Smoke-Free Home Program for Reducing Child Exposure to Smoking

(SFSC Trial)

Recruiting at 1 trial location

Overseen by Michelle Kegler, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Georgia State University

Disqualifiers: Non-smoking home, Consent form misunderstanding

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a combined program called SFSC that helps low-income families create smoke-free homes and improve parenting skills. The goal is to reduce smoke exposure and improve child safety and health. The program targets families with high smoking rates and multiple risks affecting children's well-being.

Do I have to stop taking my current medications for the trial?

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

What data supports the effectiveness of the Smoke Free SafeCare treatment for reducing child exposure to smoking?

The 'Some Things are Better Outside' intervention, which is part of the Smoke Free SafeCare program, has shown effectiveness in creating smoke-free homes across various socio-demographic groups, regardless of daily smoking habits or the number of cigarettes smoked per day. This suggests that similar approaches in the Smoke Free SafeCare treatment could help reduce children's exposure to secondhand smoke. ^{1 2 3 4 5}

Is the Smoke-Free Home Program safe for humans?

The studies reviewed focus on reducing secondhand smoke exposure, which is known to be harmful, but they do not provide specific safety data for the Smoke-Free Home Program itself. However, the interventions generally involve counseling and education, which are typically safe for participants. ^{1 3 4 6 7}

How is the Smoke-Free Home Program treatment different from other treatments for reducing child exposure to smoking?

The Smoke-Free Home Program, specifically the Smoke Free SafeCare treatment, is unique because it focuses on creating a smoke-free home environment rather than solely on smoking cessation. It involves minimal intervention aimed at both smokers and nonsmokers who allow smoking in the home, emphasizing the importance of keeping the home smoke-free to protect children from secondhand smoke exposure. ^{1 2 7 8 9}

Research Team

Shannon Self-Brown, PhD

Principal Investigator

Georgia State University

Michelle Kegler, PhD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for SafeCare providers who have completed specific training and work in high-smoking areas, as well as mothers aged 18+ with a child protection case, who smoke or live with a smoker at home, and have a child between ages 0-5 (or 0-9 in Oklahoma).

Inclusion Criteria

I am a certified SafeCare provider working in a high-smoking area.

If you are a mother who has been referred to a SafeCare Provider due to a child protection case, and you or someone who lives with you smokes inside the home at least three nights a week, and you have a child between the ages of 0 and 5 (or 0-9 in Oklahoma) then you may participate in this study. You must be at least 18 years old.

This is not a criterion, it is a word without context. Please provide more information or context.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Smoke Free SafeCare (SFSC) intervention, which integrates the STBO and SafeCare programs to promote smoke-free home rules and reduce child maltreatment risk.

18 weeks

In-home visits

Follow-up

Participants are monitored for the effectiveness of smoke-free home rules and parenting outcomes.

1 year

Assessments at 8 weeks, 20 weeks, and 1 year

Treatment Details

Interventions

• Smoke Free SafeCare (Behavioral Intervention)
• Standard SafeCare (Behavioral Intervention)

Trial Overview The study tests Smoke Free SafeCare (SFSC), which combines promoting smoke-free homes (STBO) and parent training to reduce child maltreatment (SafeCare). It's compared against the standard SafeCare program to see if it better reduces secondhand smoke exposure.

Participant Groups

Group I: Smoke Free SafeCare (SFSC) Experimental Treatment 1 Intervention

Providers randomized to this group will receive additional SFSC training and will disseminate SFSC program to families who report having a smoker in the home.

Group II: Standard SafeCare Active Control 1 Intervention

Providers randomized to this group will disseminate the Standard SafeCare program to families who report having a smoker in the home.

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Dr. Jian-Dong Li

Georgia State University

Chief Executive Officer since 2011

PhD in Biomedical Sciences from University of California, San Francisco; MD from Qingdao University School of Medicine

Dr. Steve Simonson

Georgia State University

Chief Medical Officer since 2014

MD from Medical College of Wisconsin; Master's in Health Sciences from Duke University School of Medicine

Findings from Research

A study involving 39 community-based clinics and parents of infants found that two nurse-delivered interventions aimed at reducing secondhand smoke exposure did not significantly decrease the prevalence of infants exposed to secondhand smoke after 12 months.

Neither intervention was effective in reducing the number of smoking parents or increasing household smoking bans, indicating a need for further research to develop effective strategies for child health nurses to reduce secondhand smoke exposure in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cluster Randomised Controlled Trial of a Brief Child Health Nurse Intervention to Reduce Infant Secondhand Smoke Exposure. Daly, JB., Freund, M., Burrows, S., et al.[2018]

The 'Smoke-Free Homes' intervention was effective in establishing full home smoking bans among 1506 participants from socio-economically disadvantaged backgrounds, regardless of race, education, or income levels.

