Computer-based SBIRT for marijuana use in pregnancy Planning a Stage II trial

描述(由申请人提供)：目前还没有关于怀孕期间使用大麻的循证干预措施，尽管它是迄今为止最常用的怀孕期间非法药物(尤其是在非裔美国妇女中)，尽管越来越多的证据表明它可能会造成一系列长期的认知和神经行为后果(例如，Day，Leech和Goldschmidt，2011年；Minnes，Lang和Singer，2011；Willford，Chandler，Goldschmidt和Day，2010)。此外，与其他滥用药物一样，大多数需要治疗大麻使用障碍的人既不接受也不想要(SAMHSA，2012年)。因此，建议在初级保健环境中进行普遍筛查和短暂干预，以进一步调查怀孕期间使用大麻的情况(Minnes等人，2011年)，这在酗酒和吸烟方面显示出了巨大的前景。然而，在医疗环境中实施短暂干预受到一系列重大障碍的限制，例如提供者缺乏时间和意愿，难以继续遵守关键的短暂干预原则。相比之下，技术交付的简报 干预措施可以在正常等待时间内完成，无需工作人员参与，完全可复制，便于披露，部署成本相对较低。因此，作为解决初级保健环境中不健康物质使用的一种可能方法，它们受到了相当大的关注，并在系统评价(Riper等人，2009年)以及专门针对孕妇和产后妇女的试验中(Ondersma等人，2012年；Ondersma，Svikis和Schuster，2007；Ondersma，Svikis，Thacker，Beatty和Lockhart，2013)中有很好的有效性证据。因此，这项R34临床试验计划赠款建议开发和初步验证两种用于怀孕期间使用大麻的高覆盖和相互兼容的基于技术的干预措施。第一个是以理论为基础的、同步的和高度互动的计算机提供的简短干预，将基于关于有效的技术提供的干预的关键要素的新兴知识库。第二个干预是一系列量身定做的短信，将建立在关于关键定制元素的丰富文献的基础上。这些干预措施将在报告积极使用大麻的孕妇以及卫生保健提供者的参与下制定和完善。随后将在一项试点随机试验中对它们进行单独和联合测试，该试验涉及80名在怀孕期间积极使用大麻的妇女。这一阶段的IA和IB试点工作将为第二阶段的确认性试验奠定基础。它还将产生第一个针对怀孕期间使用大麻的高度覆盖的简短干预措施。如果有效，这些方法可能会对孕妇使用大麻的人群产生重大影响，并有可能终身改善母亲和孩子的结果。

DESCRIPTION (provided by applicant): There are at present no evidence-based interventions for marijuana use during pregnancy, despite its being by far the most commonly used illicit drug during pregnancy (particularly among African-American women), and despite growing evidence that it may have a range of long-term cognitive and neurobehavioral consequences (e.g., Day, Leech, and Goldschmidt, 2011; Minnes, Lang, and Singer, 2011; Willford, Chandler, Goldschmidt, and Day, 2010). Further, as with other substances of abuse, the majority of persons needing treatment for marijuana use disorder neither receive nor want it (SAMHSA, 2012). Universal screening and brief intervention in primary care settings, which has shown significant promise with alcohol and tobacco use, has thus been recommended for further investigation with respect to marijuana use in pregnancy (Minnes, et al., 2011). However, implementation of brief interventions in medical settings has been limited by a range of substantial obstacles such as lack of time and willingness among providers, and difficulty maintaining adherence to key brief intervention principles. In contrast, technology-delivered brief interventions can be completed during normal wait times without staff involvement, are perfectly replicable, facilitate disclosure, and are relatively inexpensive to deploy. They have therefore received considerable attention as a possible way to address unhealthy substance use in primary care settings, with promising evidence of their efficacy in systematic reviews (Riper, et al., 2009), as well as in trials specifically with pregnant and post-partum women (Ondersma, et al., 2012; Ondersma, Svikis, and Schuster, 2007; Ondersma, Svikis, Thacker, Beatty, and Lockhart, 2013). This R34 clinical trial planning grant therefore proposes the development and preliminary validation of two high- reach and mutually compatible technology-based interventions for marijuana use during pregnancy. The first, a theory-based, synchronous, and highly interactive computer-delivered brief intervention, will be based on an emerging knowledge base regarding key elements of efficacious technology-delivered interventions. The second intervention, a series of tailored text messages, will build on the rich literature regardin key tailoring elements. These interventions will be developed and refined with input from pregnant women who report active use of marijuana, as well as from health care providers. They will subsequently be tested-alone and in combination-in a pilot randomized trial involving 80 women actively using marijuana during pregnancy. This Stage IA and IB pilot work would set the stage for a confirmatory Stage II trial. It would also produce the first high-reach brief interventions for marijuana use during pregnancy. If effective, these approaches could have a substantial population impact on marijuana use among pregnant women, with potential for lifelong improved outcomes for both mother and child.