Environmental Tobacco Smoke Clinical Trial
Official title:
The Third Year Project of The Associated Factors of Smoking Around School-aged Children and The Intervention Development Using the Theory of Reasoned Action
Verified date | May 2015 |
Source | Taipei Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Ministry of Health and Welfare |
Study type | Interventional |
The purpose of this project is to develop and examine the effects of a parent-child interactive program to decrease the level of children's exposure to environmental tobacco smoke(ETS) at home, promote parents' and children's preventing strategy, knowledge of its hazard and attitude against environment tobacco smoke. A clustered randomized controlled trial was administered to school-aged children and their parents. The outcome indicators, children's exposure to ETS at home and increase of strategy to prevent the exposure were measured at baseline, 8 weeks, and 20 weeks. The other outcomes, parents' and children's knowledge of and attitude toward ETS, family's anti-ETS climate and its influence, and children's self efficacy of avoiding ETS were also measured at the same time point.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - For parents:1. current smokers (people who smoked more than 100 cigarettes during their lifetime and had smoked within 30 days); 2. smoked at home over the past 7 days - For children:the third to sixth grades of primary school Exclusion Criteria: - Children who had renal disease or were cognitively impaired according to their school teachers were excluded. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Taipei Medical University |
Abdullah AS, Hitchman SC, Driezen P, Nargis N, Quah AC, Fong GT. Socioeconomic differences in exposure to tobacco smoke pollution (TSP) in Bangladeshi households with children: findings from the International Tobacco Control (ITC) Bangladesh Survey. Int J — View Citation
Abdullah AS, Hua F, Xia X, Hurlburt S, Ng P, MacLeod W, Siegel M, Griffiths S, Zhang Z. Second-hand smoke exposure and household smoking bans in Chinese families: a qualitative study. Health Soc Care Community. 2012 Jul;20(4):356-64. doi: 10.1111/j.1365-2 — View Citation
Abdullah AS, Mak YW, Loke AY, Lam TH. Smoking cessation intervention in parents of young children: a randomised controlled trial. Addiction. 2005 Nov;100(11):1731-40. — View Citation
Akhtar PC, Haw SJ, Currie DB, Zachary R, Currie CE. Smoking restrictions in the home and secondhand smoke exposure among primary schoolchildren before and after introduction of the Scottish smoke-free legislation. Tob Control. 2009 Oct;18(5):409-15. doi: — View Citation
Aveyard P, Massey L, Parsons A, Manaseki S, Griffin C. The effect of Transtheoretical Model based interventions on smoking cessation. Soc Sci Med. 2009 Feb;68(3):397-403. doi: 10.1016/j.socscimed.2008.10.036. Epub 2008 Nov 27. — View Citation
Baheiraei A, Kharaghani R, Mohsenifar A, Kazemnejad A, Alikhani S, Milani HS, Mota A, Hovell MF. Reduction of secondhand smoke exposure among healthy infants in Iran: randomized controlled trial. Nicotine Tob Res. 2011 Sep;13(9):840-7. doi: 10.1093/ntr/nt — View Citation
Baldwin SA, Christian S, Berkeljon A, Shadish WR. The effects of family therapies for adolescent delinquency and substance abuse: a meta-analysis. J Marital Fam Ther. 2012 Jan;38(1):281-304. doi: 10.1111/j.1752-0606.2011.00248.x. Epub 2011 Sep 6. — View Citation
Berman BA, Wong GC, Bastani R, Hoang T, Jones C, Goldstein DR, Bernert JT, Hammond KS, Tashkin D, Lewis MA. Household smoking behavior and ETS exposure among children with asthma in low-income, minority households. Addict Behav. 2003 Jan-Feb;28(1):111-28. — View Citation
