Dil Mil (Hearts Together)
Dil Mil (Hearts Together)
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.
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.
Inclusion Criteria:

 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

 -  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.

 Exclusion Criteria:

 -  planning to move from the area before the daughter-in-law completes 6 months
 postpartum

 -  cognitively impaired

 -  major depression or dementia