Open Access Study protocol

Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children

Stephen J Lepore1*, Jonathan P Winickoff2, Beth Moughan3, Tyra C Bryant-Stephens4, Daniel R Taylor5, David Fleece3, Adam Davey1, Uma S Nair1, Melissa Godfrey1 and Bradley N Collins13*

Author Affiliations

1 Department of Public Health, Temple University, 1301 Cecil B. Moore Ave, Ritter Annex, 9th Floor, Philadelphia, PA, 19122, USA

2 Department of Pediatrics, Massachusetts General Hospital for Children, Boston, USA

3 Department of Pediatrics, Temple University School of Medicine, Philadelphia, USA

4 Department of General Pediatrics, Children’s Hospital of Philadelphia, Philadelphia, USA

5 Department of Pediatrics, St. Christopher’s Hospital for Children, Philadelphia, USA

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BMC Public Health 2013, 13:792  doi:10.1186/1471-2458-13-792

Published: 30 August 2013



Secondhand smoke exposure (SHSe) harms children’s health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers’ advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations.


This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children < 11-years-old are recruited from pediatric clinics. The clinic-level intervention includes integrating tobacco intervention guideline prompts into electronic health record screens. The prompts guide providers to ask all parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status.


This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to “ask, advise, and refer” guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines.

Trial registration

NCT01745393 (

Secondhand smoke; Pediatrics; Randomized controlled trial; Prevention; Tobacco control; Smoking cessation; Health services; Electronic health records