Binnie V, McHugh S, Macpherson L, Borland B, Moir K, Malik K. The validation of self-reported smoking status by analysing cotinine levels in stimulated and unstimulated saliva, serum and urine. Oral Dis. 2004 Sep;10(5):287-93. — View Citation
Bolte G, Fromme H; GME Study Group. Socioeconomic determinants of children's environmental tobacco smoke exposure and family's home smoking policy. Eur J Public Health. 2009 Jan;19(1):52-8. doi: 10.1093/eurpub/ckn114. Epub 2008 Nov 25. — View Citation
Bottorff JL, Oliffe J, Kalaw C, Carey J, Mroz L. Men's constructions of smoking in the context of women's tobacco reduction during pregnancy and postpartum. Soc Sci Med. 2006 Jun;62(12):3096-108. Epub 2006 Jan 18. — View Citation
Bureau of Health Promotion, D. o. H. (2010). Taiwan Tobacco Control Annual Report, 2010 Retrieved from http://tobacco.bhp.doh.gov.tw/Upload/FTB/UpFiles/2010.pdf
Cahill K, Lancaster T, Green N. Stage-based interventions for smoking cessation. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD004492. doi: 10.1002/14651858.CD004492.pub4. Review. — View Citation
Chan S, Lam TH. Protecting sick children from exposure to passive smoking through mothers' actions: a randomized controlled trial of a nursing intervention. J Adv Nurs. 2006 May;54(4):440-9. — View Citation
Chan SS, Lam TH, Salili F, Leung GM, Wong DC, Botelho RJ, Lo SL, Lau YL. A randomized controlled trial of an individualized motivational intervention on smoking cessation for parents of sick children: a pilot study. Appl Nurs Res. 2005 Aug;18(3):178-81. — View Citation
Chen YH, Chen PL, Huang WG, Chiou HY, Hsu CY, Chao KY. Association between social climate for smoking and youth smoking behaviors in Taiwan: an ecological study. Int J Nurs Stud. 2010 Oct;47(10):1253-61. doi: 10.1016/j.ijnurstu.2010.02.007. Epub 2010 Mar — View Citation
Chen YT, Chung MC, Hsiao FH, Miao NF, Chen PL. Exploration of parental smokers' experience, perceptions, and family's influences on their smoking in the presence of children. ANS Adv Nurs Sci. 2012 Jan-Mar;35(1):E1-13. doi: 10.1097/ANS.0b013e3182445525. — View Citation
Chen YT, Hsiao FH, Miao NF, Chen PL. Factors associated with parents’ perceptions of parental smoking in the presence of children and its consequences on children. Int J Environ Res Public Health. 2013 Jan 7;10(1):192-209. doi: 10.3390/ijerph1001019 — View Citation
Conway TL, Woodruff SI, Edwards CC, Hovell MF, Klein J. Intervention to reduce environmental tobacco smoke exposure in Latino children: null effects on hair biomarkers and parent reports. Tob Control. 2004 Mar;13(1):90-2. — View Citation
Craig, L., & Sawrikar, P. (2009). Work and Family: How Does the (Gender) Balance Change as Children Grow? Gender, Work & Organization, 16(6), 684-709. doi: 10.1111/j.1468-0432.2009.00481.x
Curry SJ, Ludman EJ, Graham E, Stout J, Grothaus L, Lozano P. Pediatric-based smoking cessation intervention for low-income women: a randomized trial. Arch Pediatr Adolesc Med. 2003 Mar;157(3):295-302. — View Citation
Dhar P. Measuring tobacco smoke exposure: quantifying nicotine/cotinine concentration in biological samples by colorimetry, chromatography and immunoassay methods. J Pharm Biomed Anal. 2004 Apr 1;35(1):155-68. — View Citation
Dijk F, Reubsaet A, de Nooijer J, de Vries H. Smoking status and peer support as the main predictors of smoking cessation in adolescents from six European countries. Nicotine Tob Res. 2007 Sep;9 Suppl 3:S495-504. — View Citation
