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

基于计算机的 SBIRT 用于怀孕期间使用大麻 规划第二阶段试验

• 批准号: 8768993
• 负责人: STEVEN J. ONDERSMA
• 金额: $ 22.8万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8768993
• 关键词: Academic achievement; Address; Adherence; Adoption; African American; Alcohol consumption; Alcohol or Other Drugs use; Area; Attention; Back; Behavioral; Behavioral Sciences; Birth; Child; Clinic; Clinical Trials; Cognitive; Communities; Computer software; Computers; Data; Development; Disclosure; Disease; Elements; Evaluation; Evidence based intervention; Exposure to; Feedback; Goals; Grant; Hair; Health; Health Personnel; Illicit Drugs; Indium; Intervention; Investigation; Leeches; Life Cycle Stages; Literature; Long-Term Effects; Marijuana; Marijuana Smoking; Measures; Medical; Medical Records; Medical Staff; Meta-Analysis; Mothers; Outcome; Parents; Participant; Persons; Phase I Clinical Trials; Play; Population; Postpartum Period; Preclinical Drug Evaluation; Pregnancy; Pregnant Women; Prevalence; Privacy; Procedures; Provider; Public Health; Randomized; Recruitment Activity; Relative (related person); Reporting; Research; Role; Sampling; Series; Staging; Substance of Abuse; Technology; Testing; Text; Time; TimeLine; Tobacco use; United States Substance Abuse and Mental Health Services Administration; Urine; Validation; Woman; Work; base; brief intervention; computerized; design; drug of abuse; evidence base; fetal marijuana exposure; follow-up; improved; innovation; knowledge base; marijuana use brief intervention; neurobehavioral; pregnant; prenatal; prenatal exposure; prenatal intervention; primary care setting; programs; public health relevance; randomized trial; research study; response; screening and brief intervention; screening, brief intervention, referral, and treatment; systematic review; theories; therapy design; therapy development; trend; willingness

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.

描述（由申请人提供）：目前尚无针对怀孕期间吸食大麻的循证干预措施，尽管大麻是怀孕期间最常用的非法药物（尤其是非裔美国女性），而且越来越多的证据表明大麻可能会产生一系列长期认知和神经行为后果（例如，Day、Leech 和 Goldschmidt，2011 年；Minnes、Lang 和 Singer，2011 年；威尔福德， 钱德勒、戈德施密特和戴，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大麻（SAMHSA，2012）。因此，建议在初级保健机构中进行普遍筛查和短暂干预，这对于酒精和烟草的使用显示出巨大的希望，以进一步调查怀孕期间使用大麻的情况（Minnes 等人，2011 年）。然而，在医疗环境中实施简短干预措施受到一系列重大障碍的限制，例如提供者缺乏时间和意愿，以及难以坚持遵守关键的简短干预原则。相比之下，技术交付的简短 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，而且部署成本相对较低。因此，作为解决初级保健机构中不健康物质使用问题的一种可能方法，它们受到了相当多的关注，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 年；Ondersma、Svikis、Thacker、Beatty 和 洛克哈特，2013）。因此，这项 R34 临床试验计划拨款提议开发和初步验证两种针对怀孕期间吸食大麻的高影响力且相互兼容的基于技术的干预措施。第一个是基于理论的、同步的、高度互动的计算机提供的简短干预，它将基于关于有效技术提供的干预措施的关键要素的新兴知识库。第二项干预措施是一系列量身定制的短信，它将建立在有关关键定制元素的丰富文献的基础上。这些干预措施将根据报告积极使用大麻的孕妇以及医疗保健提供者的意见来制定和完善。随后将在一项试点随机试验中对它们进行单独和组合测试，该试验涉及 80 名在怀孕期间积极吸食大麻的妇女。 IA 和 IB 阶段试点工作将为第二阶段验证性试验奠定基础。它还将为怀孕期间使用大麻提供第一个高影响力的简短干预措施。如果有效，这些方法可能会对孕妇吸食大麻产生重大影响，并有可能改善母亲和儿童的终生结局。