Smoke-Free Home Program for Reducing Child Exposure to Smoking

(SFSC Trial)

Recruiting at 1 trial location

Overseen By Shannon Self-Brown

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Disqualifiers: Non-smoking home, Consent form misunderstanding

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

Compensation: Varies

Number of Visits: 8

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce children's exposure to secondhand smoke and improve family outcomes by testing a combined program called Smoke Free SafeCare. The program promotes smoke-free homes and enhances parenting skills to protect children in households with a high smoking rate. The trial compares this new combined approach to the standard SafeCare program. It seeks parents referred to a SafeCare provider who report smoking in their home and have children aged 0 to 5 (or up to age 9 in Oklahoma). As an unphased trial, this study offers families a unique opportunity to contribute to research that may lead to healthier home environments.

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 prior data suggests that this program is safe for reducing child exposure to smoking?

Research shows that the Smoke Free SafeCare program is generally safe for participants. Some studies have examined the "Some Things are Better Outside" component, which assists families in establishing no-smoking rules at home. These studies have not reported any serious safety concerns.

The SafeCare program, part of Smoke Free SafeCare, is also recognized for its safety. Child protective services across the United States widely use it without major issues, indicating families manage it well.

Overall, both components of the Smoke Free SafeCare program have been successfully implemented elsewhere, with no significant negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smoke-Free SafeCare (SFSC) program because it takes a proactive approach to reducing children's exposure to smoking in the home. Unlike the standard SafeCare program, SFSC includes additional training for providers to help families create smoke-free environments. This targeted intervention is designed to address smoking behaviors directly, potentially offering a more effective way to protect children from secondhand smoke compared to existing educational programs. By focusing on behavior change at the family level, SFSC could lead to healthier home environments and better long-term health outcomes for children.

What evidence suggests that the Smoke Free SafeCare program is effective for reducing child exposure to smoking?

Research shows that the Smoke Free SafeCare program, a treatment arm in this trial, can reduce exposure to secondhand smoke in homes. This program combines "Some Things Are Better Outside" (STBO), which encourages families to maintain smoke-free homes, with SafeCare, a program that helps parents enhance their caregiving skills. Studies have found that STBO effectively creates smoke-free homes, particularly in low-income areas. SafeCare, the focus of another treatment arm in this trial, is commonly used by child protective services to prevent child abuse. By integrating these two programs, Smoke Free SafeCare appears promising for reducing secondhand smoke exposure and improving family health in homes with high smoking rates. ^{1 2 4 6 7}

Who Is on the Research Team?

Michelle Kegler, PhD

Principal Investigator

Emory University

Shannon Self-Brown, PhD

Principal Investigator

Georgia State University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Smoke Free SafeCare
• Standard SafeCare

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39375710/

Evaluating the effectiveness of Smoke-Free Home SafeCare ... This study is a hybrid type 1 trial to examine the effectiveness of a systematically braided intervention to target CM risk and SHS in the home.

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08466-2

Evaluating the effectiveness of Smoke-Free Home SafeCare ... This study is a hybrid type 1 trial to examine the effectiveness of a systematically braided intervention to target CM risk and SHS in the home.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05000632

Study Details | NCT05000632 | Smoke Free SafeCare ... SafeCare is a promising mechanism to effectively increase the reach of STBO to reduce SHS (secondhand smoke) exposure in families with documented high rates of ...

4. researchgate.net researchgate.net/publication/384693658_Evaluating_the_effectiveness_of_Smoke-Free_Home_SafeCare_an_integrated_intervention_among_families_at_risk_for_secondhand_smoke_exposure_and_child_maltreatment_in_the_United_States_a_study_protocol_fo

(PDF) Evaluating the effectiveness of Smoke-Free Home ... Evaluating the effectiveness of Smoke-Free Home SafeCare, an integrated intervention, among families at risk for secondhand smoke exposure and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10175921/

Systematic braiding of Smoke-Free Home SafeCare to ... For child SHS exposure, the Smoke-Free Homes: Some Things Are Better Outside (SFH) program was selected as the evidence-based program of focus.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11457381/

Evaluating the effectiveness of Smoke-Free Home SafeCare ... This study is a hybrid type 1 trial to examine the effectiveness of a systematically braided intervention to target CM risk and SHS in the home.

7. cancercontrol.cancer.gov cancercontrol.cancer.gov/sites/default/files/2023-02/FINAL%20-%20GI_1R01CA248551-01A1.pdf

Establishing smoke-free homes with families involved in child ... Evidence-based interventions to create smoke-free homes can reduce SHS exposure among children. In three randomized trials, our team documented the.