Smoke-Free Home Program for Reducing Child Exposure to Smoking
(SFSC Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
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.
12345Is 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.
13467How 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.
12789Eligibility 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Smoke Free SafeCare (SFSC)Experimental Treatment1 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 SafeCareActive Control1 Intervention
Providers randomized to this group will disseminate the Standard SafeCare program to families who report having a smoker in the home.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Georgia State UniversityAtlanta, GA
Emory UniversityAtlanta, GA
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Who Is Running the Clinical Trial?
Georgia State UniversityLead Sponsor
References
A Cluster Randomised Controlled Trial of a Brief Child Health Nurse Intervention to Reduce Infant Secondhand Smoke Exposure. [2018]Background Exposure to secondhand smoke (SHS) is a significant contributor to ill health in children. A study was undertaken to determine the effectiveness of two brief multi-strategic child health nurse delivered interventions in: decreasing the prevalence of infants exposed to SHS; decreasing the prevalence of smoking amongst parent/carers of infants and increasing the prevalence of household smoking bans. Methods This study was a 3 arm, cluster randomised controlled trial. Clusters were 39 community based well child health clinics in one local area health service. Clinics were stratified according to annual number of client appointments and then randomly assigned in a 1:1:1 ratio, (Intervention 1: Intervention 2: Control), with 13 clinics in each cluster. Parents/carers of infants in the intervention groups received a brief multi-strategic intervention from child health nurses during clinic consultations. Treatment condition 1 included computer delivered risk assessment and feedback and nurse brief advice. Treatment condition 2 included all elements of Treatment condition 1 with the addition of biochemical feedback of infant SHS exposure. Results When compared to the Control group at 12 months, no significant differences in the prevalence of infant exposure to SHS were detected from baseline to follow-up for Treatment condition 1 (OR 1.16, 95 % CI 0.73-1.85, p = 0.53) or Treatment condition 2 (OR 1.30, 95 % CI 0.88-1.92, p = 0.19) Similarly, no significant differences were detected in the proportion of parent/carers who reported that they were smokers (T1:OR 0.95, 95 % CI 0.78-1.15, p = 0.58 and T2:OR 0.97, 95 % CI 0.80-1.18, p = 0.77), or in the proportion of households reported to have a complete smoking ban (T1:OR 1.21, 95 % CI 0.89-1.64, p = 0.23 and T2:OR 1.06, 95 % CI 0.79-1.43, p = 0.68). Conclusions Further research is required to identify effective interventions that can be consistently provided by child health nurses if the potential of such settings to contribute to reductions in child SHS exposure is to be realised.
Moderators of Establishing a Smoke-Free Home: Pooled Data from Three Randomized Controlled Trials of a Brief Intervention. [2020]Interventions to create smoke-free homes typically focus on parents, involve multiple counseling sessions and blend cessation and smoke-free home messages. Smoke-Free Homes: Some Things are Better Outside is a minimal intervention focused on smokers and nonsmokers who allow smoking in the home, and emphasizes creation of a smoke-free home over cessation. The purpose of this study is to conduct moderator analyses using pooled data from three randomized controlled trials of the intervention conducted in collaboration with 2-1-1 contact centers in Atlanta, North Carolina and Houston. 2-1-1 is a strategic partner for tobacco control as it connects over 15 million clients, largely socio-economically disadvantaged, to social and health resources each year. A total of 1506 2-1-1 callers participated across the three intervention trials. Outcomes from 6 months intent-to-treat analyses were used to examine whether sociodemographic variables and smoking-related characteristics moderated effectiveness of the intervention in establishing full home smoking bans. Intervention effectiveness was not moderated by race/ethnicity, education, income, children in the home or number of smokers in the home. Smoking status of the participant, however, did moderate program effectiveness, as did time to first cigarette. Number of cigarettes per day and daily versus nondaily smoking did not moderate intervention effectiveness. Overall, the intervention was effective across socio-demographic groups and was effective without respect to daily versus nondaily smoking or number of cigarettes smoked per day, although smoking status and level of nicotine dependence did influence effectiveness.
Full and home smoking ban adoption after a randomized controlled trial targeting secondhand smoke exposure reduction. [2021]The current study examined home and full (i.e., home plus car) smoking ban adoption as secondary outcomes to a randomized controlled trial targeting reduced secondhand smoke exposure (SHSe) for children under treatment for cancer.
