Contingency Management for Smoking Cessation in Pregnant Minority Women

描述（由申请人提供）：本研究的长期目标是通过改善少数民族孕妇和产后妇女的戒烟和复发预防干预措施，减少与烟草相关的母婴健康结果差异，这些妇女在戒烟研究中代表性明显不足。本研究将检验基于奖励的应急管理方法在社会经济上处于不利地位的少数民族怀孕吸烟者中增加戒烟和预防复发的可行性和有效性。首先，将对10名怀孕的低收入少数族裔吸烟者进行预测试，然后根据可接受性调查和焦点小组数据对干预措施进行完善。接下来，将进行一项试点研究。从一家大型教学医院的产科门诊诊所招募60名高度弱势的少数民族妇女，她们报告每天吸烟，并符合其他资格标准（例如，18岁或以上；< 28周胎龄），将被纳入并随机分配到两种研究条件之一：1)标准心理教育干预（6周，个人管理，针对怀孕的戒烟课程，目前在诊所实施；QSN-SP）；2)标准心理教育干预加应急管理（提供基于生化验证禁欲的激励；QSN-CM）。通过过期的一氧化碳和唾液浓度监测戒断将在两组的第一个戒烟日开始，并持续到产后3个月。只有QSN-CM组的参与者才会加强生化验证的禁欲，并有机会赢得价值约1美元至100美元的奖品（“鱼缸”或“奖品碗”方法）。主要研究结果包括：干预的出勤率和完成情况；持续、长期、点流行戒烟（自我报告并生化验证）。次要结局包括：孕产妇和婴儿健康结局（如胎龄；婴儿出生体重、身长和头围；分娩/新生儿并发症；婴儿生长和呼吸健康）。该研究还将检查影响治疗反应的因素（例如，抑郁、压力）。结果将通过随访研究检查（分娩和产后6个月）和医院图表审查来评估。研究结果将为促进和维持弱势孕妇戒烟的有效方法提供科学知识，并为支持更大规模的随机对照试验提供初步的可行性和有效性数据。

DESCRIPTION (provided by applicant): The long-term goal of this research is to reduce tobacco-related disparities in maternal and infant health outcomes by improving smoking cessation and relapse prevention interventions for minority pregnant and postpartum women, who have been significantly underrepresented in smoking cessation research. This study will examine the feasibility and efficacy of a prize-based contingency management approach for increasing smoking cessation and preventing relapse among socioeconomically disadvantaged minority pregnant smokers. First, the intervention will be pretested with 10 pregnant low-income minority smokers and then refined based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60 highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a large teaching hospital, who report daily smoking and who meet other eligibility criteria (e.g., 18 years or older; < 28 weeks gestational age) will be enrolled ad randomized to one of two study conditions: 1) Standard Psychoeducational Intervention (6- week, individually-administered, pregnancy-specific Quit Smoking Now curriculum, as currently implemented in the clinic; QSN-SP); 2) Standard Psychoeducational Intervention plus Contingency Management (provision of incentives contingent on biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide and salivary continues levels will occur in both groups beginning on the first quit day and continuing through 3-months postpartum. Only participants in the QSN-CM group will be reinforced for biochemically-verified abstinence with chances to win prizes ranging in value from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Primary study outcomes include: intervention attendance and completion; and continuous, prolonged and point prevalence tobacco abstinence (self-report with biochemical verification). Secondary outcomes include: maternal and infant health outcomes (e.g., gestational age; infant birth weight, length and head circumference; delivery/neonatal complications; infant growth and respiratory health). The study will also examine factors (e.g., depression, stress) influencing treatment response. Outcomes will be assessed through follow-up research exams (delivery and 6-months postpartum) and hospital chart reviews. Results should advance scientific knowledge regarding effective methods for promoting and maintaining smoking abstinence among pregnant disadvantaged women and provide preliminary feasibility and efficacy data needed to support a larger randomized controlled trial.