Minimizing risks and monitoring safety of an antenatal care intervention to mitigate domestic violence among young Indian women: The Dil Mil trial

Suneeta Krishnan, Kalyani Subbiah, Prabha Chandra, Krishnamachari Srinivasan, Suneeta Krishnan, Kalyani Subbiah, Prabha Chandra, Krishnamachari Srinivasan

Abstract

Background: Domestic violence - physical, psychological, or sexual abuse perpetrated against women by one or more family members - is highly prevalent in India. However, relatively little research has been conducted on interventions with the potential to mitigate domestic violence and its adverse health consequences, and few resources exist to guide safety planning and monitoring in the context of intervention research. Dil Mil is a promising women's empowerment-based intervention developed in India that engages with young women (daughters-in-law) and their mothers-in-law to mitigate domestic violence and related adverse health outcomes. This paper describes the design of a randomized controlled trial of Dil Mil in Bengaluru, India, with a focus on strategies used to minimize study-related risks and monitor safety.

Methods/design: A phase 2 randomized controlled trial using a parallel comparison of the Dil Mil intervention versus standard care will be implemented in three public primary health centers in Bengaluru. Young pregnant women in the first or second trimester of pregnancy will be recruited from antenatal services at study health centers and through community outreach. If eligible and willing, their mother-in-law will also be recruited. Once enrolled, dyads will participate in a baseline interview and then randomized either to the control arm and receive standard care or to the intervention arm and receive standard care plus the Dil Mil intervention. Additional evaluations will be conducted at 3 months and 6 months postpartum. Data will be analyzed to examine the feasibility and safety of the intervention and the effect of the intervention on intermediary outcomes (the empowerment of daughters-in-law and mothers-in-law), incidence of domestic violence among daughters-in-law, and health outcomes including perceived quality of life, psychosocial status and maternal and infant health outcomes.

Discussion: This study offers approaches that may help guide safety planning and monitoring in other domestic violence intervention trials in similar settings. Moreover, given the staggeringly high prevalence of domestic violence against young women in India (and indeed globally) and the dearth of data on effective interventions, this study is poised to make an important contribution to the evidence-base for domestic violence prevention.

Trial registration: ClinicalTrials.gov Identifier: NCT01337778.

Figures

Figure 1
Figure 1
Dil Mil Causal Model.
Figure 2
Figure 2
Overview of Study Procedures.

