Minimizing risks and monitoring safety of an antenatal care intervention to mitigate domestic violence among young Indian women: The Dil Mil trial.
Minimizing risks and monitoring safety of an antenatal care intervention to mitigate domestic violence among young Indian women: The Dil Mil trial.
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DOI：
10.1186/1471-2458-12-943
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发表时间：
2012-11-01
影响因子：
4.5
通讯作者：
Srinivasan K
中科院分区：
文献类型：
--
作者：
Krishnan S;Subbiah K;Chandra P;Srinivasan K
家庭暴力-一个或多个家庭成员对妇女实施的身体、心理或性虐待-在印度十分普遍。然而，对有可能减轻家庭暴力及其不利健康后果的干预措施进行的研究相对较少，而且在干预研究背景下指导安全规划和监测的资源很少。Dil Mil是在印度开发的一种有前途的增强妇女权能的干预措施，它与年轻妇女（媳妇）及其婆婆接触，以减少家庭暴力和相关的不良健康后果。本文描述了在印度班加罗尔进行的Dil Mil随机对照试验的设计，重点关注用于最大限度地降低研究相关风险和监测安全性的策略。将在本尼迪克特的三个公共初级卫生中心实施一项2期随机对照试验，将Dil Mil干预与标准护理进行平行比较。将从研究健康中心的产前服务和社区外展招募妊娠早期或中期的年轻孕妇。如果符合条件并愿意，他们的岳母也将被招募。一旦入组，二联体将参与基线访谈，然后随机分配至对照组并接受标准治疗或干预组并接受标准治疗加Dil Mil干预。将在产后3个月和6个月进行额外评价。将对数据进行分析，以检查干预措施的可行性和安全性，以及干预措施对中间结果（儿媳和婆婆的赋权）、儿媳家庭暴力发生率和健康结果（包括感知生活质量、心理社会状况和母婴健康结果）的影响。这项研究提供的方法，可能有助于指导安全规划和监测其他家庭暴力干预试验在类似的设置。此外，鉴于印度（乃至全球）对年轻妇女的家庭暴力发生率高得惊人，而且缺乏有效干预措施的数据，这项研究有望为预防家庭暴力的证据基础做出重要贡献。ClinicalTrials.gov标识符：NCT 01337778
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. 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. 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. ClinicalTrials.gov Identifier: NCT01337778
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