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
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.
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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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04045964 -
Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
|
Phase 4 |