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

May 6, 2015 updated by: ping-ling Chen, Taipei Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 8 week and 20 weeks for questionnaire/6 months for children's urine cotinine level.
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.
baseline, 8 weeks, and 20weeks
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.
baseline, 8 weeks, and 20weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 8 weeks, and 20weeks
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.
baseline, 8 weeks, and 20weeks
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.
baseline, 8 weeks, and 20weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 6, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • NSC97-2314-B-038-043-MY3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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