Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Tobacco Dependence Clinical Trial

— ABC Quit  

Official title:

Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04832659
• Other study ID #: 2021P000004/MGH
• Secondary ID: R01CA248742
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Emara Nabi, PhD
• Phone: 617-726-3419
• Email: enabi[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 868
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• CEASE
The CEASE intervention is considered the accepted standard of care according to national treatment guidelines. Parents of a child scheduled to be seen at a participating pediatric practice will be provided with a brief intake survey. Office staff and clinicians will be trained how to utilize the intake survey system and how to provide evidence-based cessation assistance to parents who smoke. The brief intake survey will conduct screening to identify household smoking. The CEASE system will provide (1) Automatic documentation of smoking cessation services requested; (2) Automatically generated prescription for nicotine replacement therapy for parents who smoke (unless they opt out of receiving the prescription); (3) Automated enrollment in the state's free tobacco Quitline and the SmokeFreeTXT program, a text message program offered by the National Cancer Institute.
• CEASE + BIO
Children randomized to the CEASE + BIO group will have leftover blood from an already collected blood sample that was taken for a clinically indicated blood draw analyzed for cotinine. Parents of children in the CEASE +BIO group will receive a report of biomarker results followed by proactive outreach from a BIO counselor. The BIO counselor will explain the laboratory results and refer all parents in the household who smoke to tobacco treatment through the parent's primary care provider and/or the state quitline. The BIO counselor will troubleshoot any barriers to obtaining nicotine replacement therapy that may have been prescribed as part of the CEASE protocol and will promote strict smoke-free and vape-free home and car policies. BIO counselors will conduct a maximum of 6 calls per enrolled smoker.

Locations

Country	Name	City	State
United States	MetroHealth System	Cleveland	Ohio

Sponsors (9)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Academy of Pediatrics, Icahn School of Medicine at Mount Sinai, Mississippi State University, National Cancer Institute (NCI), National Institutes of Health (NIH), The MetroHealth System, University of Minnesota, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost per quit	The cost per quit of CEASE+BIO relative to CEASE will compare favorably to other health system tobacco cessation interventions (< $5,000 per quit)	45 months
Primary	Parental quit rate	Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed	12 months
Secondary	Screening for tobacco use	Rates of parents receiving screening for tobacco use, assessed by validated surveys of parents	12 months
Secondary	Counseling about cessation	Rates of receiving counseling about smoking cessation, assessed by validated surveys of parents	12 months
Secondary	Counseling about smoke-free/vape-free homes and cars	Rates of receiving counseling about smoke-free and vape-free homes and cars, assessed by validated surveys of parents	12 months
Secondary	Nicotine replacement therapy prescriptions	Rates of delivery of nicotine replacement therapy prescriptions, assessed by validated surveys of parents	12 months
Secondary	State quitline referrals	Rates of referrals to the state quitline, assessed by validated surveys of parents	12 months
Secondary	Children's tobacco smoke exposure	Child's tobacco smoke exposure, assessed by child's blood cotinine level	12 months
Secondary	Smoke-free and vape-free homes and cars	Smoking and vaping inside homes and cars, strictly enforced rules prohibiting smoking and vaping in homes and cars, assessed by validated surveys of parents	12 months
Secondary	Identification of other household smokers	Rate of identifying other household members who smoke, assessed by self-report of the enrolled parents	12 months
Secondary	Smoking cessation among other household members	Quit rate among other household members who had smoked, assessed by self-report of the enrolled parents	12 months