Assessment of Biomarkers in Children to Help Parents Quit Tobacco
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 865
- Locations
- 2
- Primary Endpoint
- Parental quit rate
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Child 12 years old or younger presenting for a visit.
- •Child scheduled for or has had a clinically indicated blood draw at that visit
- •Parent/legal guardian of the child.
- •Parent/legal guardian is a current smoker (past 7 days).
Exclusion Criteria
- •Parent/legal guardian is non-English speaking.
- •Parent/legal guardian is less than 18 years of age.
Arms & Interventions
CEASE
Those assigned to the Active Comparator arm will receive the CEASE intervention.
Intervention: CEASE (Behavioral)
CEASE + BIO
Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).
Intervention: CEASE (Behavioral)
CEASE + BIO
Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).
Intervention: CEASE + BIO (Behavioral)
Outcomes
Primary Outcomes
Parental quit rate
Time Frame: 12 months
Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed (corrected for NRT use)
Parental quit rate
Time Frame: 12 months
Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed (corrected for NRT use)
Secondary Outcomes
- Self-report parental 7-day point prevalence tobacco abstinence(12 months)
Investigators
Jonathan P. Winickoff, MD, MPH
Professor
Massachusetts General Hospital