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Kids Safe and Smokefree (KiSS) Multilevel Intervention to Reduce Child Tobacco Smoke Exposure: Long-Term Results of a Randomized Controlled Trial.

ABSTRACT: Pediatricians following clinical practice guidelines for tobacco intervention (“Ask, Advise, and Refer” [AAR]) can motivate parents to reduce child tobacco smoke exposure (TSE). However, brief clinic interventions are unable to provide the more intensive, evidence-based behavioral treatments that facilitate the knowledge, skills, and confidence that parents need to both reduce child TSE and quit smoking. We hypothesized that a multilevel treatment model integrating pediatric clinic-level AAR with individual-level, telephone counseling would promote greater long-term (12-month) child TSE reduction and parent smoking cessation than clinic-level AAR alone.Pediatricians were trained to implement AAR with parents during clinic visits and reminded via prompts embedded in electronic health records. Following AAR, parents were randomized to intervention (AAR + counseling) or nutrition education attention control (AAR + control). Child TSE and parent quit status were bioverified.Participants (n = 327) were 83% female, 83% African American, and 79% below the poverty level. Child TSE (urine cotinine) declined significantly in both conditions from baseline to 12 months (p = 0.001), with no between-group differences. The intervention had a statistically significant effect on 12-month bioverified quit status (p = 0.029): those in the intervention group were 2.47 times more likely to quit smoking than those in the control. Child age was negatively associated with 12-month log-cotinine (p = 0.01), whereas nicotine dependence was positively associated with 12-month log-cotinine levels (p = 0.001) and negatively associated with bioverified quit status (p = 0.006).Pediatrician advice alone may be sufficient to increase parent protections of children from TSE. Integrating clinic-level intervention with more intensive individual-level smoking intervention is necessary to promote parent cessation.

SUBMITTER: Lepore SJ

PROVIDER: S-EPMC6025102 | biostudies-other | 2018 Jun

REPOSITORIES: biostudies-other

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Kids Safe and Smokefree (KiSS) Multilevel Intervention to Reduce Child Tobacco Smoke Exposure: Long-Term Results of a Randomized Controlled Trial.

Lepore Stephen J SJ Collins Bradley N BN Coffman Donna L DL Winickoff Jonathan P JP Nair Uma S US Moughan Beth B Bryant-Stephens Tyra T Taylor Daniel D Fleece David D Godfrey Melissa M

International journal of environmental research and public health 20180612 6

<h4>Background</h4>Pediatricians following clinical practice guidelines for tobacco intervention (“Ask, Advise, and Refer” [AAR]) can motivate parents to reduce child tobacco smoke exposure (TSE). However, brief clinic interventions are unable to provide the more intensive, evidence-based behavioral treatments that facilitate the knowledge, skills, and confidence that parents need to both reduce child TSE and quit smoking. We hypothesized that a multilevel treatment model integrating ...[more]

PMID: 29895740

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Project description:BackgroundAddressing children's tobacco smoke exposure (TSE) remains a public health priority. However, there is low uptake and ineffectiveness of treatment, particularly in low-income populations that face numerous challenges to smoking behavior change. A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), combined with nicotine replacement and intensive multimodal, individual-level behavioral intervention may improve TSE control efforts in such high-risk populations.Methods/designThis trial uses a randomized two-group design with three measurement points: baseline, 3-month and 12-month follow-up. The primary outcome is bioverified child TSE; the secondary outcome is bioverified maternal quit status. Smoking mothers of children less than 6 years old are recruited from WIC clinics. All participants receive WIC system-level intervention based on the "Ask, Advise, Refer (AAR)" best practices guidelines for pediatrics clinics. It includes training all WIC staff about the importance of maternal tobacco control; and detailing clinics with AAR intervention prompts in routine work flow to remind WIC nutrition counselors to ask all mothers about child TSE, advise about TSE harms and benefits of protection, and refer smokers to cessation services. After receiving the system intervention, mothers are randomized to receive 3 months of additional treatment or an attention control intervention: (1) The multimodal behavioral intervention (MBI) treatment includes telephone counseling sessions about child TSE reduction and smoking cessation, provision of nicotine replacement therapy, a mobile app to support cessation efforts, and multimedia text messages about TSE and smoking cessation; (2) The attention control intervention offers equivalent contact as the MBI and includes nutrition-focused telephone counseling, mobile app, and multimedia text messages about improving nutrition. The control condition also receives a referral to the state smoking cessation quitline.DiscussionThis study tests an innovative community-based, multilevel and integrated multimodal approach to reducing child TSE in a vulnerable, low-income population. The approach is sustainable and has potential for wide reach because WIC can integrate the tobacco intervention prompts into routine workflow and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines.Trial registrationClinicaltrials.gov NCT02602288 . Registered 9 November 2015.

