Bradley N Collins1, Uma S Nair2, Katie I DiSantis3, Melbourne F Hovell4, Samantha M Davis5, Daniel Rodriguez6, Janet Audrain-McGovern7. 1. Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania. Electronic address: collinsb@temple.edu. 2. Department of Health Promotion Sciences, College of Public Health, University of Arizona, Tucson, Arizona. 3. Department of Public Health, Arcadia University, Philadelphia, Pennsylvania. 4. Center for Behavioral Epidemiology and Community Health, School of Public Health, San Diego State University, San Diego, California. 5. Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania. 6. Department of Urban Public Health and Nutrition, School of Nursing and Health Sciences, La Salle University, Philadelphia, Pennsylvania. 7. Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Abstract
INTRODUCTION: Standard care interventions to reduce children's tobacco smoke exposure (TSE) may not be sufficient to promote behavior change in underserved populations. A previous study demonstrated the short-term efficacy of an experimental counseling intervention, Family Rules for Establishing Smokefree Homes (FRESH) compared with standard care on boosting low-income children's TSE reduction and maternal smoking at 16-week end of treatment (EOT). This study tested long-term posttreatment efficacy of this treatment through a 12-month follow-up. STUDY DESIGN: This study was a two-arm RCT. SETTING/PARTICIPANTS: Maternal smokers (n=300) not seeking cessation treatment were recruited from low-income, urban communities. Participants exposed their <4-year-old children to tobacco smoke daily. Data collection and analyses occurred from 2006 to 2018. INTERVENTION: The FRESH behavioral intervention included 2 home visits and 7 phone sessions. FRESH used cognitive behavioral skills training, support, problem-solving, and positive social reinforcement to facilitate the adoption of increasingly challenging TSE-protection behaviors. No nicotine-replacement therapy or medication was provided. MAIN OUTCOME MEASURES: Primary outcomes were child cotinine (TSE biomarker) and reported TSE from EOT through 12 months after treatment. A secondary outcome was bioverified maternal smoking cessation. RESULTS: Compared with controls, children in FRESH had significantly lower cotinine (β= -0.31, p<0.01) and lower maternal-reported TSE (β= -1.48, p=0.001) through the 12-month follow-up. A significant effect of time (β= -0.03, p=0.003) reflected a posttreatment decrease in cotinine. There was no treatment × time interaction, suggesting the treatment effect at EOT was sustained after treatment. Compared with controls, FRESH mothers maintained significantly higher odds of quitting smoking from EOT through 12-month follow-up (OR=8.87, 95% CI=2.33, 33.75). CONCLUSIONS: Study results with a sample of underserved maternal smokers demonstrated that the short-term effect of FRESH counseling at 16-week EOT was maintained through 12 months after treatment-for both bioverified child TSE reduction and maternal smoking cessation. Smokers in low-income communities demonstrate elevated challenges to success in standard smoking treatment. FRESH follow-up results suggest the high potential value of more-intensive behavioral intervention for vulnerable smokers. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02117947.
RCT Entities:
INTRODUCTION: Standard care interventions to reduce children's tobacco smoke exposure (TSE) may not be sufficient to promote behavior change in underserved populations. A previous study demonstrated the short-term efficacy of an experimental counseling intervention, Family Rules for Establishing Smokefree Homes (FRESH) compared with standard care on boosting low-income children's TSE reduction and maternal smoking at 16-week end of treatment (EOT). This study tested long-term posttreatment efficacy of this treatment through a 12-month follow-up. STUDY DESIGN: This study was a two-arm RCT. SETTING/PARTICIPANTS: Maternal smokers (n=300) not seeking cessation treatment were recruited from low-income, urban communities. Participants exposed their <4-year-old children to tobacco smoke daily. Data collection and analyses occurred from 2006 to 2018. INTERVENTION: The FRESH behavioral intervention included 2 home visits and 7 phone sessions. FRESH used cognitive behavioral skills training, support, problem-solving, and positive social reinforcement to facilitate the adoption of increasingly challenging TSE-protection behaviors. No nicotine-replacement therapy or medication was provided. MAIN OUTCOME MEASURES: Primary outcomes were childcotinine (TSE biomarker) and reported TSE from EOT through 12 months after treatment. A secondary outcome was bioverified maternal smoking cessation. RESULTS: Compared with controls, children in FRESH had significantly lower cotinine (β= -0.31, p<0.01) and lower maternal-reported TSE (β= -1.48, p=0.001) through the 12-month follow-up. A significant effect of time (β= -0.03, p=0.003) reflected a posttreatment decrease in cotinine. There was no treatment × time interaction, suggesting the treatment effect at EOT was sustained after treatment. Compared with controls, FRESH mothers maintained significantly higher odds of quitting smoking from EOT through 12-month follow-up (OR=8.87, 95% CI=2.33, 33.75). CONCLUSIONS: Study results with a sample of underserved maternal smokers demonstrated that the short-term effect of FRESH counseling at 16-week EOT was maintained through 12 months after treatment-for both bioverified child TSE reduction and maternal smoking cessation. Smokers in low-income communities demonstrate elevated challenges to success in standard smoking treatment. FRESH follow-up results suggest the high potential value of more-intensive behavioral intervention for vulnerable smokers. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02117947.
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