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

Krishnamachari Srinivasan³  Prabha Chandra¹  Kalyani Subbiah²  Suneeta Krishnan³ 

[1] National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore, 560029, India;Women’s Global Health Imperative, RTI International, 114 Sansome Street, Suite 500, San Francisco, CA, 94104, USA;St. John’s Research Institute, St. John’s National Academy of Health Sciences, Koramangala, Bangalore, 560034, India

关键词: India;    Randomized controlled trial;    Women’s empowerment;    Domestic violence;   

Others  :  1162888
DOI  :  10.1186/1471-2458-12-943

 received in 2012-10-08, accepted in 2012-10-22,  发布年份 2012

【 摘 要 】

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

【 授权许可】

   
2012 Krishnan et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [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.
• [2]International Institute for Population Sciences (IIPS) and Macro International: National Family Health Survey (NFHS 3), 2005-06: Fact Sheet Karnataka. Mumbai: IIPS; 2007:1-3.
• [3]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.
• [4]Ackerson LK, Subramanian SV: Domestic Violence and Chronic Malnutrition among Women and Children in India. Am J Epidemiol 2008, 167(10):1188-1196.
• [5]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.
• [6]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.
• [7]Jejeebhoy SJ, Cook RJ: State accountability for wife-beating: The Indian challenge. Lancet 1997, 349:S10-S12.
• [8]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.
• [9]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.
• [10]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.
• [11]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.
• [12]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.
• [13]NIMH Multisite Prevention Trial: Definition of adverse reactions in clinical trials of a behavioral intervention. AIDS 1997, 11(Suppl 2):S55-57.
• [14]World Health Organization: Putting women's safety first: Ethical and safety recommendations for research on domestic violence against women. Geneva: WHO; 2001:1-32.
• [15]Ellsberg M, Heise L: Bearing witness: ethics in domestic violence research. Lancet 2002, 359(9317):1599-1604.
• [16]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.
• [17]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.
• [18]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.
• [19]Fontes LA: Ethics in violence against women research: The sensitive, the dangerous, and the overlooked. Ethics & Behavior 2004, 14(2):141-174.
• [20]District Level Household and Facility Survey 2007–08: Fact Sheets - India. 2007. [http://www.rchiips.org/pdf/rch3/state/India.pdf webcite]
• [21]Child Marriage Fact Sheet. [http://www.unicef.org/india/Child_Marriage_Fact_Sheet_Nov2011_final.pdf webcite]
• [22]Barua A, Kurz K: Reproductive health-seeking by married adolescent girls in Maharashtra, India. Reprod Health Matters 2001, 9(17):53-62.
• [23]Dyson T, Moore M: On Kinship Structure, Female Autonomy, and Demographic Behavior in India. Popul Dev Rev 1983, 9(1):35-60.
• [24]Goyal RS: Dimensions of adolescent motherhood in India. Soc Biol 1994, 41(1–2):130-134.
• [25]Jejeebhoy S, Sebastian M: Actions that protect: promoting sexual and reproductive health and choice among young people in India. In South and East Asia Regional Working Papers No 18. New Delhi, India: Population Council; 2003. http://www.popcouncil.org/pdfs/wp/seasia/seawp18.pdf webcite
• [26]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.
• [27]International Institute for Population Sciences (IIPS) and Macro International: National Family Health Survey (NFHS 3), 2005-06: India, volume 1. Mumbai: IIPS; 2007.
• [28]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.
• [29]Coker AL: Does physical intimate partner violence affect sexual health? A systematic review. Trauma Violence Abuse 2007, 8(2):149-177.
• [30]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.
• [31]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.
• [32]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.
• [33]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.
• [34]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]
• [35]Staying Alive: 5th Monitoring & Evaluation 2012 on the Protection of Women from Domestic Violence Act. 2005. [http://www.lawyerscollective.org/files/Staying%20Alive%205th%20M&E.pdf webcite]
• [36]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.
• [37]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.
• [38]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.
• [39]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.
• [40]Bangalore (Bengaluru) City. http://www.census2011.co.in/census/city/448-bangalore.html webcite
• [41]Civic Health Services Guide. http://www.bmponline.org/forms-pubs/PUBs/BMP-HE-E-AUG03-P-106.pdf webcite
• [42]Code of Federal Regulations: Title 45 Public Welfare - Part 46 Protection of Human Subjects. http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf webcite
• [43]Satyanarayana VA, Chandra PS: Should mental health assessments be integral to domestic violence research? Indian J Med Ethics 2009, VI(1):15-18.
• [44]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.
• [45]Government of India: Indian Public Health Standards for Primary Health Centres. 2006. [New Delhi: Directorate General of Health Services Ministry of Health & Family Welfare] http://mohfw.nic.in/NRHM/Documents/IPHS_for_PHC.pdf webcite
• [46]World Health Organization: Antenatal Care Randomized Trial: Manual for the Implementation of the New Model. Geneva: World Health Organization; 2001. http://whqlibdoc.who.int/hq/2001/WHO_RHR_01.30.pdf webcite
• [47]Kauffman K, New C: Co-counselling: the theory and practice of re-evaluation counselling. New York, NY: Brunner-Routledge; 2004.
• [48]Begg C: Ruminations on the Intent-to-Treat Principle. Control Clin Trials 2000, 21(3):241-243.
• [49]Lachin J: Statistical Considerations in the Intent-to-Treat Principle. Control Clin Trials 2000, 21(2):167-189.
• [50]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.
• [51]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.
• [52]Jejeebhoy S: Women's autonomy and reproductive behavior in India: linkages and influence of sociocultural context. In Comparative Perspectives on Fertility Transition in South Asia: Volume I. Liege, Belgium: International Union for the Scientific Study of Population; 1996:20-26.
• [53]Zimet G, Dahlem N, Zimet S, Farley G: The Multidimensional Scale of Perceived Social Support. J Pers Assess 1988, 52(1):30-41.
• [54]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.
• [55]World Health Organization: WHOQoL Study Protocol. Geneva: WHO; 1993.
• [56]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.
• [57]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] [http://biostats.bepress.com/ucbbiostat/paper229/ webcite]
• [58]Greene JC, Caracelli VJ, Graham WF: Toward a conceptual framework for mixed-method evaluation designs. Educ Eval Pol 1989, 11(3):255-274.
• [59]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.
• [60]Miles M, Huberman A: Qualitative Data Analysis: An Expanded Sourcebook. Thousand Oaks, CA: Sage Publications; 1994.
• [61]Strauss A, Corbin JM: Grounded Theory Methodology: An Overview. In Handbook of Qualitative Research. Newbury Park, CA: Sage Publications; 1994.
• [62]Weitzman E, Miles M: Computer Programs for Qualitative Data Analysis: A Software Sourcebook. Thousand Oaks, CA: Sage Publications; 1995.