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

865 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help parents quit smoking, focusing on those with a child 12 years or younger who visits a doctor. One group receives a standard intervention called CEASE, designed to stop tobacco use. Another group receives CEASE plus additional support based on biomarker outreach, which personalizes the approach using information from a child's blood test. Parents who currently smoke and have a child undergoing a blood test during a doctor's visit may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could significantly enhance smoking cessation strategies for parents.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CEASE program, which assists parents in quitting smoking, is generally safe and well-received. Studies have found that providing parents with information and support to quit smoking has not resulted in any major safety issues.

For the CEASE + BIO version, which includes biomarker testing and personalized support, specific data on side effects is not yet available. However, since it only adds biomarker feedback to the existing CEASE program, it is expected to maintain the same level of safety.

Both programs aim to help parents stop smoking, potentially improving health without introducing new medications or invasive methods. This approach suggests a low risk of negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CEASE + BIO approach because it combines a proven tobacco cessation program with Biomarker Informed Outreach (BIO) to enhance quitting success. Unlike standard interventions that mainly rely on counseling and nicotine replacement therapies, the CEASE + BIO method uses biomarkers to personalize support, making the quitting process more tailored and potentially more effective. This innovative approach aims to address the unique needs of each parent trying to quit, offering a more customized path to a smoke-free life.

What evidence suggests that this trial's treatments could be effective for helping parents quit tobacco?

Research has shown that the CEASE program, which participants in this trial may receive, helps parents reduce smoking and attempt quitting more frequently. One study found that almost half of the parents involved engaged more with the program and smoked less. Among those who completed the program, 33% stopped smoking for a week, and 28% for a month.

In this trial, some participants will receive an additional biomarker outreach (BIO) component alongside CEASE. This method uses specific health measures in children to encourage parents to quit smoking. The extra BIO component could provide more personalized support, making it easier and more successful for parents to quit. ^{1 6 7 8 9}

Who Is on the Research Team?

Jonathan P Winickoff, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 is under 18.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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, 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]

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-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 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, 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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838073

Automated Tobacco Cessation Intervention for Parents in ... The trial showed significantly increased treatment engagement and reductions in cigarette use, with nearly half of parents in the intervention ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8017473/

Cost-effectiveness of a Smoking Cessation Intervention for ... CEASE was cost-effective at a willingness-to-pay threshold of $2000 per quit in 88.0% of simulations based on the parent-reported smoking ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025003529

Effectiveness of family-based behavioral intervention for ... Parents receiving family-based behavioral interventions showed greater reductions in daily cigarette consumption, increased quit attempts, ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555596/

Interventions for Smoking Cessation and Treatments ... - NCBI Among program completers (24% of the total sample), quit rates were 33% for 7-day point prevalence and 28% for 30-day point prevalence, and 88% of participants ...

5. tobaccopreventioncessation.com tobaccopreventioncessation.com/Costs-to-provide-a-tobacco-cessation-intervention-with-parents-of-pediatric-emergency,128320,0,2.html

Costs to provide a tobacco cessation intervention with ... This study reports on the costs of providing parental smokers who bring their children to the emergency setting, with a screening, brief intervention, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12391990/

Automated Tobacco Cessation Intervention for Parents in ... This cluster-randomized clinical trial evaluates the implementation and effectiveness of an automated electronic health record–based tobacco ...

7. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=24102596

Clinical Effort Against Secondhand Smoke Exposure (CEASE) This intervention trains pediatric practices so they can screen parents for household tobacco use and provide smoking parents with an action sheet, access to a ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11905115/

CEASE Tobacco Cessation Program: Validation of Self-Rated ... Surveys conducted through the Communities Engaged and Advocating for a Smoke-free Environment (CEASE) program reported smoking rates of 27% ...

9. researchprotocols.org researchprotocols.org/2023/1/e47978/

A Brief Digital Screening and Intervention Tool for Parental ... A medical clinic-based intervention that systematically screens parents for tobacco use and offers them direct access to evidence-based smoking cessation ...