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

NCT02440321 | Completed

• 1 other identifier: NSC97-2314-B-038-043-MY3
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Environmental Tobacco Smoke

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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 Outcomes (3)

• Parent and children reports change of knowledge of environment tobacco smoke hazard and attitude against environment tobacco smoke, as measured by developed questionnaires.

  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.

  baseline, 8 weeks, and 20weeks

• change of children's self-efficacy in avoiding environmental tobacco smoke exposure, as measured by developed questionnaires.

  baseline, 8 weeks, and 20weeks

Study Arms (2)

parent-child interactive program

EXPERIMENTAL

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

written materials

ACTIVE COMPARATOR

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

Interventions

Parent-child interactive program BEHAVIORAL

parent-child interactive program

written materials OTHER

written materials

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

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Study Officials

• Ping-Ling Chen, Ph.D.

  Graduate Institute of Injury Prevention and Control, College of Public Health and Nutrition, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Graduate Institute of Injury Prevention and Control, College of Public Health and Nutrition

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 12, 2015
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 12, 2015

Record last verified: 2015-05