Child health-centre-based promotion of a tobacco-free environment--a Swedish case study. [2019]Environmental tobacco smoke exposure is an important health risk for small children. The development, spread and evaluation of a national child health-centre-based counselling method targeting environmental tobacco smoke is described. The work progressed in six steps. In a first step, accomplished in 1994, it was found that child health nurses used a limited repertoire of techniques and were dissatisfied with their discussion on tobacco smoke. In a second step, routine recording of parental smoking status was introduced at all child health centres. In a third step, a counselling method based on Bandura's self-efficacy concept was developed, 'smoke-free children'. In a fourth step, smoke-free children was tested by 28 nurses in 128 families. At follow-up discussions, all parents said that they now smoked outdoors and that they had cut down on their smoking. In a fifth step, the national dissemination of smoke-free children was studied. A manual and a videotape were launched in 1995, supported by a newsletter and 10 regional conferences in the following years. In January 1997, 36% of the child health nurses in Sweden (three counties excluded) stated that they used the method. Training of county instructors did not seem to have improved dissemination. In a sixth step, routinely collected information on parental smoking in Stockholm county on infants born 1995-1997 was used to study the effect. Little change in smoking rates between two consecutive years was found before the introduction of smoke-free children. Yet, after training of the child health nurses, the annual decrease was 1.7% in a pilot area and later, in remaining parts of the county, 2.7%. Thus, answers to two crucial questions were given: first, that the method seemed to affect parental behaviour; and secondly, that the training of county instructors might not have affected the dissemination of smoke-free children.
Long-term Results From the FRESH RCT: Sustained Reduction of Children's Tobacco Smoke Exposure. [2021]Standard care interventions to reduce children's tobacco smoke exposure (TSE) may not be sufficient to promote behavior change in underserved populations. A previous study demonstrated the short-term efficacy of an experimental counseling intervention, Family Rules for Establishing Smokefree Homes (FRESH) compared with standard care on boosting low-income children's TSE reduction and maternal smoking at 16-week end of treatment (EOT). This study tested long-term posttreatment efficacy of this treatment through a 12-month follow-up.
Parental Smoking Cessation: Impacting Children's Tobacco Smoke Exposure in the Home. [2019]There is no safe or risk-free level of tobacco use or tobacco smoke exposure. In this randomized controlled trial, we tested a tobacco control intervention in families and specifically evaluated a tailored cessation intervention for the parents and/or caregivers (Ps/Cs) who were smokers while their children were simultaneously enrolled in tobacco prevention.
Disparities in secondhand smoke exposure--United States, 1988-1994 and 1999-2004. [2022]No level of exposure to secondhand smoke (SHS) is safe. Breathing SHS can cause heart disease and lung cancer in nonsmoking adults and increases the risk for sudden infant death syndrome, acute respiratory infections, middle-ear disease, and exacerbation of asthma in children. In the United States, exposure to SHS declined approximately 70% from the late 1980s through 2002, most likely reflecting widespread implementation of laws and policies prohibiting smoking in indoor workplaces and public places during this period. Although the major sources of SHS exposure for nonsmoking adults are the home and workplace, the primary source of SHS exposure for children is the home; therefore, eliminating smoking in workplaces and public places is less likely to reduce children's exposure to SHS. This report examines changes in the prevalence of self-reported SHS exposure at home and changes in any exposure, as measured by serum cotinine (a biologic indicator of SHS exposure), in nonsmoking children, adolescents, and adults. The analysis was conducted using data from the 1988-1994 and 1999-2004 National Health and Nutrition Examination Surveys (NHANES). The results indicated that self-reported SHS exposure at home and SHS exposure as measured by serum cotinine declined significantly (i.e., by 51.2% and 44.7%, respectively) in the U.S. population from 1988-1994 to 1999-2004; however, the decline was smaller for persons aged 4-11 years and 12-19 years. These results underscore the need to continue surveillance of SHS exposure and to focus on strategies to reduce children's SHS exposure.
Prevalence of smokefree home rules--United States, 1992-1993 and 2010-2011. [2022]Exposure to secondhand smoke (SHS) from cigarettes causes an estimated 41,000 deaths among nonsmoking U.S. adults each year and an estimated $5.6 billion annually in lost productivity caused by premature death. In a 2006 report, the Surgeon General concluded that there is no risk-free level of exposure to SHS. Although an increasing proportion of the population is covered by state or local comprehensive smokefree laws that prohibit tobacco smoking in all indoor public places and worksites, including restaurants and bars, millions of nonsmokers continue to be exposed to SHS in areas not covered by smokefree laws or policies, including homes. The home is the primary source of SHS exposure for children and a major source of exposure for nonsmoking adults. To assess progress toward increasing the proportion of households with smokefree home rules, CDC analyzed the most recent data from the Tobacco Use Supplement to the Current Population Survey. Households were considered to have a smokefree home rule if all adult respondents aged ≥18 years in the household reported that no one was allowed to smoke anywhere inside the home at any time. The analysis found that the national prevalence of smokefree home rules increased from 43.0% during 1992-1993 to 83.0% during 2010-2011. Over the same period, the national prevalence of smokefree home rules increased from 56.7% to 91.4% among households with no adult cigarette smokers and from 9.6% to 46.1% among households with at least one adult smoker. Enhanced implementation of evidence-based interventions (e.g., comprehensive smokefree laws, voluntary smokefree home rules, smokefree multiunit housing policies, and initiatives to educate the public about the health effects of SHS) is warranted to further reduce SHS exposure in the United States.
Protecting children from smoke exposure in disadvantaged homes. [2018]Smoke-free legislation and shifting norms in many countries have reduced secondhand smoke (SHS) exposure, but many children, particularly from disadvantaged homes, have high levels of exposure in homes and cars. We explored the particular challenges mothers who smoke face when attempting to protect their children from SHS exposure in disadvantaged homes.