Indirect Assessment and Intervention for Perinatal Drug Use

简介（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对药物滥用的短期干预的有效性是公认的。此外，有许多机会可以短暂接触到比例很高的物质使用障碍患者；一个理想的例子是产后，在此期间，几乎所有养育子女的妇女都住院，在此期间，干预措施可以减少母亲和儿童的风险。然而，在这个关键时刻，有两个因素限制了短期干预的潜力。首先，进行此类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，只有不到一半的药物阳性个体，特别是围产期妇女报告使用药物。其次，即使是实施简短的干预计划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，并在NIDA的支持下（DA018975），韦恩州立大学医学院的家长健康实验室开发了一种新的间接筛选器，用于评估非法药物使用的相关因素，而不是药物使用本身。这种筛选器的一个草案证明，在检测最近的药物使用情况方面，它比任何其他方法（例如，直接）都更敏感。该奖项还支持开发一种简短的、计算机提供的干预措施，旨在在不假定吸毒的情况下建立改变动机；该干预措施草案在第一阶段测试中显示出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措施，在II期/ IIb期试验中验证计算机传递的间接筛查和干预过程，通过间接药物使用筛查确定有风险的妇女。据我们所知，这将构成对间接短期干预方法的首次对照调查。具体而言，我们计划：(a)通过同时收集WIDUS协议和毛发/尿液样本，继续开发和验证WIDUS筛选器；(b)根据专家和参与者的反馈意见修订和升级间接干预草案；(c)从城市产科医院招募500名高危妇女；(d)随机将参与者分为干预组和对照组，在3个月和6个月时进行盲法随访评估。主要结果将包括WIDUS在新样本中的预测效度、前3个月期间的用药天数，以及通过尿液毒理学测试验证的用药点流行率。次要结果将包括干预所涉及的相关因素（酒精使用、暴力、艾滋病毒风险、心理健康）以及观察到的任何短暂干预与结果之间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大增加对高危产后妇女使用药物的简短干预的范围，从而对人口产生影响。此外，对产妇使用药物的任何影响将因对处于危险中的儿童的间接影响而进一步成倍增加。

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.