Project description:BACKGROUND:Provider adherence to best practice guidelines (ask, advise, refer [AAR]) for addressing child tobacco smoke exposure (TSE) motivates parents to reduce TSE. However, high-risk, vulnerable populations of smokers may require more intensive treatment. We hypothesized that a pragmatic, multilevel treatment model including AAR coupled with individualized, telephone-based behavioral counseling promoting child TSE reduction would demonstrate greater child TSE reduction than would standard AAR. METHODS:In this 2-arm randomized controlled trial, we trained pediatric providers in systems serving low-income communities to improve AAR adherence by using decision aid prompts embedded in routine electronic health record assessments. Providers faxed referrals to the study and received ongoing AAR adherence feedback. Referred participants were eligible if they were daily smokers, >17 years old, and spoke English. Participants were randomly assigned to telephone-based behavioral counseling (AAR and counseling) or nutrition education (AAR and attention control). Participants completed prerandomization and 3-month follow-up assessments. RESULTS:Of providers, >80% (n = 334) adhered to AAR procedures and faxed 2949 referrals. Participants (n = 327) were 83% women, 83% African American, and 79% low income (below poverty level). Intention-to-treat logistic regression showed robust, positive treatment effects: more parents in AAR and counseling than in AAR and attention control eliminated all sources of TSE (45.8% vs 29.9%; odds ratio 1.99 [95% confidence interval 1.44-2.74]) and quit smoking (28.2% vs 8.2%; odds ratio 3.78 [95% confidence interval 1.51-9.52]). CONCLUSIONS:The results indicate that the integration of clinic- and individual-level smoking interventions produces improved TSE and cessation outcomes relative to standalone clinic AAR intervention. Moreover, this study was among the first in which researchers demonstrated success in embedding AAR decision aids into electronic health records and seamlessly facilitated TSE intervention into routine clinic practice.

Project description:The developing fetus is especially vulnerable to environmental toxicants, including tobacco constituents. The aim of this study was to assess the impact of environmental tobacco smoke (ETS) exposure during pregnancy on child neurodevelopment within the first two years of life. The study population consisted of 461 non-smoking pregnant women (saliva cotinine level <10 ng/mL). Maternal passive smoking was assessed based on the cotinine level in saliva analyzed by the use of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-ESI + MS/MS) and by questionnaire data. The cotinine cut-off value for passive smoking was established at 1.5 ng/mL (sensitivity 63%, specificity 71%). Psychomotor development was assessed in children at the age of one- and two-years using the Bayley Scales of Infant and Toddler Development. Approximately 30% of the women were exposed to ETS during pregnancy. The multivariate linear regression model indicated that ETS exposure in the 1st and the 2nd trimesters of pregnancy were associated with decreasing child language functions at the age of one (? = -3.0, p = 0.03, and ? = -4.1, p = 0.008, respectively), and two years (? = -3.8, p = 0.05, and ? = -6.3, p = 0.005, respectively). A negative association was found for cotinine level ?1.5 ng/mL in the 2nd trimester of pregnancy and child cognition at the age of 2 (? = -4.6, p = 0.05), as well as cotinine levels ?1.5 ng/mL in all trimesters of pregnancy and child motor abilities at two years of age (? = -3.9, p = 0.06, ? = -5.3, p = 0.02, and ? = -4.2, p = 0.05, for the 1st, the 2nd, and the 3rd trimester of pregnancy, respectively; for the 1st trimester the effect was of borderline statistical significance). This study confirmed that ETS exposure during pregnancy can have a negative impact on child psychomotor development within the first two years of life and underscore the importance of public health interventions aiming at reducing this exposure.

Project description:BACKGROUND:Exposure to secondhand smoke (SHS) early in life increases the risk of sudden infant death syndrome (SIDS), asthma, and respiratory illnesses. Since children's primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a quickly reversible cause of excess morbidity, few low-income homes strictly enforce smoking restrictions. OBJECTIVE:This study aims to test a novel approach to motivate the adoption of home smoking restrictions and to eliminate child SHS exposure by providing parents with objective data documenting home SHS exposure and "biomarker feedback" of child ingestion of tobacco toxins, that is, objective, laboratory-based results of assays performed on child urine, documenting levels of nicotine; cotinine; and NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), which is a metabolite of the known tobacco carcinogen NNK (4-[methylnitro-samino]-1-[3-pyridyl]-1-butanone). METHODS:From 2011 to 2013, 195 low-income, female smokers with children aged ?10 years residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: biomarker feedback (n=98) and health education (n=97). In-home assessments were administered at baseline, week 16, and week 26. Children's home SHS exposure and nicotine, cotinine, and NNAL levels from urine samples, measured through a passive nicotine dosimeter and a surface sample of residual tobacco smoke (ie, thirdhand smoke), were collected at all three time points. Primary outcome was dosimeter-verified, self-reported complete home smoking restrictions at 6 months after randomization. Secondary outcomes included parental self-report of smoking behavior change and child urine tobacco toxin (biomarker) change. RESULTS:Data collection and analyses are complete, and the results are being interpreted. CONCLUSIONS:The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting home and child exposure to SHS on parental smoking behavior change. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/12654.

