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Active (not recruiting) Not applicable NCT04832659

Assessment of Biomarkers in Children to Help Parents Quit Tobacco

No applicable phase (e.g. observational)
Conditions: Tobacco Dependence

Sponsor: Massachusetts General Hospital

trial.available_in: БГ
Overview
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.
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.
Who can participate
Inclusion Criteria: 1. Child 12 years old or younger presenting for a visit. 2. Child scheduled for or has had a clinically indicated blood draw at that visit 3. Parent/legal guardian of the child. 4. Parent/legal guardian is a current smoker (past 7 days). Exclusion Criteria: 1. Parent/legal guardian is non-English speaking. 2. Parent/legal guardian is less than 18 years of age.
Interventions
CEASE
BEHAVIORAL
CEASE + BIO
BEHAVIORAL
Locations 1
United States (1)
MetroHealth System
Cleveland , Ohio
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.01.2023
Completion date
01.06.2026
Registry ID
NCT04832659
Source
clinicaltrials.gov
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