References

    1. Rocca C, Rathod S, Falle T, Pande R, Krishnan S. Challenging assumptions about women’s empowerment: social and economic resources and domestic violence among young married women in urban South India. Int J Epidemiol. 2009;38(2):577–585.
    1. International Institute for Population Sciences (IIPS) and Macro International. National Family Health Survey (NFHS 3), 2005-06: Fact Sheet Karnataka. Mumbai: IIPS; 2007. pp. 1–3.
    1. Ackerson LK, Kawachi I, Barbeau EM, Subramanian SV. Effects of Individual and Proximate Educational Context on Intimate Partner Violence: A Population-Based Study of Women in India. Am J Public Health. 2008;98(3):507–514. doi: 10.2105/AJPH.2007.113738.
    1. Ackerson LK, Subramanian SV. Domestic Violence and Chronic Malnutrition among Women and Children in India. Am J Epidemiol. 2008;167(10):1188–1196. doi: 10.1093/aje/kwn049.
    1. Chandran M, Tharyan P, Muliyil J, Abraham S. Post-partum depression in a cohort of women from a rural area of Tamil Nadu, India - Incidence and risk factors. Br J Psychiatry. 2002;181:499–504. doi: 10.1192/bjp.181.6.499.
    1. Jejeebhoy SJ. Associations between wife-beating and fetal and infant death: Impressions from a survey in rural India. Stud Fam Plan. 1998;29(3):300–308. doi: 10.2307/172276.
    1. Jejeebhoy SJ, Cook RJ. State accountability for wife-beating: The Indian challenge. Lancet. 1997;349:S10–S12.
    1. Jeyaseelan LK, Neelakantan S, Peedicayil N, Pillai R, Duvvury N. Physical spousal violence against women in India: some risk factors. J Biosoc Sci. 2007;39:657–670. doi: 10.1017/S0021932007001836.
    1. Koenig MA, Stephenson R, Ahmed S, Jejeebhoy SJ, Campbell J. Individual and contextual determinants of domestic violence in north India. Am J Public Health. 2006;96(1):132–138. doi: 10.2105/AJPH.2004.050872.
    1. Martin SL, Mackie L, Kupper LL, Buescher P, Moracco KE. Physical abuse of women before, during, and after pregnancy. JAMA. 2001;285(12):1581–1584. doi: 10.1001/jama.285.12.1581.
    1. Silverman J, Decker M, Kapur N, Gupta J, Raj A. Violence against wives, sexual risk and sexually transmitted infection among Bangladeshi men. Sex Transm Infect. 2007;83:211–215.
    1. Czaja SJ, Schulz R, Belle SH, Burgio LD, Armstrong N, Gitlin LN, Coon DW, Martindale-Adams J, Klinger J, Stahl SM. Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Clin Trials. 2006;3(2):107–118. doi: 10.1191/1740774506cn136oa.
    1. NIMH Multisite Prevention Trial. Definition of adverse reactions in clinical trials of a behavioral intervention. AIDS. 1997;11(Suppl 2):S55–57.
    1. World Health Organization. Putting women's safety first: Ethical and safety recommendations for research on domestic violence against women. Geneva: WHO; 2001. pp. 1–32.
    1. Ellsberg M, Heise L. Bearing witness: ethics in domestic violence research. Lancet. 2002;359(9317):1599–1604. doi: 10.1016/S0140-6736(02)08521-5.
    1. Andersson N, Cockcroft A, Ansari N, Omer K, Chaudhry UU, Khan A, Pearson L. Collecting reliable information about violence against women safely in household interviews: experience from a large-scale national survey in South Asia. Violence Against Women. 2009;15(4):482–496. doi: 10.1177/1077801208331063.
    1. Jewkes R, Watts C, Abrahams N, Penn-Kekana L, Garcia-Moreno C. Ethical and methodological issues in conducting research on gender-based violence in Southern Africa. Reprod Health Matters. 2000;8(15):93–103. doi: 10.1016/S0968-8080(00)90010-7.
    1. Sikweyiya Y, Jewkes R. Perceptions and experiences of research participants on gender-based violence community based survey: implications for ethical guidelines. PLoS One. 2012;7(4):e35495. doi: 10.1371/journal.pone.0035495.
    1. Fontes LA. Ethics in violence against women research: The sensitive, the dangerous, and the overlooked. Ethics & Behavior. 2004;14(2):141–174. doi: 10.1207/s15327019eb1402_4.
    1. District Level Household and Facility Survey 2007–08: Fact Sheets - India. 2007. [ ]
    1. Child Marriage Fact Sheet. [ ]
    1. Barua A, Kurz K. Reproductive health-seeking by married adolescent girls in Maharashtra, India. Reprod Health Matters. 2001;9(17):53–62. doi: 10.1016/S0968-8080(01)90008-4.
    1. Dyson T, Moore M. On Kinship Structure, Female Autonomy, and Demographic Behavior in India. Popul Dev Rev. 1983;9(1):35–60. doi: 10.2307/1972894.
    1. Goyal RS. Dimensions of adolescent motherhood in India. Soc Biol. 1994;41(1–2):130–134.
    1. Jejeebhoy S, Sebastian M. South and East Asia Regional Working Papers No 18. New Delhi, India: Population Council; 2003. Actions that protect: promoting sexual and reproductive health and choice among young people in India. .
    1. Krishnan S, Rocca C, Hubbard A, Subbiah K, Edmeades J, Padian NS. Do Changes in Spousal Employment Status Lead to Domestic Violence? Insights from a Prospective Study in Bangalore, India. Soc Sci Med. 2009;70(1):136–143.
    1. International Institute for Population Sciences (IIPS) and Macro International. National Family Health Survey (NFHS 3), 2005-06: India, volume 1. Mumbai: IIPS; 2007.
    1. Campbell JC. Abuse during pregnancy: a quintessential threat to maternal and child health - so when do we start to act? Can Med Assoc J. 2001;164(11):1578–1579.
    1. Coker AL. Does physical intimate partner violence affect sexual health? A systematic review. Trauma Violence Abuse. 2007;8(2):149–177. doi: 10.1177/1524838007301162.
    1. Koenig LJ, Whitaker DJ, Royce RA, Wilson TE, Ethier K, Fernandez MI. Physical and sexual violence during pregnancy and after delivery: A prospective multistate study of women with or at risk for HIV infection. Am J Public Health. 2006;96(6):1052–1059. doi: 10.2105/AJPH.2005.067744.