Project description:BACKGROUND: Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to M?ori. METHODS/DESIGN: This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants. DISCUSSION: Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children.

Project description:INTRODUCTION:Compared with the general smoking population, low-income smokers face elevated challenges to success in evidence-based smoking cessation treatment. Moreover, their children bear increased disease burden. Understanding behavioral mechanisms related to successful reduction of child tobacco smoke exposure (TSE) could inform future smoking interventions in vulnerable, underserved populations. METHODS:Smoking parents were recruited from pediatric clinics in low-income communities and randomized into a multilevel intervention including a pediatric clinic intervention framed in best clinical practice guidelines ("Ask, Advise, Refer" [AAR]) plus individualized telephone counseling (AAR + counseling), or AAR + control. Mediation analysis included treatment condition (independent variable), 12-month child cotinine (TSE biomarker, criterion), and four mediators: 3-month end-of-treatment self-efficacy to protect children from TSE and smoking urge coping skills, and 12-month perceived program (intra-treatment) support and bioverified smoking abstinence. Analyses controlled for baseline nicotine dependence, depressive symptoms, child age, and presence of other residential smokers. RESULTS:Participants (n = 327) included 83% women and 83% African Americans. Multilevel AAR + counseling was associated with significantly higher levels of all four mediators (ps < .05). Baseline nicotine dependence (p < .05), 3-month self-efficacy (p < .05) and 12-month bioverified smoking abstinence (p < .001) related significantly to 12-month child cotinine outcome. The indirect effects of AAR + counseling intervention on cotinine via self-efficacy for child TSE protection and smoking abstinence (ps < .05) suggested mediation through these pathways. CONCLUSIONS:Compared with AAR + control, multilevel AAR + counseling improved all putative mediators. Findings suggest that fostering TSE protection self-efficacy during intervention and encouraging parental smoking abstinence may be key to promoting long-term child TSE-reduction in populations of smokers with elevated challenges to quitting smoking. IMPLICATIONS:Pediatric harm reduction interventions to protect children of smokers from tobacco smoke have emerged to address tobacco-related health disparities in underserved populations. Low-income smokers experience greater tobacco-related disease burden and more difficulty with smoking behavior change in standard evidence-based interventions than the general population of smokers. Therefore, improving knowledge about putative behavioral mechanisms of smoking behavior change that results in lower child exposure risk could inform future intervention improvements.

Project description:BackgroundPoor child feces management (CFM) is believed to be an important source of exposure to enteric pathogens that contribute to a large disease burden in low-income settings. While access to sanitation facilities is improving, national surveys indicate that even households with latrines often do not safely dispose of their child's feces. Working with caregivers in rural Odisha, India, we co-developed an intervention aimed at improving safe disposal of child feces and encouraging child latrine use at an earlier age. We describe the rationale for the intervention and summarize the protocol for a cluster randomized trial (CRT) to evaluate its effectiveness at changing CFM practices.MethodsThe intervention consists of six behavior change strategies together with hardware provision: wash basin and bucket with lid to aid safe management of soiled nappies and a novel latrine training mat to aid safe disposal and latrine training. The intervention will be offered at the village level to interested caregivers of children < 5 years of age by a community-based organization. Following a baseline survey, 74 villages were randomly allocated to either intervention or control arm. The primary outcome is caregiver reported safe disposal of child feces after last defecation, either by the caregiver disposing of the child's feces into the latrine or the child using the latrine, measured approximately four to six months following intervention delivery. Secondary outcomes include fecal contamination of household drinking water and the childs' hands. A process evaluation will also be conducted to assess intervention fidelity and reach, and explore implementer and participant feedback.DiscussionThis study addresses a crucial knowledge gap in sanitation by developing a scalable intervention to improve safe management of child feces. The behavior change strategies were designed following the Risks, Attitudes, Norms, Abilities and Self-Regulation (RANAS) approach, which has shown to be effective for other environmental behavior change interventions in low-income settings. The latrine training mat hardware is a novel design developed cooperatively and manufactured locally. The evaluation follows a rigorous CRT study design assessing the impact of the intervention on CFM behavior change, as well as fecal contamination of two sources of potential exposure.Trial registrationThis trial is registered at ISRCTN: ISRCTN15831099.

Dataset Information

Kids Safe and Smokefree (KiSS) Multilevel Intervention to Reduce Child Tobacco Smoke Exposure: Long-Term Results of a Randomized Controlled Trial.

Publications

Kids Safe and Smokefree (KiSS) Multilevel Intervention to Reduce Child Tobacco Smoke Exposure: Long-Term Results of a Randomized Controlled Trial.

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