Ding D, Wahlgren DR, Liles S, Jones JA, Hughes SC, Hovell MF. Secondhand smoke avoidance by preteens living with smokers: to leave or stay? Addict Behav. 2010 Nov;35(11):989-94. doi: 10.1016/j.addbeh.2010.06.016. Epub 2010 Jun 22. — View Citation
Doubeni CA, Li W, Fouayzi H, Difranza JR. Perceived accessibility as a predictor of youth smoking. Ann Fam Med. 2008 Jul-Aug;6(4):323-30. doi: 10.1370/afm.841. — View Citation
Ekerbicer HC, Celik M, Guler E, Davutoglu M, Kilinc M. Evaluating environmental tobacco smoke exposure in a group of Turkish primary school students and developing intervention methods for prevention. BMC Public Health. 2007 Aug 10;7:202. — View Citation
Emmons KM, Hammond SK, Fava JL, Velicer WF, Evans JL, Monroe AD. A randomized trial to reduce passive smoke exposure in low-income households with young children. Pediatrics. 2001 Jul;108(1):18-24. — View Citation
Escoffery C, McCormick L, Bateman K. Development and process evaluation of a web-based smoking cessation program for college smokers: innovative tool for education. Patient Educ Couns. 2004 May;53(2):217-25. — View Citation
Farber HJ, Knowles SB, Brown NL, Caine L, Luna V, Qian Y, Lavori P, Wilson SR. Secondhand tobacco smoke in children with asthma: sources of and parental perceptions about exposure in children and parental readiness to change. Chest. 2008 Jun;133(6):1367-7 — View Citation
Fossum B, Arborelius E, Bremberg S. Evaluation of a counseling method for the prevention of child exposure to tobacco smoke: an example of client-centered communication. Prev Med. 2004 Mar;38(3):295-301. — View Citation
Green E, Courage C, Rushton L. Reducing domestic exposure to environmental tobacco smoke: a review of attitudes and behaviours. J R Soc Promot Health. 2003 Mar;123(1):46-51. Review. — View Citation
Grigsby, J. (1997). Telemedicine in the United States. In R. L. Bashshur, J. H. Sanders & G. W. Shannon (Eds.), Telemedicine: Theory and Practice (pp. 265-290). Springfield, IL: Charles C Thomas.
Gursoy ST, Soyer MT, Ocek Z, Ciceklioglu M, Aksu F. Why are Turkish children at risk of exposure to environmental tobacco smoke in their homes? Asian Pac J Cancer Prev. 2008 Jul-Sep;9(3):467-72. — View Citation
Hannöver W, Thyrian JR, Röske K, Grempler J, Rumpf HJ, John U, Hapke U. Smoking cessation and relapse prevention for postpartum women: results from a randomized controlled trial at 6, 12, 18 and 24 months. Addict Behav. 2009 Jan;34(1):1-8. doi: 10.1016/j. — View Citation
Heck JE, Stücker I, Allwright S, Gritz ER, Haglund M, Healton CG, Kralikova E, Sanchez Del Mazo S, Tamang E, Dresler CM, Hashibe M. Home and workplace smoking bans in Italy, Ireland, Sweden, France and the Czech Republic. Eur Respir J. 2010 May;35(5):969- — View Citation
Hill SC, Liang L. Smoking in the home and children's health. Tob Control. 2008 Feb;17(1):32-7. doi: 10.1136/tc.2007.020990. — View Citation
Ho SY, Wang MP, Lo WS, Mak KK, Lai HK, Thomas GN, Lam TH. Comprehensive smoke-free legislation and displacement of smoking into the homes of young children in Hong Kong. Tob Control. 2010 Apr;19(2):129-33. doi: 10.1136/tc.2009.032003. — View Citation
Hollis JF, McAfee TA, Fellows JL, Zbikowski SM, Stark M, Riedlinger K. The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline. Tob Control. 2007 Dec;16 Suppl 1:i53-9. — View Citation
Hovell MF, Meltzer SB, Wahlgren DR, Matt GE, Hofstetter CR, Jones JA, Meltzer EO, Bernert JT, Pirkle JL. Asthma management and environmental tobacco smoke exposure reduction in Latino children: a controlled trial. Pediatrics. 2002 Nov;110(5):946-56. — View Citation
