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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02440321
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
ping-ling Chen, Taipei Medical University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Environmental Tobacco Smoke Behavioral: Parent-child interactive program Other: written materials Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Study Start Date : April 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: parent-child interactive program
The 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.
Behavioral: Parent-child interactive program
Active Comparator: written materials
The mailed materials included information on ETS and its adverse effects, smoking behavior that causes ETS at home, and a workbook for smoking cessation.
Other: written materials



Primary Outcome Measures :
  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. [ Time Frame: baseline, 8 week and 20 weeks for questionnaire/6 months for children's urine cotinine level. ]
    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.

  2. Parent reports Change of strategies for preventing children's exposure to environmental tobacco smoke at home as measured by developed questionnaire. [ Time Frame: baseline, 8 weeks, and 20weeks ]
    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.

  3. Child report change of environmental tobacco smoke avoidance behavior at home as measured by developed questionnaire. [ Time Frame: baseline, 8 weeks, and 20weeks ]
    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.


Secondary Outcome Measures :
  1. Parent and children reports change of knowledge of environment tobacco smoke hazard and attitude against environment tobacco smoke, as measured by developed questionnaires. [ Time Frame: baseline, 8 weeks, and 20weeks ]
    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.

  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. [ Time Frame: baseline, 8 weeks, and 20weeks ]
    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.

  3. change of children's self-efficacy in avoiding environmental tobacco smoke exposure, as measured by developed questionnaires. [ Time Frame: baseline, 8 weeks, and 20weeks ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440321


Sponsors and Collaborators
Taipei Medical University
Investigators
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Principal Investigator: Ping-Ling Chen, Ph.D. Graduate Institute of Injury Prevention and Control, College of Public Health and Nutrition, Taipei Medical University
Publications of Results:
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

Other 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.
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
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

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Responsible Party: ping-ling Chen, Professor, Graduate Institute of Injury Prevention and Control, College of Public Health and Nutrition, Taipei Medical University
ClinicalTrials.gov Identifier: NCT02440321    
Other Study ID Numbers: NSC97-2314-B-038-043-MY3
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015