    1. Muthal-Rathore A, Tripathi R, Arora R. Domestic violence against pregnant women interviewed at a hospital in New Delhi. Int J Gynaecol Obstet. 2002;76(1):83–85. doi: 10.1016/S0020-7292(01)00533-1.
    1. Purwar MB, Jeyaseelan L, Varhadpande U, Motghare V, Pimplakute S. Survey of physical abuse during pregnancy GMCH, Nagpur, India. J Obstet Gynaecol Res. 1999;25(3):165–171. doi: 10.1111/j.1447-0756.1999.tb01142.x.
    1. Varma D, Chandra PS, Thomas T, Carey MP. Intimate partner violence and sexual coercion among pregnant women in India: Relationship with depression and post-traumatic stress disorder. J Affect Disord. 2007;102(1–3):227–235.
    1. Krishnan S, Iyengar S, Pande RP, Subbiah K, Roca E, Anuradha R, Measham D. Marriage and Motherhood: Influences on Women’s Power in Sexual Relationships. 2005. (Population Association of America, 2005 Annual Meeting. Philadelphia).
    1. Staying Alive: 5th Monitoring & Evaluation 2012 on the Protection of Women from Domestic Violence Act. 2005. [ ]
    1. Krishnan S, Subbiah K, Khanum S, Chandra PS, Padian NS. An intergenerational women's empowerment intervention to mitigate domestic violence: results of a pilot study in Bengaluru, India. Violence Against Women. 2012;18(3):346–370. doi: 10.1177/1077801212442628.
    1. Parker B, McFarlane J, Socken K, Silva C, Reel S. Testing an intervention to prevent further abuse to pregnant women. Res Nurs Heal. 1999;22:59–66. doi: 10.1002/(SICI)1098-240X(199902)22:1<59::AID-NUR7>;2-B.
    1. Pronyk PM, Hargreaves JR, Kim JC, Morison LA, Phetla G, Watts C, Busza J, Porter JDH. Effect of a structural intervention for the prevention of intimate-partner violence and HIV in rural South Africa: a cluster randomised trial. Lancet. 2006;368(9551):1973–1983. doi: 10.1016/S0140-6736(06)69744-4.
    1. Tiwari A, Leung WC, Leung TW, Humphreys J, Parker B, Ho PC. A randomised controlled trial of empowerment training for Chinese abused pregnant women in Hong Kong. BJOG. 2005;112(9):1249–1256. doi: 10.1111/j.1471-0528.2005.00709.x.
    1. Bangalore (Bengaluru) City. .
    1. Civic Health Services Guide. .
    1. Code of Federal Regulations: Title 45 Public Welfare - Part 46 Protection of Human Subjects. .
    1. Satyanarayana VA, Chandra PS. Should mental health assessments be integral to domestic violence research? Indian J Med Ethics. 2009;VI(1):15–18.
    1. Logan TK, Walker R, Shannon L, Cole J. Combining ethical considerations with recruitment and follow-up strategies for partner violence victimization research. Violence Against Women. 2008;14(11):1226–1251. doi: 10.1177/1077801208323976.
    1. Government of India. Indian Public Health Standards for Primary Health Centres. 2006. (New Delhi: Directorate General of Health Services Ministry of Health & Family Welfare). .
    1. World Health Organization. Antenatal Care Randomized Trial: Manual for the Implementation of the New Model. Geneva: World Health Organization; 2001. .
    1. Kauffman K, New C. Co-counselling: the theory and practice of re-evaluation counselling. New York, NY: Brunner-Routledge; 2004.
    1. Begg C. Ruminations on the Intent-to-Treat Principle. Control Clin Trials. 2000;21(3):241–243. doi: 10.1016/S0197-2456(00)00050-7.
    1. Lachin J. Statistical Considerations in the Intent-to-Treat Principle. Control Clin Trials. 2000;21(2):167–189.
    1. Verma RK, Pulerwitz J, Mahendra V, Khandekar S, Barker G, Fulpagare P, Singh SK. Challenging and changing gender attitudes among young men in Mumbai, India. Reprod Health Matters. 2006;14(28):135–43. doi: 10.1016/S0968-8080(06)28261-2.
    1. Swindale A, Bilinsky P. Development of a universally applicable household food insecurity measurement tool: process, current status, and outstanding issues. J Nutr. 2006;136(Suppl):1449S–52S.
    1. Jejeebhoy S. Comparative Perspectives on Fertility Transition in South Asia: Volume I. Liege, Belgium: International Union for the Scientific Study of Population; 1996. Women's autonomy and reproductive behavior in India: linkages and influence of sociocultural context; pp. 20–26.
    1. Zimet G, Dahlem N, Zimet S, Farley G. The Multidimensional Scale of Perceived Social Support. J Pers Assess. 1988;52(1):30–41. doi: 10.1207/s15327752jpa5201_2.
    1. Garcia-Moreno C, Jansen HAFM, Ellsberg M, Heise L, Watts C. WHO Multi-country Study on Women’s Health and Domestic Violence against Women. Initial results on prevalence, health outcomes and women’s responses. Geneva: World Health Organization; 2005.
    1. World Health Organization. WHOQoL Study Protocol. Geneva: WHO; 1993.
    1. Benjamin D, Chandramohan A, Annie I, Prasad J, Jacob K. Validation of the Tamil version of Edinburgh post-partum depression scale. J Obstet Gynaecol India. 2005;55(3):241–3.
    1. Rubin DB, van der Laan M. Covariate Adjustment for the Intention-to-Treat Parameter with Empirical Efficiency Maximization. UC Berkeley: Division of Biostatistics; 2008. (Working Paper Series. Working Paper 229). [ ]
    1. Greene JC, Caracelli VJ, Graham WF. Toward a conceptual framework for mixed-method evaluation designs. Educ Eval Pol. 1989;11(3):255–274.
    1. Carey JW, Morgan M, Oxtoby MJ. Intercoder agreement in analysis of responses to open-ended interview questions: Examples from tuberculosis research. Cultural Anthropology Methods. 1996;8(3):1–5.
    1. Miles M, Huberman A. Qualitative Data Analysis: An Expanded Sourcebook. Thousand Oaks, CA: Sage Publications; 1994.
    1. Strauss A, Corbin JM. Handbook of Qualitative Research. Newbury Park, CA: Sage Publications; 1994. Grounded Theory Methodology: An Overview.
    1. Weitzman E, Miles M. Computer Programs for Qualitative Data Analysis: A Software Sourcebook. Thousand Oaks, CA: Sage Publications; 1995.

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