Hovell MF, Zakarian JM, Matt GE, Hofstetter CR, Bernert JT, Pirkle J. Effect of counselling mothers on their children's exposure to environmental tobacco smoke: randomised controlled trial. BMJ. 2000 Aug 5;321(7257):337-42. — View Citation
Hovell MF, Zakarian JM, Matt GE, Liles S, Jones JA, Hofstetter CR, Larson SN, Benowitz NL. Counseling to reduce children's secondhand smoke exposure and help parents quit smoking: a controlled trial. Nicotine Tob Res. 2009 Dec;11(12):1383-94. doi: 10.1093 — View Citation
Hoving EF, Mudde AN, de Vries H. Predictors of smoking relapse in a sample of Dutch adult smokers; the roles of gender and action plans. Addict Behav. 2006 Jul;31(7):1177-89. Epub 2005 Oct 19. — View Citation
Huang HL, Yen YY, Lin PL, Chiu CH, Hsu CC, Chen T, Hu CY, Lin YY, Lee CH, Chen FL. Household secondhand smoke exposure of elementary schoolchildren in Southern Taiwan and factors associated with their confidence in avoiding exposure: a cross-sectional stu — View Citation
Hugg TT, Jaakkola MS, Ruotsalainen RO, Pushkarev VJ, Jaakkola JJ. Parental smoking behaviour and effects of tobacco smoke on children's health in Finland and Russia. Eur J Public Health. 2008 Feb;18(1):55-62. Epub 2007 Jun 14. — View Citation
Hughes SC, Corcos IA, Hofstetter CR, Hovell MF, Irvin VL. Longitudinal study of household smoking ban adoption among Korean Americans. Am J Prev Med. 2009 Nov;37(5):437-40. doi: 10.1016/j.amepre.2009.06.015. — View Citation
Hyland A, Higbee C, Travers MJ, Van Deusen A, Bansal-Travers M, King B, Cummings KM. Smoke-free homes and smoking cessation and relapse in a longitudinal population of adults. Nicotine Tob Res. 2009 Jun;11(6):614-8. doi: 10.1093/ntr/ntp022. Epub 2009 Apr — View Citation
Lampert T. Smoking and passive smoking exposure in young people: results of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS). Dtsch Arztebl Int. 2008 Apr;105(15):265-71. doi: 10.3238/arztebl.2008.0265. Epub 2008 Apr — View Citation
Li MF, Wang RH. Factors related to avoidance of environmental tobacco smoke among adolescents in southern Taiwan. J Nurs Res. 2006 Jun;14(2):103-12. — View Citation
Martinelli AM. Development and validation of the avoidance of environmental tobacco smoke scale. J Nurs Meas. 1998 Summer;6(1):75-86. — View Citation
Matt GE, Bernert JT, Hovell MF. Measuring secondhand smoke exposure in children: an ecological measurement approach. J Pediatr Psychol. 2008 Mar;33(2):156-75. Epub 2007 Dec 13. Review. — View Citation
Matt GE, Quintana PJ, Hovell MF, Bernert JT, Song S, Novianti N, Juarez T, Floro J, Gehrman C, Garcia M, Larson S. Households contaminated by environmental tobacco smoke: sources of infant exposures. Tob Control. 2004 Mar;13(1):29-37. — View Citation
Mills AL, Messer K, Gilpin EA, Pierce JP. The effect of smoke-free homes on adult smoking behavior: a review. Nicotine Tob Res. 2009 Oct;11(10):1131-41. doi: 10.1093/ntr/ntp122. Epub 2009 Jul 24. Review. — View Citation
Mills LM, Semple SE, Wilson IS, MacCalman L, Amos A, Ritchie D, O'Donnell R, Shaw A, Turner SW. Factors influencing exposure to secondhand smoke in preschool children living with smoking mothers. Nicotine Tob Res. 2012 Dec;14(12):1435-44. doi: 10.1093/ntr — View Citation
Moore GF, Currie D, Gilmore G, Holliday JC, Moore L. Socioeconomic inequalities in childhood exposure to secondhand smoke before and after smoke-free legislation in three UK countries. J Public Health (Oxf). 2012 Dec;34(4):599-608. doi: 10.1093/pubmed/fds — View Citation
Nattala P, Leung KS, Nagarajaiah, Murthy P. Family member involvement in relapse prevention improves alcohol dependence outcomes: a prospective study at an addiction treatment facility in India. J Stud Alcohol Drugs. 2010 Jul;71(4):581-7. — View Citation
