is a dearth of evidence to guide program planning and policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and potential effectiveness of an innovative women's empowerment intervention to reduce GBV and related adverse health outcomes. It is expected that the study findings will provide evidence to determine if a phase 3 effectiveness trial is merited and advance the science underlying GBV prevention.
Detailed description
The prevalence of physical, psychological, and sexual gender-based violence (GBV) is staggeringly high among young, married women in India. However, few GBV prevention interventions have been implemented, and none of these interventions has been rigorously evaluated. The investigators aim to fill this gap by conducting exploratory research on an innovative women's empowerment-based GBV prevention intervention. The proposed study builds on our previous research in urban poor communities in Bangalore, India, which revealed that efforts to enhance young, married women's power and to mitigate GBV will be limited if the broader context of their lives, which is shaped mainly by the marital family, is unaddressed. Previous research suggests that mothers-in-law (MILs) are a strategic familial entry point and that it may be possible to redirect the power they wield in the family toward reducing GBV against daughters-in-law (DILs). Based on this evidence and women's empowerment approaches that have successfully reduced GBV elsewhere, the investigators developed the intervention Dil Mil (meaning "Hearts Together" in India's national language, Hindi).
Guided by the Social Cognitive Theory and Heise's social-ecological framework of GBV, Dil Mil aims to empower DIL-MIL dyads with knowledge, skills, and social support critical to the mitigation of GBV and related adverse health outcomes among DILs. The investigators chose antenatal care as the context for implementing this intervention because of women's nearly universal use of antenatal care in urban India. A phase 1 pilot study demonstrated that our approach is acceptable and likely to be safe. The aim of this R21 is to conduct a phase 2 trial to examine the feasibility, safety, and potential effectiveness of Dil Mil in order to determine if a phase 3 effectiveness trial is merited.
The proposed study is a randomized controlled trial with 140 dyads comprising pregnant DILs (aged 18 to 30 years, in their first or second trimester of pregnancy, with a history of GBV) and their MILs. Recruitment will take place at four primary health centers serving poor communities in Bangalore. Dyads will be offered standard care or standard care plus the Dil Mil intervention, and evaluations will be conducted at 3 months and 6 months postpartum. The investigators will characterize the study population using descriptive statistics and assess feasibility and safety of the intervention using qualitative and quantitative data (Aim 1). Data on the effect of the intervention on intermediary outcomes-the empowerment of DILs and MILs (Aim 2)-and on the incidence of GBV among DILs during the first 6 months postpartum, DILs' perceived quality of life and psychosocial status, and maternal and infant health outcomes (Aim 3) will be analyzed using the intention-to-treat principle. Based on this evidence, the investigators will determine if a phase 3 trial is merited. In conclusion, this study will generate important insights on a novel, urgently needed response to GBV in a high prevalence setting and is highly likely to have a significant public health impact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Care for DILs | Active comparator | Behavioral: Primary care for Daughters-in-LawPrimary care for DILs will be offered based on national and international standards and include access to critical support services for women who have experienced gender-based violence. A comprehensive health examination for mothers-in-law will include a gynecological exam and screening for diabetes and hypertension, along with appropriate information, prescriptions, and/or referrals. We will routinely offer GBV-related resources, such as information, counseling, and referrals to all participants. Referrals will be documented using a Referral Care Form and reviewed on a routine basis to ensure that appropriate care is being provided and to detect any potential study-related risks. |
| Standard Care plus Dil Mil Intervention | Experimental | Behavioral: The Dil Mil InterventionThe Dil Mil intervention will be implemented during the second and third trimesters of the daughter-in-law's (DILs) pregnancy. It consists of 2 half-day group sessions with DILs, 5 half-day group sessions with mothers-in-law (MILs), and one joint half-day session with DILs and MILs. The sessions are based on participatory learning and action principles and use stories, role-play, and discussion to enhance participants' knowledge, skills, and social support. The DIL-MIL joint session ends in a short celebration (based on a traditional ritual) in which MILs bless their DILs, and the MIL sessions culminate in a ceremony in which MILs' position in the family and community is recognized and celebrated. MILs draw up a family health action plan and take a pledge to reduce gender-based violence (GBV) and protect and promote their family's health. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- married
- age 18 years to 30 years
- have ever experienced physical, psychological, or sexual violence perpetrated by husbands, mothers-in-law, or other marital family members
- pregnant and in the first or second trimester
- Kannada or Tamil speaking
Key exclusion criteria (3 listed)
- planning to move from the area before the daughter-in-law completes 6 months postpartum
- cognitively impaired
- major depression or dementia
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 |
|---|---|---|
| Primary care for Daughters-in-LawPrimary care for DILs will be offered based on national and international standards and include access to critical support services for women who have experienced GBV.A comprehensive health examination for MILs will include a gynecological exam and screening for diabetes and hypertension, along with appropriate information, prescriptions, and/or referrals. We will routinely offer GBV-related resources, such as information, counseling, and referrals to all participants. Referrals will be documented using a Referral Care Form and reviewed on a routine basis to ensure that appropriate care is being provided and to detect any potential study-related risks. | Behavioural | Primary Care for DILs |
| The Dil Mil InterventionThe Dil Mil intervention will be implemented during the second and third trimesters of the DILs' pregnancy. It consists of 2 half-day group sessions with DILs, 5 half-day group sessions with MILs, and one joint half-day session with DILs and MILs. The sessions are based on participatory learning and action principles and use stories, role-play, and discussion to enhance participants' knowledge, skills, and social support. Participants are encouraged to critically analyze their relationships and to develop and implement responses appropriate to their families and communities. The DIL-MIL joint session ends in a short celebration (based on a traditional ritual) in which MILs bless their DILs, and the MIL sessions culminate in a ceremony in which MILs' position in the family and community is recognized and celebrated. MILs draw up a family health action plan and take a pledge to reduce GBV and protect and promote their family's health. | Behavioural | Standard Care plus Dil Mil Intervention |
Primary outcome
Incident Gender-Based Violence (GBV)
Time frame: 3 months postpartum
Measured in terms of any physical, psychological, or sexual violence perpetrated by husbands, MILs, or other family members
Incident GBV
Time frame: 6 months postpartum
Measured in terms of any physical, psychological, or sexual violence perpetrated by husbands, MILs, or other family members
8 secondary outcomes
Safety
Time frame: 3 months postpartum
Safety
Time frame: 6 months postpartum
Feasibility
Time frame: 3 months postpartum
Feasibility
Time frame: 6 months postpartum
Daughter-in-Laws' (DILs') Knowledge
Time frame: 3 months postpartum
DILs' Knowledge
Time frame: 6 months postpartum
Mother-in-Laws' Knowledge
Time frame: 3 months postpartum
MILs' Knowledge
Time frame: 6 months postpartum
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 4 Nov 2013.
- Derived from this study: PubMed 23116189Krishnan S, Subbiah K, Chandra P, Srinivasan K. Minimizing risks and monitoring safety of an antenatal care intervention to mitigate domestic violence among young Indian women: The Dil Mil trial. BMC Public Health. 2012 Nov 1;12:943. doi: 10.1186/1471-2458-12-943.
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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.
Suneeta Krishnan, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Primary care for Daughters-in-Law and The Dil Mil Intervention in people with Gender Based Violence and Women's Health, run by RTI International at 1 site 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 12 inclusion and 3 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 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incident Gender-Based Violence (GBV) (time frame: 3 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01337778, which also lists 1 linked publication.
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 4 Nov 2013.