Clinical trial NCT02440321: Effects of Parent-child Interactive Intervention in Preventing Children's Environmental Tobacco Smoke Exposure at Home
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Tobacco Smoke
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: baseline, 8 week and 20 weeks for questionnaire/6 months for children's urine cotinine level.
measure: Parent reports Change of strategies for preventing children's exposure to environmental tobacco smoke at home as measured by developed questionnaire.
timeFrame: baseline, 8 weeks, and 20weeks
measure: Child report change of environmental tobacco smoke avoidance behavior at home as measured by developed questionnaire.
timeFrame: baseline, 8 weeks, and 20weeks
Secondary outcomes:
measure: Parent and children reports change of knowledge of environment tobacco smoke hazard and attitude against environment tobacco smoke, as measured by developed questionnaires.
timeFrame: baseline, 8 weeks, and 20weeks
measure: Parent reports change of family's anti-smoking responses and parent's reaction to family's anti-smoking responses, as measured by developed questionnaires.
timeFrame: baseline, 8 weeks, and 20weeks
measure: change of children's self-efficacy in avoiding environmental tobacco smoke exposure, as measured by developed questionnaires.
timeFrame: baseline, 8 weeks, and 20weeks
Other outcomes:
Locations:
Study officials:
affiliation: Graduate Institute of Injury Prevention and Control, College of Public Health and Nutrition, Taipei Medical University
name: Ping-Ling Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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