||5R01CA105183-05 Interpret this number
||Temple Univ Of The Commonwealth
||Shs Treatment for Postpartum African American Smokers
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.
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