2.1. Design, Participant Recruitment and Screening

RA Robert T. Ammerman
JK Jane C. Khoury
MT Meredith E. Tabangin
LD Lili Ding
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Parents presented with their child to one of two PEDs or UCs which are part of a single Midwestern tertiary care children’s hospital with over 150,000 PED/UC annual visits. The hospital Institutional Review Board approved this study. Parental participants provided written informed consent and child participants ≥age 11 provided written assent. This RCT is called Healthy Families and is registered in www.clinicaltrials.gov NCI-2531594 [23].

Clinical research coordinators (CRCs) screened a convenience sample of participants for 37 months starting in April 2016. Adults were eligible if they were ≥18 years old, spoke English, smoked combustible tobacco products daily, had a permanent address, had a working phone number, had no plans to move within the next six months, lived within a 50 mile radius of the PED/UC, and were the parent/legal guardian of a 0–17 year old patient who presented to the PED/UC with a TSE-related complaint (e.g., wheezing). Parents were excluded from enrollment into the study if: they were exclusive users of chewing tobacco or electronic cigarettes; taking smoking cessation medications; their child was an active user of cigarettes, electronic cigarettes or marijuana; or they or their child could not participate for medical or cognitive reasons.

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