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This randomized controlled trial will test whether adding biomarker measurement and informed outreach for tobacco smoke exposure as part of routine practice increases identification and improves treatment, effectiveness, and sustainability of a parental tobacco control intervention that will be integrated into pediatric practice.
This trial will examine the effectiveness of systematic cotinine testing of children 12 years old or younger using blood already collected at any visit to a practice that sees pediatric patients where there is a clinically indicated blood draw. We hypothesize that providing cotinine biomarker results to pediatricians, personalized cotinine feedback to parents about their child's toxin exposure, and offering support to all household tobacco users to quit tobacco use (Biomarker Informed Outreach (BIO)) when added to the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention will increase delivery of tobacco cessation assistance, increase household cessation, reduce tobacco smoke exposure in children, and be cost-effective. This is a 2-arm randomized controlled trial with family-level randomization to either CEASE+BIO or CEASE arms at the time of the child's baseline visit. To compare the effectiveness of CEASE+BIO vs. CEASE, we will follow-up with enrolled parents 12 months later to assess parental quit rate and children's tobacco smoke exposure.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
MetroHealth System
Cleveland, Ohio, United States
Start Date
January 20, 2023
Primary Completion Date
February 28, 2026
Completion Date
February 28, 2026
Last Updated
October 9, 2025
865
ACTUAL participants
CEASE
BEHAVIORAL
CEASE + BIO
BEHAVIORAL
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT06543407
NCT06488443
NCT06218056
Data Source & Attribution
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