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Protecting children from secondhand smoke at home: a feasibility study of a novel interventionDr Laura JonesUniversity of Birmingham & UKCTCS27th June 2013

1AcknowledgementsCo authorsJohn MarshTim ColemanAnn McNeillSarah Lewis

Nottingham SFH TeamJacqueline PurdyAlex Larwood

New Leaf supportJane HassallJulie GreenwoodIndu HariMichelle Battlemuch

This talk summarises independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0608-10020). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.2Extent of the problem600,000 global deaths directly related to SHS exposure per year 165,000 of these are children40% of children worldwide are exposed to SHS - mainly in domestic settingsOver half (52%) of children in UK households who live with at least one smoker are regularly exposed to SHS at homeEvery day in the UK, around 26 children are taken to hospital with SHS related problems

3SHS exposure: health risksSHS health risks well established and documentedWe know why childrens exposure to SHS should be a public health priorityHoweverWe know less about why children are exposed to SHS at homeOr how we can help families to reduce or prevent childrens exposure to SHS

The health effects associated with children's exposure to SHS are well established and so I am not going to go through them all as part of this presentation. What I want to highlight is that this tells us WHY childrens exposure to SHS should be a Government priority, but what it doesnt tell us is WHY children are exposed to SHS and HOW we can support families to reduce their childrens exposure to SHS.

4What does the current evidence base tell us?Cochrane SHS Systematic Review 200836 studies (11 showed significant effect)Conclusion: At present, there is insufficient evidence to recommend one particular strategy to reduce the prevalence of SHS exposure in children

SFH Narrative Synthesis 201112 studies (2 showed significant effect)Conclusion: mixed evidence for the effectiveness of interventions to reduce parental environmental tobacco smoke in early infancy

Priest et al. (2008); Baxter et al. (2011)So what does the evidence base tell us about interventions that can help reduce childrens exposure to SHS in the home. There have been two reviews in recent years, one systematic and one narrative.

PRIEST Objective: to determine the effectiveness of any intervention aiming to reduce exposure of children to SHSStudies based in well and ill child clinics and predominantly from American and other high income countries 11 of these 36 studies showed a statistically significant intervention effect 4 of these successful studies employed intensive counselling interventions targeted at smoking parents and delivered by physicians success of these studies cannot be extrapolated to child health settings resource intensive and small target group Lack of support for more intensive counselling for parents in the clinical setting Difficult to implement at a national level 17 of the 36 studies showed a reduction in SHS exposure in both the intervention and control groups suggesting either a measurement effect or this may be an indication of overall population trends towards lower exposure over time

BAXTERPredominantly American studies or from high income countries such as Sweden, Italy and FinlandObjective: to determine the effectiveness of interventions to encourage the establishment of SFH during pregnancy and in the neonatal period17 eligible studies: counselling, counselling plus additional elements, individually adapted programmes and motivational interviewingMajority used self-reported changes to smoking behaviours but only 12 included in the analysisOf the 12 included, 7 showed no significant effect, 2 showed a significant effect (one in a clinic and one not reported where intervention took place) and the rest showed an effect in one or two measures or just a positive effect.

Only presenting review data here, and we know that the evidence base around SHS and SFH growing, for example, the REFRESH study in Scotland is showing promising results. The REFRESH study was a small pilot feasibility with 54 families of an intervention that is delivered in the home over a one month period and involved providing personalised feedback on home air quality and a motivational interview to encourage parental smoking behaviour change.

However, overall its clear this is still a need for novel intervention strategies to reduce SHS exposure in children.

