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

基本信息

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
项目类别：
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

项目摘要

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）：目前尚无怀孕期间大麻使用的基于证据的干预措施，尽管它是迄今为止怀孕期间最常用的非法药物（尤其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，但曾经是一系列的后果Chandler，Goldschmidt和Day，2010年）。此外，与其他虐待物质一样，大多数需要接受大麻使用障碍治疗的人既不接受也不想要它（Samhsa，2012年）。因此，已建议对初级保健环境进行普遍筛查和对初级保健环境的简短干预，这表明了酒精和烟草的使用有很大的希望，因此建议在妊娠中使用大麻使用大麻的进一步研究（Minnes等，2011）。但是，在医疗环境中进行简短干预措施的实施受到一系列重大障碍的限制，例如提供者之间缺乏时间和意愿，以及难以维持遵守关键的简短干预原则。相比之下，技术交付的简介干预措施可以在正常的等待时间内完成，而无需人员参与，完全可复制，促进披露，并且相对便宜。因此，他们受到了极大的关注，作为解决初级保健环境中不健康药物使用的一种可能方法，并有很有希望的证据表明其在系统评价中的功效（Riper等，2009）以及专门针对怀孕和产后妇女的试验（Ondersma等人（Ondersma等）（Ondersma等人，2012; Ondersma，ondersma，svikis＆Svikis and Schustry and Schustry and Schustry;洛克哈特，2013年）。因此，这项R34临床试验计划赠款提出了两种高覆盖范围和相互兼容的基于技术的大麻在怀孕期间使用大麻的开发和初步验证。首先是基于理论，同步且高度交互式计算机传递的简短干预措施，它将基于有关有效技术传递干预措施的关键要素的新兴知识基础。第二次干预是一系列量身定制的短信，它将基于丰富的文献依靠关键剪裁元素。这些干预措施将通过报告积极使用大麻以及医疗保健提供者的孕妇的意见来制定和完善。随后，他们将进行单独测试，并结合一项试验随机试验，涉及80名妇女在怀孕期间积极使用大麻。这一阶段IA和IB飞行员工作将为确认性II阶段试验奠定基础。这也将产生怀孕期间大麻使用的首次高度触及的简短干预措施。如果有效，这些方法可能会对孕妇的大麻使用产生重大影响，并且可能会改善母亲和儿童的终身预后。