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OpenTrials
Completed

NCT Number: NCT04832659

Assessment of Biomarkers in Children to Help Parents Quit Tobacco

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.

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Key information

Conditions

Tobacco Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth System

Cleveland, Ohio, 44109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Parent/legal guardian is non-English speaking.
  • Parent/legal guardian is less than 18 years of age.

Treatment and study plan

CEASE

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Parental quit rate

    Time frame: 12 months

    Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed (corrected for NRT use)

Secondary outcomes

  1. Self-report parental 7-day point prevalence tobacco abstinence

    Time frame: 12 months

    Self-report parental 7-day point prevalence tobacco abstinence at 12-month follow up, assessed by validated surveys of parents

Other outcomes

  1. Cost per quit

    Time frame: 45 months

    The cost per quit of CEASE+BIO relative to CEASE will compare favorably to other health system tobacco cessation interventions (< $5,000 per quit)

  2. Parental 7-day point-prevalence tobacco abstinence (corrected for NRT and e-cig use)

    Time frame: 12 months

    Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed (corrected for NRT and e-cig use)

  3. Nicotine replacement therapy prescriptions

    Time frame: 12 months

    Rates of delivery of nicotine replacement therapy prescriptions, assessed by validated surveys of parents

  4. SmokefreeTXT referrals

    Time frame: 12 months

    Rates of referrals to the SmokefreeTXT, assessed by validated surveys of parents

  5. Children's tobacco smoke exposure (dual use, cotinine levels, ecig users- correlate with self report)

    Time frame: 12 months

    Child's tobacco smoke exposure, assessed by child's blood cotinine level

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Academy of Pediatrics
  • Icahn School of Medicine at Mount Sinai
  • MetroHealth System, Ohio
  • Mississippi State University
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • University of Minnesota
  • University of Rochester

Registry information

Acronym: ABC Quit

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2021
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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