Women's Global Health Imperative, RTI International, 114 Sansome Street, Suite 500, San Francisco, CA 94104, USA.
BMC Public Health. 2012 Nov 1;12:943. doi: 10.1186/1471-2458-12-943.
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.
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.
家庭暴力——指一个或多个家庭成员对女性实施的身体、心理或性虐待——在印度非常普遍。然而，针对具有减轻家庭暴力及其不良健康后果潜力的干预措施的研究相对较少，而且几乎没有资源可以指导干预研究背景下的安全规划和监测。Dil Mil 是一种在印度开发的基于增强妇女权能的有前途的干预措施，它与年轻妇女（媳妇）及其婆婆合作，以减轻家庭暴力和相关的不良健康结果。本文描述了在印度班加罗尔进行的 Dil Mil 的随机对照试验设计，重点介绍了用于最小化研究相关风险和监测安全性的策略。
方法/设计：一项使用 Dil Mil 干预与标准护理的平行比较的 2 期随机对照试验将在班加罗尔的三个公共初级保健中心实施。将从研究保健中心的产前服务和社区外展中招募处于妊娠第一或第二孕期的年轻孕妇。如果符合条件并愿意，她们的婆婆也将被招募。一旦入组，对双胞胎进行基线访谈，然后随机分配到对照组接受标准护理或干预组接受标准护理加 Dil Mil 干预。还将在产后 3 个月和 6 个月进行额外评估。将分析数据以检查干预措施的可行性和安全性，以及干预措施对中介结果（媳妇和婆婆的赋权）、媳妇中家庭暴力的发生率以及包括生活质量感知、心理社会状况和母婴健康结果在内的健康结果的影响。
本研究提供了一些方法，可能有助于指导类似环境中其他家庭暴力干预试验的安全规划和监测。此外，鉴于印度（甚至全球）年轻妇女遭受家庭暴力的惊人高发生率以及有效干预措施的数据匮乏，这项研究有望为预防家庭暴力提供重要的证据基础。
ClinicalTrials.gov 标识符：NCT01337778。