5What else do we know?Promoting caregiver quittingPromoting smoke-free homesRequires substantial behaviour changeParents may face significant barriers

Although there is limited evidence from the literature about the success of specific interventions to reduce childrens exposure we do know that there are several things that we should be doing at the individual or household level. We know that the most effective control measure is for parents and carers to quit smoking entirely. However, we know that there are a proportion of smoking parents who for whatever reason cannot or are not yet ready to quit. So what is it that we should be doing for those families? The next best thing to do is to encourage and support families to make their homes completely smoke-free. A complete home smoking ban is the key because measures targeted at individuals or households and intended to reduce smoking in the home while stopping short of making the home smoke-free are unlikely to have a major impact on SHS exposure at home. Studies involving measurements of SHS exposure in rooms of different sizes, and with different ventilation systems, show that the most reliable means of reducing SHS exposure is to stop smoking indoors. This is supported by research showing that the levels of cotinine in childrens urine only declines when parents prohibit all smoking in the home, in contrast with lesser measures such as not smoking in front of children inside the home. Having said this, for some making their home completely smoke-free is actually no easier than quitting as it still requires significant behaviour change and we know that some families may face significant barriers.

6Nottingham SFH studiesOverall aim: to develop an intervention to reduce childrens exposure to domestic SHS

Interview study one - 36 semi-structured interviews with families Interview study two - 29 semi-structured interviews with HCPs Feasibility trial - two phase study Exploratory randomised controlled trial Over the last four years weve been working towards developing an intervention in Nottingham to help to support disadvantaged families to make their homes completely smoke-free. There have been three studies conducted so far and the fourth (RCT) is currently on-going. Weve previously presented the qualitative results, and some of you may have seen us talk about them before. Today, Im going to focus on the feasibility study.

7Feasibility studyAim: to test the feasibility and acceptability of the interventionPrimary outcomeBiochemically validated change in SHS exposureSecondary outcomesSelf-reported changes in home smokingCigarette consumption/quit attemptsUse of NRT for TAMain trial design Recruitment pathwaysRetention/attritionEffectiveness of different components

The aim of the feasibility study was to test the feasibility and acceptability of the proposed intervention

Primary outcome: Biochemically validated reduction in childs home SHS exposure between baseline and 3 month follow-up

Secondary outcomes include changes in: Self-reported home smoking behavioursAttitudes and beliefs around smoking in the homeQuit attemptsUse of NRT for TAMain trial design issuesSample size estimatesRetention/attrition ratesSuccess of recruitment pathwaysSubjective ratings of the effectiveness of the different intervention components8Feasibility studyTwo phases with protocol reviewPhase 1: Sept 2011 to Feb 2012 Phase 2: March to August 2012

Recruitment via Childrens Centres

Six families recruited into each phase

Typical study participant:Single female aged 26 yearsTwo childrenSocially disadvantagedWe ran the study as two separate phases, so that we could review the protocol (intervention) in betweenPhase 1 ran between September 2011 and February 2012Phase 2 ran between March and August 2012Families were recruited via Childrens Centres in Nottingham City

A total of 12 families took part, six in each phase. Eight were enrolled into phase 1 but 2 were lost to follow up. Six were enrolled in phase 2 with none lost to follow up. The typical participant was female, aged 26 with two children and were socially disadvantaged.

Phase 1 recruitment: 14 week period at 39 CC sessions256 people were approached to assess eligibility/ 19 met inclusion criteria/ 8 recruited into the study/ 2 lost to follow up

Phase 2 recruitment: 9 week period from 26 CC sessions197 approached to assess eligibility/ 11 met inclusion criteria/ 6 recruited into the study/ 0 lost to follow up

9What did the intervention look like initially?12 week home based intensive interventionBehavioural and emotional support Educational materials (SFH pack)Impact feedback (childs salivary cotinine)Nicotine replacement therapy

