Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Not Applicable

Recruiting

• Conditions: Tobacco Dependence
• Interventions: Behavioral: CEASE; Behavioral: CEASE + BIO

• 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: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 868

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

Arm && Interventions

Group	Intervention	Description
CEASE + BIO	CEASE + BIO	Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).
CEASE	CEASE	Those assigned to the Active Comparator arm will receive the CEASE intervention.
CEASE + BIO	CEASE	Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).

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

Secondary Outcome Measures

Name	Time	Method
Children's tobacco smoke exposure	12 months	Child's tobacco smoke exposure, assessed by child's blood cotinine level
Smoke-free and vape-free homes and cars	12 months	Smoking and vaping inside homes and cars, strictly enforced rules prohibiting smoking and vaping in homes and cars, assessed by validated surveys of parents
Smoking cessation among other household members	12 months	Quit rate among other household members who had smoked, assessed by self-report of the enrolled parents
Counseling about cessation	12 months	Rates of receiving counseling about smoking cessation, assessed by validated surveys of parents
Screening for tobacco use	12 months	Rates of parents receiving screening for tobacco use, assessed by validated surveys of parents
Counseling about smoke-free/vape-free homes and cars	12 months	Rates of receiving counseling about smoke-free and vape-free homes and cars, assessed by validated surveys of parents
Nicotine replacement therapy prescriptions	12 months	Rates of delivery of nicotine replacement therapy prescriptions, assessed by validated surveys of parents
State quitline referrals	12 months	Rates of referrals to the state quitline, assessed by validated surveys of parents
Identification of other household smokers	12 months	Rate of identifying other household members who smoke, assessed by self-report of the enrolled parents

Trial Locations

Locations (1)

MetroHealth System; 🇺🇸 Cleveland, Ohio, United States