Nierkens V, Stronks K, de Vries H. Attitudes, social influences and self-efficacy expectations across different motivational stages among immigrant smokers: replication of the Ø pattern. Prev Med. 2006 Oct;43(4):306-11. Epub 2006 Aug 17. — View Citation
Nierkens V, Stronks K, van Oel CJ, de Vries H. Beliefs of Turkish and Moroccan immigrants in The Netherlands about smoking cessation: implications for prevention. Health Educ Res. 2005 Dec;20(6):622-34. Epub 2005 Mar 21. — View Citation
Phillips R, Amos A, Ritchie D, Cunningham-Burley S, Martin C. Smoking in the home after the smoke-free legislation in Scotland: qualitative study. BMJ. 2007 Sep 15;335(7619):553. Epub 2007 Sep 9. — View Citation
Poole-Di Salvo E, Liu YH, Brenner S, Weitzman M. Adult household smoking is associated with increased child emotional and behavioral problems. J Dev Behav Pediatr. 2010 Feb-Mar;31(2):107-15. doi: 10.1097/DBP.0b013e3181cdaad6. — View Citation
Prochaska JO, Velicer WF, Redding C, Rossi JS, Goldstein M, DePue J, Greene GW, Rossi SR, Sun X, Fava JL, Laforge R, Rakowski W, Plummer BA. Stage-based expert systems to guide a population of primary care patients to quit smoking, eat healthier, prevent — View Citation
Robinson J, Kirkcaldy AJ. 'Imagine all that smoke in their lungs': parents' perceptions of young children's tolerance of tobacco smoke. Health Educ Res. 2009 Feb;24(1):11-21. Epub 2007 Dec 20. — View Citation
Robinson J, Kirkcaldy AJ. 'You think that I'm smoking and they're not': why mothers still smoke in the home. Soc Sci Med. 2007 Aug;65(4):641-52. Epub 2007 May 7. — View Citation
Robinson J, Kirkcaldy AJ. Disadvantaged mothers, young children and smoking in the home: mothers' use of space within their homes. Health Place. 2007 Dec;13(4):894-903. Epub 2007 Mar 21. — View Citation
Roseby R, Waters E, Polnay A, Campbell R, Webster P, Spencer N. Family and carer smoking control programmes for reducing children's exposure to environmental tobacco smoke. Cochrane Database Syst Rev. 2003;(3):CD001746. Review. Update in: Cochrane Databas — View Citation
Rosen LJ, Ben Noach M. Systematic reviews on tobacco control from Cochrane and the Community Guide: different methods, similar findings. J Clin Epidemiol. 2010 Jun;63(6):596-606. doi: 10.1016/j.jclinepi.2009.09.010. Epub 2010 Jan 13. Review. — View Citation
Rosen LJ, Noach MB, Winickoff JP, Hovell MF. Parental smoking cessation to protect young children: a systematic review and meta-analysis. Pediatrics. 2012 Jan;129(1):141-52. doi: 10.1542/peds.2010-3209. Epub 2011 Dec 26. Review. — View Citation
Schumann A, John U, Ulbricht S, Rüge J, Bischof G, Meyer C. Computer-generated tailored feedback letters for smoking cessation: theoretical and empirical variability of tailoring. Int J Med Inform. 2008 Nov;77(11):715-22. doi: 10.1016/j.ijmedinf.2008.03.0 — View Citation
Tanner-Smith EE, Wilson SJ, Lipsey MW. The comparative effectiveness of outpatient treatment for adolescent substance abuse: a meta-analysis. J Subst Abuse Treat. 2013 Feb;44(2):145-58. doi: 10.1016/j.jsat.2012.05.006. Epub 2012 Jul 2. — View Citation
Tyc VL, Hovell MF, Winickoff J. Reducing secondhand smoke exposure among children and adolescents: emerging issues for intervening with medically at-risk youth. J Pediatr Psychol. 2008 Mar;33(2):145-55. doi: 10.1093/jpepsy/jsm135. Epub 2008 Jan 11. Review — View Citation