Participant smoking status and nicotine dependence influenced the effectiveness of the intervention, indicating that while the program worked broadly, those with different levels of smoking habits may experience varying degrees of success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderators of Establishing a Smoke-Free Home: Pooled Data from Three Randomized Controlled Trials of a Brief Intervention. Kegler, MC., Haardörfer, R., Bundy, LT., et al.[2020]

In a study involving 119 families with children undergoing cancer treatment, both home and full smoking bans increased over time, with a significant rise in full smoking bans (OR = 1.37) particularly noted within the first 3 months for the intervention group.

Parents who were married and had higher confidence in managing secondhand smoke exposure were more likely to adopt smoking bans, suggesting that targeted interventions could effectively support families in reducing secondhand smoke exposure for their medically vulnerable children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full and home smoking ban adoption after a randomized controlled trial targeting secondhand smoke exposure reduction. Nicholson, JS., McDermott, MJ., Huang, Q., et al.[2021]

A national counselling method called 'smoke-free children' was developed and tested, leading to positive changes in parental smoking behavior, with all participating parents reporting they now smoked outdoors and reduced their smoking after the intervention.

The implementation of this method resulted in a significant annual decrease in smoking rates among parents, with a 1.7% decrease in a pilot area and a 2.7% decrease in the wider county, indicating its effectiveness in promoting smoke-free environments for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child health-centre-based promotion of a tobacco-free environment--a Swedish case study. Arborelius, E., Bremberg, S.[2019]

The FRESH intervention, which included home visits and phone sessions, significantly reduced tobacco smoke exposure in children and helped mothers quit smoking, with effects lasting for 12 months after treatment in a study of 300 low-income maternal smokers.

Children in the FRESH group had lower cotinine levels and reported less tobacco smoke exposure compared to controls, indicating the long-term efficacy of this behavioral intervention in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Results From the FRESH RCT: Sustained Reduction of Children's Tobacco Smoke Exposure. Collins, BN., Nair, US., DiSantis, KI., et al.[2021]

In a randomized controlled trial involving 453 parents and caregivers, a tailored cessation intervention for smokers resulted in a significant increase in self-reported smoking abstinence over time, with 40.6% of participants remaining abstinent by year 4 compared to only 13.2% in the control group.

The intervention also led to a notable decrease in saliva cotinine levels (a marker of tobacco exposure) from baseline to year 4, indicating reduced tobacco smoke exposure for children in families participating in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Smoking Cessation: Impacting Children's Tobacco Smoke Exposure in the Home. Caldwell, AL., Tingen, MS., Nguyen, JT., et al.[2019]

No level of exposure to secondhand smoke (SHS) is safe, as it can lead to serious health issues like heart disease and lung cancer in adults, and increased risks of sudden infant death syndrome and respiratory problems in children.

From 1988-1994 to 1999-2004, self-reported SHS exposure at home and serum cotinine levels in the U.S. population significantly declined by 51.2% and 44.7%, respectively, but the reduction was less pronounced in children aged 4-19, highlighting the need for ongoing efforts to protect this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in secondhand smoke exposure--United States, 1988-1994 and 1999-2004. [2022]

Secondhand smoke (SHS) exposure is responsible for approximately 41,000 deaths among nonsmoking adults in the U.S. each year, highlighting the significant health risks associated with SHS.

The prevalence of smokefree home rules has dramatically increased from 43% in 1992-1993 to 83% in 2010-2011, indicating progress in reducing SHS exposure, especially in homes with no adult smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of smokefree home rules--United States, 1992-1993 and 2010-2011. King, BA., Patel, R., Babb, SD.[2022]

Disadvantaged mothers are motivated to protect their young children from secondhand smoke (SHS) due to concerns about future health and financial burdens, but face significant challenges such as unstable living conditions and social relationships.

Key barriers to creating smoke-free homes include the increasing mobility of children and the complexities of single parenthood, while facilitators include mothers' awareness of their children's perceptions of smoking and access to outdoor spaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protecting children from smoke exposure in disadvantaged homes. Rowa-Dewar, N., Lumsdaine, C., Amos, A.[2018]

References

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

A Cluster Randomised Controlled Trial of a Brief Child Health Nurse Intervention to Reduce Infant Secondhand Smoke Exposure. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Moderators of Establishing a Smoke-Free Home: Pooled Data from Three Randomized Controlled Trials of a Brief Intervention. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Full and home smoking ban adoption after a randomized controlled trial targeting secondhand smoke exposure reduction. [2021]

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

Child health-centre-based promotion of a tobacco-free environment--a Swedish case study. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term Results From the FRESH RCT: Sustained Reduction of Children's Tobacco Smoke Exposure. [2021]

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

Parental Smoking Cessation: Impacting Children's Tobacco Smoke Exposure in the Home. [2019]

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

Disparities in secondhand smoke exposure--United States, 1988-1994 and 1999-2004. [2022]

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

Prevalence of smokefree home rules--United States, 1992-1993 and 2010-2011. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Protecting children from smoke exposure in disadvantaged homes. [2018]