Assessment of Biomarkers in Children to Help Parents Quit Tobacco
ABC Quit
2 other identifiers
interventional
865
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedStudy Start
First participant enrolled
January 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 20, 2026
April 1, 2026
3.3 years
March 25, 2021
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parental quit rate
Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed (corrected for NRT use)
12 months
Secondary Outcomes (1)
Self-report parental 7-day point prevalence tobacco abstinence
12 months
Other Outcomes (5)
Cost per quit
45 months
Parental 7-day point-prevalence tobacco abstinence (corrected for NRT and e-cig use)
12 months
Nicotine replacement therapy prescriptions
12 months
- +2 more other outcomes
Study Arms (2)
CEASE
ACTIVE COMPARATORThose assigned to the Active Comparator arm will receive the CEASE intervention.
CEASE + BIO
EXPERIMENTALThose assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Child 12 years old or younger presenting for a visit.
- Child scheduled for or has had a clinically indicated blood draw at that visit
- Parent/legal guardian of the child.
- Parent/legal guardian is a current smoker (past 7 days).
You may not qualify if:
- Parent/legal guardian is non-English speaking.
- Parent/legal guardian is less than 18 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
- University of Minnesotacollaborator
- American Academy of Pediatricscollaborator
- Mississippi State Universitycollaborator
- University of Rochestercollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- MetroHealth System, Ohiocollaborator
Study Sites (1)
MetroHealth System
Cleveland, Ohio, 44109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan P Winickoff, MD, MPH
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 25, 2021
First Posted
April 6, 2021
Study Start
January 20, 2023
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will become available at the conclusion of the study, after the research findings have been published.
- Access Criteria
- The dataset will be made publicly available.
The study dataset will be made publicly available with the approval the Institutional Review Board of record at Massachusetts General Hospital and Health Information Services Group (responsible for ensuring HIPPA compliance). The data will be de-identified and validated. The dataset will include a codebook that defines the variables and describes the structure of the dataset.