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

Mass General Brigham

Status: Active, not recruiting

Conditions: Tobacco Dependence

Treatments: Behavioral: CEASE + BIO; Behavioral: CEASE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04832659

R01CA248742 (U.S. NIH Grant/Contract)

2021P000004/MGH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 865 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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865 participants in 2 patient groups

CEASE

Active Comparator group

Description:

Those assigned to the Active Comparator arm will receive the CEASE intervention.

Treatment:

Behavioral: CEASE

CEASE + BIO

Experimental group

Description:

Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).

Treatment:

Behavioral: CEASE

Behavioral: CEASE + BIO