Tyc VL, Huang Q, Nicholson J, Schultz B, Hovell MF, Lensing S, Vukadinovich C, Hudson MM, Zhang H. Intervention to reduce secondhand smoke exposure among children with cancer: a controlled trial. Psychooncology. 2013 May;22(5):1104-11. doi: 10.1002/pon.31 — View Citation
U.S. Department of Health and Human Services. (2006). The health consequences of involuntary exposure to tobacco smoke: A report of the Surgeon General. . Atlanta, GA: U.S. Department of Health and Human Services. Centers for Disease Control and Prevention, Coordinating Center for Health Promotion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health
Wagener TL, Gregor KL, Busch AM, McQuaid EL, Borrelli B. Risk perception in smokers with children with asthma. J Consult Clin Psychol. 2010 Dec;78(6):980-5. doi: 10.1037/a0021094. — View Citation
Wamboldt FS, Balkissoon RC, Rankin AE, Szefler SJ, Hammond SK, Glasgow RE, Dickinson WP. Correlates of household smoking bans in low-income families of children with and without asthma. Fam Process. 2008 Mar;47(1):81-94. — View Citation
Wang WL, Herting JR, Tung YY. Adolescents' avoidance of secondhand smoke exposure: model testing. West J Nurs Res. 2008 Nov;30(7):836-51. doi: 10.1177/0193945908319251. Epub 2008 May 30. — View Citation
Wilkinson AV, Shete S, Prokhorov AV. The moderating role of parental smoking on their children's attitudes toward smoking among a predominantly minority sample: a cross-sectional analysis. Subst Abuse Treat Prev Policy. 2008 Jul 14;3:18. doi: 10.1186/1747 — View Citation
Wilson SR, Farber HJ, Knowles SB, Lavori PW. A randomized trial of parental behavioral counseling and cotinine feedback for lowering environmental tobacco smoke exposure in children with asthma: results of the LET'S Manage Asthma trial. Chest. 2011 Mar;13 — View Citation
Winickoff JP, Friebely J, Tanski SE, Sherrod C, Matt GE, Hovell MF, McMillen RC. Beliefs about the health effects of "thirdhand" smoke and home smoking bans. Pediatrics. 2009 Jan;123(1):e74-9. doi: 10.1542/peds.2008-2184. — View Citation
Woods SE, Springett J, Porcellato L, Dugdill L. 'Stop it, it's bad for you and me': experiences of and views on passive smoking among primary-school children in Liverpool. Health Educ Res. 2005 Dec;20(6):645-55. Epub 2005 Apr 13. — View Citation
World Health Organization. (2009). Exposure to secondhand tobacco smoke and early death, at WHO Report on the Global Tobacco Epidemic, 2009: Implementing smoke-free environments
Wu D, Ma GX, Zhou K, Zhou D, Liu A, Poon AN. The effect of a culturally tailored smoking cessation for Chinese American smokers. Nicotine Tob Res. 2009 Dec;11(12):1448-57. doi: 10.1093/ntr/ntp159. Epub 2009 Nov 13. — View Citation
Yilmaz G, Karacan C, Yöney A, Yilmaz T. Brief intervention on maternal smoking: a randomized controlled trial. Child Care Health Dev. 2006 Jan;32(1):73-9. — View Citation
Young JM, Girgis S, Bruce TA, Hobbs M, Ward JE. Acceptability and effectiveness of opportunistic referral of smokers to telephone cessation advice from a nurse: a randomised trial in Australian general practice. BMC Fam Pract. 2008 Feb 28;9:16. doi: 10.11 — View Citation
Yousey Y. Family attitudes about tobacco smoke exposure of young children at home. MCN Am J Matern Child Nurs. 2007 May-Jun;32(3):178-83. — View Citation
Zakarian JM, Hovell MF, Sandweiss RD, Hofstetter CR, Matt GE, Bernert JT, Pirkle J, Hammond SK. Behavioral counseling for reducing children's ETS exposure: implementation in community clinics. Nicotine Tob Res. 2004 Dec;6(6):1061-74. — View Citation
* Note: There are 84 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
