Long-term Results From the FRESH RCT: Sustained Reduction of Children's Tobacco Smoke Exposure

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.