Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Not Applicable

Active, not recruiting

• Conditions: Tobacco Dependence

• Registration Number: NCT04832659
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-06
• Study Start: 2023-01-20
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-07
• Last Update Posted: 2025-10-09
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 865

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Parental quit rate	12 months	Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed (corrected for NRT use)

Secondary Outcome Measures

Name	Time	Method
Self-report parental 7-day point prevalence tobacco abstinence	12 months	Self-report parental 7-day point prevalence tobacco abstinence at 12-month follow up, assessed by validated surveys of parents

Trial Locations

Locations (1)

MetroHealth System; 🇺🇸 Cleveland, Ohio, United States