SHS Treatment for Postpartum African American Smokers

描述（由申请人提供）：美国每天有超过1900万儿童暴露于二手烟（SHS）中。婴儿最容易受到二手烟的伤害，对于五岁以下儿童来说，接触二手烟造成的死亡比所有儿童意外伤害的总和还要多。为了响应2010年健康人群目标和NCI的优先事项，该试验旨在减少服务不足的城市非洲裔美国人（AA）人口中婴儿的SHS暴露，同时促进产后母亲戒烟。拟议的为期16周的试验“费城FRESH（建立无烟家庭的家庭规则）”将随机将450名有两岁以下儿童的母亲分为两个治疗组。随机接受多模式、个性化治疗（MIT）的母亲将收到1.)儿科医生的建议，2.)两次密集的、以家庭为中心的家庭行为咨询，3.)一份文化敏感的治疗手册，分四部分邮寄，从第一周开始每两周邮寄一次，4.)七次后续电话咨询。标准护理控制组（SCC）的母亲将接受儿科医生的评估、建议和一份综合自助手册，其中包含有关SHS及其减少、戒烟和复发预防的信息。我们预测，通过12个月的随访，MIT组将比SCC组表现出更好的婴儿SHS暴露和母亲吸烟结果（通过自我报告、婴儿尿液可替宁和母亲唾液可替宁来衡量）。我们的试验还将测试社会支持的中介作用，感知婴儿对二手烟的易感性，以及对吸烟结果的负面影响，通过纳入治疗成分来促进和维持自然孕产妇支持系统，增加对二手烟风险和减少二手烟的益处的认识，并改善情绪管理。我们假设这些变量的改善将对治疗结果产生积极影响。最后，我们的试验将测试基线体重担忧和抑郁症状的调节作用。我们假设基线体重担忧和抑郁对结果有主要影响，以及相互作用：与SCC相比，基线体重担忧和抑郁程度更高的母亲在MIT的结果更好。我们将使用GEE分析来检验基线、8周、16周（EOT）、3个月和12个月随访时间点的假设吸烟行为变化，并探讨调节变量的影响。通径分析将检验中介变量对结果的影响。

DESCRIPTION (provided by applicant): More than 19 million children in the U.S. are exposed to second-hand smoke (SHS) on a daily basis. Infants are the most susceptible to SHS harm, and for children under five, SHS exposure causes more deaths than all unintentional childhood injuries combined. In response to Healthy People 2010 goals and NCI priorities, this trial aims to reduce infant SHS exposure in an under-served urban African American (AA) population while simultaneously promoting smoking cessation among the postpartum (Pp) mothers. The proposed 16-week trial, "Philadelphia FRESH (Family Rules for Establishing Smoke-free Homes)," will randomize 450 Pp mothers of children up to two years old into two treatment groups. Mothers randomized to the multimodal, individualized treatment (MIT) will receive 1.) pediatrician advice, 2.) two intensive, family-centered, in-home behavioral counseling sessions, 3.) a culturally-sensitive treatment manual mailed in four sections, biweekly starting week 1, and 4.) seven follow-up phone counseling sessions. Mothers in the standard care control (SCC) group will receive pediatrician assessment, advice, and one comprehensive self-help manual with information on SHS and its reduction, smoking cessation, and relapse prevention. We predict that through 12-month follow-up, the MIT group will demonstrate better infant SHS exposure and maternal smoking outcomes (measured by self-report, infant urine cotinine, and maternal saliva cotinine) than the SCC group. Our trial will also test the mediating influence of social support, perceived infant vulnerability to SHS, and negative affect on smoking outcomes by incorporating treatment components to boost and sustain natural maternal support systems, increase knowledge of SHS risks and benefits of SHS reduction, and improve mood management. We hypothesize that improvements in these variables will positively impact treatment outcome. Finally, our trial will test the moderating effects of baseline weight concerns and depression symptoms. We hypothesize a main effect for baseline weight concerns and depression on outcomes, as well as an interaction: moms with greater baseline weight concern and depression will have better outcomes in MIT compared to SCC. We will use GEE analysis to test hypothesized smoking behavior changes across baseline, 8-week, 16-week (EOT), 3-mo and 12-month follow-up time points and explore the influence of moderating variables. Path analysis will test mediating variables' influence on outcomes.