Reinforcement Based Treatment for Pregnant Drug Abusers

描述(由申请人提供)：在NIDA行为治疗开发第一和第二阶段的支持下，成瘾和怀孕中心的研究人员开发并测试了一种针对吸毒成瘾孕妇的强化门诊复发预防方法，基于强化的治疗(RBT)。RBT基于社会学习理论的原则，将禁欲相关的生活技能培训、娱乐治疗、就业准备和安置作为强化日间治疗咨询计划的常规方面。RBT已经在四个随机对照试验4-7中进行了测试，最新的试验是在没有资格接受美沙酮治疗或拒绝接受美沙酮治疗的孕妇身上进行的，作为护理的辅助。后一项试验的结果表明，与CAP标准护理参与者相比，RBT参与者在3个月时显著更多地利用CAP治疗(61%比21%)，在研究后3个月和6个月分别显著更高地戒除海洛因(52%比29%；67%比20%)和可卡因(48%比13%；56%比20%)。目的：这一修订后的应用程序是一项第二阶段的行为发育研究，旨在回答在将RBT传播到更大的治疗社区之前仍然必要的关键问题。这些问题集中在对吸毒成瘾的孕妇最有效的RBT强度水平，决定哪种RBT治疗水平对哪个患者最好的个体调解人和调节者，以及RBT治疗的成本效益。设计：建议的研究利用一种新的方法来进行对照临床试验，即序贯多分配随机试验(SMART)设计。参与者(N=300)将首先在治疗开始时被随机分为常规治疗RBT组或降低强度RBT组。所有参与者都将根据他们最初两周的治疗依从性评估接受随后的随机化。早期不符合要求的参与者将被随机接受相同水平或更高水平的RBT治疗强度，而早期符合要求的参与者将被随机接受相同水平或更低水平的治疗强度和范围。主要结果衡量标准包括治疗完成率和产妇海洛因和可卡因使用情况。次要结果测量包括母体测量HIV危险行为、其他药物使用、心理社会功能和新生儿住院时间、身体出生参数、神经完整性和行为功能。创新和意义：拟议项目的创新包括：创新的RBT，使用尖端的智能模型，应用先进的统计技术，并纳入成本效益方法。拟议项目的意义非常大，因为它将为后期的第三阶段研究奠定基础，这些研究的重点是传播针对吸毒成瘾孕妇的分步护理治疗方案，这些方案不仅可以在综合护理诊所实施，而且可以在为这类妇女提供服务的不同社区环境中实施。 公共卫生相关性：这项II阶段开发研究采用SMART(序贯多重分配试验)设计来回答剩余的关键问题，即RBT对孕妇最有效的强度水平及其成本效益，这在将该疗法传播到更大的治疗社区之前是必要的。

DESCRIPTION (provided by applicant): With NIDA Behavioral Treatment Development Stage I and II support, researchers at the Center for Addiction and Pregnancy have developed and tested an intensive outpatient relapse-prevention approach, Reinforcement Based Treatment (RBT), for drug-addicted pregnant women. RBT is based on the principles of social learning theory and employs abstinence-contingent access to life-skills training, recreational therapy, and employment preparation and placement as routine aspects of an intensive day treatment counseling program. RBT has been tested in four randomized controlled trials4-7, with the most recent trial in pregnant patients who did not qualify for or refused methadone treatment as an adjunct to care. Results of this latter trial indicated that RBT participants, as compared to CAP standard care participants, had significantly greater CAP treatment utilization (61% v. 21%) at 3 months and significantly greater rates of abstinence from heroin (52% v. 29%; 67% v. 20%) and cocaine (48% v. 13%; 56% v. 20%) at 3 and 6 months, respectively, post-study entry. Objectives: This revised application is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating RBT to the larger treatment community. These questions focus on the levels of intensity of RBT most efficacious for drug-addicted pregnant patients, the individual mediators and moderators that determine which RBT treatment level is best for which patient, and the cost-effectiveness of RBT treatment. Design: The proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (SMART) design. Participants (N=300) will first be randomized at treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All participants will receive a subsequent randomization based upon an assessment of their initial two weeks of treatment compliance. Early-non-compliant participants will be randomized to receive either the same or an increased level of RBT treatment intensity while early-compliant participants will be randomized to receive either the same or decreased level of treatment intensity and scope. Primary outcome measures include treatment completion and maternal heroin and cocaine use. Secondary outcome measures include maternal measures of HIV risk behavior, other drug use, and psychosocial functioning and neonatal measures of length of hospitalization, physical birth parameters, neurological integrity, and behavioral functioning. Innovation and Significance: The proposed project's innovation includes: the novelty RBT, use of a cutting- edge SMART model, application of advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed project's significance is exceedingly high, as it will lay the foundation for later Stage III studies focused on dissemination of stepped care treatment programs for drug-addicted pregnant women that can be implemented not only in comprehensive care clinics but in diverse community settings that provide services to such women. PUBLIC HEALTH RELEVANCE: This Stage II development study utilizes a SMART (sequential multiple assignment trial) design to answer remaining critical questions, regarding the levels of intensity of RBT most efficacious for pregnant patients and its cost-efficacy, necessary before disseminating this therapy to the larger treatment community.