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Environmental Tobacco SmokeNCT02440321

Effects of Parent-child Interactive Intervention in Preventing Children's Environmental Tobacco Smoke Exposure at Home

A study testing Parent-child interactive program and written materials in people with Environmental Tobacco Smoke, run by Taipei Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Environmental Tobacco Smoke
What is being tested?
Parent-child interactive program and written materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
Apr 2011to Jul 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Children who had renal disease or were cognitively impaired according to their school teachers were excluded.

About this study

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

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.

Read the detailed description

Children exposing to environmental tobacco smoke (ETS) has been a global concern in public health. Home environment, especially parental smoking, has been identified as the major exposing source for children. Therefore parents' involvement becomes critical in preventing program. 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 at home, promote parents' and children's preventing strategy, knowledge of its hazard and attitude against environment tobacco smoke. The other purposes included promoting family's anti-ETS climate that parents perceived and children's self-efficacy of ETS avoidant behavior.

A clustered randomized controlled trial was administered to 75 parents of school-aged children (ITT) and their children (parent-child dyads) from six primary schools in New Taipei City, Taiwan. Parent-child dyads in intervention group received a parent-child interactive program comprising three weekly group sessions and one individual telephone counseling session, which was administered 4 weeks after the group sessions. The participants in the control group received written materials related to tobacco information by mail four times during the same time period in place of the intervention sessions. The parent-child interactive intervention was developed according to the Transtheoretical Model and I-change Model. The main focuses of the intervention are to instill knowledge regarding the mechanism of the harmful effect of ETS, correct people's perceptions of the smoking patterns that lead to ETS exposure at home and effective and ineffective strategies for reducing ETS, and assist parent-child dyads in formulating strategies for maintaining a smoke-free home. The written materials mailed to participants in control group included information on ETS and its adverse effects, smoking behavior that causes ETS at home, and smoking cessation.

The outcome indicators were measured at baseline, 8 weeks, and 20 weeks. The primary outcome include children's exposure of ETS at home and prevention of children's ETS exposure. Children's exposure of ETS at home was measured by parents smoking at home and at the presence of the children for the last 7 days, and children's urinary cotinine level. The final collection of children's urine was performed 6 months after the intervention rather than 3 months after the intervention because of a delay in receiving urine cotinine measurement kits. Prevention of ETS exposure was measured by Parent-reported preventing strategies and child-reported avoiding behaviors. The second outcomes include parent/children reported knowledge of and attitude toward ETS, parents-reported family's anti-ETS climate and its influence, and children-reported their self-efficacy in avoiding ETS exposure. Collected data was analyzed by Chi-square test and generalized estimating equation. A pre-and-posttest pilot study on 10 parent-child dyads from two primary schools was conducted before this study.

Being tested
Parent-child interactive program, written materials

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent-child interactive programBehavioural

  • written materialsOther

Study groups in NCT02440321
Study groupRoleWhat they receive
parent-child interactive programExperimentalThe parent-child interactive program is designed by three phase: precontemplation/ contemplation stage, preparation stage, and action/maintenance stage. In phase 1, the main focus is to promote motivation through information providing and being aware of children's perception toward ETS and smoking. In phase 2, the main focus is strengthening parents/children's ability to plan and implement smoke-free home. In phase 3, intervention focus is on maintaining behavioral change and smoke-free home by continuously strengthening implementing ability, identifying and eliminating barriers, and reinforcing successful experience. Parent-child interaction is designed through three phases, and parents perceive children's feedback through all phases.
Receives: Behavioral: Parent-child interactive program
written materialsActive comparatorThe mailed materials included information on ETS and its adverse effects, smoking behavior that causes ETS at home, and a workbook for smoking cessation.
Receives: Other: written materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 8 week and 20 weeks for questionnaire/6 months for children's urine cotinine level.

  2. 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.

    Measured: baseline, 8 weeks, and 20weeks

  3. 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.

    Measured: baseline, 8 weeks, and 20weeks

Secondary outcomes (3)
  1. 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.

    Measured: baseline, 8 weeks, and 20weeks

  2. 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.

    Measured: baseline, 8 weeks, and 20weeks

  3. 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.

    Measured: baseline, 8 weeks, and 20weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02440321
Sponsor's protocol ID
NSC97-2314-B-038-043-MY3
Status last verified
May 2015
First submitted
23 Apr 2015
Last updated
12 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • 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.

  • 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. doi: 10.1093/jpepsy/jsm123. Epub 2007 Dec 13.

    PubMed 18079169
  • Nierkens V, Stronks K, de Vries H. Attitudes, social influences and self-efficacy expectations across different motivational stages among immigrant smokers: replication of the O pattern. Prev Med. 2006 Oct;43(4):306-11. doi: 10.1016/j.ypmed.2006.05.005. Epub 2006 Aug 17.

    PubMed 16919321
  • Office on Smoking and Health (US). The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2006. Available from http://www.ncbi.nlm.nih.gov/books/NBK44324/

    PubMed 20669524
  • 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

  • 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 Environ Res Public Health. 2011 Mar;8(3):842-60. doi: 10.3390/ijerph8030842. Epub 2011 Mar 15.

    PubMed 21556182
  • 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.1365-2524.2011.01035.x. Epub 2011 Oct 27.

    PubMed 22029412
  • 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. doi: 10.1111/j.1360-0443.2005.01231.x.

    PubMed 16277633
  • 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: 10.1136/tc.2009.030627. Epub 2009 Aug 10.

    PubMed 19671536
  • 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.

    PubMed 19038483
  • 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/ntr085. Epub 2011 Apr 18.

    PubMed 21504887
  • 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.

    PubMed 22283391
  • 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. doi: 10.1016/s0306-4603(01)00221-0.

    PubMed 12507531
  • 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. doi: 10.1111/j.1601-0825.2004.01018.x.

    PubMed 15315646

Questions about this trial

What is this clinical trial studying?

A study testing Parent-child interactive program and written materials in people with Environmental Tobacco Smoke, run by Taipei Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: baseline, 8 week and 20 weeks for questionnaire/6 months for children's urine cotinine level.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02440321, which also lists 84 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.

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