CEASE + Biomarker Outreach for Helping Parents Quit Tobacco

(ABC Quit Trial)

Recruiting at 1 trial location

Overseen By Emara Nabi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Non-English speaking, Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

868 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the CEASE treatment for helping parents quit tobacco?

The CEASE treatment has been shown to effectively help parents quit smoking by integrating technology in child healthcare settings, which increases the identification of tobacco users and offers cessation assistance. In a study, 57% of smokers who wanted to quit were given prescriptions, and 93% of those who requested connection to a quitline received enrollment forms, demonstrating improved delivery of smoking cessation services. ^{1 2 3 4 5}

How is the CEASE treatment unique for helping parents quit tobacco?

The CEASE treatment is unique because it integrates technology-based platforms in child healthcare settings to screen for tobacco use and deliver cessation assistance, including motivational videos and electronic prescriptions, making it easier for families to access support and resources to quit smoking. ^{4 5 6 7 8}

Research Team

Jonathan P Winickoff, MD, MPH

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for parents or legal guardians who smoke and have a child 12 years old or younger, visiting the pediatrician. The parent must be an English speaker over 18 years old, and their child should have a blood draw scheduled during the visit.

Inclusion Criteria

Parent/legal guardian of the child.

The parent or legal guardian has smoked within the last 7 days.

Child scheduled for or has had a clinically indicated blood draw at that visit.

Exclusion Criteria

My parent or legal guardian does not speak English.

My parent or legal guardian is under 18.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Visit

Initial visit where baseline data is collected and randomization occurs

1 day

1 visit (in-person)

Intervention

Participants receive either the CEASE intervention or CEASE + BIO intervention

12 months

Regular follow-ups (in-person or virtual)

Follow-up

Participants are monitored for parental quit rate and children's tobacco smoke exposure

12 months

1 visit (in-person or virtual)

Treatment Details

Interventions

• CEASE
• CEASE + BIO

Trial Overview The study tests if adding biomarker checks to regular pediatric visits helps identify tobacco smoke exposure more effectively and improves quitting support for smoking parents. It compares standard CEASE intervention with CEASE plus biomarker feedback (CEASE + BIO).

Participant Groups

Group I: CEASE + BIO Experimental Treatment 2 Interventions

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

Group II: CEASE Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

MetroHealth System, Ohio

Collaborator

Trials

8

Recruited

26,100+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

American Academy of Pediatrics

Collaborator

Trials

46

Recruited

4,071,000+

Mississippi State University

Collaborator

Trials

8

Recruited

3,300+

The MetroHealth System

Collaborator

Trials

5

Recruited

24,500+

Findings from Research

Nicotine-assisted reduction programs can effectively motivate unwilling quitters by providing nicotine replacement, allowing for flexible quit attempts over an extended period, which can last more than a year.

The proposed outcome measure of 'floating prolonged abstinence' would better capture the success of quit attempts made during treatment, rather than relying on fixed follow-up points, making it more suitable for evaluating the effectiveness of cessation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence. Aveyard, P., Wang, D., Connock, M., et al.[2022]

The CEASE-4 intervention, a tailored tobacco cessation program for underserved populations, showed varying quit rates among different groups, with the four-session class achieving the highest cessation rate of 13.0% compared to 2.3% in the self-help group.

This study highlights the effectiveness of a structured, theory-based approach to smoking cessation, suggesting that more intensive interventions (like the four-session class) are more beneficial than less comprehensive options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Smoking Cessation Program for Underserved Ethnic Minority Communities: Results of a Smoking Cessation Trial. Sheikhattari, P., Apata, J., Bleich, L., et al.[2023]

The CEASE program, which helps parents and adolescents quit smoking and vaping, is being tested in Canada with a target of 100 participants, including both parents and adolescents, to evaluate its feasibility and preliminary effectiveness.

This pilot study will measure outcomes like self-reported cessation rates and motivation to quit, with the goal of informing a larger randomized controlled trial if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Digital Screening and Intervention Tool for Parental and Adolescent Tobacco and Electronic Cigarette Use in Pediatric Medical Care in Canada: Protocol for a Pilot Randomized Controlled Trial. Chadi, N., Diamant, E., Perez, T., et al.[2023]

The CEASE intervention, enhanced by technology like electronic tablet screeners, successfully identified tobacco use in 50,111 family members across five states, revealing that 6,885 families had children exposed to tobacco smoke.

Of the smokers screened, 57% expressed a desire for prescriptions to quit smoking, and 93% of those who wanted to connect to a quitline received enrollment forms, demonstrating the effectiveness of integrating technology in pediatric practices to improve smoking cessation support for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in parental smoking cessation assistance delivered in the child healthcare setting. Nabi-Burza, E., Winickoff, JP., Drehmer, JE., et al.[2021]

The CEASE intervention, aimed at reducing secondhand smoke exposure in children, was influenced by factors such as the adaptability of the program, available resources, and the culture of the practices involved, as identified through qualitative interviews with 11 clinicians and staff after two years of implementation.

Understanding these factors can enhance the effectiveness and sustainability of family-centered tobacco control interventions in pediatric settings, highlighting the importance of clinician knowledge and practice priorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Study of Factors Influencing Implementation of Tobacco Control in Pediatric Practices. Nabi-Burza, E., Winickoff, JP., Drehmer, JE., et al.[2022]

Child health care clinicians can play a crucial role in addressing family smoking by integrating evidence-based tobacco use screening and cessation strategies during outpatient visits.

Effective strategies include assessing a family's readiness to quit, providing tailored advice, prescribing cessation medications, and utilizing resources like state quitlines to support families in creating smoke-free environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Family Smoking in Child Health Care Settings. Hall, N., Hipple, B., Friebely, J., et al.[2021]

The CEASE intervention aims to improve pediatric clinicians' ability to address family tobacco use and exposure, highlighting a significant gap in routine clinical practice.

During training for the CEASE intervention, clinicians expressed concerns about prescribing nicotine replacement therapy and the operational impact of implementing tobacco control strategies, indicating potential barriers to effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician Telephone Training to Reduce Family Tobacco Use: Analysis of Transcribed Recordings. Walters, BH., Ossip, DJ., Drehmer, JE., et al.[2022]

The CEASE intervention, delivered through a distance-based training program, significantly improved pediatricians' rates of asking parents about smoking behaviors, with increases from 22% to 41% for parental smoking inquiries and from 25% to 44% for smoke-free home rules among low-income families.

This study, involving 647 parents from two health clinics, demonstrates that training pediatricians to routinely address family smoking can be an effective first step in promoting tobacco-free environments for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distance-based training in two community health centers to address tobacco smoke exposure of children. Hipple, B., Nabi-Burza, E., Hall, N., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of a Smoking Cessation Program for Underserved Ethnic Minority Communities: Results of a Smoking Cessation Trial. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

A Brief Digital Screening and Intervention Tool for Parental and Adolescent Tobacco and Electronic Cigarette Use in Pediatric Medical Care in Canada: Protocol for a Pilot Randomized Controlled Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Innovations in parental smoking cessation assistance delivered in the child healthcare setting. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A Qualitative Study of Factors Influencing Implementation of Tobacco Control in Pediatric Practices. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Addressing Family Smoking in Child Health Care Settings. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Clinician Telephone Training to Reduce Family Tobacco Use: Analysis of Transcribed Recordings. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Distance-based training in two community health centers to address tobacco smoke exposure of children. [2021]