Indirect Assessment and Intervention for Perinatal Drug Use

描述(由申请人提供)：对围产期药物使用的间接评估和干预PI：史蒂文·J·翁德斯马，韦恩州立大学医学院博士针对药物滥用的短暂干预的有效性是公认的。此外，有许多机会可以短暂接触高比例的药物使用障碍患者；一个理想的例子是产后时期，在此期间，几乎所有育儿妇女都住院，干预措施可以降低母亲和孩子的风险。然而，有两个因素限制了在此关头进行短暂干预的潜力。首先，进行此类干预的能力取决于披露药物使用情况的意愿。这是一个重大障碍，因为有证据表明，只有少至一半的药物阳性个人--特别是围产期妇女--报告使用这种药物。其次，实施哪怕是短暂的干预计划也存在后勤和财务障碍，特别是在培训和提供者意愿方面。为了应对这些限制，在NIDA的支持下(DA018975)，韦恩州立大学医学院的父母健康实验室开发了一种新的间接筛查方法，它评估非法药物使用的相关性，而不是药物使用本身。该筛查器的一个草案版本证明，在检测最近的药物使用方面，它比任何替代(例如，直接)方法更敏感。该奖项还支持开发一种简短的、计算机提供的干预措施，旨在建立改变的动机，而不假定使用药物；该干预措施草案在第一阶段测试中证明了良好的可行性和可接受性。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，在第二阶段/第二阶段试验中验证计算机提供的间接筛查和干预过程，通过间接药物使用筛查确定妇女处于危险之中。据我们所知，这将构成对间接短暂干预方法的第一次受控调查。具体来说，我们计划：(A)通过同时收集WIDUS方案和头发/尿液样本，继续开发和验证WIDUS筛查；(B)根据专家和参与者线人反馈，修订和升级间接干预草案；(C)从一家城市产科医院招募500名高危妇女；以及(D)随机将参与者分配到干预和控制条件下，并在3个月和6个月时进行盲法跟踪评估。主要结果将包括这一新样本中的WIDUS预测有效性、前3个月期间的药物使用天数，以及经尿毒学测试证实的药物使用率。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、精神健康)，以及短暂干预与结果之间任何观察到的关联的潜在调节因素。如果被证明是有效的，这种在后勤上可行、可复制和低成本的方法可能会大幅增加对高危产后妇女进行药物使用的短暂干预的覆盖范围--因此对人口的影响。此外，对母亲吸毒的任何影响都将进一步扩大对高危儿童的间接影响。

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.