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）：尽管大麻是迄今为止怀孕期间最常用的非法药物（特别是在非裔美国妇女中），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，但目前尚无针对怀孕期间使用大麻的证据干预措施（例如，Day, Leech, and Goldschmidt, 2011; Minnes, Lang, and Singer, 2011; Willford, Chandler, 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没有接受治疗，也不想接受治疗（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，以对酒精和烟草的使用显示出重大希望，并对怀孕期间使用大麻进行进一步调查（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，以及难以坚持关键的简短干预原则。相比之下，技术带来的是短暂的