The intervention that we have developed in Nottingham was originally based around four key componentsPeople who smoked in the home and had a least one child under the age of 5 years were enrolled.Other adult smokers within the household could also be enrolled and one took part in the first phase and none in the second.Families were seen face to face in their own home on FOUR separate occasions over a 12 week periodThey received behavioural and emotional support from a specialist smoke-free homes advisor to promote and encourage home smoking behaviour change. The received information on SHS and tips on how to make changes to their home smoking behaviour in the form of a specially developed booklet that was developed with the local stop smoking serviceThey will also be offered personalised feedback on the youngest childs salivary cotinine levelsThey are offered nicotine replacement therapy for temporary abstinence and/or for helping them to cut down the number of cigarettes that they smoking inside the house10Feasibility study phase 112 weeksInterventionOutcomesVisit 1 (Baseline)Behavioural supportNRTQuestionnaireUrine & saliva sampleVisit 1a (1-2 wks)Recruitment evaluation interviewVisit 4 (12 wks)Behavioural supportNRTCotinine feedbackQuestionnaireUrine & saliva sampleVisit 3 (8 wks)Behavioural supportNRTCotinine feedbackQuestionnaireUrine & saliva sampleVisit 2 (4 wks)Behavioural supportNRTCotinine feedbackQuestionnaireUrine & saliva sampleVisit 4a (13-14 wks)Evaluation interviewThis it the protocol for phase one in diagrammatic formThe top line shows the intervention and the bottom line shows the outcome data that we collectedIn week 2 we conducted a recruitment evaluation interview to gain insight into the recruitment process and the baseline appointment this was then followed up at the end of the intervention period with an evaluation interview.First feedback on baseline cotinine was given face to face at week 4.We provided each parent with a simple information sheet with their childs cotinine levels and then basic information on what we could expect (i.e. closer to zero the better) and then a comparator in the form of adults who work in smoky bars.11Protocol reviewBehavioural supportTiming and intensity of visitsFeedbackSaliva vs. urineCotinine vs. air monitoringEducational materialsNRT Provision of sample bagsAt the end of the first phase we conducted a protocol reviewThis review was based on the research teams own experiences of the process both recruiting and seeing families through the intervention period and on the feedback from the families who took part. With regards to the behavioural support it became clear that we werent providing enough support in the beginning and that it was weighted more towards the end of the 12 weeks.Also needed more intensive support and this didnt necessarily have to be face to face, but phone and text would be good, especially in the early stagesPersonalised feedback caused us the most issues. We initially collected both urine and saliva samples; however, it proved difficult to get urine samples from children didnt go whilst we were there or insufficient sample or contaminatedSaliva samples much easier to collect mums and children happy with the collection techniqueWhat was more difficult was the fact that the saliva results were so variableChildren living in these households tend to spend a lot of time outside of the main intervention house ie with dad or other family members so whilst mum might be making really good changes at home as part of the intervention this may not be reflected in the childs cotinine measuresSpent time trying to reassure that making changes was worth it and was detrimental to the aims of the interventionWhilst we were conducting the feasibility study, REFRESH study came along which showed that home air monitors (PM2.5) were effective for promoting home smoking behaviour changeGiven issued wed had with saliva, for phase 2 we decided to use PM2.5 (in addition to saliva) and use this to measure changes within the household and for feedbackThe educational materials we provided in phase 1 were dropped for phase 2 as they didnt go down well and the families reported that they preferred to receive the information and facts during the face to face sessions, so that could ask questions and not via a booklet which the didnt or couldnt readThe provision of NRT remained largely the same for the second phase, other than we offered sample bags at the beginning rather than getting them to choose a product from the beginning and then having to change it if it didnt suit them etc.

12Revised intervention12 week home based intensive interventionBehavioural and emotional support Impact feedback (home air quality PM2.5)Nicotine replacement therapy

