NCT04832659

Assessment of Biomarkers in Children to Help Parents Quit Tobacco

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 865 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.

Timeline

• Start date: 2023-01-20
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2021-04-06
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States