Assessment of Biomarkers in Children to Help Parents Quit Tobacco (ABC Quit)

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Dependence
• Intervention / Treatment: Behavioral: CEASE; Behavioral: CEASE + BIO

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.

• Study Type: Interventional
• Enrollment (Anticipated): 868
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emara Nabi, PhD; Phone Number: 617-726-3419; Email: enabi@mgh.harvard.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Recruiting
      • MetroHealth System
      • Contact: Emara Nabi, PhD; Phone Number: 617-726-3419; Email: enabi@mgh.harvard.edu
      • Principal Investigator: Jonathan P Winickoff, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CEASE; Those assigned to the Active Comparator arm will receive the CEASE 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.
EXPERIMENTAL: CEASE + BIO; Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental quit rate	Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening for tobacco use	Rates of parents receiving screening for tobacco use, assessed by validated surveys of parents	12 months
Counseling about cessation	Rates of receiving counseling about smoking cessation, assessed by validated surveys of parents	12 months
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
Nicotine replacement therapy prescriptions	Rates of delivery of nicotine replacement therapy prescriptions, assessed by validated surveys of parents	12 months
State quitline referrals	Rates of referrals to the state quitline, assessed by validated surveys of parents	12 months
Children's tobacco smoke exposure	Child's tobacco smoke exposure, assessed by child's blood cotinine level	12 months
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
Identification of other household smokers	Rate of identifying other household members who smoke, assessed by self-report of the enrolled parents	12 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2023
• Primary Completion (ANTICIPATED): February 1, 2026
• Study Completion (ANTICIPATED): February 1, 2026

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (ACTUAL): April 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; parents; tobacco treatment; tobacco control
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 2021P000004/MGH; R01CA248742 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available at the conclusion of the study, after the research findings have been published.
• IPD Sharing Access Criteria: The dataset will be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No