So just to summarise, this is how the intervention looks for the second phase.Three rather than four components and feedback based on home air quality rather than salivary cotinine13Feasibility study phase 212 weeksInterventionOutcomesVisit 1 (Baseline)QuestionnaireSaliva samplePM2.5 dataVisit 2 (1 wk)Behavioural supportNRTPM2.5 feedbackVisit 5(12 wks)Behavioural supportNRTPM2.5 feedbackQuestionnaireSaliva samplePM2.5 feedbackVisit 4 (7 wks)Behavioural supportNRTPM2.5 feedbackQuestionnaireSaliva samplePM2.5 dataVisit 3 (4 wks)Behavioural supportNRTQuestionnaireSaliva sampleVisit 5a (13-14 wks)Evaluation interviewThis is the protocol for phase 2 and again shows the intervention and outcomes with visit numbers and timing across the topThe format is essentially the sameAt the baseline appointment we only collected outcome data and there was no intervention delivered this was because the participants reported that having gone through the consent process and all of the information about the study, it was too much to take in to received behavioural support and information about NRTThe main intervention was then delivered at visit 2 (within one week of the baseline appointment) and no outcome data were collected at this pointWe also dropped the interview at 2 weeks and just evaluated the intervention at the endProactive telephone support was also provided once a week between appointments for the first four weeks and then in a reactive manner after thatVisits, 3-5 were the same as phase 1 with the only difference being the feedback being based around PM2.5 rather than saliva

14Home air quality dataI thought that you might like to see an example of the home air quality dataIt shows home air quality over a 24 hours periodWe collect data for up to 48 hours prior to each of the three appointments and then give feedback in the face to face visitBaseline in red shows clear spikes that relate to cigarette smokingAs you can see by week 7 the family report having a SFH and this is evident from the graph (no spikes now)They maintain their smoke-free home into week 12Both week 7 and week 12 fall below the WHO 24 hour safety level of 25

Average for baseline 59, 11 for week 7 and 11 for week 12.15Key findingsPersonalised feedback was ranked as the most important component followed by behavioural supportSaliva results highly variable but no change over time (21ng/ml at baseline vs. 20ng/ml at week 12)Average 24 hour PM2.5 reduced by 49% between baseline and week 1250% self-reported SFH at week 12100% self-reported that complete indoor ban for visitors at week 12Most families reported cutting down (by ~43%) and small number made a quit attempt16Views on taking partIt was told in a decent way, I was never once made to feel bad or like they was disgusted in what I was doing or anything like that, that was the nice part about it because you wasn't ... singled out and made to look a certain, you know how some people can single you out, you're a smoking mum, makes you feel a bit like badI think the best outcome is I dont really smoke so much. I smoke only when Im not at home which is a lot betterThe next couple of slides show some of the quotes from the evaluation interviews from both phasesThe top quote highlights that participating in the study lead to women cutting down the amount that they smoked by only smoking away from homeThe bottom quote talks about the behavioural support that was received and highlights the importance of the relationship between the advisor and the family and the need to be sensitive to the fact that some women do feel stigmatised as a smoking parent.17Views on taking partIts [intervention] definitely encouraged me to [make home smoke-free] without a doubt. Seeing the results of the graph was the most shocking, that basically smoking outside of the room its still that much comes back in the room, it is similar to smoking in the roomI just didnt realise that I did have the strength to actually do it, and it was so easy just to, like, take smoking outside, but some people dont think like that and I think even though Ive surprised myself, even when we had the snow, I was still smoking outside, even though it was hard, but I thought, no, Ive done it for so long, why, just because its snow[ing] why am I going to bring the smoke in the house and that The quotes highlight the impact that the intervention can have a really positive impact.The top quote highlights that see the home air quality graph was shocking and that smoking by the door does not protect children which a number of families thought would be enough. Overall the intervention helped her to encouraged her to make changes.The bottom quote shows how the intervention can build self-efficacy and confidence and that they can overcome issues which may have previously lead them to bringing smoking back inside such as bad weather. We spent a significant amount of time in the behavioural support sessions helping families to devise strategies to overcome challenges such as this. It also shows that with support, its easier than they perhaps first thought. 18SummaryChildrens exposure to SHS still a significant public health concernStarting to understanding better why children are exposed to SHS at home and how we can helpNottingham SFH intervention is both feasible and acceptableEvidence for initial effectiveness Main RCT started November 2012

19A few final thoughtswe can make a difference

This is a video of two families who took part in the first phase of the feasibility trial.Making your home smoke free can have a significant impact on the lives of the socially disadvantaged families20l.l.jones@bham.ac.uk21