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 (ß= -0.31, p<0.01) and lower maternal-reported TSE (ß= -1.48, p=0.001) through the 12-month follow-up. A significant effect of time (ß= -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.

Reducing Underserved Children's Exposure to Tobacco Smoke: A Randomized Counseling Trial With Maternal Smokers.

INTRODUCTION: Addressing maternal smoking and child tobacco smoke exposure is a public health priority. Standard care advice and self-help materials to help parents reduce child tobacco smoke exposure is not sufficient to promote change in underserved populations. We tested the efficacy of a behavioral counseling approach with underserved maternal smokers to reduce infant's and preschooler's tobacco smoke exposure. DESIGN: A two-arm randomized trial: enhanced behavior counseling (experimental) versus enhanced standard care (control). Assessment staff members were blinded. SETTING/PARTICIPANTS: Three hundred randomized maternal smokers were recruited from low-income urban communities. Participants had a child aged <4 years exposed to two or more maternal cigarettes/day at baseline. INTERVENTION: Philadelphia Family Rules for Establishing Smoke-free Homes (FRESH) included 16 weeks of counseling. Using a behavioral shaping approach within an individualized cognitive-behavioral therapy framework, counseling reinforced efforts to adopt increasingly challenging tobacco smoke exposure-protective behaviors with the eventual goal of establishing a smoke-free home. MAIN OUTCOME MEASURES: Primary outcomes were end-of-treatment child cotinine and reported tobacco smoke exposure (maternal cigarettes/day exposed). Secondary outcomes were end-of-treatment 7-day point-prevalence self-reported cigarettes smoked/day and bioverified quit status. RESULTS: Participation in FRESH behavioral counseling was associated with lower child cotinine (ß=-0.18, p=0.03) and reported tobacco smoke exposure (ß=-0.57, p=0.03) at the end of treatment. Mothers in behavioral counseling smoked fewer cigarettes/day (ß=-1.84, p=0.03) and had higher bioverified quit rates compared with controls (13.8% vs 1.9%, χ(2)=10.56, p<0.01). There was no moderating effect of other smokers living at home. CONCLUSIONS: FRESH behavioral counseling reduces child tobacco smoke exposure and promotes smoking quit rates in a highly distressed and vulnerable population. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02117947.