Assessment of Biomarkers in Children to Help Parents Quit Tobacco

NAActive, not recruitingINTERVENTIONAL
Enrollment

865

Participants

Timeline

Start Date

January 20, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Tobacco Dependence
Interventions
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.

Trial Locations (1)

44109

MetroHealth System, Cleveland

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

University of Minnesota

OTHER

collaborator

American Academy of Pediatrics

OTHER

collaborator

Mississippi State University

OTHER

collaborator

University of Rochester

OTHER

collaborator

Icahn School of Medicine at Mount Sinai

OTHER

collaborator

MetroHealth System, Ohio

OTHER

lead

Massachusetts General Hospital

OTHER