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Indirect Assessment and Intervention for Perinatal Drug Use

围产期药物使用的间接评估和干预

基本信息

批准号：
8705481
负责人：
STEVEN J. ONDERSMA
金额：
$ 40.94万
依托单位：
WAYNE STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-15 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8705481
关键词：
Address Alcohol abuse Alcohol consumption Alcohol or Other Drugs use Area Award Behavior Behavior Therapy Biological Markers Blinded Child Classification Clinical Trials Collection Complex Computer software Computers Development Discipline of obstetrics Doctor of Philosophy Drug abuse Drug usage Emotional Esthesia Face Family health status Feedback Financial cost HIV risk Hair Health Home environment Hospitals Illicit Drugs Individual Infant Health Intervention Investigation Life Style Logistics Maternal and Child Health Mental Health Methods Modeling Mothers Motivation National Institute of Drug Abuse Outcome Parenting behavior Parents Participant Patient Self-Report Patients Perinatal Pharmaceutical Preparations Phase Phase II Clinical Trials Population Pregnancy Prevalence Process Protocols documentation Provider Randomized Recruitment Activity Reporting Risk Safety Sampling Smoking Societies Software Design Staging Substance Use Disorder Substance abuse problem System Testing Time Touch sensation Toxicology Training Universities Urban Hospitals Urine Validation Violence Woman base brief intervention brief motivational intervention checkup examination cost emotional distress fetal drug exposure follow-up informant innovation intervention program maternal drug use medical schools novel perinatal intervention primary outcome response screening screening and brief intervention secondary outcome skills social stigma substance abuse brief intervention therapy design therapy development willingness

项目摘要

DESCRIPTION (provided by applicant): Indirect Assessment and Intervention for Perinatal Drug Use PI: Steven J. Ondersma, PhD Wayne State University School of Medicine The efficacy of brief interventions for substance abuse is well-established. Further, numerous opportunities exist for brief access to high proportions of individuals with substance use disorders; an ideal example is the post-partum period, during which nearly all parenting women are hospitalized, and in which interventions may reduce risks for both mother and child. However, two factors limit the potential of brief interventions at this juncture. First, the ability to conduct such interventions is dependent upon willingness to disclose drug use. This is a significant obstacle given evidence that as few as half of drug-positive individuals-particularly women in the perinatal period-report that use. Second, there are logistic and financial obstacles to implementing even brief intervention programs, particularly with regard to training and provider willingness. In response to these limitations, and with NIDA support (DA018975), the Parent Health Lab at the Wayne State University School of Medicine developed a novel indirect screener that evaluates correlates of illicit drug use rather than drug use itself. A draft version of this screener proved itself to be more sensitive than any alternative (e.g., direct) approach at detecting recent drug use. This award also supported the development of a brief, computer-delivered intervention designed to build change motivation without presuming drug use; this draft intervention has demonstrated good feasibility and acceptability in Phase I testing. Following NIDA's Stage Model of Behavioral Therapy Development, the proposed study will take the next step of validating the computer-delivered indirect screening and intervention process in a Phase II/Stage IIb trial with women determined to be at risk by the indirect drug use screener. This would, to our knowledge, constitute the first controlled investigation of an indirect brief intervention approach. Specifically, we plan to: (a) continue development and validation of the WIDUS screener via concomitant collection of WIDUS protocols and hair/urine samples; (b) revise and upgrade the draft indirect intervention based on expert and participant informant feedback; (c) recruit 500 at-risk women from an urban obstetric hospital; and (d) randomly assign participants into intervention and control conditions, with blinded follow-up assessments at 3- and 6-months. Primary outcomes will include WIDUS predictive validity in this new sample, number of drug-using days during the previous 3-month period, and point prevalence of drug use as validated by urine toxicology tests. Secondary outcomes will include related factors touched on by the intervention (alcohol use, violence, HIV risk, mental health) and potential moderators of any observed association between the brief intervention and outcomes. If proven efficacious, this logistically feasible, replicable, and low-cost approach could allow a dramatic increase in the reach--and therefore the population impact--of brief interventions for drug use among at-risk post-partum women. Further, any impact on maternal drug use would be further multiplied by indirect effects on the at-risk child.

描述（由申请人提供）：围产期药物使用的间接评估和干预PI：Steven J. Ondersma，博士韦恩州立大学医学院药物滥用的简短干预的疗效是公认的。此外，有许多机会可以短暂接触到比例很高的药物使用障碍患者;一个理想的例子是产后期，在此期间，几乎所有育儿妇女都住院，在此期间，干预措施可以减少母亲和儿童的风险。然而，有两个因素限制了在此关头进行简短发言的可能性。首先，进行这种干预的能力取决于披露吸毒情况的意愿。这是一个重大障碍，因为有证据表明，只有一半的药物阳性个体，特别是围产期妇女，报告使用。第二，即使是实施简短的干预方案，也存在后勤和财政障碍，特别是在培训和提供者意愿方面。为了应对这些限制，并与NIDA的支持（DA 018975），父母健康实验室在韦恩州立大学医学院开发了一种新的间接筛选，评估相关的非法药物使用，而不是药物使用本身。事实证明，该筛选程序的草稿版本比任何替代方案都更敏感（例如，直接）检测最近药物使用的方法。该奖项还支持了一个简短的，计算机提供的干预措施，旨在建立改变的动机，而不假定药物使用的发展;这一草案的干预措施已经证明了良好的可行性和可接受性，在第一阶段的测试。根据NIDA的行为治疗发展阶段模型，拟议的研究将采取下一步措施，在II期/IIb期试验中验证计算机提供的间接筛查和干预过程，其中女性被间接药物使用筛查确定为有风险。据我们所知，这将构成间接简短干预方法的第一次对照研究。具体而言，我们计划：（a）通过同时收集WIDUS协议和头发/尿液样本，继续开发和验证WIDUS筛查工具;（B）根据专家和参与者提供的反馈意见，修订和更新间接干预措施草案;（c）从一家城市产科医院招募500名高危妇女;和（d）将参与者随机分配到干预和对照条件下，在3个月和6个月进行盲法随访评估。主要结果将包括该新样本中的WIDUS预测有效性、前3个月期间的吸毒天数以及经尿液毒理学测试验证的吸毒点患病率。次要结果将包括干预涉及的相关因素（酒精使用，暴力，艾滋病毒风险，心理健康）和任何观察到的简短干预和结果之间的关联的潜在调节因素。如果证明有效，这种后勤上可行、可复制和低成本的方法可以大幅度增加高危产后妇女使用毒品的简短干预措施的覆盖面，从而增加对人口的影响。此外，对母亲吸毒的任何影响都会因对高危儿童的间接影响而进一步倍增。