Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
539 participants
INTERVENTIONAL
2010-08-31
2013-10-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Primary Care for DILs
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.
Primary care for Daughters-in-Law
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.
Standard Care plus Dil Mil Intervention
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.
The Dil Mil Intervention
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.
Interventions
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Primary care for Daughters-in-Law
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 Intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* cognitively impaired
* major depression or dementia
18 Years
85 Years
FEMALE
Yes
Sponsors
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St. John's Research Institute
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
RTI International
OTHER
Responsible Party
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Principal Investigators
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Suneeta Krishnan, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
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St. John's Research Institute, St. John's National Academy of Health Sciences
Kormangala, Bangalore, India
Countries
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References
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