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: 9091551
• 负责人: STEVEN J. ONDERSMA
• 金额: $ 22.57万
• 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 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9091551
• 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; Elements; Evaluation; Evidence based intervention; Exposure to; Feedback; Goals; Grant; Hair; Health; Health Personnel; Indium; Intervention; Investigation; Leeches; Life Cycle Stages; Literature; Long-Term Effects; Marijuana; 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; 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; alcohol consumption during pregnancy; base; brief intervention; computerized; design; drug of abuse; evidence base; fetal marijuana exposure; follow-up; illicit drug use; improved outcome; innovation; knowledge base; marijuana use; marijuana use brief intervention; marijuana use disorder; neurobehavioral; pregnant; prenatal exposure; prenatal intervention; primary care setting; programs; 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）：目前没有针对怀孕期间使用大麻的循证干预措施，尽管它是迄今为止怀孕期间最常用的非法药物（特别是在非洲裔美国妇女中），尽管越来越多的证据表明它可能具有一系列长期的认知和神经行为后果（例如，Day，Leech，and Goldschmidt，2011; Minnes，Lang，and Singer，2011; Willford，钱德勒，Goldschmidt，and Day，2010）.此外，与其他滥用物质一样，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）。因此，建议在初级保健环境中进行普遍筛查和短暂干预，这对酒精和烟草的使用具有重要的前景，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，以及难以坚持关键的简短干预原则。相比之下， 干预可以在正常等待时间内完成，无需工作人员参与，完全可以复制，便于披露，部署成本相对较低。因此，它们作为在初级保健环境中解决不健康物质使用的可能方式受到了相当大的关注，在系统综述中有关于其功效的有希望的证据（Riper等人，2009），以及在特别是对孕妇和产后妇女的试验中（Ondersma等人，2012; Ondersma，Svikis和Schuster，2007; Ondersma，Svikis，Thacker，Beatty和Lockhart，2013）。因此，这项R34临床试验计划拨款提出了两项高范围和相互兼容的基于技术的干预措施的开发和初步验证，用于怀孕期间使用大麻。第一，一个理论为基础的，同步的，高度互动的计算机提供的简短干预，将基于一个新兴的知识基础上有效的技术提供的干预措施的关键要素。第二个干预措施是一系列定制的短信，将建立在丰富的文献基础上，包括关键的定制元素。这些干预措施将在报告积极使用大麻的孕妇以及医疗保健提供者的投入下制定和完善。随后，他们将在一项涉及80名怀孕期间积极使用大麻的妇女的试点随机试验中单独和联合进行测试。第一阶段和第二阶段的试验工作将为第二阶段的确定性试验奠定基础。它还将为怀孕期间使用大麻提供第一个高范围的简短干预。如果有效，这些方法可能会对孕妇使用大麻产生重大的人口影响，并有可能改善母亲和孩子的终身结局。