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Primary | Change of Children's exposure of environmental tobacco smoke at home as measured by children's urine cotinine level, and questionnaire of parents smoking at home and in the presence of children for the last 7 days reported by parents and their children. | This outcome measure is a composite outcome consisting of bio-marker (cotinine) and self-reported data. Questions of parents smoking at home and in the presence of children for the last 7 days reported by parents and their children were modified from related items in the Adult Smoking Behavior Survey and Chinese Version of the Global Youth Tobacco Survey. | baseline, 8 week and 20 weeks for questionnaire/6 months for children's urine cotinine level. | No |
Primary | Parent reports Change of strategies for preventing children's exposure to environmental tobacco smoke at home as measured by developed questionnaire. | The questionnaire was developed on the basis of a qualitative study and tested for content validity by 6 experts and internal consistency by using a sample of 182 parental smokers and their school-aged children who lived together. The mean item content validity index (CVI) for the entire scale was calculated resulting in a mean item CVI of 0.97. Cronbach's alpha for the scale was 0.72 in a prior survey of 182 parental smokers. | baseline, 8 weeks, and 20weeks | No |
Primary | Child report change of environmental tobacco smoke avoidance behavior at home as measured by developed questionnaire. | The questionnaire was based on the Avoidance of ETS scale originally developed by Martinelli and then translated and revised by Li and Wang. The CVI was 0.96, Cronbach's alpha for the scale was 0.89 in a previous study of 182 children of parental smokers. | baseline, 8 weeks, and 20weeks | No |
Secondary | Parent and children reports change of knowledge of environment tobacco smoke hazard and attitude against environment tobacco smoke, as measured by developed questionnaires. | The questionnaires were developed on the basis of a qualitative study and tested for content validity by 6 experts and internal consistency by using a sample of 182 parental smokers and their school-aged children who lived together. The mean item content validity index (CVI) was 0.87 to 0.97. Cronbach's alpha/KR 20 for the scale was 0.72 to 0.89 in a prior survey of 182 parental smokers and children. | baseline, 8 weeks, and 20weeks | No |
Secondary | Parent reports change of family's anti-smoking responses and parent's reaction to family's anti-smoking responses, as measured by developed questionnaires. | The questionnaire was developed on the basis of a qualitative study and tested for content validity by 6 experts and internal consistency by using a sample of 182 parental smokers and their school-aged children who lived together. The mean item content validity index (CVI) was 0.94 to 0.97. Cronbach's alpha for the scale was 0.86 to 0.93 in a prior survey of 182 parental smokers. | baseline, 8 weeks, and 20weeks | No |
Secondary | change of children's self-efficacy in avoiding environmental tobacco smoke exposure, as measured by developed questionnaires. | The questionnaire was based on the Self-efficacy of Avoiding ETS scale originally developed by Martinelli and then translated and revised by Li and Wang. The CVI was 0.94, Cronbach's alpha for the scale was 0.83 in a previous study of 182 children of parental smokers. | baseline, 8 weeks, and 20weeks | No |
Status | Clinical Trial | Phase | |
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Completed |
NCT04045964 -
Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
|
Phase 4 |